DJPH - Vaccine Preventable Disease

Volume 8 | Issue 1

Delaware Journal of

March 2022

Public Health A publication of the Delaware Academy of Medicine / Delaware Public Health Association

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Delaware Academy of Medicine

Board of Directors: OFFICERS S. John Swanson, M.D. President Lynn Jones, FACHE President-Elect Professor Rita Landgraf Vice President Jeffrey M. Cole, D.D.S., M.B.A. Treasurer Stephen C. Eppes, M.D. Secretary Omar A. Khan, M.D., M.H.S. Immediate Past President Timothy E. Gibbs, M.P.H. Executive Director, Ex-officio DIRECTORS David M. Bercaw, M.D. Lee P. Dresser, M.D. Eric T. Johnson, M.D. Erin M. Kavanaugh, M.D. Joseph Kelly, D.D.S. Joseph F. Kestner, Jr., M.D. Brian W. Little, M.D., Ph.D. Arun V. Malhotra, M.D. Daniel J. Meara, M.D., D.M.D. Ann Painter, M.S.N., R.N. John P. Piper, M.D. Charmaine Wright, M.D., M.S.H.P. EMERITUS Robert B. Flinn, M.D. Barry S. Kayne, D.D.S.

Delaware Public Health Association

Advisory Council:

Omar Khan, M.D., M.H.S. Chair Timothy E. Gibbs, M.P.H. Executive Director

Delaware Journal of

March 2022

Public Health Volume 8 | Issue 1

A publication of the Delaware Academy of Medicine / Delaware Public Health Association

3 | In This Issue

Omar A. Khan, M.D., M.H.S. Timothy E. Gibbs, M.P.H.

4 | Guest Editors

Stephen C. Eppes, M.D. Omar A. Khan, M.D., M.H.S.

6 | Vaccine Communication: Honesty and Analogy

36 | Pneumococcal Immunization for Adults in 2022 John H. O’Neill, Jr., D.O., M.A.C.P.

40 | Travel Vaccination Update Salwa Sulieman, D.O.

42 | Immigrants and Immunizations

80 | Dispelling COVID-19 Myths: Implications of Vaccination Acceptance by African Americans and Others in Marginalized Communities Marlene A. Saunders, D.S.W., L.M.S.W., M.S.W.

48 | Global Health Matters Jan-Feb 2022

84 | Towards Eliminating Nonmedical Vaccination Exemptions Among School-Age Children

Fogarty International Center

Neal D. Goldstein, Ph.D. Joanna S. Suder, J.D.

60 | An Informed Approach to Vaccine Hesitancy and Uptake in Children

90 | Mid-Atlantic Public Health Partnership Conference

Jonathan M. Miller, M.D., F.A.A.P. Ricki Carroll, M.D., M.B.E.

Isabelle Raynard Jody Gan, M.P.H., C.H.E.S.

Michelle Eng, M.D. Liza Hashim, D.O.

68 | Vaccines for COVID-19

91 | All of Us Research Program, the National Institutes of Health

14 | The Journey of Your Child’s Vaccine

69 | COVID-19 Vaccine Interim Immunization Schedule for Ages 5 Years and Older

Timothy E. Gibbs, M.P.H.

8 | Review of Vaccination Coverage Assessed by the Kindergarten Immunization Survey in Delaware

Nikki Kupferman, M.S.

12 | Pediatric Vaccines: What’s New for 2022

Katherine Smith, M.D., M.P.H.

Stephen C. Eppes, M.D.

18 | Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger 28 | Recommended Adult Immunization Schedule for ages 19 years or older

Louis E. Bartoshesky, M.D., M.P.H. Gerard Gallucci, M.D., M.H.S.

72 | COVID-19 Vaccine Hesitancy and Refusal: The Same But Different?

Neil Rellosa, M.D.

78 | Meningococcal Vaccination: An Update on Meningococcal Vaccine Recommendations for the Primary Care Physician

96 | From the Archives: the Healing Arts in History “Of the Importance of General Vaccination and the Groundlessness of the Prejudices Against It” Sharon Folkenroth Hess, M.A.

98 | Vaccines Lexicon & Resources 101| Index of Advertisers

Justin Nichols, M.D. Stephen C. Eppes, M.D.

Richard E. Killingsworth, M.P.H. Erin K. Knight, Ph.D., M.P.H. Melissa K. Melby, Ph.D. Mia A. Papas, Ph.D. Karyl T. Rattay, M.D., M.S. William J. Swiatek, M.A., A.I.C.P.

Delaware Journal of Public Health Timothy E. Gibbs, M.P.H. Publisher Omar Khan, M.D., M.H.S. Editor-in-Chief Stephen C. Eppes, M.D. Omar Khan, M.D., M.H.S. Guest Editors Liz Healy, M.P.H. Managing Editor Kate Smith, M.D., M.P.H. Copy Editor Suzanne Fields Image Director ISSN 2639-6378

COVER

Vaccines are one of the greatest success stories in public health. Through use of vaccines, we have eradicated smallpox and nearly eliminated wild polio virus. The number of people who experience the devastating effects of preventable infectious diseases like measles, diphtheria, and whooping cough is at an all-time low.

The Delaware Journal of Public Health (DJPH), first published in 2015, is the official journal of the Delaware Academy of Medicine / Delaware Public Health Association (Academy/DPHA).

only the opinions of the authors and do not necessarily reflect the official policy of the Delaware Public Health Association or the institution with which the author(s) is (are) affiliated, unless so specified.

Submissions: Contributions of original unpublished research, social science analysis, scholarly essays, critical commentaries, departments, and letters to the editor are welcome. Questions? Write ehealy@delamed.org or call Liz Healy at 302-733-3989.

Any report, article, or paper prepared by employees of the U.S. government as part of their official duties is, under Copyright Act, a “work of United States Government” for which copyright protection under Title 17 of the U.S. Code is not available. However, the journal format is copyrighted and pages June not be photocopied, except in limited quantities, or posted online, without permission of the Academy/ DPHA. Copying done for other than personal or internal reference use-such as copying for general distribution, for advertising or promotional purposes, for creating new collective works, or for resale- without the expressed permission of the Academy/DPHA is prohibited. Requests for special permission should be sent to ehealy@delamed.org.

Advertising: Please write to ehealy@delamed.org or call 302-733-3989 for other advertising opportunities. Ask about special exhibit packages and sponsorships. Acceptance of advertising by the Journal does not imply endorsement of products.

Copyright © 2022 by the Delaware Academy of Medicine / Delaware Public Health Association.

Opinions expressed by authors of articles summarized, quoted, or published in full in this journal represent

I N T H I S I S SU E Over the centuries of recorded history public health has enjoyed some significant advances. We credit ancient Rome with infrastructure that includes roads, sewers, and running water; ancient Egypt with irrigation. In ancient China, during the Qin dynasty (221 – 206 BC), an integrated response system for infectious disease was established that included prevention, diagnosis, and isolation. Vaccination efforts first occurred during the Song Dynasty (960 – 1279 A.D.).1 If you are surprised by this fact, you are not alone. The western world’s point of view is that Edward Jenner founded vaccinology in 1796.2 Fast forward to today, the science of vaccinology has advanced in a myriad of ways – so much so that the rapid development of a COVID-19 vaccine was met with skepticism by some who may not have appreciated just how long foundational advances had been in the works.

Cholera illustrates this point from a historical and contemporary perspective. Observed for centuries as a diarrheal illness, the causative organism was discovered twice; independently by Pacini in Italy and Koch in India, both in the 1800s. Causing tremendous morbidity and mortality, it was a disease of sub-par sanitation practices, and at one point in time affected London and Florence as much as it did Calcutta.

Yet, while we regard cholera vaccines to be a recent phenomenon, they were actually tested by Pasteur and others in the 1800s. It wasn’t until the 1990s that oral vaccines became generally available: Dukoral and Shanchol, both recognized by the World Health Organization, followed by Vaxchora, the only cholera vaccine with US FDA approval.

While social media messages around vaccine misconceptions may vex public health folks, in fact, social media has also been leveraged as tool to get people vaccinated. We have done this by communicating basic science, culturally competent messaging, and the locations and times of testing and vaccination events. There is a theoretical framework3 called the 5Cs that goes much further in explaining the psychological considerations that impact individual level behavior leading to vaccine acceptance or hesitancy. Those 5 Cs include Confidence (importance, safety, and efficacy of vaccines); Complacency (perception of low risk and low disease severity); Convenience (access issues dependent on the context, time and specific vaccine being offered); Communications (sources of information); and Context (sociodemographic characteristics).4 Since so much of vaccination and disease epidemiology has to do with community engagement and outreach, we wish to direct the reader’s attention to the annual ACCEL Community Research Exchange conference on May 9, 2022. Organized by the NIH-funded Delaware Clinical & Translational Research Program, attendance is free, and the extensive program includes many opportunities for scientists, policy makers, and community members to engage with Delaware’s health issues.

With this introduction in mind, we hope that you enjoy this issue of the Journal. It includes a special section on the National Institutes of Health “All of Us” research program in which we hope you might consider becoming a partner, or recommending as much to your clients, patients, friends and family.

Omar A. Khan, M.D., M.H.S. Editor-in-Chief, Delaware Journal of Public Health

Timothy E. Gibbs, M.P.H Publisher, Delaware Journal of Public Health

REFERENCES 1. Huigang, L., Xiaowei, X., Cui, H., Haixia, M., & Zhiming, Y. (2020, March). A brief history of the development of infectious disease prevention, control, and biosafety programs in China. Journal of Biosafety and Biosecurity, 2(1), 23–26. https://doi.org/10.1016/j.jobb.2019.10.002 2. T he Immunisation Advisory Centre. (2020, Jan). A brief history of vaccination.

Retrieved from https://www.immune.org.nz/vaccines/vaccine-development/brief-history-vaccination 3. B etsch, C., Schmid, P., Heinemeier, D., Korn, L., Holtmann, C., & Böhm, R. (2018, December 7). Beyond confidence: Development of a measure assessing the 5C psychological antecedents of vaccination. PLoS One, 13(12), e0208601. https://doi.org/10.1371/journal.pone.0208601 PubMed 4. Razai, M. S., Oakeshott, P., Esmail, A., Wiysonge, C. S., Viswanath, K., & Mills, M. C. (2021, June). COVID-19 vaccine hesitancy: The five Cs to tackle behavioural and sociodemographic factors. Journal of the Royal Society of Medicine, 114(6), 295–298. https://doi.org/10.1177/01410768211018951 PubMed DOI: 10.32481/djph.2022.03.001

3

Stephen C. Eppes, M.D. Director, Pediatric Infectious Diseases and Vice Chair, Department of Pediatrics, ChristianaCare; Co-Chair, Immunization Coalition of Delaware Omar A. Khan, M.D., M.H.S. President and CEO, Delaware Health Sciences Alliance; Physician Leader, Research Administration & Scientific Affairs, ChristianaCare

We are living in an interesting and challenging time when it comes to immunizations. One of the greatest triumphs in this current pandemic has been the development of very effective and safe vaccines for COVID-19. Amazingly, they were ready to go into arms 11 months after the genome of the virus was first sequenced. These vaccines will take us out of the pandemic, and presumably into the endemic phase of COVID-19, for which we are likely to need vaccines for the foreseeable future. But beyond COVID, other great things have been happening in the field of immunizations.

Advances in immunology, molecular biology, and genetics have resulted in groundbreaking developments in vaccinology. In addition, the advent of population-based post licensure reporting of potential adverse effects has contributed greatly to the current safety of vaccines.

THE HISTORY OF IMMUNIZATION PROGRAMS The goals of immunization in the human population include prevention of infection, elimination of a disease, and ultimately eradication of the pathogen. To date, four

viral pathogens have been eradicated from the world, including smallpox, wild polio viruses types 2 and 3, and the veterinary pathogen rinderpest. Measles was declared eliminated in the United States in the year 2000 (meaning no endemic transmission for the preceding 12 months).

The U.S. almost lost that status in 2019, owing to significant endemic transmission of measles related to lower rates of immunization in certain populations. Most vaccine preventable diseases are at historic lows, compared with rates prior to the availability of vaccines.

We like to refer to an article that was published in the MMWR several years ago which we call “731,700 Reasons to Celebrate Vaccines.” This study looked at rates of 13 vaccine preventable diseases in the modern era in a cohort of children born in the United States from 1994 to 2013 compared with rates prior to the availability of vaccines. Over 322 million illnesses, 21 million hospitalizations, and 731,700 deaths were prevented as a result of vaccines (figure 1).1 As exciting and important as the results of US childhood immunization have been, developments in the world of

Figure 1. Data on Estimated Illnesses, Hospitalizations, and Deaths Prevented by Routine Childhood Immunization, 1994-20131 4 Delaware Journal of Public Health - March 2022

DOI: 10.32481/djph.2022.03.002

adult immunization have been equally impressive. When one of us (S.E.) entered medical school, the only routine vaccine for adults was the flu shot; the first pneumococcal vaccine came about when he was a junior medical student.

We now have highly effective, multivalent pneumococcal conjugate vaccines that have made a huge difference in invasive pneumococcal infection in adults, as well as in children. The US Centers for Disease Control and Prevention (CDC) is emphasizing the importance of hepatitis B immunization of adults, and we now have a highly effective adjuvanted vaccine against hepatitis B. Herpes zoster (shingles) can be a terrible condition; we now have a very effective recombinant vaccine that can prevent 90% of cases. Human papilloma virus (HPV) causes over 40,000 cases of cancer in the United States each year.

The current vaccine has the potential to markedly reduce those numbers, and we are already seeing real-world effects of the virus on HPV-associated conditions. There are other vaccines that are routinely given to adults, or are recommended for adults with certain risk factors. The current 2022 CDC recommended vaccine schedule can be found within this issue, and online.

THE FUTURE OF IMMUNIZATIONS There are many challenges and opportunities in the developing world regarding immunization, and readers should remember that vaccine preventable diseases are at most 18 hours away by plane from any part of the world.

As we mention elsewhere in this issue, there are reasonably effective cholera vaccines (orally administered, one of them FDA-approved). In 2020, there were 241 million cases of malaria worldwide, resulting in 627,000 deaths.

But this year, the introduction of an effective malaria vaccine (“RTS,S” more easily remembered by the trade name Mosquirix) has the potential to truly transform those numbers. Dengue, another mosquito-borne disease (albeit via a different mosquito--the Aedes species, which can also transmit Zika and yellow fever), affects over 100 countries worldwide. Affecting greater than five million cases globally, there is an effective vaccine (the FDA-approved Dengvaxia).

HIV remains one of the most elusive viruses for which we are still working to develop a vaccine. Given the worldwide morbidity and mortality from AIDS (33 million deaths since the start of the epidemic), there has been predictable interest in the topic, but relatively little progress until recently.

Utilizing mRNA technology, a promising HIV vaccine is being trialed by Moderna this year (the name Moderna is itself a mashup of the terms ‘modified’ and ‘RNA’).

VACCINES AND DELAWARE In resource-rich countries like the U.S., comprehensive immunization programs provide consistently high levels of vaccine coverage, and are incredibly effective public health measures, dramatically reducing the incidence of all vaccine preventable diseases. The State of Delaware, in general, compares favorably with other states in immunization rates. We must continue to have high immunization rates or suffer the possibility of resurgence of vaccine preventable diseases. In this regard, vaccine hesitancy (the subject of several articles in this issue of Delaware Journal of Public Health) presents major challenges.

Figure 2. Logo of the Immunization Coalition of Delaware

Dr. John O’Neill, author of one of the articles in this issue, and Dr. Eppes co-chair the Immunization Coalition of Delaware (https://immunizedelaware.org, figure 2). Most of the Coalition’s successes, however, are the result of work done by Dr. Kate Smith who, among her other roles, is Copy Editor for the Journal.

The ICD was formed in 2006 in conjunction with the Delaware Division of Public Health, and is a program of the Delaware Academy of Medicine/Delaware Public Health Association. The ICD consists of a diverse group of passionate, energetic, and committed partners working together to advocate for, educate about, and provide access to vaccination, and to ensure that no one in Delaware suffers from vaccine preventable illnesses.

REFERENCES 1. Whitney, C. G., Zhou, F., Singleton, J., & Schuchat, A., & the Centers for Disease Control and Prevention (CDC). (2014, April 25). Benefits from immunization during the vaccines for children program era - United States, 1994-2013. MMWR. Morbidity and Mortality Weekly Report, 63(16), 352–355. https://pubmed.ncbi.nlm.nih.gov/24759657

Our Guest Editors getting their COVID-19 vaccines.

“It is worth mentioning that, while “mRNA vaccines” entered our popular lexicon recently via COVID-19 vaccination, the technology has been around for decades. In 1987, Dr. Robert Malone, then a graduate student at the Salk Institute in California, started experimenting with mRNA for vaccines (and also started a convoluted chain of disputed ownership and intellectual property rights). What remained clear was that mRNA was seen as sufficiently difficult to work with. Slow advances were catalyzed by funding in 2015 by the US Defense Advance Research Projects Agency (DARPA), which provided seed funding for mRNA vaccines and therapeutics. Moderna was one the companies to be built by the funding; when in 2020 the COVID-19 genome became available, they collaborated with the US National Institute of Allergy and Infectious Diseases (NIAID, the agency led by Dr. Anthony Fauci), to rapidly conduct clinical trials. BioNTech, another company developing mRNA technology, partnered with Pfizer to achieve a similarly rapid outcome. Both companies, along with many others including Janssen and AstraZeneca, ultimately developed COVID-19 vaccines.”

5

Vaccine Communication: Honesty and Analogy

Timothy E. Gibbs, M.P.H. Publisher, Delaware Journal of Public Health

While it is true that there are some people who will probably never get vaccinated for COVID-19 (and perhaps not for anything else either), I have found some success in swaying people’s opinions and actions by honesty and by analogy.

But first, I want to make an observation about the last two year’s flu seasons in Delaware compared to the years leading up to 2020 (see Figure 1). According to the Delaware Division of Public Health1 every year in the United States, on average:

asking the person if they use a safety belt. According to the National Highway Traffic Safety Administration, the national rate of safety belt use in 2021 was at 90.4%.2 That is an impressive and important level of compliance. I ask, does wearing a safety belt prevent a car accident? Most often the answer is, correctly, “no.” Then I pivot the conversation – “Then why wear a safety belt?” I ask. “Because I don’t want to get injured, my child injured, etc.” “Exactly!” I exclaim. Getting a vaccine might not prevent the accident, but it can and does significantly reduce the risk of injury or death.

• 5% to 20% of the population gets the flu; • More than 200,000 people are hospitalized from flu complications, and; • About 36,000 people die from flu.

What was different about the 2020-2021 flu season? Masking, handwashing, social distancing, lack of large crowd gatherings, and (presumably) flu vaccinations. While an epidemiologist can (and has) delve into the data to tease out meaning and causation, the bottom line is that radical lifestyle changes and protective measures had an equally impressive impact on flu morbidity and mortality. I’ve committed these numbers to memory and pull them out when someone wonders about the efficacy of these controls. Often that represents the “ah ha” moment that public health interventionalists seek.

1. Delaware Division of Public Health. (n.d.). Delaware weekly influenza surveillance reports. Retrieved from https://dhss.delaware.gov/dhss/dph/epi/influenzawkly.html

I have also had success with using analogies to other known behaviors. A favorite is the “Safety Belt” analogy. I start by

2. National Highway Traffic Safety Administration. (n.d.). Seat belts. Retrieved from https://www.nhtsa.gov/risky-driving/seat-belts

What are your success stories in communicating to your friends, colleagues, customers, clients, and patients? If nothing else, we must meet people where they are, with understanding and a factual tool chest of communication strategies to get that shot in the arm, the mask on the face, and our numbers of vaccination of preventable disease incidents down. Its public health, it’s what we do.

REFERENCES

Figure 1. Delaware Influenza by Year1 6 Delaware Journal of Public Health - March 2022

DOI: 10.32481/djph.2022.03.003

HIGHLIGHTS FROM

The

NATION’S HEALTH A P U B L I C AT I O N O F T H E A M E R I C A N P U B L I C H E A LT H A S S O C I AT I O N

February/March 2022 The Nation’s Health headlines Online-only news from The Nation’s Health newspaper Stories of note include: Health misinformation a ‘threat to public health’ — Leaders call out sources of disinformation, social media sites Kim Krisberg US omicron surge underscores benefits of COVID-19 vaccination Michele Late Local resilience programs take on COVID-19, disaster relief — Employing residents for public good Mark Barna Tips for a healthy gut: How to feed your amazing microbiome Teddi Nicolaus APHA debuts ‘That’s Public Health’ web series — Science-based public health information shared on YouTube Michele Late Newsmakers: February/March 2022 Aaron Warnick Resources: February/March 2022 Aaron Warnick

https://www.thenationshealth.org/ 7

Review of Vaccination Coverage Assessed by the Kindergarten Immunization Survey in Delaware Nikki Kupferman, M.S. Vaccine Preventable Disease Epidemiologist, Division of Public Health, Delaware Department of Health and Social Services

ABSTRACT Vaccinations are the primary means used in public health to avert morbidity and mortality from preventable diseases and are crucial for reducing the development of infectious disease outbreaks. To ensure a high level of vaccine coverage, the State of Delaware requires that all children receive specific vaccinations against dangerous pathogens prior to enrolling in a school. By requiring all children to be vaccinated against certain diseases, individuals who have religious or medical exemptions for receiving vaccines are also protected. The percentage of vaccine coverage among kindergarten students is surveyed annually by the Delaware Immunization Program and the Centers for Disease Control and Prevention (CDC), via random sampling. Data acquired during the period from 2016 to 2021 shows that vaccine coverages have a declining trend, which may be due in part to the COVID-19 pandemic and increased vaccine hesitancy. Reviewing these data allows for a more robust understanding of disease trends and provides an indication as to where resources may need to be allocated to address lagging vaccine rates.

INTRODUCTION Vaccines are the cornerstone of public health interventions and one of the most important tools used in the protection of our population’s health. The creation of vaccines has saved countless lives, increased life expectancies, decreased health disparities, improved quality of life for many, and saved trillions of dollars in health care costs.1 Many vaccines have been approved for children starting at just two months of age when maternal antibodies begin to wane.2 Administering vaccines to children on schedule and from an early age has been proven to decrease their risk of infection from harmful pathogens and any complications that may be associated with them, and additionally interrupts potential transmission to adults and their peers.

To protect its population, the State of Delaware requires all children attending licensed daycare centers, as well as those entering kindergarten through grade 12 at public, private, and home schools, to receive several age-appropriate vaccines prior to enrolling. These immunizations provide protection against measles, mumps, and rubella (MMR); tetanus, diphtheria, and pertussis (Tdap/DTaP); and polio (IPV or OPV).1 These diseases can be fatal or have serious complications which may result in chronic conditions or disabilities. To ensure this regulation is followed, the Delaware Immunization Program works with the CDC to conduct an annual survey of kindergarten students to monitor the level of coverage for each required vaccination. The State of Delaware recognizes religious and medical exemptions to the vaccine requirement, they are accounted for in the annual survey. As routine vaccination frequency begins to wane during adolescence and into adulthood, conducting a survey of school-aged children is a good indicator of immunity for cohorts as they age.3 High vaccine coverage is critical for preventing poor outcomes for the individual receiving them and for those who are unable to receive vaccines due to medical contraindications or their religious beliefs. When the population around susceptible individuals are vaccinated, it supports the effects of herd 8 Delaware Journal of Public Health - March 2022

immunity and can decrease the likelihood of these individuals being exposed to dangerous pathogens. Despite the proven success of vaccinations, there has been a recent increase in controversy and misinformation regarding primarily COVID-19 vaccines, which has led to increased hesitancy in whether a parent decides to vaccinate their children.4 If this hesitancy leads to less people getting vaccinated, many vaccine-preventable diseases could re-emerge. Small numbers of these re-emerging diseases could impart large public health implications and require intervention to mitigate further risk and transmission.

BACKGROUND Since the previous review of the kindergarten survey data in 2019, several outbreaks of vaccine-preventable diseases occurred nationwide and within Delaware.1 These occurrences emphasize the importance of maintaining a high level of vaccine coverage in Delaware, starting with children, who have the potential to easily spread diseases among their peers and families. In 2019, the United States had the highest number of measles cases (1,249 confirmed cases) reported since 1992, prior to measles being eliminated in the U.S. in 2000.5 While the bordering states of New Jersey, Pennsylvania, and Maryland experienced measles cases during this outbreak, Delaware did not have any cases. Similarly, in 2014, the United States reported 667 cases of measles and Delaware once again did not observe any.1 In both situations, cases had spread rapidly through communities with low MMR vaccination rates after a single person was exposed during international travel.5 The lack of cases seen in Delaware was credited to Delaware’s high immunization coverage, which the CDC recognized at the 2018 National Immunization Conference.1 Without this high level of protection, Delaware citizens could have contributed to the case counts, and illnesses that these outbreaks brought to many other states.

As national hepatitis A outbreaks began to emerge in many states beginning in 2017, transmission was identified as personto-person and was associated with people who partake in DOI: 10.32481/djph.2022.03.004

intravenous drug use as well as those experiencing unstable housing, rather than transmission via contaminated food products as had been seen in the past.6 As the nation continued to see a rise in the opioid epidemic, hepatitis A cases also continued to surge. Due to these trends, Delaware began to take steps to protect its population in 2018 by partnering with homeless shelters, transitional housing organizations, and outpatient facilities to provide the hepatitis A vaccine. In Delaware, cases associated with this outbreak were detected in August 2019 and a statewide outbreak was declared soon after.

The Delaware Division of Public Health (DPH) took quick action to increase access to the hepatitis A vaccine by adding it to the flu vaccination clinics and connecting contacts of cases with the vaccine as post-exposure prophylaxis (PEP). Over the course of this outbreak, which was declared to be over in July 2021, 38 cases were identified. The hepatitis A vaccine is not required for school enrollment but has been more routinely recommended for children. While the outbreak-associated cases in Delaware did not include children, they are still at risk of being exposed to individuals, either in public or at home, and to contaminated food sources. Many children infected with hepatitis A are asymptomatic or mildly symptomatic carriers, which may lead to further transmission to their caregivers and increases the potential for a larger outbreak.

with two sibling contacts who were only partially vaccinated.

Since the other 44% of the class remained susceptible and could have potentially developed chickenpox from exposure, these susceptible contacts were asked to quarantine for 21 days and monitor for symptom development per CDC guidelines.

Quarantines such as this can create problems for parents who may need to take time off from work to be with their children.

There was no transmission to other classrooms from the infected siblings, most likely due to the partial vaccination status of the other students and lack of prolonged exposure.

Mumps outbreaks have also been observed nationwide, largely at university campuses and among those considered to be up to date on immunizations. Unfortunately, the mumps component of the MMR vaccine has been noted to wane in efficacy over time.7 However, individuals infected with mumps who were previously vaccinated are less likely to develop severe symptoms or complications.7 Delaware experienced a small outbreak of mumps cases (seven confirmed cases and four probable cases) in early 2020 at a school where all the afflicted individuals were upto-date on the MMR vaccine. It has been demonstrated that the attack rate of mumps is lower in vaccinated populations compared to those with unvaccinated individuals.7 During this outbreak, a small number of susceptible students were identified and excluded post-exposure, though it is believed that transmission was indeed slowed due to the overall vaccination coverage of the student body. None of the cases associated with this outbreak reported severe symptoms or complications.

METHODS

Delaware has experienced multiple pertussis outbreaks in the past decade, with major case counts recorded in 2014 (202 cases) and 2018 (183 cases). The individuals impacted by these outbreaks were members of Delaware’s Amish communities as well as those who are involved with or live near these communities. In 2019, a small cluster of pertussis cases were detected in an Amish community where transmission was likely introduced from an out-of-town guest. DPH quickly communicated with affected families and provided increased testing and PEP to vulnerable individuals. Pertussis outbreaks experienced within Amish communities typically do not expand due to the high Tdap/DTaP coverage of the surrounding population.

Despite the declining number of observed cases of varicella, chickenpox infections can still create difficult situations in school settings. In 2021, a varicella outbreak was detected in a Delaware daycare center. The affected classroom was comprised of infants too young to receive the varicella vaccination. Once introduced into the classroom, 56% of the roster became infected along

With these pathogens still circulating locally and globally, it is of paramount importance to protect children and their families by maintaining a high proportion of vaccinated individuals in Delaware. The Delaware Administrative Code 4202, outlines the steps and regulations set forth by state government to ensure the safety of its people. This code calls for certain diseases to be reported to the state, allows for public health officials to intervene to mitigate and control infectious agents should the need arise, and to put preventative measures in place, such as requiring children to be vaccinated against certain diseases prior to enrollment in schools.8 It is through these regulations that Delaware can prevent major outbreaks of infectious diseases from rapidly impacting the population at large and, in turn, protect vulnerable individuals.

Data for the kindergarten survey is collected annually by coordinating with the Department of Education to obtain a list of all schools, both public and private, that have kindergartenaged students. This list is subsequently sent to the CDC, which returns a randomized sample of schools to be surveyed.

The school nurses from the selected school then provide immunization data on a sample of their students. Data collected includes number of doses received by the students for required immunizations and any exemption data available. These data are then collected by the Delaware Immunization Program and are subsequently reported to the CDC. They are displayed on the DPH school immunization webpage with data currently extending through the 2020-2021 school year.9 The CDC also compiles vaccine coverage data for young children who are within the range of 0-36 months of age and can be found on their “SchoolVaxView” website. Currently, data provided through the CDC is updated through 2018.

For the scope of this review, the data utilized from this source contained data from children age 36 months, or those closest to enrolling in school, and those born between 2016 and 2018, in order to collect accurate information on hepatitis A vaccine coverage. According to the CDC’s child immunization schedule, children are recommended to have two doses of the hepatitis A vaccine by 24 months of age.10 Hepatitis A is not currently included on the kindergarten survey and is not required for school enrollment in Delaware.

RESULTS In 2016, the coverage for all required vaccines for school enrollment were greater than 97% (Figure 1). In the subsequent five years, coverage followed a decreasing trend. The DTaP vaccine, which had 98.4% coverage, saw the greatest decrease in uptake over this time, falling as low as 93.1% and not exceeding 9

Figure 1. Percentage of Immunized Kindergarteners, Delaware, 2016-17 through 2020-21 School Years.

Source: Division of Public Health, Delaware Immunization Program, 2022. *The data for the school years 2019-20 and 20-21, may have been impacted by the COVID-19 Pandemic

94.1% (Figure 1). In the 2020-2021 school year, the kindergarten immunization survey showed that only two vaccines surpassed 95% coverage, the MMR and polio vaccines, at 95.3 and 95.4%, respectively (Figure 1). Coverage for the hepatitis A vaccine in Delaware, with at least two doses recorded, was greater than the average coverages reported for the United States in children 35 months of age who were born between 2016 and 2018 (Table 1). Despite this, hepatitis A immunization coverage recorded in Delaware for these three cohorts was 83.3% in 2017, which was also lower than any of the school required vaccines observed within the state (Table 1).

Table 1. Percentage of Children (aged 35 Months) with Two or More Doses of Hepatitis A Vaccine, Delaware and US, 2016-2018 2016

2017

2018††

Delaware

78.1

83.3

81.6

United States

76.2

77.4

78.4

Source: Centers for Disease Control and Disease Prevention, National Immunization Survey – Child, 2016-2018. †† 2018 data is preliminary and is not finalized by the CDC until after the release of the 2021 data

The level of compliance to vaccination requirements prior to school enrollment showed that the number of students found to be non-compliant, or considered not up to date on vaccination, had increased in the 2020-21 school year (Figure 2). Over 5% of students surveyed were missing some component of the required vaccines, without an approved exemption on file, which is twice as many from the previous year (Figure 2.). Of note, the 2020-21 school year also showed an increase of students with religious exemptions to the vaccine requirements, from 1.0% in the 201920 school year to 2.4% in the 2020-21 school year (Figure 2).

10 Delaware Journal of Public Health - March 2022

CONCLUSION Vaccine-preventable diseases are actively circulating and could still have significant impacts on Delawareans. Major outbreaks such as measles, hepatitis, mumps, pertussis, and varicella have all been mitigated due to the effectiveness of vaccination campaigns. Review and analysis of the kindergarten survey data indicates a decreasing trend of vaccine coverage from previous years and an increasing amount of non-compliant students, which could be due to a multitude of factors. The 2019-20 and 2020-21 school years were greatly impacted due to the COVID-19 pandemic. It is possible that vaccine coverage was lower during this time because fewer people sought medical care or opted to have virtual instead of in-person health visits.

In the future, it will be paramount to ensure the children of this cohort are caught up on their routine vaccinations as the world acclimates to living with endemic COVID-19. Decreases in vaccine coverage can also be detected prior to the pandemic, particularly in regard to hepatitis B and DTaP immunizations.

This change could be an indicator that the public perception on vaccines has been shifting even before COVID-19. The key to boosting these percentages will be utilizing a targeted approach to determine which communities or populations exhibit lapses in vaccine coverage and to provide them with appropriate resources. These resources could include providing educational materials to combat vaccine hesitancy as well as facilitating increased vaccine availability to undersupplied practices.

By working to increase vaccine coverage for both required and recommended vaccines in children, Delaware is taking preemptive steps to reduce morbidity and mortality.

The kindergarten survey is a useful tool to assess the vaccination trends of children in Delaware, but it does not cover all children

Figure 2. Percentage of Kindergarten Students Exempt from Immunization, Delaware, 2016-17 through 2020-21 School Years

Source: Division of Public Health, Delaware Immunization Program, 2022. * The data for the school years 2019-20 and 20-21, may have been impacted by the COVID-19 Pandemic

enrolled in Delaware schools. While the random sampling design of the survey lends itself to being representative of the Delaware population, a comprehensive review of the complete immunization records of all enrolled students would provide the most accurate results. Delaware’s immunization program is currently partnering with the Department of Education to integrate record systems, which potentially allows for this analysis to cover all students in the state. This would provide a more robust indication of where the state’s resources are most needed to promote vaccination.

Ms. Kupferman can be contacted at Nikki.kupferman@delaware.gov

REFERENCES 1. Talbott, J. E. (2019). Survey shows Delaware surpassing vaccination goals. Delaware Medical Journal, 91, 22–25.

Retrieved from: http://digital-editions.todaymediacustom.com/medical-society-ofdelaware/delaware-medical-journal/jan-2019/#p=22 2. Edwards, K. M. (2015, November 25). Maternal antibodies and infant immune responses to vaccines. Vaccine, 33(47), 6469–6472. https://doi.org/10.1016/j.vaccine.2015.07.085 3. Nelson, J. C., Bittner, R. C. L., Bounds, L., Zhao, S., Baggs, J., Donahue, J. G., . . . Jackson, L. A. (2009, October).

Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: Results from a vaccine safety datalink study. American Journal of Public Health, 99(Suppl 2), S389–S397. https://doi.org/10.2105/AJPH.2008.151332

4. Olson, O., Berry, C., & Kumar, N. (2020, October 8). Addressing parental vaccine hesitancy towards childhood vaccines in the United States: A systematic literature review of communication interventions and strategies. Vaccines, 8(4), 590. https://doi.org/10.3390/vaccines8040590 5. Patel, M., Lee, A. D., Clemmons, N. S., Redd, S. B., Poser, S., Blog, D., . . . Gastañaduy, P. A. (2019, October 11). National update on measles cases and outbreaks— United States, January 1–October 1, 2019. MMWR. Morbidity and Mortality Weekly Report, 68(40), 893–896. https://doi.org/10.15585/mmwr.mm6840e2 6. Centers for Disease Control and Development. (n.d.).

Widespread person-to-person outbreaks of hepatitis A across the United States. https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm 7. Cortese, M. M., Jordan, H. T., Curns, A. T., Quinlan, P. A., Ens, K. A., Denning, P. M., & Dayan, G. H. (2008, April 15).

Mumps vaccine performance among university students during a mumps outbreak. Clin Infect Dis, 46(8), 1172–1180. https://doi.org/10.1086/529141 8. Control of Communicable and Other Disease Conditions.

Title 16, 4202 Delaware Administrative Code. https://regulations.delaware.gov/register/january2022/ emergency/25%20DE%20Reg%20670%2001-01-22.pdf 9. Delaware Division of Public Health. (n.d.). School Immunizations. https://www.dhss.delaware.gov/dph/dpc/school-immunizations.html 10. CDC. (n.d.). SchoolVaxView. https://www.cdc.gov/vaccines/imz-managers/coverage/childvaxview/ interactive-reports/index.html 11

Pediatric Vaccines: What’s New for 2022 Michelle Eng, M.D. and Liza Hashim, D.O. PGY-3 Pediatric Residents, Nemours Children’s Hospital-Delaware

ABSTRACT Childhood immunizations have proven to be tremendously successful in eradicating diseases that have previously been considered to be fatal. Though current immunizations are generally well tolerated, it is important to constantly evaluate existing methods and be amenable to changes when they present. Newer formulations of products have been in development to improve vaccine completion, vaccine efficacy, and protection against emerging diseases.

Growing interest in health economics has led to production of new vaccines that promote healthier outcomes in all populations, especially those vulnerable to infectious disease, children.

NEW VACCINES Childhood immunizations have had a profound impact on rates of communicable diseases worldwide. It continues to be important to invest in this global health domain. Recently, multiple new vaccines were approved and made available for use in children. These include Vaxelis, Flucelvax, Pfizer-BioTech COVID-19 vaccine, and Moquirix.

Vaxelis, the hexavalent vaccine for diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, and hepatitis B from Merck and Sanofi, was made available for use in the United States and included in the pediatric vaccination schedule update for 2022. Vaccination compliance and completion rates increase with administration of combination vaccines.

Studies suggest this is due to reduced distress experienced visits when a single injection is offered.1 The new vaccine combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus from Sanofi with Haemophilus influenzae type b and hepatitis B from Merck reduces the quantity of needle sticks required for pediatric vaccine series. The series is recommended at 2, 4, and 6 months as a 3-dose series. The Food and Drug Administration (FDA) approved the vaccine for children 6 weeks to 4 years of age in 2018, and it became available in the United States in 2021.2 Flucelvax, the quadrivalent cell-based influenza vaccine from Seqirus, was approved by the FDA for use in children 6 months and older in 2021 (previously approved for use in children 2 years and older). Approval occurred following a Phase 3 study demonstrating safety and noninferiority immunogenicity of the cell-based vaccine when compared with other quadrivalent influenza vaccines currently on the market.3 Flucelvax remains the only cell-based quadrivalent inactivated influenza vaccine approved for use by the FDA. This vaccine is grown in mammalian cultured cells in order to avoid risk of mutations of influenza virus that occurs with egg-based production.

Preparation in this way promotes fewer instances of antigenic mismatch, raising vaccine efficacy.4 The Pfizer-BioNTech (BNT162b2) COVID-19 vaccine was also approved for use in pediatric patients 5 to 18 years of age in 2021.

Trials are still ongoing for pediatric patients 6 months through 4 years of age. BNT162b2 remains the only vaccine approved for 12 Delaware Journal of Public Health - March 2022

use in children in the United States. Children 5 to 11 years of age receive a pediatric dose of the vaccine, while adolescents 12 years of age and older receive the adult dose.5 The recommended series for an immunocompetent child is a 2-dose series separated by three weeks with a booster available for children 12 years of age and older (see updates to vaccine schedule and special considerations for immunocompromised children below).6 In patients 12-18 years of age, vaccination with BNT162b2 has been shown to be protective against sequelae including multisystem inflammatory syndrome in children. Acute myocarditis is rare but has been reported as a severe adverse effect of the vaccine in this age range.7 Outside of the United States, Moquirix (RTS,S/AS01), the malaria vaccine from GlaskoSmithKline, has been recommended by the World Health Organization (WHO) in 2021 for vaccination for children at risk for P. falciparum malaria in Africa and Asia.8 It is recommended as a 4-dose series in children five months of age and older. The vaccine is currently available in Ghana, Kenya, and Malawi and production will increase to make it more widely available.9

EMERGING VACCINES In addition to newly approved vaccines, there are numerous emerging vaccines currently undergoing further testing and clinical trials. These include the Ebola, Chikungunya, Lyme, and Middle Eastern Respiratory Syndrome (MERS) vaccines. Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) is the 2-dose Ebola vaccine regimen in development from Johnson & Johnson, has received European Commission authorization in 2020 and WHO prequalification in 202110 following a Phase 3 trial including children 1-17 years of age,11 though has not yet been approved for use by the FDA. Currently, there is only one FDA approved vaccine for protection against Ebola, Ervebo, which is only approved for ages 18 and up. VLA1553, the Chikungunya vaccine candidate from Valneva, is currently undergoing Phase 3 trial with a plan to move forward with regulatory approval in 2022.12 VLA15, the Lyme disease vaccine candidate from Pfizer hasrecently completed a Phase 2 trial with a plan to move forward to a Phase 3 trial in 2022.13 INO-4700, the MERS vaccine candidate from Inovio, is currently undergoing a Phase 2 trial.14 DOI: 10.32481/djph.2022.03.005

PEDIATRIC VACCINATION SCHEDULE FOR 2022 The Advisory Committee on Immunization Practices released its newest recommendations for 2022 on the Center for Disease Control and Prevention (CDC) website (https://www.cdc.gov/ vaccines/acip). This updated schedule has been reviewed and approved by multiple advisory committees including the CDC, the American Academy of Pediatrics, and the National Association of Pediatric Nurse Practitioners. Changes included addition of vaccines to the schedule, clarification to the existing vaccines on the schedule, and an appendix with contraindication and precautions for all of the vaccines. Additions include dengue and COVID. Dengue is recommended as a 3-dose series for children 9-16 years old who have had previous Dengue infection and live in endemic areas.15 Recommendations for the 2-dose COVID vaccine series were also included (3 dose for moderately to severely immunocompromised children) as well as the booster 5 months after series completion for children 12 years and older (3 months after for moderately to severely immunocompromised children 12 years and older).6 Clarifications were made regarding Haemophilus influenzae type b, hepatitis A, hepatitis B, human papillomavirus, varicella, and the measles, mumps, and rubella vaccines. Haemophilus influenzae type b vaccination with the Vaxelis combination vaccine was clarified for use only in the primary series and not as a booster at age 12-15 months.

Hepatitis A vaccination was clarified to be recommended at age 12-23 months. Hepatitis B revaccination was clarified to be recommended for infants of hepatitis B surface antigen positive moms, hemodialysis patients, and immunocompromised patients with post vaccination serology demonstrating insufficient immunity. Human papillomavirus vaccination was recommended to be a 3-dose series for immunocompromised patients (including patients with HIV) regardless of age at series initiation. Varicella and the measles, mumps, and rubella vaccines were recommended to be administered separately for dose 1 for children ages 12- 47 months.15 Dr. Eng may be contacted at michelle.eng@nemours.org.

REFERENCES 1. Kurosky, S. K., Davis, K. L., & Krishnarajah, G. (2017, November 2). Effect of combination vaccines on completion and compliance of childhood vaccinations in the United States. Human Vaccines & Immunotherapeutics, 13(11), 2494–2502. https://doi.org/10.1080/21645515.2017.1362515 2. Fortunato, F., Martinelli, D., Lopalco, P. L., & Prato, R. (2021, November 27). Safety evaluation of the DTaP5-IPV-Hib-HepB vaccine: A review. Expert Opinion on Drug Safety, 1–8. https://doi.org/10.1080/14740338.2022.2007882 3. Sylvester, G. C. (2021). FLUCELVAX quadrivalent (ccIIV4) a phase III randomized controlled trial: immunogenicity & safety results in young children (6 through 47 months of age).

Retrieved from https://stacks.cdc.gov/view/cdc/109098 4. Nguyen, V. H., Hilsky, Y., & Mould-Quevedo, J. (2021, September 28). The epidemiological and economic impact of a cell-based quadrivalent influenza vaccine in adults in the US: A Dynamic Modeling Approach. Vaccines, 9(10), 1095. https://doi.org/10.3390/vaccines9101095 5. Hause, A. M., Baggs, J., Marquez, P., Myers, T. R., Gee, J., Su, J. R., . . . Shay, D. K. (2021, December 31). COVID-19 vaccine safety in children aged 5–11 years—United States, November

3–December 19, 2021. MMWR. Morbidity and Mortality Weekly Report, 70(5152), 1755–1760. https://doi.org/10.15585/mmwr.mm705152a1 6. Centers for Disease Control and Prevention. (2022). Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. CDC: Atlanta, GA, USA. 7. Zambrano, L. D., Newhams, M. M., Olson, S. M., Halasa, N. B., Price, A. M., Boom, J. A., . . . Randolph, A. G., & the Overcoming COVID-19 Investigators. (2022, January 14). Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA vaccination against multisystem inflammatory syndrome in children among persons aged 12–18 years—United States, July–December 2021. MMWR. Morbidity and Mortality Weekly Report, 71(2), 52–58. https://doi.org/10.15585/mmwr.mm7102e1 8. World Health Organization. (2021). WHO recommends groundbreaking malaria vaccine for children at risk. World Heal. Organ, 1. Retrieved from https://www.who.int/news/item/06-10-2021-who-recommendsgroundbreaking-malaria-vaccine-for-children-at-risk 9. Laurens, M. B. (2020, March 3). RTS,S/AS01 vaccine (Mosquirix™): An overview. Human Vaccines & Immunotherapeutics, 16(3), 480–489. https://doi.org/10.1080/21645515.2019.1669415 10. Sargent, J., Kumar, S., Garrity, T., & McIntyre, J. (2021).

Johnson & Johnson Ebola vaccine regimen demonstrated robust and durable immune response in adults and children in data published in The Lancet Infectious Diseases. Retrieved from https://www.jnj.com/johnson-johnson-ebola-vaccine-regimendemonstrated-robust-and-durable-immune-response-in-adults-andchildren-in-data-published-in-the-lancet-infectious-diseases 11. Afolabi, M. O., Ishola, D., Manno, D., Keshinro, B., Bockstal, V., Rogers, B., . . . Watson-Jones, D., & the EBL3001 study group. (2022, January). Safety and immunogenicity of the twodose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: A randomised, double-blind, controlled trial. The Lancet. Infectious Diseases, 22(1), 110–122. https://doi.org/10.1016/S1473-3099(21)00128-6 12. Mahase, E. (2021). Covid-19: Valneva’s vaccine produces stronger immune response than AstraZeneca’s, company reports. BMJ: British Medical Journal (Online), 375.

13. Dattwyler, R. J., & Gomes-Solecki, M. (2022). The year that shaped the outcome of the OspA vaccine for human Lyme disease. NPJ Vaccines, 7(1), 1–5. https://doi.org/10.1038/s41541-022-00429-5 14. Patel, A., Reuschel, E. L., Xu, Z., Zaidi, F. I., Kim, K. Y., Scott, D. P., . . . Weiner, D. B. (2021, May 24). Intradermal delivery of a synthetic DNA vaccine protects macaques from Middle East respiratory syndrome coronavirus. JCI Insight, 6(10), 146082. https://doi.org/10.1172/jci.insight.146082 15. Wodi, A. P., Murthy, N., Bernstein, H., McNally, V., Cineas, S., & Ault, K. (2022, February 18). Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger—United States, 2022. MMWR. Morbidity and Mortality Weekly Report, 71(7), 234–237. https://doi.org/10.15585/mmwr.mm7107a2 13

The Journey of Your Child’s Vaccine Before a new vaccine is ever given to people, extensive lab testing is done that can take several years. Once testing in people begins, it can take several more years before clinical studies are complete and the vaccine is licensed.

How a new vaccine is developed, approved and manufactured The Food and Drug Administration (FDA) sets rules for the three phases of clinical trials to ensure the safety of the volunteers. Researchers test vaccines with adults first.

PHASE 1

PHASE 2

20-100 healthy volunteers

Is this vaccine safe?

Does this vaccine seem to work?

Are there any serious side effects?

How is the size of the dose related to side effects?

several hundred volunteers What are the most common short-term side effects?

How are the volunteers’ immune systems responding to the vaccine?

FDA licenses the vaccine only if:

hundreds or thousands of volunteers How do people who get the vaccine and people who do not get the vaccine compare?

Is the vaccine safe?

Is the vaccine effective?

What are the most common side effects?

It’s safe and effective Benefits outweigh risks

Manufacturers must test all lots to make sure they are safe, pure and potent. The lots can only be released once FDA reviews their safety and quality.

Vaccines are made in batches called lots.

PHASE 3

The FDA inspects manufacturing facilities regularly to ensure quality and safety.

FOR MORE INFORMATION, VISIT HTTPS://WWW.FDA.GOV/CBER If Health the FDA licenses 14 Delaware Journal of Public - March 2022

a vaccine, experts may consider adding it to the recommended immunization schedule.

Vaccines are made in batches called lots.

to make sure they are safe, pure and potent. The lots can only be released once FDA reviews their safety and quality.

manufacturing facilities regularly to ensure quality and safety.

FOR MORE INFORMATION, VISIT HTTPS://WWW.FDA.GOV/CBER If the FDA licenses a vaccine, experts may consider adding it to the recommended immunization schedule.

How a vaccine is added to the U.S. Recommended Immunization Schedule ACIP

The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts.

Members of the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) are among some of the groups that also bring related immunization expertise to the committee. This group carefully reviews all available data about the vaccine from clinical trials and other studies to develop recommendations for vaccine use. The ACIP continues to monitor vaccine safety and effectiveness data even after the vaccine’s routine use and may change or update recommendations based on that data.

When making recommendations, ACIP considers:

ACIP recommendations are not official until the CDC Director reviews and approves them and they are published. These recommendations then become part of the United States official childhood immunization schedule.

How safe is the vaccine when given at specific ages?

How well does the vaccine work at specific ages?

How serious is the disease this vaccine prevents?

How many children would get the disease the vaccine prevents if we didn’t have the vaccine?

At 1 month of age, HepB (1-2 months), At 2 months of age, HepB (1-2 months), DTaP, PCV, Hib, Polio, and RV At 4 months of age, DTaP, PCV, Hib, Polio, and RV At 6 months of age, HepB (6-18 months), DTaP, PCV, Hib, Polio (6-18 months), RV, and Influenza (yearly, 6 months through 18 years)* At 12 months of age, MMR (12-15

2018 Recommended Immunizations for Children from Birth Through 6 Years Old

Birth

HepB

New vaccine to protect your child against a disease is added to the schedule.

2

1

month

months

4

months

6

months

HepB

†

months), PCV (12-15 months) , Hib (12-15 months), Varicella (12-15 months), HepA (12-23 months)§, and Influenza (yearly, 6 months through 18 years)* At 4-6 years, DTaP, IPV, MMR, Varicella, and Influenza (yearly, 6 months through 18 years)*

Is your family

growing? To protect your new baby and yourself against whooping cough, get a Tdap vaccine.

The recommended time is the 27th through 36th week of pregnancy. Talk to your doctor for more details.

12

months

15

months

18

months

19–23 months

2–3

years

4–6

years

HepB RV

RV

RV

DTaP

DTaP

DTaP

Hib

Hib

Hib

PCV13

PCV13

PCV13

IPV

IPV

DTaP

DTaP

Hib PCV13 IPV

IPV Influenza (Yearly)*

MMR

MMR Varicella

Shaded boxes indicate the vaccine can be given during shown age range.

Varicella HepA§

NOTE:

FOOTNOTES:

If your child misses a shot, you don’t need to start over, just go back to your child’s doctor for the next shot.

Talk with your child’s doctor if you have questions about vaccines.

* Two doses given at least four weeks apart are recommended for children aged 6 months through 8 years of age who are getting an influenza (flu) vaccine for the first time and for some other children in this age group. §

Two doses of HepA vaccine are needed for lasting protection. The first dose of HepA vaccine should be given between 12 months and 23 months of age. The second dose should be given 6 to 18 months later. HepA vaccination may be given to any child 12 months and older to protect against HepA. Children and adolescents who did not receive the HepA vaccine and are at high-risk, should be vaccinated against HepA. If your child has any medical conditions that put him at risk for infection or is traveling outside the United States, talk to your child’s doctor about additional vaccines that he may need.

See back page for more information on vaccinepreventable diseases and the vaccines that prevent them.

For more information, call toll free 1-800-CDC-INFO (1-800-232-4636) or visit www.cdc.gov/vaccines/parents

FOR MORE INFORMATION, VISIT HTTPS://WWW.CDC.GOV/VACCINES After being added to the U.S. Recommended Immunization Schedule, health experts continue to monitor the vaccine’s safety and effectiveness.

How a vaccine’s safety continues

RISK BENEFIT

15

FOR MORE INFORMATION, VISIT HTTPS://WWW.CDC.GOV/VACCINES After being added to the U.S. Recommended Immunization Schedule, health experts continue to monitor the vaccine’s safety and effectiveness.

How a vaccine’s safety continues to be monitored

RISK BENEFIT

FDA and CDC closely monitor vaccine safety after the public begins using the vaccine.

The purpose of monitoring is to watch for adverse events (possible side effects). Monitoring a vaccine after it is licensed helps ensure that possible risks associated with the vaccine are identified.

Vaccine Adverse Event Reporting System (VAERS) VAERS collects and analyzes reports of adverse events that happen after vaccination.

Anyone can submit a report, including parents, patients and healthcare professionals.

Vaccine Safety Datalink (VSD) and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Two networks of healthcare organizations across the U.S. VSD can analyze healthcare information from over 24 million people.

PRISM can analyze healthcare information from over 190 million people.

Scientists use these systems to actively monitor vaccine safety.

Clinical Immunization Safety Assessment Project (CISA) CISA is a collaboration between CDC and 7 medical research centers.

Vaccine safety experts assist U.S. healthcare providers with complex vaccine safety questions about their patients.

CISA conducts clinical research studies to better understand vaccine safety and identify prevention strategies for adverse events following immunization.

Vaccine recommendations may change if safety monitoring reveals new information on vaccine risks (like if scientists detect a new serious side effect).

FOR MORE INFORMATION, VISIT HTTPS://WWW.CDC.GOV/VACCINESAFETY The United States currently has the safest vaccine supply in its history.

These vaccines keep children, families and communities protected from serious diseases.

16 Delaware Journal of Public Health - March 2022

U.S. Department of Health and Human Services Centers for Disease Control and Prevention

NCIRDig706 | 07/30/18

2022 Evelyn R. Hayes Innovations in Healthcare Symposium

"Improving Health Outcomes and Advancing Health Equity Through Behavioral Change"

Thursday, April 21st 5:30-7:00PM Virtual Via Zoom Free and Open to the Public Registration Required - udel.edu/008921

Yendelela Cuffee, PhD Assistant Professor, UD Epidemiology Program

Dr. Cuffee will present the keynote on "Storytelling as an Approach for Promoting Lifestyle and Behavioral Change" which will be followed by a Q&A session moderated by Rita Landgraf, Director of UD's Partnershps for Healthy Communities.

We are excited that a demonstration by Healthcare Theatre and call to action will round out the programming centered around this important topic. We hope to see you there!

TO REGISTER: udel.edu/008921 17

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger

Vaccines in the Child and Adolescent Immunization Schedule* Vaccine

Abbreviation(s)

Trade name(s)

Dengue vaccine

DEN4CYD

Dengvaxia®

Diphtheria, tetanus, and acellular pertussis vaccine

DTaP

Daptacel® Infanrix®

Diphtheria, tetanus vaccine

DT

No trade name

Haemophilus influenzae type b vaccine

Hib (PRP-T)

ActHIB® Hiberix® PedvaxHIB®

Hib (PRP-OMP) Hepatitis A vaccine

HepA

Havrix® Vaqta®

Hepatitis B vaccine

HepB

Engerix-B® Recombivax HB®

Human papillomavirus vaccine

HPV

Gardasil 9®

Influenza vaccine (inactivated)

IIV4

Multiple

Influenza vaccine (live, attenuated)

LAIV4

FluMist® Quadrivalent

Measles, mumps, and rubella vaccine

MMR

M-M-R II®

Meningococcal serogroups A, C, W, Y vaccine

MenACWY-D

Menactra®

MenACWY-CRM

Menveo®

MenACWY-TT

MenQuadfi®

MenB-4C

Bexsero®

MenB-FHbp

Trumenba®

Pneumococcal 13-valent conjugate vaccine

PCV13

Prevnar 13®

Pneumococcal 23-valent polysaccharide vaccine

PPSV23

Pneumovax 23®

Poliovirus vaccine (inactivated)

IPV

IPOL®

Rotavirus vaccine

RV1 RV5

Rotarix® RotaTeq®

Tetanus, diphtheria, and acellular pertussis vaccine

Tdap

Adacel® Boostrix®

Tetanus and diphtheria vaccine

Td

Tenivac® Tdvax™

Meningococcal serogroup B vaccine

Varicella vaccine

VAR

Varivax®

Combination vaccines (use combination vaccines instead of separate injections when appropriate) DTaP, hepatitis B, and inactivated poliovirus vaccine

DTaP-HepB-IPV

Pediarix®

DTaP, inactivated poliovirus, and Haemophilus influenzae type b vaccine

DTaP-IPV/Hib

Pentacel®

DTaP and inactivated poliovirus vaccine

DTaP-IPV

Kinrix® Quadracel®

DTaP, inactivated poliovirus, Haemophilus influenzae type b, and hepatitis B vaccine

DTaP-IPV-HibHepB

Vaxelis®

Measles, mumps, rubella, and varicella vaccine

MMRV

ProQuad®

*Administer recommended vaccines if immunization history is incomplete or unknown. Do not restart or add doses to vaccine series for extended intervals between doses. When a vaccine is not administered at the recommended age, administer at a subsequent visit.

The use of trade names is for identification purposes only and does not imply endorsement by the ACIP or CDC.

18 Delaware Journal of Public Health - March 2022

UNITED STATES

2022

How to use the child and adolescent immunization schedule

1

Determine recommended vaccine by age (Table 1)

2

Determine recommended interval for catchup vaccination (Table 2)

3

Assess need for additional recommended vaccines by medical condition or other indication (Table 3)

4

Review vaccine types, frequencies, intervals, and considerations for special situations (Notes)

5

Review contraindications and precautions for vaccine types (Appendix)

Recommended by the Advisory Committee on Immunization Practices (www.cdc.gov/vaccines/acip) and approved by the Centers for Disease Control and Prevention (www.cdc.gov), American Academy of Pediatrics (www.aap.org), American Academy of Family Physicians (www.aafp.org), American College of Obstetricians and Gynecologists (www.acog.org), American College of Nurse-Midwives (www.midwife.org), American Academy of Physician Associates (www.aapa.org), and National Association of Pediatric Nurse Practitioners (www.napnap.org).

Report

y Suspected cases of reportable vaccine-preventable diseases or outbreaks to your state or local health department

y Clinically significant adverse events to the Vaccine Adverse Event Reporting System (VAERS) at www.vaers.hhs.gov or 800-822-7967

Questions or comments Contact www.cdc.gov/cdc-info or 800-CDC-INFO (800-232-4636), in English or Spanish, 8 a.m.–8 p.m. ET, Monday through Friday, excluding holidays Download the CDC Vaccine Schedules app for providers at www.cdc.gov/vaccines/schedules/hcp/schedule-app.html

Helpful information

y Complete Advisory Committee on Immunization Practices (ACIP) recommendations: www.cdc.gov/vaccines/hcp/acip-recs/index.html

y General Best Practice Guidelines for Immunization (including contraindications and precautions): www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html

y Vaccine information statements:

www.cdc.gov/vaccines/hcp/vis/index.html

y Manual for the Surveillance of Vaccine-Preventable Diseases (including case identification and outbreak response): www.cdc.gov/vaccines/pubs/surv-manual y ACIP Shared Clinical Decision-Making Recommendations www.cdc.gov/vaccines/acip/acip-scdm-faqs.html

Scan QR code for access to online schedule

CS310020-A

Table 1

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

These recommendations must be read with the notes that follow. For those who fall behind or start late, provide catch-up vaccination at the earliest opportunity as indicated by the green bars.

To determine minimum intervals between doses, see the catch-up schedule (Table 2).

Vaccine

Birth

Hepatitis B (HepB)

1st dose

1 mo

2 mos

4 mos

----- 2nd dose -----

6 mos

9 mos

12 mos

15 mos

18 mos 19–23 mos 2–3 yrs

4–6 yrs

7–10 yrs 11–12 yrs 13–15 yrs

1st dose

2nd dose See Notes

Diphtheria, tetanus, acellular pertussis (DTaP <7 yrs)

1st dose

2nd dose

Haemophilus influenzae type b (Hib)

1st dose

2nd dose See Notes

Pneumococcal conjugate (PCV13)

1st dose

2nd dose

Inactivated poliovirus (IPV <18 yrs)

1st dose

2nd dose

3rd dose

3rd dose

----- 4th dose ------

5th dose

3rd or 4th dose,  See Notes --

--

----- 4th dose -----

---------------------------- 3rd dose ----------------------------

Influenza (IIV4)

4th dose

Annual vaccination 1 or 2 doses

or

Annual vaccination 1 dose only Annual vaccination 1 or 2 doses

Influenza (LAIV4) Measles, mumps, rubella (MMR)

See Notes

Varicella (VAR) Hepatitis A (HepA)

----- 1st dose -----

2nd dose

----- 1st dose -----

2nd dose

See Notes

or Annual vaccination 1 dose only

2-dose series, See Notes

Tetanus, diphtheria, acellular pertussis (Tdap ≥7 yrs)

1 dose

Human papillomavirus (HPV)

See Notes

Meningococcal (MenACWY-D ≥9 mos, MenACWY-CRM ≥2 mos, MenACWY-TT ≥2years)

1st dose

See Notes

2nd dose See Notes

Meningococcal B (MenB-4C, MenBFHbp) Pneumococcal polysaccharide (PPSV23)

See Notes Seropositive in endemic areas only (See Notes)

Dengue (DEN4CYD; 9-16 yrs) Range of recommended ages for all children

17–18 yrs

---------------------------- 3rd dose ----------------------------

Rotavirus (RV): RV1 (2-dose series), RV5 (3-dose series)



16 yrs



Range of recommended ages for catch-up vaccination



Range of recommended ages for certain high-risk groups



Recommended vaccination can begin in this age group



Recommended vaccination based on shared clinical decision-making



No recommendation/ not applicable

19

Table 2

Recommended Catch-up Immunization Schedule for Children and Adolescents Who Start Late or Who Are More than 1 Month Behind, United States, 2022

The table below provides catch-up schedules and minimum intervals between doses for children whose vaccinations have been delayed. A vaccine series does not need to be restarted, regardless of the time that has elapsed between doses. Use the section appropriate for the child’s age. Always use this table in conjunction with Table 1 and the Notes that follow.

Children age 4 months through 6 years Vaccine

Minimum Age for Dose 1

Dose 1 to Dose 2 4 weeks

Hepatitis B

Birth

Rotavirus

6 weeks 4 weeks Maximum age for first dose is 14 weeks, 6 days.

6 weeks 4 weeks

Diphtheria, tetanus, and acellular pertussis Haemophilus influenzae type b

6 weeks

No further doses needed if first dose was administered at age 15 months or older.

4 weeks if first dose was administered before the 1st birthday.

8 weeks (as final dose) if first dose was administered at age 12 through 14 months.

Pneumococcal conjugate

6 weeks

Inactivated poliovirus

6 weeks

No further doses needed for healthy children if first dose was administered at age 24 months or older 4 weeks if first dose was administered before the 1st birthday 8 weeks (as final dose for healthy children) if first dose was administered at the 1st birthday or after 4 weeks

Measles, mumps, rubella Varicella Hepatitis A Meningococcal ACWY

12 months 12 months 12 months 2 months MenACWY-CRM 9 months MenACWY-D 2 years MenACWY-TT

4 weeks 3 months 6 months 8 weeks

Meningococcal ACWY Tetanus, diphtheria; tetanus, diphtheria, and acellular pertussis

Not applicable (N/A) 7 years

8 weeks 4 weeks

Human papillomavirus

9 years

Hepatitis A Hepatitis B Inactivated poliovirus

N/A N/A N/A

Routine dosing intervals are recommended.

6 months 4 weeks 4 weeks

Measles, mumps, rubella Varicella

N/A N/A

4 weeks 3 months if younger than age 13 years.

4 weeks if age 13 years or older

Dengue

9 years

6 months

Minimum Interval Between Doses Dose 2 to Dose 3 8 weeks and at least 16 weeks after first dose minimum age for the final dose is 24 weeks 4 weeks maximum age for final dose is 8 months, 0 days

Dose 3 to Dose 4

Dose 4 to Dose 5

4 weeks

6 months

6 months

No further doses needed if previous dose was administered at age 15 months or older 4 weeks if current age is younger than 12 months and first dose was administered at younger than age 7 months and at least 1 previous dose was PRP-T (ActHib®, Pentacel®, Hiberix®), Vaxelis® or unknown 8 weeks and age 12 through 59 months (as final dose) if current age is younger than 12 months and first dose was administered at age 7 through 11 months; OR if current age is 12 through 59 months and first dose was administered before the 1st birthday and second dose was administered at younger than 15 months; OR if both doses were PedvaxHIB® and were administered before the 1st birthday No further doses needed for healthy children if previous dose was administered at age 24 months or older 4 weeks if current age is younger than 12 months and previous dose was administered at <7 months old 8 weeks (as final dose for healthy children) if previous dose was administered between 7–11 months (wait until at least 12 months old); OR if current age is 12 months or older and at least 1 dose was administered before age 12 months

8 weeks (as final dose) This dose only necessary for children age 12 through 59 months who received 3 doses before the 1st birthday.

4 weeks if current age is <4 years 6 months (as final dose) if current age is 4 years or older

6 months (minimum age 4 years for final dose)

See Notes

See Notes

8 weeks (as final dose) This dose only necessary for children age 12 through 59 months who received 3 doses before age 12 months or for children at high risk who received 3 doses at any age.

Children and adolescents age 7 through 18 years

20 Delaware Journal of Public Health - March 2022

4 weeks if first dose of DTaP/DT was administered before the 1st birthday 6 months (as final dose) if first dose of DTaP/DT or Tdap/Td was administered at or after the 1st birthday

8 weeks and at least 16 weeks after first dose 6 months A fourth dose is not necessary if the third dose was administered at age 4 years or older and at least 6 months after the previous dose.

6 months

6 months if first dose of DTaP/DT was administered before the 1st birthday

A fourth dose of IPV is indicated if all previous doses were administered at <4 years or if the third dose was administered <6 months after the second dose.

Table 3

Recommended Child and Adolescent Immunization Schedule by Medical Indication, United States, 2022

Always use this table in conjunction with Table 1 and the Notes that follow.

INDICATION HIV infection CD4+ count1

VACCINE

Pregnancy

Immunocompromised status (excluding HIV infection)

<15% or total CD4 cell count of <200/mm3

≥15% and total CD4 cell count of ≥200/mm3

Kidney failure, end-stage renal disease, or on hemodialysis

Heart disease or chronic lung disease

CSF leak or cochlear implant

Asplenia or persistent complement component deficiencies

Chronic liver disease

Diabetes

Hepatitis B Rotavirus

SCID2

Diphtheria, tetanus, and acellular pertussis (DTaP) Haemophilus influenzae type b Pneumococcal conjugate Inactivated poliovirus Influenza (IIV4)

or Influenza (LAIV4)

Asthma, wheezing: 2–4yrs3

Measles, mumps, rubella

*

Varicella

*

Hepatitis A Tetanus, diphtheria, and acellular pertussis (Tdap) Human papillomavirus

*

Meningococcal ACWY Meningococcal B Pneumococcal polysaccharide Dengue



Vaccination according to the routine schedule recommended



Recommended for persons with an additional risk factor for which the vaccine would be indicated

Vaccination is recommended, and additional doses may be necessary based on medical condition or vaccine. See Notes.



Precaution—vaccine might be indicated if benefit of protection outweighs risk of adverse reaction



Contraindicated or not recommended—vaccine should not be administered *Vaccinate after pregnancy



No recommendation/not applicable

1 For additional information regarding HIV laboratory parameters and use of live vaccines, see the General Best Practice Guidelines for Immunization, “Altered Immunocompetence,” at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html and Table 4-1 (footnote J) at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html.

2 Severe Combined Immunodeficiency 3 LAIV4 contraindicated for children 2–4 years of age with asthma or wheezing during the preceding 12 months

21

Notes

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

For vaccination recommendations for persons ages 19 years or older, see the Recommended Adult Immunization Schedule, 2022.

Additional information COVID-19 Vaccination COVID-19 vaccines are recommended for use within the scope of the Emergency Use Authorization or Biologics License Application for the particular vaccine. ACIP recommendations for the use of COVID-19 vaccines can be found at www.cdc.gov/ vaccines/hcp/acip-recs/vacc-specific/covid-19.html.

CDC’s interim clinical considerations for use of COVID-19 vaccines can be found at www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html.

y Consult relevant ACIP statements for detailed recommendations at

www.cdc.gov/vaccines/hcp/acip-recs/index.html. y For calculating intervals between doses, 4 weeks = 28 days. Intervals of ≥4 months are determined by calendar months.

y Within a number range (e.g., 12–18), a dash (–) should be read as “through.”

y Vaccine doses administered ≤4 days before the minimum age or

interval are considered valid. Doses of any vaccine administered ≥5 days earlier than the minimum age or minimum interval should not be counted as valid and should be repeated as age appropriate.

The repeat dose should be spaced after the invalid dose by the recommended minimum interval. For further details, see Table 3-1, Recommended and minimum ages and intervals between vaccine doses, in General Best Practice Guidelines for Immunization at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html.

y Information on travel vaccination requirements and recommendations is available at www.cdc.gov/travel/.

y For vaccination of persons with immunodeficiencies, see

Table 8-1, Vaccination of persons with primary and secondary immunodeficiencies, in General Best Practice Guidelines for Immunization at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/ immunocompetence.html, and Immunization in Special Clinical Circumstances (In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds.

Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed.

Itasca, IL: American Academy of Pediatrics; 2018:67–111).

y For information about vaccination in the setting of a vaccine-

preventable disease outbreak, contact your state or local health department.

y The National Vaccine Injury Compensation Program (VICP) is a no-fault alternative to the traditional legal system for resolving vaccine injury claims. All routine child and adolescent vaccines are covered by VICP except for pneumococcal polysaccharide vaccine (PPSV23). For more information, see www.hrsa.gov/vaccinecompensation/index.html.

Dengue vaccination (minimum age: 9 years) Routine vaccination

y Age 9–16 years living in dengue endemic areas AND have laboratory

confirmation of previous dengue infection - 3-dose series administered at 0, 6, and 12 months y Endemic areas include Puerto Rico, American Samoa, US Virgin Islands, Federated States of Micronesia, Republic of Marshall Islands, and the Republic of Palau. For updated guidance on dengue endemic areas and pre-vaccination laboratory testing see www.cdc.gov/mmwr/ volumes/70/rr/rr7006a1.htm?s_cid=rr7006a1_w and www.cdc.gov/ dengue/vaccine/hcp/index.html

Diphtheria, tetanus, and pertussis (DTaP) vaccination (minimum age: 6 weeks [4 years for Kinrix® or Quadracel®]) Routine vaccination

y 5-dose series at age 2, 4, 6, 15–18 months, 4–6 years - Prospectively: Dose 4 may be administered as early as age 12 months if at least 6 months have elapsed since dose 3.

- Retrospectively: A 4th dose that was inadvertently administered as early as age 12 months may be counted if at least 4 months have elapsed since dose 3.

Catch-up vaccination

y Dose 5 is not necessary if dose 4 was administered at age 4 years or older and at least 6 months after dose 3.

y For other catch-up guidance, see Table 2.

Special situations

y Wound management in children less than age 7 years with history of

3 or more doses of tetanus-toxoid-containing vaccine: For all wounds except clean and minor wounds, administer DTaP if more than 5 years since last dose of tetanus-toxoid-containing vaccine. For detailed information, see www.cdc.gov/mmwr/volumes/67/rr/rr6702a1.htm.

Haemophilus influenzae type b vaccination (minimum age: 6 weeks) Routine vaccination

y ActHIB®, Hiberix®, Pentacel®, or Vaxelis®: 4-dose series (3 dose

primary series at age 2, 4, and 6 months, followed by a booster dose* at age 12–15 months) - *Vaxelis® is not recommended for use as a booster dose. A different Hib-containing vaccine should be used for the booster dose. y PedvaxHIB®: 3-dose series (2-dose primary series at age 2 and 4 months, followed by a booster dose at age 12–15 months)

Catch-up vaccination

y Dose 1 at age 7–11 months: Administer dose 2 at least 4 weeks later and dose 3 (final dose) at age 12–15 months or 8 weeks after dose 2 (whichever is later). y Dose 1 at age 12–14 months: Administer dose 2 (final dose) at least 8 weeks after dose 1.

22 Delaware Journal of Public Health - March 2022

y Dose 1 before age 12 months and dose 2 before age 15 months: Administer dose 3 (final dose) at least 8 weeks after dose 2.

y 2 doses of PedvaxHIB® before age 12 months: Administer dose 3 (final dose) at 12–59 months and at least 8 weeks after dose 2.

y 1 dose administered at age 15 months or older: No further doses needed

y Unvaccinated at age 15–59 months: Administer 1 dose. y Previously unvaccinated children age 60 months or older who

are not considered high risk: Do not require catch-up vaccination For other catch-up guidance, see Table 2. Vaxelis® can be used for catchup vaccination in children less than age 5 years. Follow the catch-up schedule even if Vaxelis® is used for one or more doses. For detailed information on use of Vaxelis® see www.cdc.gov/mmwr/volumes/69/ wr/mm6905a5.htm.

Special situations

y Chemotherapy or radiation treatment:

Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose Doses administered within 14 days of starting therapy or during therapy should be repeated at least 3 months after therapy completion. y Hematopoietic stem cell transplant (HSCT): - 3-dose series 4 weeks apart starting 6 to 12 months after successful transplant, regardless of Hib vaccination history y Anatomic or functional asplenia (including sickle cell disease): Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose Unvaccinated* persons age 5 years or older - 1 dose y Elective splenectomy: Unvaccinated* persons age 15 months or older - 1 dose (preferably at least 14 days before procedure) y HIV infection: Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose Unvaccinated* persons age 5–18 years - 1 dose y Immunoglobulin deficiency, early component complement deficiency: Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose *Unvaccinated = Less than routine series (through age 14 months) OR no doses (age 15 months or older)

Notes

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

Hepatitis A vaccination (minimum age: 12 months for routine vaccination) Routine vaccination

y 2-dose series (minimum interval: 6 months) at age 12–23 months

Catch-up vaccination

y Unvaccinated persons through age 18 years should complete a

2-dose series (minimum interval: 6 months). y Persons who previously received 1 dose at age 12 months or older should receive dose 2 at least 6 months after dose 1. y Adolescents age 18 years or older may receive the combined HepA and HepB vaccine, Twinrix®, as a 3-dose series (0, 1, and 6 months) or 4-dose series (3 doses at 0, 7, and 21–30 days, followed by a booster dose at 12 months).

International travel

y Persons traveling to or working in countries with high or intermediate endemic hepatitis A (www.cdc.gov/travel/): - Infants age 6–11 months: 1 dose before departure; revaccinate with 2 doses, separated by at least 6 months, between age 12–23 months.

- Unvaccinated age 12 months or older: Administer dose 1 as soon as travel is considered.

Hepatitis B vaccination (minimum age: birth) Birth dose (monovalent HepB vaccine only)

y Mother is HBsAg-negative: - All medically stable infants ≥2,000 grams: 1 dose within 24 hours of birth

- Infants <2,000 grams: Administer 1 dose at chronological age

1 month or hospital discharge (whichever is earlier and even if weight is still <2,000 grams). y Mother is HBsAg-positive: - Administer HepB vaccine and hepatitis B immune globulin (HBIG) (in separate limbs) within 12 hours of birth, regardless of birth weight. For infants <2,000 grams, administer 3 additional doses of vaccine (total of 4 doses) beginning at age 1 month.

- Test for HBsAg and anti-HBs at age 9–12 months. If HepB series is delayed, test 1–2 months after final dose. y Mother’s HBsAg status is unknown: - Administer HepB vaccine within 12 hours of birth, regardless of birth weight.

- For infants <2,000 grams, administer HBIG in addition to HepB vaccine (in separate limbs) within 12 hours of birth. Administer 3 additional doses of vaccine (total of 4 doses) beginning at age 1 month.

- Determine mother’s HBsAg status as soon as possible. If mother is HBsAg-positive, administer HBIG to infants ≥2,000 grams as soon as possible, but no later than 7 days of age.

Routine series

y 3-dose series at age 0, 1–2, 6–18 months (use monovalent HepB vaccine for doses administered before age 6 weeks)

y Infants who did not receive a birth dose should begin the series as soon as feasible (see Table 2).

y Administration of 4 doses is permitted when a combination vaccine

containing HepB is used after the birth dose. y Minimum age for the final (3rd or 4th ) dose: 24 weeks y Minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 8 weeks / dose 1 to dose 3: 16 weeks (when 4 doses are administered, substitute “dose 4” for “dose 3” in these calculations)

Catch-up vaccination

y Unvaccinated persons should complete a 3-dose series at 0, 1–2, 6 months.

y Adolescents age 11–15 years may use an alternative 2-dose

schedule with at least 4 months between doses (adult formulation Recombivax HB® only). y Adolescents age 18 years or older may receive a 2-dose series of HepB (Heplisav-B®) at least 4 weeks apart. y Adolescents age 18 years or older may receive the combined HepA and HepB vaccine, Twinrix®, as a 3-dose series (0, 1, and 6 months) or 4-dose series (3 doses at 0, 7, and 21–30 days, followed by a booster dose at 12 months). y For other catch-up guidance, see Table 2.

Special situations

y Revaccination is not generally recommended for persons with a

normal immune status who were vaccinated as infants, children, adolescents, or adults. y Post-vaccination serology testing and revaccination (if anti-HBs < 10mlU/mL) is recommended for certain populations, including: - Infants born to HBsAg-positive mothers - Hemodialysis patients - Other immunocompromised persons For detailed revaccination recommendations, see www.cdc.gov/ vaccines/hcp/acip-recs/vacc-specific/hepb.html.

Human papillomavirus vaccination (minimum age: 9 years) Routine and catch-up vaccination

y HPV vaccination routinely recommended at age 11–12 years (can

start at age 9 years) and catch-up HPV vaccination recommended for all persons through age 18 years if not adequately vaccinated y 2- or 3-dose series depending on age at initial vaccination: - Age 9–14 years at initial vaccination: 2-dose series at 0, 6–12 months (minimum interval: 5 months; repeat dose if administered too soon) - Age 15 years or older at initial vaccination: 3-dose series at 0, 1–2 months, 6 months (minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 12 weeks / dose 1 to dose 3: 5 months; repeat dose if administered too soon) y Interrupted schedules: If vaccination schedule is interrupted, the series does not need to be restarted. y No additional dose recommended when any HPV vaccine series has been completed using the recommended dosing intervals.

Special situations

y Immunocompromising conditions, including HIV infection:

3-dose series, even for those who initiate vaccination at age 9 through 14 years. y History of sexual abuse or assault: Start at age 9 years.

y Pregnancy: Pregnancy testing not needed before vaccination; HPV

vaccination not recommended until after pregnancy; no intervention needed if vaccinated while pregnant

Influenza vaccination (minimum age: 6 months [IIV], 2 years [LAIV4], 18 years [recombinant influenza vaccine, RIV4]) Routine vaccination

y Use any influenza vaccine appropriate for age and health status annually: - 2 doses, separated by at least 4 weeks, for children age 6 months–8 years who have received fewer than 2 influenza vaccine doses before July 1, 2021, or whose influenza vaccination history is unknown (administer dose 2 even if the child turns 9 between receipt of dose 1 and dose 2) - 1 dose for children age 6 months–8 years who have received at least 2 influenza vaccine doses before July 1, 2021 - 1 dose for all persons age 9 years or older y For the 2021-2022 season, see www.cdc.gov/mmwr/volumes/70/rr/ rr7005a1.htm. y For the 2022–23 season, see the 2022–23 ACIP influenza vaccine recommendations.

Special situations

y Egg allergy, hives only: Any influenza vaccine appropriate for age and health status annually

y Egg allergy with symptoms other than hives (e.g., angioedema,

respiratory distress) or required epinephrine or another emergency medical intervention: see Appendix listing contraindications and precautions y Severe allergic reaction (e.g., anaphylaxis) to a vaccine component or a previous dose of any influenza vaccine: see Appendix listing contraindications and precautions

Measles, mumps, and rubella vaccination (minimum age: 12 months for routine vaccination) Routine vaccination

y 2-dose series at age 12–15 months, age 4–6 years y MMR or MMRV may be administered

Note: For dose 1 in children age 12–47 months, it is recommended to administer MMR and varicella vaccines separately. MMRV may be used if parents or caregivers express a preference.

Catch-up vaccination

y Unvaccinated children and adolescents: 2-dose series at least 4 weeks apart

y The maximum age for use of MMRV is 12 years. y Minimum interval between MMRV doses: 3 months

Special situations International travel

y Infants age 6–11 months: 1 dose before departure; revaccinate with

2-dose series at age 12–15 months (12 months for children in high-risk areas) and dose 2 as early as 4 weeks later. y Unvaccinated children age 12 months or older: 2-dose series at least 4 weeks apart before departure

23

Notes

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

Meningococcal serogroup A,C,W,Y vaccination (minimum age: 2 months [MenACWY-CRM, Menveo], 9 months [MenACWY-D, Menactra], 2 years [MenACWY-TT, MenQuadfi]) Routine vaccination

y 2-dose series at age 11–12 years; 16 years

Catch-up vaccination

y Age 13–15 years: 1 dose now and booster at age 16–18 years (minimum interval: 8 weeks)

y Age 16–18 years: 1 dose

Special situations

Anatomic or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (e.g., eculizumab, ravulizumab) use: y Menveo - Dose 1 at age 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months) - Dose 1 at age 3–6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months) - Dose 1 at age 7–23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) - Dose 1 at age 24 months or older: 2-dose series at least 8 weeks apart y Menactra - Persistent complement component deficiency or complement inhibitor use: Age 9–23 months: 2-dose series at least 12 weeks apart Age 24 months or older: 2-dose series at least 8 weeks apart - Anatomic or functional asplenia, sickle cell disease, or HIV infection: Age 9–23 months: Not recommended Age 24 months or older: 2-dose series at least 8 weeks apart Menactra® must be administered at least 4 weeks after completion of PCV13 series. y MenQuadfi® - Dose 1 at age 24 months or older: 2-dose series at least 8 weeks apart Travel in countries with hyperendemic or epidemic meningococcal disease, including countries in the African meningitis belt or during the Hajj (www.cdc.gov/travel/): y Children less than age 24 months: - Menveo® (age 2–23 months) Dose 1 at age 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months) Dose 1 at age 3–6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months) Dose 1 at age 7–23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) - Menactra® (age 9–23 months) 2-dose series (dose 2 at least 12 weeks after dose 1; dose 2 may be administered as early as 8 weeks after dose 1 in travelers) y Children age 2 years or older: 1 dose Menveo®, Menactra®, or MenQuadfi® First-year college students who live in residential housing (if not previously vaccinated at age 16 years or older) or military recruits: y 1 dose Menveo®, Menactra®, or MenQuadfi®

24 Delaware Journal of Public Health - March 2022

Adolescent vaccination of children who received MenACWY prior to age 10 years: y Children for whom boosters are recommended because of an ongoing increased risk of meningococcal disease (e.g., those with complement deficiency, HIV, or asplenia): Follow the booster schedule for persons at increased risk. y Children for whom boosters are not recommended (e.g., a healthy child who received a single dose for travel to a country where meningococcal disease is endemic): Administer MenACWY according to the recommended adolescent schedule with dose 1 at age 11–12 years and dose 2 at age 16 years.

Note: Menactra® should be administered either before or at the same time as DTaP. MenACWY vaccines may be administered simultaneously with MenB vaccines if indicated, but at a different anatomic site, if feasible.

For MenACWY booster dose recommendations for groups listed under “Special situations” and in an outbreak setting and additional meningococcal vaccination information, see www.cdc.gov/mmwr/ volumes/69/rr/rr6909a1.htm.

Meningococcal serogroup B vaccination (minimum age: 10 years [MenB-4C, Bexsero®; MenB-FHbp, Trumenba®]) Shared clinical decision-making

y Adolescents not at increased risk age 16–23 years (preferred age

16–18 years) based on shared clinical decision-making: - Bexsero®: 2-dose series at least 1 month apart - Trumenba®: 2-dose series at least 6 months apart; if dose 2 is administered earlier than 6 months, administer a 3rd dose at least 4 months after dose 2.

Special situations

Anatomic or functional asplenia (including sickle cell disease), persistent complement component deficiency, complement inhibitor (e.g., eculizumab, ravulizumab) use: y Bexsero®: 2-dose series at least 1 month apart y Trumenba®: 3-dose series at 0, 1–2, 6 months Note: Bexsero® and Trumenba® are not interchangeable; the same product should be used for all doses in a series.

For MenB booster dose recommendations for groups listed under “Special situations” and in an outbreak setting and additional meningococcal vaccination information, see www.cdc.gov/mmwr/ volumes/69/rr/rr6909a1.htm.

Pneumococcal vaccination (minimum age: 6 weeks [PCV13], 2 years [PPSV23]) Routine vaccination with PCV13

y 4-dose series at age 2, 4, 6, 12–15 months

Catch-up vaccination with PCV13

y 1 dose for healthy children age 24–59 months with any incomplete* PCV13 series

y For other catch-up guidance, see Table 2.

Special situations

Underlying conditions below: When both PCV13 and PPSV23 are indicated, administer PCV13 first. PCV13 and PPSV23 should not be administered during same visit.

Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure); chronic lung disease (including asthma treated with high-dose, oral corticosteroids); diabetes mellitus: Age 2–5 years y Any incomplete* series with: - 3 PCV13 doses: 1 dose PCV13 (at least 8 weeks after any prior PCV13 dose) - Less than 3 PCV13 doses: 2 doses PCV13 (8 weeks after the most recent dose and administered 8 weeks apart) y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after completing all recommended PCV13 doses) Age 6–18 years y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after completing all recommended PCV13 doses) Cerebrospinal fluid leak, cochlear implant: Age 2–5 years y Any incomplete* series with: - 3 PCV13 doses: 1 dose PCV13 (at least 8 weeks after any prior PCV13 dose) - Less than 3 PCV13 doses: 2 doses PCV13 (8 weeks after the most recent dose and administered 8 weeks apart) y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after any prior PCV13 dose) Age 6–18 years y No history of either PCV13 or PPSV23: 1 dose PCV13, 1 dose PPSV23 at least 8 weeks later y Any PCV13 but no PPSV23: 1 dose PPSV23 at least 8 weeks after the most recent dose of PCV13 y PPSV23 but no PCV13: 1 dose PCV13 at least 8 weeks after the most recent dose of PPSV23 Sickle cell disease and other hemoglobinopathies; anatomic or functional asplenia; congenital or acquired immunodeficiency; HIV infection; chronic renal failure; nephrotic syndrome; malignant neoplasms, leukemias, lymphomas, Hodgkin disease, and other diseases associated with treatment with immunosuppressive drugs or radiation therapy; solid organ transplantation; multiple myeloma: Age 2–5 years y Any incomplete* series with: - 3 PCV13 doses: 1 dose PCV13 (at least 8 weeks after any prior PCV13 dose) - Less than 3 PCV13 doses: 2 doses PCV13 (8 weeks after the most recent dose and administered 8 weeks apart) y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after any prior PCV13 dose) and a dose 2 of PPSV23 5 years later Age 6–18 years y No history of either PCV13 or PPSV23: 1 dose PCV13, 2 doses PPSV23 (dose 1 of PPSV23 administered 8 weeks after PCV13 and dose 2 of PPSV23 administered at least 5 years after dose 1 of PPSV23) y Any PCV13 but no PPSV23: 2 doses PPSV23 (dose 1 of PPSV23 administered 8 weeks after the most recent dose of PCV13 and dose 2 of PPSV23 administered at least 5 years after dose 1 of PPSV23) y PPSV23 but no PCV13: 1 dose PCV13 at least 8 weeks after the most recent PPSV23 dose and a dose 2 of PPSV23 administered 5 years after dose 1 of PPSV23 and at least 8 weeks after a dose of PCV13

Notes

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

Chronic liver disease, alcoholism: Age 6–18 years y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after any prior PCV13 dose) *Incomplete series = Not having received all doses in either the recommended series or an age-appropriate catch-up series See Tables 8, 9, and 11 in the ACIP pneumococcal vaccine recommendations (www.cdc.gov/mmwr/pdf/rr/rr5911.pdf) for complete schedule details.

Poliovirus vaccination (minimum age: 6 weeks) Routine vaccination

y 4-dose series at ages 2, 4, 6–18 months, 4–6 years; administer the

Catch-up vaccination

y Do not start the series on or after age 15 weeks, 0 days. y The maximum age for the final dose is 8 months, 0 days. y For other catch-up guidance, see Table 2.

Tetanus, diphtheria, and pertussis (Tdap) vaccination (minimum age: 11 years for routine vaccination, 7 years for catch-up vaccination) Routine vaccination

y Adolescents age 11–12 years: 1 dose Tdap y Pregnancy: 1 dose Tdap during each pregnancy, preferably in early part of gestational weeks 27–36.

final dose on or after age 4 years and at least 6 months after the previous dose. y 4 or more doses of IPV can be administered before age 4 years when a combination vaccine containing IPV is used. However, a dose is still recommended on or after age 4 years and at least 6 months after the previous dose.

y Tdap may be administered regardless of the interval since the last

Catch-up vaccination

Tdap as part of the catch-up series (preferably the first dose); if additional doses are needed, use Td or Tdap. y Tdap administered at age 7–10 years: - Children age 7–9 years who receive Tdap should receive the routine Tdap dose at age 11–12 years.

- Children age 10 years who receive Tdap do not need the routine Tdap dose at age 11–12 years. y DTaP inadvertently administered on or after age 7 years: - Children age 7–9 years: DTaP may count as part of catch-up series. Administer routine Tdap dose at age 11–12 years.

- Children age 10–18 years: Count dose of DTaP as the adolescent Tdap booster. y For other catch-up guidance, see Table 2.

y In the first 6 months of life, use minimum ages and intervals only for travel to a polio-endemic region or during an outbreak.

y IPV is not routinely recommended for U.S. residents age 18 years or older.

Series containing oral polio vaccine (OPV), either mixed OPV-IPV or OPV-only series: y Total number of doses needed to complete the series is the same as that recommended for the U.S. IPV schedule. See www.cdc.gov/ mmwr/volumes/66/wr/mm6601a6.htm?s_%20cid=mm6601a6_w. y Only trivalent OPV (tOPV) counts toward the U.S. vaccination requirements.

- Doses of OPV administered before April 1, 2016, should be counted (unless specifically noted as administered during a campaign).

- Doses of OPV administered on or after April 1, 2016, should not be counted.

- For guidance to assess doses documented as “OPV,” see www.cdc.gov/mmwr/volumes/66/wr/mm6606a7.htm?s_ cid=mm6606a7_w. y For other catch-up guidance, see Table 2.

Rotavirus vaccination (minimum age: 6 weeks) Routine vaccination

y Rotarix®: 2-dose series at age 2 and 4 months y RotaTeq®: 3-dose series at age 2, 4, and 6 months y If any dose in the series is either RotaTeq® or unknown, default to

tetanus- and diphtheria-toxoid-containing vaccine.

Catch-up vaccination

y Adolescents age 13–18 years who have not received Tdap: 1 dose Tdap, then Td or Tdap booster every 10 years

y Persons age 7–18 years not fully vaccinated* with DTaP: 1 dose

Varicella vaccination (minimum age: 12 months) Routine vaccination

y 2-dose series at age 12–15 months, 4–6 years y VAR or MMRV may be administered* y Dose 2 may be administered as early as 3 months after dose 1

(a dose inadvertently administered after at least 4weeks may be counted as valid) *Note: For dose 1 in children age 12–47 months, it is recommended to administer MMR and varicella vaccines separately. MMRV may be used if parents or caregivers express a preference.

Catch-up vaccination

y Ensure persons age 7–18 years without evidence of immunity (see

MMWR at www.cdc.gov/mmwr/pdf/rr/rr5604.pdf) have a 2-dose series: - Age 7–12 years: routine interval: 3 months (a dose inadvertently administered after at least 4 weeks may be counted as valid) - Age 13 years and older: routine interval: 4–8 weeks (minimum interval: 4 weeks) - The maximum age for use of MMRV is 12 years.

Special situations

y Wound management in persons age 7 years or older with history

of 3 or more doses of tetanus-toxoid-containing vaccine: For clean and minor wounds, administer Tdap or Td if more than 10 years since last dose of tetanus-toxoid-containing vaccine; for all other wounds, administer Tdap or Td if more than 5 years since last dose of tetanus-toxoid-containing vaccine. Tdap is preferred for persons age 11 years or older who have not previously received Tdap or whose Tdap history is unknown. If a tetanus-toxoid-containing vaccine is indicated for a pregnant adolescent, use Tdap. y For detailed information, see www.cdc.gov/mmwr/volumes/69/wr/ mm6903a5.htm. *Fully vaccinated = 5 valid doses of DTaP OR 4 valid doses of DTaP if dose 4 was administered at age 4 years or older

3-dose series.

2/17/2022

Centers for Disease Control and Prevention | Recommended Child and Adolescent Immunization Schedule, United States, 2022

25

Appendix

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

Guide to Contraindications and Precautions to Commonly Used Vaccines Adapted from Table 4-1 in Advisory Committee on Immunization Practices (ACIP) General Best Practice Guidelines for Immunization: Contraindication and Precautions available at www.cdc.gov/vaccines/hcp/aciprecs/general-recs/contraindications.html and ACIP’s Recommendations for the Prevention and Control of 2021-22 seasonal influenza with Vaccines available at www.cdc.gov/mmwr/volumes/70/rr/rr7005a1.htm.

Interim clinical considerations for use of COVID-19 vaccines including contraindications and precautions can be found at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html Vaccine

Contraindications1

Precautions2

Influenza, egg-based, inactivated injectable (IIV4)

• Severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV of any valency) • Severe allergic reaction (e.g., anaphylaxis) to any vaccine component3 (excluding egg)

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Persons with egg allergy with symptoms other than hives (e.g., angioedema, respiratory distress) or required epinephrine or another emergency medical intervention: Any influenza vaccine appropriate for age and health status may be administered. If using egg-based IIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Moderate or severe acute illness with or without fever

Influenza, cell culture-based inactivated injectable [(ccIIV4), Flucelvax® Quadrivalent]

• Severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency, or to any component3 of ccIIV4

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Persons with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any egg-based IIV, RIV, or LAIV of any valency. If using ccIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Moderate or severe acute illness with or without fever

Influenza, recombinant injectable [(RIV4), Flublok® Quadrivalent]

• Severe allergic reaction (e.g., anaphylaxis) to any RIV of any valency, or to any component3 of RIV4

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Persons with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any egg- based IIV, ccIIV, or LAIV of any valency. If using RIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Moderate or severe acute illness with or without fever

Influenza, live attenuated [LAIV4, Flumist® Quadrivalent]

• Severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV of any valency) • Severe allergic reaction (e.g., anaphylaxis) to any vaccine component3 (excluding egg) • Children age 2 – 4 years with a history of asthma or wheezing • Anatomic or functional asplenia • Immunocompromised due to any cause including, but not limited to, medications and HIV infection • Close contacts or caregivers of severely immunosuppressed persons who require a protected environment • Pregnancy • Cochlear implant • Active communication between the cerebrospinal fluid (CSF) and the oropharynx, nasopharynx, nose, ear or any other cranial CSF leak • Children and adolescents receiving aspirin or salicylate-containing medications • Received influenza antiviral medications oseltamivir or zanamivir within the previous 48 hours, peramivir within the previous 5 days, or baloxavir within the previous 17 days

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Asthma in persons aged 5 years old or older • Persons with egg allergy with symptoms other than hives (e.g., angioedema, respiratory distress) or required epinephrine or another emergency medical intervention: Any influenza vaccine appropriate for age and health status may be administered. If using LAIV4 (which is egg based), administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Persons with underlying medical conditions (other than those listed under contraindications) that might predispose to complications after wild-type influenza virus infection [e.g., chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)] • Moderate or severe acute illness with or without fever

When a contraindication is present, a vaccine should NOT be administered. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/ contraindications.html 2. When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html 3. Vaccination providers should check FDA-approved prescribing information for the most complete and updated information, including contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at www.fda.gov/vaccines-blood-biologics/approved-products/vaccines-licensed-use-united-states 1.

26 Delaware Journal of Public Health - March 2022

Appendix

Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022

Vaccine

Contraindications1

Precautions2

Dengue (DEN4CYD)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component • Severe immunodeficiency (e.g., hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long- term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised)

• Pregnancy • HIV infection without evidence of severe immunosuppression • Moderate or severe acute illness with or without fever

Diphtheria, tetanus, pertussis (DTaP) Tetanus, diphtheria (DT)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For DTaP only: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) not attributable to another identifiable cause within 7 days of administration of previous dose of DTP or DTaP

• Guillain-Barré syndrome (GBS) within 6 weeks after previous dose of tetanus-toxoid–containing vaccine • History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid— containing or tetanus-toxoid– containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid- containing vaccine • For DTaP only: Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy; defer DTaP until neurologic status clarified and stabilized • Moderate or severe acute illness with or without fever

Haemophilus influenzae type b (Hib)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For Hiberix, ActHib, and PedvaxHIB only: History of severe allergic reaction to dry natural latex • Less than age 6 weeks

• Moderate or severe acute illness with or without fever

Hepatitis A (HepA)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 including neomycin

• Moderate or severe acute illness with or without fever

Hepatitis B (HepB)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 including yeast • For Heplisav-B only: Pregnancy

• Moderate or severe acute illness with or without fever

Hepatitis A- Hepatitis B vaccine [HepA-HepB, (Twinrix®)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 including neomycin and yeast

• Moderate or severe acute illness with or without fever

Human papillomavirus (HPV)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

• Moderate or severe acute illness with or without fever

Measles, mumps, rubella (MMR)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe immunodeficiency (e.g., hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised) • Pregnancy • Family history of altered immunocompetence, unless verified clinically or by laboratory testing as immunocompetent

• • • •

Meningococcal ACWY (MenACWY) [MenACWY-CRM (Menveo®); MenACWY-D (Menactra®); MenACWY-TT (MenQuadfi®)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For MenACWY-D and Men ACWY-CRM only: severe allergic reaction to any diphtheria toxoid– or CRM197– containing vaccine • For MenACWY-TT only: severe allergic reaction to a tetanus toxoid-containing vaccine

• For MenACWY-CRM only: Preterm birth if less than age 9 months • Moderate or severe acute illness with or without fever

Meningococcal B (MenB) [MenB-4C (Bexsero®); MenB-FHbp (Trumenba®)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Pregnancy • For MenB-4C only: Latex sensitivity • Moderate or severe acute illness with or without fever

Pneumococcal conjugate (PCV13)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe allergic reaction (e.g., anaphylaxis) to any diphtheria-toxoid– containing vaccine or its component3

• Moderate or severe acute illness with or without fever

Pneumococcal polysaccharide (PPSV23)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Moderate or severe acute illness with or without fever

Poliovirus vaccine, inactivated (IPV)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Pregnancy • Moderate or severe acute illness with or without fever

Rotavirus (RV) [RV1 (Rotarix®), RV5 (RotaTeq®)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe combined immunodeficiency (SCID) • History of intussusception

• • • •

Tetanus, diphtheria, and acellular pertussis (Tdap) Tetanus, diphtheria (Td)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For Tdap only: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) not attributable to another identifiable cause within 7 days of administration of previous dose of DTP, DTaP, or Tdap

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of tetanus-toxoid–containing vaccine • History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid— containing or tetanus-toxoid– containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid– containing vaccine • For Tdap only: Progressive or unstable neurological disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized • Moderate or severe acute illness with or without fever

Varicella (VAR)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe immunodeficiency (e.g., hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long- term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised) • Pregnancy • Family history of altered immunocompetence, unless verified clinically or by laboratory testing as immunocompetent

• Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product) • Receipt of specific antiviral drugs (acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination (avoid use of these antiviral drugs for 14 days after vaccination) • Use of aspirin or aspirin-containing products • Moderate or severe acute illness with or without fever

3

3

Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product) History of thrombocytopenia or thrombocytopenic purpura Need for tuberculin skin testing or interferon-gamma release assay (IGRA) testing Moderate or severe acute illness with or without fever

Altered immunocompetence other than SCID Chronic gastrointestinal disease RV1 only: Spina bifida or bladder exstrophy Moderate or severe acute illness with or without fever

1. When a contraindication is present, a vaccine should NOT be administered. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html 2. When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction. Kroger A, Bahta L, Hunter P. ACIP General Best Practice

Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html

3. Vaccination providers should check FDA-approved prescribing information for the most complete and updated information, including contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at

www.fda.gov/vaccines-blood-biologics/approved-products/vaccines-licensed-use-united-states.

27

Recommended Adult Immunization Schedule for ages 19 years or older

How to use the adult immunization schedule

1

Determine recommended vaccinations by age (Table 1)

2

Assess need for additional recommended vaccinations by medical condition or other indication (Table 2)

3

Review vaccine types, frequencies, intervals, and considerations for special situations (Notes)

4

Review contraindications and precautions for vaccine types (Appendix)

UNITED STATES

2022

Recommended by the Advisory Committee on Immunization Practices (www.cdc.gov/vaccines/acip) and approved by the Centers for Disease Control and Prevention (www.cdc.gov), American College of Physicians (www.acponline.org), American Academy of Family Physicians (www.aafp. org), American College of Obstetricians and Gynecologists (www.acog.org), American College of Nurse-Midwives (www.midwife.org), and American Academy of Physician Associates (www.aapa.org), and Society for Healthcare Epidemiology of America (www.shea-online.org).

Report

Vaccines in the Adult Immunization Schedule* Vaccine

Abbreviation(s)

Trade name(s)

Haemophilus influenzae type b vaccine

Hib

ActHIB® Hiberix® PedvaxHIB®

y Suspected cases of reportable vaccine-preventable diseases or outbreaks to the local or state health department y Clinically significant postvaccination reactions to the Vaccine Adverse Event Reporting System at www.vaers.hhs.gov or 800-822-7967

Injury claims All vaccines included in the adult immunization schedule except pneumococcal 23-valent polysaccharide (PPSV23) and zoster (RZV) vaccines are covered by the Vaccine Injury Compensation Program. Information on how to file a vaccine injury claim is available at www.hrsa.gov/vaccinecompensation.

Hepatitis A vaccine

HepA

Havrix® Vaqta®

Hepatitis A and hepatitis B vaccine

HepA-HepB

Twinrix®

Hepatitis B vaccine

HepB

Engerix-B® Recombivax HB® Heplisav-B®

Human papillomavirus vaccine

HPV

Gardasil 9®

Influenza vaccine (inactivated)

IIV4

Many brands

Influenza vaccine (live, attenuated)

LAIV4

FluMist® Quadrivalent

Influenza vaccine (recombinant)

RIV4

Flublok® Quadrivalent

Helpful information

Measles, mumps, and rubella vaccine

MMR

M-M-R II®

Meningococcal serogroups A, C, W, Y vaccine

MenACWY-D MenACWY-CRM MenACWY-TT

Menactra® Menveo® MenQuadfi®

Meningococcal serogroup B vaccine

MenB-4C MenB-FHbp

Bexsero® Trumenba®

Pneumococcal 15-valent conjugate vaccine

PCV15

Vaxneuvance™

Pneumococcal 20-valent conjugate vaccine

PCV20

Prevnar 20™

Pneumococcal 23-valent polysaccharide vaccine

PPSV23

Pneumovax 23®

Tetanus and diphtheria toxoids

Td

Tenivac® Tdvax™

Tetanus and diphtheria toxoids and acellular pertussis vaccine

Tdap

Adacel® Boostrix®

y Complete Advisory Committee on Immunization Practices (ACIP) recommendations: www.cdc.gov/vaccines/hcp/acip-recs/index.html y General Best Practice Guidelines for Immunization (including contraindications and precautions): www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html y Vaccine information statements: www.cdc.gov/vaccines/hcp/vis/index.html y Manual for the Surveillance of Vaccine-Preventable Diseases (including case identification and outbreak response): www.cdc.gov/vaccines/pubs/surv-manual y Travel vaccine recommendations: www.cdc.gov/travel y Recommended Child and Adolescent Immunization Schedule, United States, 2022: www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html y ACIP Shared Clinical Decision-Making Recommendations: Scan QR code for access to www.cdc.gov/vaccines/acip/acip-scdm-faqs.html

Varicella vaccine

VAR

Varivax®

Zoster vaccine, recombinant

RZV

Shingrix

Questions or comments Contact www.cdc.gov/cdc-info or 800-CDC-INFO (800-232-4636), in English or Spanish, 8 a.m.–8 p.m. ET, Monday through Friday, excluding holidays.

Download the CDC Vaccine Schedules app for providers at www.cdc.gov/vaccines/schedules/hcp/schedule-app.html.

online schedule

*Administer recommended vaccines if vaccination history is incomplete or unknown. Do not restart or add doses to vaccine series if there are extended intervals between doses. The use of trade names is for identification purposes only and does not imply endorsement by the ACIP or CDC. CS310021-A

28 Delaware Journal of Public Health - March 2022

Table 1

Recommended Adult Immunization Schedule by Age Group, United States, 2022

Vaccine

19–26 years

27–49 years

Influenza inactivated (IIV4) or Influenza recombinant (RIV4) or Influenza live, attenuated (LAIV4)

or 1 dose annually 1 dose Tdap each pregnancy; 1 dose Td/Tdap for wound management (see notes) 1 dose Tdap, then Td or Tdap booster every 10 years

Measles, mumps, rubella (MMR)

Zoster recombinant (RZV) Human papillomavirus (HPV)

1 or 2 doses depending on indication (if born in 1957 or later) 2 doses (if born in 1980 or later)

2 or 3 doses depending on age at initial vaccination or condition

27 through 45 years 1 dose PCV15 followed by PPSV23 OR 1 dose PCV20

2 or 3 doses depending on vaccine 2, 3,on orvaccine 4 dosesor depending 2, 3, or 4 doses depending condition on vaccine or condition

Meningococcal A, C, W, Y (MenACWY)

1 or 2 doses depending on indication, see notes for booster recommendations 2 or 3 doses depending on vaccine and indication, see notes for booster recommendations 19 through 23 years

Haemophilus influenzae type b (Hib)



2 doses

1 dose PCV15 followed by PPSV23 OR 1 dose PCV20 (see notes)

Hepatitis A (HepA)

Meningococcal B (MenB)

2 doses

2 doses for immunocompromising conditions (see notes)

Pneumococcal (PCV15, PCV20, PPSV23)

Hepatitis B (HepB)

≥65 years

1 dose annually

Tetanus, diphtheria, pertussis (Tdap or Td)

Varicella (VAR)

50–64 years

Recommended vaccination for adults who meet age requirement, lack documentation of vaccination, or lack evidence of past infection

1 or 3 doses depending on indication



Recommended vaccination for adults with an additional risk factor or another indication



Recommended vaccination based on shared clinical decision-making



No recommendation/ Not applicable

29

Table 2 Vaccine

Recommended Adult Immunization Schedule by Medical Condition or Other Indication, United States, 2022 Pregnancy

Immunocompromised (excluding HIV infection)

HIV infection CD4 percentage and count ≥15% and ≥200 mm3

<15% or <200 mm3

End-stage Asplenia, Heart or Chronic liver renal complement lung disease; disease disease, or on deficiencies alcoholism1 hemodialysis

IIV4 or RIV4 or

1 dose Tdap each pregnancy

MMR

Contraindicated*

Contraindicated

VAR

Contraindicated*

Contraindicated

Not Recommended*

Precaution

1 or 2 doses depending on indication 2 doses

2 doses at age ≥19 years

2 doses at age ≥50 years

3 doses through age 26 years

2 or 3 doses through age 26 years depending on age at initial vaccination or condition

Pneumococcal (PCV15, PCV20, PPSV23)

1 dose PCV15 followed by PPSV23 OR 1 dose PCV20 (see notes) 2 or 3 doses depending on vaccine

HepA 3 doses (see notes)

2, 3, or 4 doses depending on vaccine or condition 1 or 2 doses depending on indication, see notes for booster recommendations

MenACWY Precaution

2 or 3 doses depending on vaccine and indication, see notes for booster recommendations 3 doses HSCT3 recipients only

Hib



1 dose annually

1 dose Tdap, then Td or Tdap booster every 10 years

RZV

MenB

Men who have sex with men

or Contraindicated

Tdap or Td

HepB

Health care personnel2

1 dose annually

LAIV4

HPV

Diabetes

Recommended vaccination for adults who meet age requirement, lack documentation of vaccination, or lack evidence of past infection



Recommended vaccination for adults with an additional risk factor or another indication

1 dose



Recommended vaccination based on shared clinical decision-making



Precaution—vaccination might be indicated if benefit of protection outweighs risk of adverse reaction



Contraindicated or not recommended—vaccine should not be administered. *Vaccinate after pregnancy.

1. Precaution for LAIV4 does not apply to alcoholism. 2. See notes for influenza; hepatitis B; measles, mumps, and rubella; and varicella vaccinations. 3. Hematopoietic stem cell transplant.

30 Delaware Journal of Public Health - March 2022



No recommendation/ Not applicable

Notes

Recommended Adult Immunization Schedule for ages 19 years or older, United States, 2022

For vaccine recommendations for persons 18 years of age or younger, see the Recommended Child and Adolescent Immunization Schedule.

COVID-19 Vaccination COVID-19 vaccines are recommended within the scope of the Emergency Use Authorization or Biologics License Application for the particular vaccine. ACIP recommendations for the use of COVID-19 vaccines can be found at www.cdc.gov/ vaccines/hcp/acip-recs/vacc-specific/covid-19.html.

CDC’s interim clinical considerations for use of COVID-19 vaccines can be found at www.cdc.gov/ vaccines/covid-19/clinical-considerations/covid-19vaccines-us.html.

Haemophilus influenzae type b vaccination Special situations y Anatomical or functional asplenia (including sickle cell disease): 1 dose if previously did not receive Hib; if elective splenectomy, 1 dose, preferably at least 14 days before splenectomy y Hematopoietic stem cell transplant (HSCT): 3-dose series 4 weeks apart starting 6–12 months after successful transplant, regardless of Hib vaccination history

Hepatitis A vaccination Routine vaccination y Not at risk but want protection from hepatitis A (identification of risk factor not required): 2-dose series HepA (Havrix 6–12 months apart or Vaqta 6–18 months apart [minimum interval: 6 months]) or 3-dose series HepAHepB (Twinrix at 0, 1, 6 months [minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 5 months])

Special situations y At risk for hepatitis A virus infection: 2-dose series HepA or 3-dose series HepA-HepB as above - Chronic liver disease (e.g., persons with hepatitis B, hepatitis C, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal)

- HIV infection - Men who have sex with men - Injection or noninjection drug use - Persons experiencing homelessness - Work with hepatitis A virus in research laboratory or with nonhuman primates with hepatitis A virus infection - Travel in countries with high or intermediate endemic hepatitis A (HepA-HepB [Twinrix] may be administered on an accelerated schedule of 3 doses at 0, 7, and 21–30 days, followed by a booster dose at 12 months) - Close, personal contact with international adoptee (e.g., household or regular babysitting) in first 60 days after arrival from country with high or intermediate endemic hepatitis A (administer dose 1 as soon as adoption is planned, at least 2 weeks before adoptee’s arrival) - Pregnancy if at risk for infection or severe outcome from infection during pregnancy - Settings for exposure, including health care settings targeting services to injection or noninjection drug users or group homes and nonresidential day care facilities for developmentally disabled persons (individual risk factor screening not required)

Hepatitis B vaccination Routine vaccination y Age 19 through 59 years: complete a 2- or 3-, or 4-dose series - 2-dose series only applies when 2 doses of Heplisav-B* are used at least 4 weeks apart - 3-dose series Engerix-B or Recombivax HB at 0, 1, 6 months [minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 8 weeks / dose 1 to dose 3: 16 weeks]) - 3-dose series HepA-HepB (Twinrix at 0, 1, 6 months [minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 5 months]) - 4-dose series HepA-HepB (Twinrix) accelerated schedule of 3 doses at 0, 7, and 21–30 days, followed by a booster dose at 12 months - 4-dose series Engerix-B at 0, 1, 2, and 6 months for persons on adult hemodialysis (note: each dosage is double that of normal adult dose, i.e., 2 mL instead of 1 mL)

*Note: Heplisav-B not recommended in pregnancy due to lack of safety data in pregnant women

Special situations y Age 60 years or older* and at risk for hepatitis B virus infection: 2-dose (Heplisav-B) or 3-dose (Engerix-B, Recombivax HB) series or 3-dose series HepA-HepB (Twinrix) as above - Chronic liver disease (e.g., persons with hepatitis C, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice upper limit of normal) - HIV infection - Sexual exposure risk (e.g., sex partners of hepatitis B surface antigen [HBsAg]-positive persons; sexually active persons not in mutually monogamous relationships; persons seeking evaluation or treatment for a sexually transmitted infection; men who have sex with men) - Current or recent injection drug use - Percutaneous or mucosal risk for exposure to blood (e.g., household contacts of HBsAg-positive persons; residents and staff of facilities for developmentally disabled persons; health care and public safety personnel with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids; hemodialysis, peritoneal dialysis, home dialysis, and predialysis patients; patients with diabetes) - Incarcerated persons - Travel in countries with high or intermediate endemic hepatitis B

*Note: Anyone age 60 years or older who does not meet risk-based recommendations may still receive Hepatitis B vaccination.

Human papillomavirus vaccination Routine vaccination y HPV vaccination recommended for all persons through age 26 years: 2- or 3-dose series depending on age at initial vaccination or condition: - Age 15 years or older at initial vaccination: 3-dose series at 0, 1–2 months, 6 months (minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 12 weeks / dose 1 to dose 3: 5 months; repeat dose if administered too soon) - Age 9–14 years at initial vaccination and received 1 dose or 2 doses less than 5 months apart: 1 additional dose - Age 9–14 years at initial vaccination and received 2 doses at least 5 months apart: HPV vaccination series complete, no additional dose needed

31

Notes

Recommended Adult Immunization Schedule, United States, 2022

y Interrupted schedules: If vaccination schedule is interrupted, the series does not need to be restarted y No additional dose recommended when any HPV vaccine series has been completed using the recommended dosing intervals.

Shared clinical decision-making y Some adults age 27–45 years: Based on shared clinical decision-making, 2- or 3-dose series as above

Special situations y Age ranges recommended above for routine and catchup vaccination or shared clinical decision-making also apply in special situations - Immunocompromising conditions, including HIV infection: 3-dose series, even for those who initiate vaccination at age 9 through 14 years.

- Pregnancy: Pregnancy testing is not needed before vaccination; HPV vaccination is not recommended until after pregnancy; no intervention needed if inadvertently vaccinated while pregnant

Influenza vaccination Routine vaccination y Age 19 years or older: 1 dose any influenza vaccine appropriate for age and health status annually y For the 2021–2022 season, see www.cdc.gov/mmwr/ volumes/70/rr/rr7005a1.htm y For the 2022–23 season, see the 2022–23 ACIP influenza vaccine recommendations.

Special situations y Egg allergy, hives only: any influenza vaccine appropriate for age and health status annually y Egg allergy–any symptom other than hives (e.g., angioedema, respiratory distress) or required epinephrine or another emergency medical intervention: see Appendix listing contraindications and precautions y Severe allergic reaction (e.g., anaphylaxis) to a vaccine component or a previous dose of any influenza vaccine: see Appendix listing contraindications and precautions y History of Guillain-Barré syndrome within 6 weeks after previous dose of influenza vaccine: Generally, should not be vaccinated unless vaccination benefits outweigh risks for those at higher risk for severe complications from influenza

32 Delaware Journal of Public Health - March 2022

Measles, mumps, and rubella vaccination

Meningococcal vaccination

Routine vaccination

Special situations for MenACWY

y No evidence of immunity to measles, mumps, or rubella: 1 dose - Evidence of immunity: Born before 1957 (health care personnel, see below), documentation of receipt of MMR vaccine, laboratory evidence of immunity or disease (diagnosis of disease without laboratory confirmation is not evidence of immunity)

y Anatomical or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (e.g., eculizumab, ravulizumab) use: 2-dose series MenACWY-D (Menactra, Menveo, or MenQuadfi) at least 8 weeks apart and revaccinate every 5 years if risk remains y Travel in countries with hyperendemic or epidemic meningococcal disease, or microbiologists routinely exposed to Neisseria meningitidis: 1 dose MenACWY (Menactra, Menveo, or MenQuadfi) and revaccinate every 5 years if risk remains y First-year college students who live in residential housing (if not previously vaccinated at age 16 years or older) or military recruits: 1 dose MenACWY (Menactra, Menveo, or MenQuadfi) y For MenACWY booster dose recommendations for groups listed under “Special situations” and in an outbreak setting (e.g., in community or organizational settings and among men who have sex with men) and additional meningococcal vaccination information, see www.cdc.gov/ mmwr/volumes/69/rr/rr6909a1.htm

Special situations y Pregnancy with no evidence of immunity to rubella: MMR contraindicated during pregnancy; after pregnancy (before discharge from health care facility), 1 dose y Nonpregnant women of childbearing age with no evidence of immunity to rubella: 1 dose y HIV infection with CD4 percentages ≥15% and CD4 count ≥200 cells/mm3 for at least 6 months and no evidence of immunity to measles, mumps, or rubella: 2-dose series at least 4 weeks apart; MMR contraindicated for HIV infection with CD4 percentage <15% or CD4 count <200 cells/mm3 y Severe immunocompromising conditions: MMR contraindicated y Students in postsecondary educational institutions, international travelers, and household or close, personal contacts of immunocompromised persons with no evidence of immunity to measles, mumps, or rubella: 2-dose series at least 4 weeks apart if previously did not receive any doses of MMR or 1 dose if previously received 1 dose MMR y Health care personnel: - Born before 1957 with no evidence of immunity to measles, mumps, or rubella: Consider 2-dose series at least 4 weeks apart for measles or mumps or 1 dose for rubella - Born in 1957 or later with no evidence of immunity to measles, mumps, or rubella: 2-dose series at least 4 weeks apart for measles or mumps or at least 1 dose for rubella

Shared clinical decision-making for MenB y Adolescents and young adults age 16–23 years (age 16–18 years preferred) not at increased risk for meningococcal disease: Based on shared clinical decisionmaking, 2-dose series MenB-4C (Bexsero) at least 1 month apart or 2-dose series MenB-FHbp (Trumenba) at 0, 6 months (if dose 2 was administered less than 6 months after dose 1, administer dose 3 at least 4 months after dose 2); MenB-4C and MenB-FHbp are not interchangeable (use same product for all doses in series)

Special situations for MenB y Anatomical or functional asplenia (including sickle cell disease), persistent complement component deficiency, complement inhibitor (e.g., eculizumab, ravulizumab) use, or microbiologists routinely exposed to Neisseria meningitidis: y 2-dose primary series MenB-4C (Bexsero) at least 1 month apart or 3-dose primary series MenB-FHbp (Trumenba) at 0, 1–2, 6 months (if dose 2 was administered at least 6 months after dose 1, dose 3 not needed); MenB-4C and MenB-FHbp are not interchangeable (use same product for all doses in series); 1 dose MenB booster 1 year after primary series and revaccinate every 2–3 years if risk remains

Notes

Recommended Adult Immunization Schedule, United States, 2022

y Pregnancy: Delay MenB until after pregnancy unless at increased risk and vaccination benefits outweigh potential risks y For MenB booster dose recommendations for groups listed under “Special situations” and in an outbreak setting (e.g., in community or organizational settings and among men who have sex with men) and additional meningococcal vaccination information, see www.cdc.gov/ mmwr/volumes/69/rr/rr6909a1.htm

Note: MenB vaccines may be administered simultaneously with MenACWY vaccines if indicated, but at a different anatomic site, if feasible.

Pneumococcal vaccination Routine vaccination

y Age 65 years or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown: 1 dose PCV15 or 1 dose PCV20. If PCV15 is used, this should be followed by a dose of PPSV23 given at least 1 year after the PCV15 dose. A minimum interval of 8 weeks between PCV15 and PPSV23 can be considered for adults with an immunocompromising condition,* cochlear implant, or cerebrospinal fluid leak to minimize the risk of invasive pneumococcal disease caused by serotypes unique to PPSV23 in these vulnerable groups. y For guidance for patients who have already received a previous dose of PCV13 and/or PPSV23, see www.cdc.gov/mmwr/volumes/71/wr/mm7104a1.htm.

Special situations

y Age 19–64 years with certain underlying medical conditions or other risk factors** who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown: 1 dose PCV15 or 1 dose PCV20. If PCV15 is used, this should be followed by a dose of PPSV23 given at least 1 year after the PCV15 dose. A minimum interval of 8 weeks between PCV15 and PPSV23 can be considered for adults with an immunocompromising condition,* cochlear implant, or cerebrospinal fluid leak to minimize the risk of invasive pneumococcal disease caused by serotypes unique to PPSV23 in these vulnerable groups. y For guidance for patients who have already received a previous dose of PCV13 and/or PPSV23, see www.cdc.gov/mmwr/volumes/71/wr/mm7104a1.htm.

2/17/2022

*Note: Immunocompromising conditions include chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies. **Note: Underlying medical conditions or other risk factors include alcoholism, chronic heart/liver/lung disease, chronic renal failure, cigarette smoking, cochlear implant, congenital or acquired asplenia, CSF leak, diabetes mellitus, generalized malignancy, HIV, Hodgkin disease, immunodeficiency, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplants, or sickle cell disease or other hemoglobinopathies.

Tetanus, diphtheria, and pertussis vaccination Routine vaccination

y Previously did not receive Tdap at or after age 11 years: 1 dose Tdap, then Td or Tdap every 10 years

Special situations

y Previously did not receive primary vaccination series for tetanus, diphtheria, or pertussis: 1 dose Tdap followed by 1 dose Td or Tdap at least 4 weeks after Tdap and another dose Td or Tdap 6–12 months after last Td or Tdap (Tdap can be substituted for any Td dose, but preferred as first dose), Td or Tdap every 10 years thereafter y Pregnancy: 1 dose Tdap during each pregnancy, preferably in early part of gestational weeks 27–36 y Wound management: Persons with 3 or more doses of tetanus-toxoid-containing vaccine: For clean and minor wounds, administer Tdap or Td if more than 10 years since last dose of tetanus-toxoid-containing vaccine; for all other wounds, administer Tdap or Td if more than 5 years since last dose of tetanus-toxoid-containing vaccine. Tdap is preferred for persons who have not previously received Tdap or whose Tdap history is unknown. If a tetanus-toxoidcontaining vaccine is indicated for a pregnant woman, use Tdap. For detailed information, see www.cdc.gov/mmwr/ volumes/69/wr/mm6903a5.htm

Varicella vaccination

- Evidence of immunity: U.S.-born before 1980 (except for pregnant women and health care personnel [see below]), documentation of 2 doses varicella-containing vaccine at least 4 weeks apart, diagnosis or verification of history of varicella or herpes zoster by a health care provider, laboratory evidence of immunity or disease

Special situations

y Pregnancy with no evidence of immunity to varicella: VAR contraindicated during pregnancy; after pregnancy (before discharge from health care facility), 1 dose if previously received 1 dose varicella-containing vaccine or dose 1 of 2-dose series (dose 2: 4–8 weeks later) if previously did not receive any varicella-containing vaccine, regardless of whether U.S.-born before 1980 y Health care personnel with no evidence of immunity to varicella: 1 dose if previously received 1 dose varicellacontaining vaccine; 2-dose series 4–8 weeks apart if previously did not receive any varicella-containing vaccine, regardless of whether U.S.-born before 1980 y HIV infection with CD4 percentages ≥15% and CD4 count ≥200 cells/mm3 with no evidence of immunity: Vaccination may be considered (2 doses 3 months apart); VAR contraindicated for HIV infection with CD4 percentage <15% or CD4 count <200 cells/mm3 y Severe immunocompromising conditions: VAR contraindicated

Zoster vaccination Routine vaccination

y Age 50 years or older: 2-dose series RZV (Shingrix) 2–6 months apart (minimum interval: 4 weeks; repeat dose if administered too soon), regardless of previous herpes zoster or history of zoster vaccine live (ZVL, Zostavax) vaccination (administer RZV at least 2 months after ZVL)

Special situations

y Pregnancy: There is currently no ACIP recommendation for RZV use in pregnancy. Consider delaying RZV until after pregnancy. y Immunocompromising conditions (including HIV): RZV recommended for use in persons age 19 years or older who are or will be immunodeficient or immunosuppressed because of disease or therapy. For detailed information, see www.cdc.gov/mmwr/volumes/71/wr/mm7103a2.htm.

Routine vaccination

y No evidence of immunity to varicella: 2-dose series 4–8 weeks apart if previously did not receive varicella-containing vaccine (VAR or MMRV [measles-mumps-rubella-varicella vaccine] for children); if previously received 1 dose varicellacontaining vaccine, 1 dose at least 4 weeks after first dose Centers for Disease Control and Prevention | Recommended Adult Immunization Schedule, United States, 2022

33

Appendix

Recommended Adult Immunization Schedule, United States, 2022

Guide to Contraindications and Precautions to Commonly Used Vaccines

Adapted from Table 4-1 in Advisory Committee on Immunization Practices (ACIP) General Best Practice Guidelines for Immunization: Contraindication and Precautions available at www.cdc. gov/vaccines/hcp/acip-recs/general-recs/contraindications.html and ACIP’s Recommendations for the Prevention and Control of 2021-22 Seasonal Influenza with Vaccines available at www.cdc.gov/mmwr/volumes/70/rr/rr7005a1.htm

Interim clinical considerations for use of COVID-19 vaccines including contraindications and precautions can be found at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html Vaccine

Contraindications1

Precautions2

Influenza, egg-based, inactivated injectable (IIV4)

• Severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV of any valency) • Severe allergic reaction (e.g., anaphylaxis) to any vaccine component3 (excluding egg)

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Persons with egg allergy with symptoms other than hives (e.g., angioedema, respiratory distress) or required epinephrine or another emergency medical intervention: Any influenza vaccine appropriate for age and health status may be administered. If using egg-based IIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Moderate or severe acute illness with or without fever

Influenza, cell culture-based inactivated injectable [(ccIIV4), Flucelvax® Quadrivalent]

• Severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency, or to any component3 of ccIIV4

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Persons with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any egg-based IIV, RIV, or LAIV of any valency. If using ccIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Moderate or severe acute illness with or without fever

Influenza, recombinant injectable [(RIV4), Flublok® Quadrivalent]

• Severe allergic reaction (e.g., anaphylaxis) to any RIV of any valency, or to any component3 of RIV4

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Persons with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any egg-based IIV, ccIIV, or LAIV of any valency. If using RIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Moderate or severe acute illness with or without fever

Influenza, live attenuated [LAIV4, Flumist® Quadrivalent]

• Severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV of any valency) • Severe allergic reaction (e.g., anaphylaxis) to any vaccine component3 (excluding egg) • Adults age 50 years or older • Anatomic or functional asplenia • Immunocompromised due to any cause including, but not limited to, medications and HIV infection • Close contacts or caregivers of severely immunosuppressed persons who require a protected environment • Pregnancy • Cochlear implant • Active communication between the cerebrospinal fluid (CSF) and the oropharynx, nasopharynx, nose, ear, or any other cranial CSF leak • Received influenza antiviral medications oseltamivir or zanamivir within the previous 48 hours, peramivir within the previous 5 days, or baloxavir within the previous 17 days.

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of any type of influenza vaccine • Asthma in persons aged 5 years old or older • Persons with egg allergy with symptoms other than hives (e.g., angioedema, respiratory distress) or required epinephrine or another emergency medical intervention: Any influenza vaccine appropriate for age and health status may be administered. If using LAIV4 (which is egg based), administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions. May consult an allergist.

• Persons with underlying medical conditions (other than those listed under contraindications) that might predispose to complications after wild-type influenza virus infection [e.g., chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)] • Moderate or severe acute illness with or without fever

When a contraindication is present, a vaccine should NOT be administered. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/ contraindications.html 2. When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html 3. Vaccination providers should check FDA-approved prescribing information for the most complete and updated information, including contraindications, warnings, and precautions. Package inserts for U.S.licensed vaccines are available at www.fda.gov/vaccines-blood-biologics/approved-products/vaccines-licensed-use-united-states.

1.

34 Delaware Journal of Public Health - March 2022

Appendix

Recommended Adult Immunization Schedule, United States, 2022

Vaccine

Contraindications1

Precautions2

Haemophilus influenzae type b (Hib)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For Hiberix, ActHib, and PedvaxHIB only: History of severe allergic reaction to dry natural latex

• Moderate or severe acute illness with or without fever

Hepatitis A (HepA)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 including neomycin

• Moderate or severe acute illness with or without fever

Hepatitis B (HepB)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 including yeast • For Heplisav-B only: Pregnancy

• Moderate or severe acute illness with or without fever

Hepatitis A- Hepatitis B vaccine [HepA-HepB, (Twinrix®)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 including neomycin and yeast

• Moderate or severe acute illness with or without fever

Human papillomavirus (HPV)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Moderate or severe acute illness with or without fever

Measles, mumps, rubella (MMR)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe immunodeficiency (e.g., hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised) • Pregnancy • Family history of altered immunocompetence, unless verified clinically or by laboratory testing as immunocompetent

• Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product) • History of thrombocytopenia or thrombocytopenic purpura • Need for tuberculin skin testing or interferon-gamma release assay (IGRA) testing • Moderate or severe acute illness with or without fever

Meningococcal ACWY (MenACWY) [MenACWY-CRM (Menveo®); MenACWY-D (Menactra®); MenACWY-TT (MenQuadfi®)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For MenACWY-D and Men ACWY-CRM only: severe allergic reaction to any diphtheria toxoid– or CRM197–containing vaccine • For MenACWY-TT only: severe allergic reaction to a tetanus toxoid-containing vaccine

• Moderate or severe acute illness with or without fever

Meningococcal B (MenB) [MenB-4C (Bexsero); MenB-FHbp (Trumenba)]

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Pregnancy • For MenB-4C only: Latex sensitivity • Moderate or severe acute illness with or without fever

Pneumococcal conjugate (PCV15)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe allergic reaction (e.g., anaphylaxis) to any diphtheria-toxoid–containing vaccine or to its vaccine component3

• Moderate or severe acute illness with or without fever

Pneumococcal conjugate (PCV20)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe allergic reaction (e.g., anaphylaxis) to any diphtheria-toxoid– containing vaccine or to its vaccine component3

• Moderate or severe acute illness with or without fever

Pneumococcal polysaccharide (PPSV23)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Moderate or severe acute illness with or without fever

Tetanus, diphtheria, and acellular pertussis (Tdap) Tetanus, diphtheria (Td)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • For Tdap only: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP, DTaP, or Tdap

• Guillain-Barré syndrome (GBS) within 6 weeks after a previous dose of tetanus-toxoid–containing vaccine • History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid— containing or tetanus-toxoid– containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid–containing vaccine • Moderate or severe acute illness with or without fever • For Tdap only: Progressive or unstable neurological disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized

Varicella (VAR)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3 • Severe immunodeficiency (e.g., hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long- term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised) • Pregnancy • Family history of altered immunocompetence, unless verified clinically or by laboratory testing as immunocompetent

• Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product) • Receipt of specific antiviral drugs (acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination (avoid use of these antiviral drugs for 14 days after vaccination) • Use of aspirin or aspirin-containing products • Moderate or severe acute illness with or without fever

Zoster recombinant vaccine (RZV)

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component3

• Moderate or severe acute illness with or without fever • Current herpes zoster infection 1. When a contraindication is present, a vaccine should NOT be administered. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html 2. When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction. Kroger A, Bahta L, Hunter P. ACIP General Best Practice Guidelines for Immunization. www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html 3. Vaccination providers should check FDA-approved prescribing information for the most complete and updated information, including contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at www.fda.gov/vaccines-blood-biologics/approved-products/vaccines-licensed-use-united-states.

35

Pneumococcal Immunization for Adults in 2022 John H. O’Neill, Jr., D.O., M.A.C.P. Internal Medicine Physician, Academic Hospitalist, Faculty Member, ChristianaCare; Co-Chair, Immunization Coalition of Delaware

INTRODUCTION Infections caused by Streptococcus pneumoniae continue to be a significant cause of morbidity and mortality worldwide.

Pneumococcal infections cause an estimated 150,000 hospitalizations per year in the USA, and pneumococcal bacteremia and meningitis (with case fatality rates of 12% and 14%, respectively) caused approximately 3,250 deaths in the USA in 2019.1,2 The World Health Organization estimates that more than 300,000 deaths occur globally each year in children under the age of 5 as a result of pneumococcal infections.3 The discovery and subsequent development of penicillin in 1941 has substantially reduced suffering and mortality. Vaccines against pneumococcal infection have a greater proven potential to prevent illness and death, and also to reduce the problem of emergence of antimicrobial resistance.2 Recently, the recommendations for immunization of adults against pneumococcal infections have been updated by the Advisory Committee on Immunization Practices (ACIP),4 and are presented here.

THE HISTORY OF THE PNEUMOCOCCAL VACCINES Vaccines against the pneumococcus have been available for over 40 years, beginning with pneumococcal polysaccharide vaccine, 14 valent (PPSV14), in 1977, which was replaced by PPSV23 in 1983. This vaccine induces an antibody response to its 23 polysaccharide bacterial surface antigens in 80% of adults who receive it, but antibody levels decline more than five years after vaccination, and antibody response is reduced in immunosuppressed persons. PPSV23 has not conclusively been shown to prevent (non-bacteremic) pneumococcal pneumonia, but it has been shown in clinical trials to reduce the incidence of invasive pneumococcal disease (IPD) caused by the strains of pneumococcus included in the vaccine by 60-70%.5 The range of pneumococcal infections includes acute otitis media, sinusitis, pneumonia, and IPD, which includes bacteremia, pneumococcal pneumonia with bacteremia, meningitis, osteomyelitis and septic arthritis. More than 100 serotypes of pneumococcus are known, most can cause serious illness, but the majority of cases of pneumococcal infections are caused by relatively few serotypes, which vary by patient age and geographic area.2 Pneumococcal conjugate vaccine, 7 valent (PCV7), was introduced in 2000 for use in the pediatric population. This vaccine conjugates the surface polysaccharide antigens of the seven serotypes of pneumococcus covalently to a non-toxic diphtheria toxin protein called CRM147. Polysaccharide vaccines such as PPSV23 have been shown to be ineffective in children under the age of 2, and conjugated vaccines such as PCV have been shown to stimulate more effective plasma cell transformation and antibody production, as well as enhanced T cell responses.6 Large clinical trials have demonstrated a 97% reduction of IPD in children caused by the strains in PCV7, a 7% reduction in acute otitis media, a 20% reduction in the need for tympanostomy tubes, a 20% reduction in the incidence of pneumonia, and decreased nasal carriage of these strains from the vaccine.7 36 Delaware Journal of Public Health - March 2022

PCV7 was replaced by PCV13 in 2010. PCV13 has 12 antigens in common with the PPSV23 vaccine. PCV10 has also been used in other countries since 2009. For adults with immunosuppression, Cerebrospinal fluid (CSF) leaks, or cochlear implants, PCV13 was recommended by the ACIP starting in 2012, followed by an expanded indication for all adults 65 years of age and older in 2014. PPSV23 was recommended 2-12 months following PCV13 in adults, with up to two additional doses at five year intervals depending on the presence and severity of immunosuppression.

In 2015, Bonten and colleagues published their study demonstrating the effectiveness of PCV13 with a 45% reduction in vaccine-type non-bacteremic pneumococcal pneumonia as well as a 75% reduction in IPD in older adults.8 In 2019, ACIP recommended shared decision making between the patient and their physician regarding the indication for PCV13, given the observed decline in the incidence of vaccinetype pneumococcal disease to historic lows in the adult population, attributed to more than a decade of use of PCV7 and PCV13 in the pediatric schedule and the ensuing community immunity.9 The observed decline in antimicrobial resistance of pneumococcus in the United States over the past decade has been attributed to the success of these conjugate vaccines as well.2 PCV13 was also recommended for patients who lived in long term care institutions, who were living in or travelling to areas where pediatric access to PCV13 was low, or where there was known increased incidence of non-PCV13 vaccine-type pneumococcal infection.

THE UPDATED ACIP RECOMMENDATIONS FOR PNEUMOCOCCAL IMMUNIZATION OF ADULTS For 2022, we now have the availability of PCV15 and PCV20 vaccines for use in adult patients. PCV15 has two additional conjugated polysaccharide antigens compared to PCV13, and PCV20 has seven additional antigens, including the two new antigens found in PCV15 (see Figure 1). Based on a review of the data on immunogenicity, safety, and cost effectiveness from clinical trials associated with these vaccines, on October 20, 2021, the ACIP recommended that adults 65 years of age and older who have not previously received a pneumococcal conjugate vaccine in adulthood (or if the vaccination history is unknown), be given either PCV20 (but not PPSV23), or PCV15 followed in at least a year by PPSV23. The one year duration between vaccines in immunocompetent patients over 65 years of age results in optimal antibody production, compared to a shorter duration. No booster of any PCV vaccine is recommended subsequently after a person has received PCV13, PCV15, or PCV20 once. If the patient has previously received PCV13, but has not yet received PPSV23, they should receive PPSV23 if it has been a year since getting PCV13.

Following receipt of one dose of PPSV23 vaccine, no additional booster doses are recommended going forward. If an adult patient who has an indication for pneumococcal vaccine has previously received PPSV23, but not a PCV, they should receive either PCV15, or PCV20, at least a year after having received PPSV23.

No additional doses of PPSV23 are necessary, subsequently.4 DOI: 10.32481/djph.2022.03.006

Figure 1. Serotypes Contained in Current and New Pneumococcal Vaccines

For adult patients age 19-64 with immunosuppression/special conditions or risk factors listed in Table 1, a dose of PCV20 (but not PPSV23), or a dose of PCV15, followed by a dose of PPSV23 in at least 2-12 months, should be administered. If PCV13 has previously been given, but not PPSV23, then the dose of PPSV23 may be administered at least two months following PCV13, to receive extra protection against the vaccine strains in PPSV23 in the near term. No booster doses of PPSV23 are necessary subsequently, after this first dose. No additional doses of PCV15 or PCV20 are indicated if a patient has previously received PCV13, PCV15 or PCV20 in adulthood.4

CONCLUSION

CSF leak

Vaccination of immunocompetent adult patients 65 years and over, and adults age 19-64 with immunosuppression or other high risk conditions against Streptococcus pneumoniae has the potential to dramatically reduce the incidence of IPD, related morbidity and mortality, pneumococcal pneumonia, and hospitalizations. Potential cost savings associated with such a public health intervention could be enormous. ACIP’s updated recommendations for 2022 make pneumococcal vaccination simpler for clinicians, and more effective for patients with the additional pneumococcal antigens covered by the regimen options. With disease prevention comes an added benefit of reduced antimicrobial resistance of the pneumococcus to current antibiotics as a result of the effectiveness of the conjugate vaccines. The calling for our health care system and its “immunization neighborhoods” is to maximize adult immunization rates. Currently we fall far short of where we need to be to realize the benefits of our interventions. The most recently published National Health Interview Survey (NHIS) data from 2017 indicate that only 69% (73% White, 57% Black, 51% Hispanic) of persons 65 or older had received a pneumococcal immunization (PI), and only 24.5% of persons in the 19-64 age group with immunosuppression/other high risk conditions had received PI.10 The low vaccination rates are disturbing, and the racial disparities are alarming. Immunization of our population against vaccine preventable diseases remains one of the huge public health challenges of our present and future. Healthy People 2030 goals for ACIP recommended vaccines are > 90%.11 We have good work to do!

Congenital or acquired asplenia

Dr. O’Neill can be contacted at johnoneill@christianacare.org

Sickle cell disease/other hemoglobinopathy

REFERENCES

SAFETY OF PCV VACCINES Adverse reactions to PCV15 included fatigue, malaise and injection site discomfort. There were no serious adverse reactions (SAE) or deaths attributed to PCV15 compared to PCV13. Similar reactions were noted with PCV20, including myalgia, joint pain, headache, fatigue, and injection site discomfort, and no SAEs or deaths were attributed to PCV20 compared to controls.4 Table 1. Indications for Pneumococcal Vaccine, Ages 19-644 Underlying Condition/Risk Factor Alcoholism Chronic heart disease (includes CHF, cardiomyopathy) Chronic liver disease Chronic lung disease (includes COPD and asthma) Cigarette smoking Diabetes Mellitus Cochlear implant

Congenital or acquired immunodeficiency HIV infection Iatrogenic immunosuppression Chronic renal failure Nephrotic syndrome Generalized malignancy Hodgkin Disease Lymphomas Leukemias Multiple myeloma Solid organ transplant

1. Centers for Disease Control and Prevention. (2022).

Pneumococcal. Retrieved from: https://www.cdc.gov/pneumococcal/about/facts.html 2. Gierke, R., Wodi, P., & Kobayashi, M. (2021, Aug).

Pneumococcal Disease. In Epidemiology and Prevention of Vaccine-Preventable Diseases, Retrieved from: https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo. html#streptococcus-pneumoniae 3. Centers for Disease Control and Prevention. (2022). Global pneumococcal disease and vaccination. Retrieved from: https://www.cdc.gov/pneumococcal/global.html 37

4. Kobayashi, M., Farrar, J. L., Gierke, R., Britton, A., Childs, L., Leidner, A. J., . . . Pilishvili, T. (2022, January 28). Use of 15-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among U.S. Adults: Updated recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR. Morbidity and Mortality Weekly Report, 71(4), 109–117. https://doi.org/10.15585/mmwr.mm7104a1 5. Jackson, L. A., Neuzil, K. M., Yu, O., Benson, P., Barlow, W. E., Adams, A. L., . . . Thompson, W. W., & the Vaccine Safety Datalink. (2003, May 1). Effectiveness of pneumococcal polysaccharide vaccine in older adults. The New England Journal of Medicine, 348(18), 1747–1755. https://doi.org/10.1056/NEJMoa022678 6. Rappuoli, R., De Gregorio, E., & Costantino, P. (2019, January 2). On the mechanisms of conjugate vaccines. Proc Natl Acad Sci USA, 116(1), 14–16. https://doi.org/10.1073/pnas.1819612116 7. Centers for Disease Control and Prevention. (2022). About pneumococcal vaccines. Retrieved from: https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html 8. Bonten, M. J. M., Huijts, S. M., Bolkenbaas, M., Webber, C., Patterson, S., Gault, S., . . . Grobbee, D. E. (2015, March 19).

Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. The New England Journal of Medicine, 372(12), 1114–1125. https://doi.org/10.1056/NEJMoa1408544

9. Matanock, A., Lee, G., Gierke, R., Kobayashi, M., Leidner, A., & Pilishvili, T. (2019, November 22). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: Updated recommendations of the Advisory Committee on Immunization Practices. MMWR. Morbidity and Mortality Weekly Report, 68(46), 1069–1075. https://doi.org/10.15585/mmwr.mm6846a5 10. Centers for Disease Control and Prevention. (2018, Feb).

Vaccination coverage among adults in the United States, National Health Interview Survey, 2017. Retrieved from: https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/ pubs-resources/NHIS-2017.html 11. US Department of Health and Human Services. (n.d.).

Healthy People 2030: Increase the proportion of adults age 19 years or older who get recommended vaccines. Retrieved from: https://health.gov/healthypeople/objectives-and-data/browseobjectives/vaccination/increase-proportion-adults-age-19-years-orolder-who-get-recommended-vaccines-iid-d03

The CDC offers two useful immunization apps, available for free download from the Apple and Android App stores: The PneumoRecs VaxAdvisor APP, which has a tool for determining your patient’s pneumococcal vaccine recommendations: https://www.cdc.gov/vaccines/vpd/pneumo/hcp/pneumoapp.html and the updated CDC Vaccine Schedules APP for all adult vaccines: https://www.cdc.gov/vaccines/schedules/hcp/schedule-app.html#download

38 Delaware Journal of Public Health - March 2022

PLEASE SAVE THE DATE Thursday, May 26, 2022 92nd Annual Meeting Dupont Country Club 6:30 pm Keynote Speaker Senator Sarah Mcbride www.delamed.org 39

Travel Vaccination Update Salwa Sulieman, D.O. Pediatric Infectious Diseases, Nemours Children’s Hospital, Delaware

ABSTRACT As international travel increases, an update on the current guidance regarding travel vaccinations is important for healthcare providers. There have been recent changes to availability of certain vaccines that providers should familiarize themselves with. This article provides adult and pediatric-specific guidance for the most commonly required and requested travel vaccines, particularly the Japanese encephalitis vaccine, typhoid vaccines, and the yellow fever vaccine.

In addition to routine adult and childhood vaccination, travel vaccination is a key component to traveler’s health when going abroad. Consultation with a primary care physician and/or travel medicine specialist can be helpful to review guidance at least six weeks prior to travel. The need for travel vaccinations is based on the individual’s previous vaccination status, underlying health conditions, and expected exposures when traveling. Endemic pathogens and need for vaccination based on country of travel can be found on the Centers for Disease Control (CDC) website under Traveler’s Health and Destination.1 In the United States, the available travel vaccines include cholera, hepatitis A, hepatitis B, Japanese encephalitis, meningococcal vaccine, polio, rabies, typhoid, and yellow fever. The cholera and typhoid vaccines paused manufacturing In December 2020 as the COVID-19 pandemic decreased travel and the need for vaccination. The manufacturers plan on restarting production in the future, but no timeline has been given. This article discusses the current guidance regarding some of the most common adult and childhood travel-specific vaccines (see Table 1).

JAPANESE ENCEPHALITIS (JE) VACCINE Japanese encephalitis virus is an RNA virus that belongs to the genus Flavivirus and is transmitted via the bite of an infected Culex mosquito. Most infections are asymptomatic; however, approximately one percent of infected persons will go on to develop acute encephalitis.2 The virus is endemic in most of Asia and parts of the western Pacific. JE primarily affects children.

Most adults in endemic countries have natural immunity after childhood infection, but individuals of any age may be affected.

The virus is transmitted mostly in areas of rice cultivation and flood irrigation as well as during the monsoon rains where mosquitos are drawn to water. Each individual country has specific JE virus seasons that can be referenced on the CDC website.1 The incidence in endemic areas is 6-11 cases per 100k children; however, the incidence in travelers from nonendemic countries is less than one case per one million travelers.

Since the likelihood of developing disease is low, the vaccine is recommended only in those persons that are considered to be at higher risk for developing infection.2,3

Table 1. Travel-Specific Vaccines Given in the United States2,3 Disease

Vaccine

Adult Dose

Pediatric Dose

Booster Dose

Japanese Encephalitis

Ixiaro

Dose: 0.5 ml IM/dose for two total doses 18 to 65 years: 1st dose: day 0 2nd dose: between days 7 to 28 >65 years: 1st dose: day 0 2nd dose: day 28

2 months to <3 years: 0.25 mL IM/dose for two doses 1st dose: day 0 2nddose: day 28 ≥3 years: 0.5 ml IM/dose for two doses 1st dose: day 0 2nd dose: day 28

Single booster dose given >1 year after completion of primary series if identified to have ongoing risk

Typhoid Fever

Ty21a (Vivotif)

Dose for all adults: 1 capsule by mouth every other day x 4 doses

≥6 years: 1 capsule by mouth every other day x 4 doses

Repeat full four dose regimen every 5 years if identified to have ongoing risk

Vi polysaccharide vaccine

Dose for all adults: 0.5 mL IM for one dose

≥2 years: 0.5 mL IM for one dose

Repeat single injection every 2 years if identified to have ongoing risk

YF-VAX

Dose for all adults: 0.5 mL SQ for one dose

≥9 months: 0.5 mL SQ for one dose

Single dose considered to provide lifelong protection High risk travelers with ongoing risk can consider a single booster dose every 10 years

Yellow Fever

40 Delaware Journal of Public Health - March 2022

DOI: 10.32481/djph.2022.03.007

There is only one JE virus vaccine licensed and available in the US. Ixiaro is an inactivated Vero cell culture-derived vaccine that protects against five JE virus genotypes. It was FDA approved in March 2009 for use in persons ages 17 years and over, and in May 2013 for use in children ages two months through 16 years. There are other JE virus vaccines available outside of the US, which includes the childhood vaccine given in endemic areas around 12 months of age.

JE vaccine is recommended for those individuals moving to a JE endemic area to take up residence, longer term travelers (one month or longer) to a JE endemic area, frequent travelers to JE endemic areas, and laboratory workers with potential exposure to JE viruses other than vaccine virus. JE vaccine can be considered for those who are unclear of the duration of travel and for those shorter-term travelers (less than one month) with an increased risk for development of disease based on travel duration, season, location, activities, and accommodations. JE vaccine is not recommended for those with short travel times in urban areas outside of JE virus transmission season.

JE vaccine is a two-dose primary series given at days 0 and 28, and should be completed at least one week prior to travel. For those 18 years of age or older, the second dose can be given between days 7 and 28. A booster dose can be given one year or more after the primary series. Some individuals with frequent travel and ongoing risk can consider a booster dose every 10 years for prolonged protection. A single dose in the prefilled adult syringe is 0.5 ml, but children two months to two years of age should only be given 0.25 ml. There have not been any safety concerns after approval of this vaccine.

TYPHOID VACCINE Salmonella enterica serotype typhi is a Gram-negative bacteria that invades the blood stream and causes a severe, febrile illness termed typhoid fever. Transmission is via the ingestion of contaminated food or water and within 6 to 30 days, travelers develop fever, headache, myalgias, abdominal pain, and/or diarrhea. Most cases occur in southern Asia (India, Pakistan, Bangladesh), but other areas that are considered a risk include Africa, Southeast Asia, South America, and the Caribbean.

Each year, there are 26 million cases of typhoid fever worldwide and 215,000 deaths. In the US, 85% of typhoid cases are from international travel. There are currently three typhoid vaccines being manufactured. Two are available in the US and one available outside of the US.2,3 Ty21a (Vivotif) is an oral, live-attenuated vaccine that is indicated for children and adults six years of age and older. It is administered as one capsule given every other day for four doses. The capsules must be kept refrigerated, taken with a cool liquid lower than body temperature, and given one hour before a meal and two or more hours after a previous meal. All doses should be completed more than one week before travel.

A booster dose is recommended every five years for those travelers that remain at risk. Since this is a live vaccine, it is contraindicated in immunocompromised patients, pregnant women, and those with acute gastroenteritis.

The Vi capsular polysaccharide vaccine (ViCPS) is a single dose, injectable vaccine indicated for children and adults two

years of age and older. It should be administered more than two weeks before travel. A booster dose is recommended every two years for those travelers that remain at risk.

The third type of vaccine is the protein-conjugate Vi vaccines that are indicated for children six months of age and older, and have been shown to have greater efficacy in children greater than two years old as well as longer duration of protection compared to the polysaccharide vaccine. Two of these vaccines have been licensed in India and are currently in use. They are not available in the US.2,3

YELLOW FEVER VACCINE Yellow fever virus is an RNA virus that belongs to the genus Flavivirus. Transmission is via the bite of the Aedes or Haemogogus mosquito in tropical areas of Africa and South America. Worldwide cases approach 200,000 annually and deaths as high as 30,000 per year. Most individuals will be asymptomatic or have mild symptoms including fever, chills, body aches, and fatigue. There will be a small proportion of travelers that develop severe disease characterized by high fever, jaundice, organ failure, bleeding, and shock.2,3 YF-VAX is a single dose Yellow fever vaccine available in the US and is a live, attenuated injectable vaccine given to adults and children nine months of age and older. Proof of Yellow fever vaccination is valid ten days after injection. It is required for all travelers arriving from an area where Yellow fever is endemic. A single dose is now considered to provide life-long protection, but a booster dose ten years later can be considered for those living or traveling to areas where there are outbreaks.

The vaccine was not readily available for many years due to manufacturing issues, but in April 2021 it is now available and ready for administration.

Yellow fever vaccine should not be given to immunocompromised persons or pregnant women. Since it is a live vaccine, it should be given either with other live vaccines or separated by 30 days. There are three well-described vaccine adverse reactions (1) hypersensitivity or anaphylaxis, (2) vaccine-associated neurologic disease, and (3) vaccineassociated viscerotropic disease. Children 6-8 months of age and adults over 60 years of age have a higher risk of a vaccine adverse event and immunization in these age groups should be considered carefully.

Dr. Sulieman can be contacted at salwa.sulieman@nemours.org

REFERENCES 1. Centers for Disease Control and Prevention. (n.d.). Traveler’s Health: Destinations. https://wwwnc.cdc.gov/travel/destinations/list/ 2. Centers for Disease Control and Prevention. CDC Yellow Book 2020: Health Information for International Travel. New York: Oxford University Press, 2017. https://wwwnc.cdc.gov/travel/page/yellowbook-home-2020 3. World Health Organization. (2022, March).

Travel advice – vaccines. Retrieved from https://www.who.int/travel-advice/vaccines 41

Immigrants and Immunizations Katherine Smith, M.D., M.P.H. Program Manager, Immunization Coalition of Delaware

The United States has more immigrants than any other country in the world.1 From 1900 to 1930, immigrants made up approximately 12-15% of the US population; in 2020, they accounted for 13.7% of the overall population.1 The highest percentage on record was 14.8% in 1890, when there were approximately 9.2 million foreign-born individuals living in the US.

LEGAL STATUS Immigrants to the United States have been subject to different acts of regulation by the government since the United States was formed. The 1921 Emergency Quota Act capped the total annual immigration into the US at 350,000.2 The Johnson-Reed Act in 1924 further restricted immigration, capping the total number of individuals at 165,000 and creating Nationality quotas at two percent of that nationality present in the 1890 census.2 In 1952, the Immigration and Nationality Act removed race as an exclusion for immunization and naturalization, updated the national origins quota, and granted 100 visas per year to individuals coming from Asian countries.2 A 1965 amendment to the Immigration and Nationality Act replaced the quota system with a seven-category preference

system.2 This system emphasizes family reunification and skilled trades, and is the basis for the immigration system in the country today.

Over 75% of immigrants to the United States have entered the country legally.1 In 2017, the number of naturalized citizens equaled 20.7 million (45% of legal immigrants), and lawful permanent residents equaled 12.3 million (27%). Temporary visas were granted to 2.2 million people (5%). The remaining 23% of immigrants were unauthorized, and made up of refugees, asylum seekers, and undocumented immigrants.1 Since the creation of the 1980 Federal Refugee Resettlement Program, the United States has accepted and resettled about three million individuals.1,2 In 2019, the nation resettled 30,000 individuals from countries like the Democratic Republic of the Congo (12,958), Burma (Myanmar, 4,932), and the Ukraine (4,451).1 In 2018, 64% of the foreignborn population of the United States live in twenty major metropolitan areas (see Figure 1).1 It is believed that up to half of the undocumented immigrants in the country are individuals who have overstayed their visitor, student, or work visas.1 These individuals obtained lawful documentation and health screenings, and entered the country legally.

Figure 1. The Metropolitan Areas with the Largest Number of Immigrants, 20181

42 Delaware Journal of Public Health - March 2022

DOI: 10.32481/djph.2022.03.008

MEDICAL SCREENINGS The Immigration and Nationality Act3,4 defines an inadmissible alien as someone who: - Is determined to have a communicable disease of public health significance; - Failed to present documentation of having received vaccination against vaccine-preventable diseases; - Has or has had a physical or mental disorder and associated behavior that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others, and which behavior is likely to recur or lead to other harmful behavior; or - Who is determined to be a drug abuser or addict.

Waivers are available for minors less than ten years who are in the process of being adopted by US citizens, and if a physician has signed an affidavit stating they will see the individual within 30 days of admission for medical evaluation.

However, individuals with criminal convictions, who are drug traffickers, or are entering for purposes of prostitution are completely inadmissible.

The Division of Global Migration and Quarantine (DGMQ) provides the medical screening guidelines required by the Immigration and Nationality Act.4 All refugees, applicants applying for an immigrant visa, and resident aliens currently living in the United States and applying for an adjustment of their immigration status to permanent resident are required to undergo a medical exam.4,5 Anyone applying for temporary admission (a non-immigrant visa) may be required to undergo a medical exam at the discretion of the a consular or immigration officer if they have reason to believe an inadmissible health-related condition exists.

The medical exam must consist of a thorough medical history, including a review of any hospitalizations or

institutionalizations for mental or physical chronic conditions, a review of illnesses or disabilities, a review of any other records available (police, military, school, employment, etc.), and a review of any history of drug and/or alcohol use, harmful behavior, or psychiatric illness. Individuals must also undergo a physical exam, including a mental status exam, and review of systems.5 All individuals wishing to enter the country must also undergo all diagnostic tests required to identify communicable diseases of public health significance. This list includes tuberculosis, syphilis, gonorrhea, and Hansen’s Disease (leprosy), as well as other quarantainable diseases.5 Quarantainable communicable diseases are designated by Presidential Executive Order, and include • Influenza: novel or re-emergent viruses that cause or have the potential to cause a pandemic (e.g. avian H5N1); • Severe Acute Respiratory Syndromes (e.g. COVID-19, MERS, SARS); • Viral Hemorrhagic Fevers (e.g. Ebola, Marburg); • Cholera; • Yellow Fever; • Plague; • Measles; • Diphtheria; • Infectious Tuberculosis; and • Smallpox.

This also includes diseases that are reportable to the World Health Organization (WHO) as Public Health Emergencies of International Concern (PHEIC). This list includes COVID-19, any new-subtype of human influenza type A(H1), wild-type poliomyelitis, SARS, and smallpox, and other disease that require notification through the use of the 2005 IHR algorithm.5,6

Table 1. Vaccines Offered to Eligible U.S. Bound Refugees7 Age

Vaccines

Birth – Adult

HepB x 2 doses

6 weeks – Less than 15 weeks

Rotavirus x 2 doses

6 weeks – Less than 5 years

Hib x 2 doses PCV x 2 doses

6 weeks – Less than 7 years

DTP x 1 dose

6 weeks – Less than 11 years

Polio x 2 doses (OPV, IPV, or 1 each)

5 years – Adult

COVID-19 x 2

7 years – Adult

Td x 2 doses MenACWY x 1 dose

Over one year – less than 20 years Over one year – those born before 1957

Varicella x 1 dose MMR x 2 doses

Note: Please see source for full information. Hepatitis B (HepB); Hemophilus influenzae (Hib); pneumococcal conjugate vaccine (PCV); diphtheria, tetanus, pertussis (DTP); oral polio vaccine (OPV); inactivated polio vaccine (IPV); tetanus, diphtheria (Td); meningococcal conjugate vaccine with protection against serogroups A, C, W, and Y (MenACWY); measles, mumps, and rubella (MMR).

43

LOCATION

REFERENCES

The overall goal of these screenings is to promote and improve the health of the refugee, prevent disease, and familiarize refugees and immigrants with the United States healthcare system. Screenings can be completed overseas and domestically.

1. Budiman, A. (2020, Aug). Key findings about U.S. immigrants.

Pew Research Center. Retrieved from: https://www.pewresearch.org/fact-tank/2020/08/20/key-findings-aboutu-s-immigrants/

First, refugees and immigrants are screened by Panel Physicians in their countries of origin. Panel physicians, a team of over 600 physicians identified by the Department of State, provide pre-departure presumptive treatments (for malaria, intestinal parasites, etc.) and updates to any vaccine series that refugees or immigrants may need.

2. Pew Research Center. (2015, Sept). Selected U.S. immigration legislation and executive actions, 1790-2014. Retrieved from: https://www.pewresearch.org/hispanic/2015/09/28/selected-u-simmigration-legislation-and-executive-actions-1790-2014/

Once in country, domestic screenings are completed by civil surgeons (a group of over 5,000 physicians selected by United States Citizenship and Immigration Services), state public health departments, and medical providers 30-90 days after an immigrant or refugee arrives in the country.5 These screenings check for diseases unique to specific populations and diseases not or rarely seen in the United States (i.e. intestinal parasites, female genital mutilation). They also offer preventative screening, counseling, and testing, and a continuation of vaccine series.7

VACCINES FOR US-BOUND REFUGEES Routine vaccination of US-bound refugees before travel to the United States is not legally required (note: the current exception to this at the time of writing is the COVID-19 vaccine). Vaccines are recommended to protect an individual’s health, prevent travel delays due to disease outbreaks, and allow more rapid integration into schools after arrival.8 As part of the Vaccination Program for US-bound Refugees,7 refugees begin the series of Advisory Committee on Immunization Practices (ACIP) recommended vaccines.

Refugees and Visa 93 applicants are offered immunizations depending on age, vaccine history, and eligibility. The vaccine offered must be age-appropriate (as recommended by ACIP for the general population) and must protect against a disease that has the potential to cause an outbreak (i.e. influenza), and/or protect against a disease that has been or is in the process of being eliminated in the United States.9 The goal is to provide up to two doses of each vaccine (see Table 1) before individuals enter the United States, depending on the availability and logistics at each overseas site. Valid vaccination records and camp vaccine cards are counted towards this schedule when applicable.

After a year in the United States, refugees can apply for a change of status to legal permanent resident; at that time individuals are required to be fully vaccinated in accordance with the CDC Technical Instructions for status adjustment.9

CONCLUSION Despite social media’s messaging to the contrary, there is no evidence that immigrants have been the source of any modern disease outbreaks in the United States.10 Immigrants and refugees are carefully screened before being granted entry into the United States for any major health condition, and are offered the same vaccines recommended to US citizens every day.

Dr. Smith may be contacted at ksmith@delamed.org 44 Delaware Journal of Public Health - March 2022

3. US Citizenship and Immigration Services. (n.d.). Immigration and Nationality Act. Retrieved from: https://www.uscis.gov/laws-and-policy/legislation/immigration-andnationality-act 4. Centers for Disease Control and Prevention. (n.d.). Laws and regulations for the medical examination of aliens. Retrieved from: https://www.cdc.gov/immigrantrefugeehealth/laws-regulations.html 5. United States Code of Federal Regulations. (2016, Jan). USC 42.1.C.34. Retrieved from: https://www.ecfr.gov/current/title-42/part-34 6. World Health Organization. (n.d.). International health regulations. Retrieved from: http://www.who.int/ihr/en/ 7. Centers for Disease Control and Prevention. (2021, Jun).

Overseas refugee health guidance. Retrieved from: https://www.cdc.gov/immigrantrefugeehealth/guidelines/overseasguidelines.html 8. Centers for Disease Control and Prevention. (2019, Mar).

Vaccines for immigrants and refugees. Retrieved from: https://www.cdc.gov/vaccines/adults/rec-vac/immigrants-refugees.html 9. Centers for Disease Control and Prevention. (2021, Dec). Civil Surgeons: Vaccination. Retrieved from: https://www.cdc.gov/immigrantrefugeehealth/civil-surgeons/ vaccinations.html 10. Anti-Defamation League. (n.d.). Eight facts about immigrants and immigration. Retrieved from: https://www.adl.org/resources/fact-sheets/myths-and-facts-aboutimmigrants-and-immigration-en-espanol

The DPH Bulletin

From the Delaware Division of Public Health

March 2022

Governor Carney ends mask mandate in schools and most public buildings Governor John Carney terminated the COVID-19 State of Emergency and the masking requirement in public and private K-12 schools, school buses, and child care facilities effective March 1.

He also lifted the mask requirement in most State buildings effective March 2. The U.S. Centers for Disease Control and Prevention (CDC) announced new masking guidance on February 25.

Vaccine and testing requirements for educators and state employees expired February 28.

At the same time, Governor Carney issued a narrower Public Health Emergency Order to replace the one issued on July 12, 2021 to allow hospitals and long-term care facilities continued flexibility to respond to COVID-19 cases.

“There are a lot of reasons to be optimistic about where we’re headed,” Governor Carney said. “Over the last month, COVID-19 cases and hospitalizations have fallen dramatically, and we are clearly moving into a new phase of this pandemic.

Today’s announcement is consistent with new guidance from the CDC. And it’s consistent with the latest thinking from Delaware’s experts at the Division of Public Health. Delawareans who want to continue wearing a mask – including children in our schools – should be supported and encouraged to do so, even as we move into this new phase. We’ll also continue to encourage all eligible Delawareans to get up to date on their COVID-19 vaccinations.”

The Delaware Department of Education (DOE) and the Division of Public Health (DPH) issued updated guidance to district and school leaders to aid response efforts following the expiration of the mask requirement. Click here to read the new mask guidance for schools shared by DOE and DPH. Read the latest on masking recommendations and requirements in Delaware at: https://coronavirus.delaware.gov/guidance-for-facecoverings/.

Delawareans may choose to wear a mask at any time and should consider it if they have symptoms, are immunocompromised or living with someone who is, and when in communities with high levels of COVID-19 transmission. To determine community transmission levels, use the CDC’s County Checker tool: https://bit.ly/community_levels.

Brickworks Brewing and Eats in Smyrna was the first restaurant to receive the Restaurant Accolade Program’s Bronze Award.

Pictured from left to right are Ronald E. Harper, Jr., Mark Black, and Jefford McCutcheon. Photo by Jamaaladeen Brady.

Restaurant workers invited to take free trainings on substance use disorders and overdose response The Division of Public Health’s (DPH) Office of Health Crisis Response (OHCR) is launching a Restaurant Accolade Program to train restaurant workers on how to recognize and respond to substance use disorders and overdoses.

The food service industry had the second highest portion of drug overdose deaths of any industry in Delaware in 2017, as reported in the Drug Overdose Mortality Surveillance Report, Delaware, 2017.

Through virtual sessions, restaurant owners, managers, and staff receive overdose response training and Narcan, the medication that can reverse an opioid overdose, possibly saving a life. Participants will also receive certificates and window-cling decals.

The Restaurant Accolade Program has gold, silver, and bronze tiers. Completing each tier is encouraged.

To register for a training, click on the course date: • March 23, 2022, 3:00 p.m. to 4:00 p.m.

• March 24, 2022, 9:00 a.m. to 10:00 a.m.

For more information, contact OHCR at OHCR@delaware.gov.

45

Bureau of Oral Health and Dental Services shares 26 fact sheets Delaware Cancer Consortium convenes retreat on April 11 The Delaware Cancer Consortium (DCC), the legislative body formed in 2001 to address Delaware's Cancer burden, will hold its annual retreat on April 11, 2022 from 8:30 a.m. to 11:30 a.m. as a virtual event. The theme is Guided by our Legacy, Forging a Path to Healthy Lifestyles.

2022 is the 20th anniversary of the creation of the Delaware Advisory Council on Cancer Incidence and Mortality in April 2002. The DCC includes a Governor-appointed Advisory Council and three sub-committees.

The Division of Public Health’s Comprehensive Cancer Program facilitates the work of the Consortium and all subcommittees.

The live-streamed event is free. Medical providers, patient navigators, legislators, community members, committee members, and state officials are invited to register at https://www.healthydelaware.org/Consortium.

Delaware Healthy Mother and Infant Consortium Summit is April 26

Flossing, mouthguards, and baby teeth are some of the fact sheets created by the Division of Public Health’s Bureau of Oral Health and Dental Services (BOHDS). BOHDS recently doubled the number of its fact sheets posted at https://dhss.delaware.gov/dhss/dph/hsm/ohpfactshe etlist.html. Now 26 are available to the public, dental providers, and other health professionals.

“We identified a need to provide more information and recommendations about additional ways to achieve optimum oral and dental health,” said BOHDS Chief Nicholas Conte. “Good oral and dental health helps protect the rest of the body.”

BOHDS staff updated its smoking tobacco and quitting fact sheet and added three oral cancer fact sheets, plus another about smokeless tobacco and vaping. Other new fact sheets discuss diabetes, women’s health, pregnancy, antibiotic prophylaxis, infection control, denture care, and dental anxiety.

For more information about BOHDS, visit https://dhss.delaware.gov/dhss/dph/hsm/ohphome.html.

The 16th Delaware Healthy Mother and Infant Consortium (DHMIC) Summit will be held as a virtual event on April 26, 2022 from 8:30 a.m. to 3:00 p.m.

The summit convenes leaders in the area of family health to discuss new approaches to enhance the health of women, children, and families of all ages.

The live-streamed event runs from 8:30 a.m. to 3:00 p.m. and is open to the public. Registration is required; visit https://dethrives.com/summit-2022.

During the summit, two Kitty Esterly, MD Health Equity Champion awards will be presented to an individual and an organization that work tirelessly for the well-being of mothers and children in Delaware, as well as for the health of the community, by advancing equity. Dr. Kitty Esterly, Delaware’s first neonatologist, was an active voice, champion, and advocate on behalf of women, infants, and children. Nominations will be accepted until March 25 at https://dethrives.com/summit-2022.

The DPH Bulletin – March 2022 46 Delaware Journal of Public Health - March 2022

Page 2 of 3

Four cases of avian influenza confirmed Federal laboratory testing confirmed four cases of highly pathogenic H5N1 avian influenza (HPAI) on two poultry farms in New Castle County, Delaware, and in Cecil and Queen Anne’s counties, Maryland between February 23 and March 9. The Delaware Department of Agriculture and the Division of Public Health (DPH) are closely monitoring the cases.

Avian influenza is a highly contagious airborne respiratory virus that spreads quickly among birds through nasal and eye secretions and manure. Persons who have direct contact with infected birds are at greater risk for infection.

The Centers for Disease Control and Prevention (CDC) considers the general public to be at low risk from the HPAI H5 viruses in commercial poultry, backyard flocks, and wild birds. No known humanto-human transmission has occurred with the A(H5N1) virus lineage that is currently circulating in birds in the U.S. and globally, according to the CDC. Poultry meat and egg products are safe to eat.

Follow this advice from DPH to prevent HPAI: • Properly cook eggs and poultry products to an internal temperature of 165˚F. • Do not harvest or handle wild birds that are obviously sick or found dead.

• Do not eat, drink, or smoke while cleaning game.

• Wear rubber gloves while cleaning game or cleaning bird feeders.

• Wash hands with soap and water immediately after handling game or cleaning bird feeders.

Individuals who develop flu-like symptoms and were exposed to a backyard flock, poultry setting, or are involved in hunting should contact their medical provider. They should tell their medical provider about their symptoms and that they had recent contact with birds or poultry, or possible contact with bird/poultry waste due to hobbies such as hunting.

For more information about avian influenza and to access backyard flock registration forms, visit https://agriculture.delaware.gov/poultry-animalhealth/poultry/.

The DPH Bulletin – March 2022

Endometriosis disorders can be managed and treated

Endometriosis, a disorder where endometrial-type tissue grows outside the uterus, affects more than 11 percent of American women between 15 and 44, according to the U.S. Office of Women’s Health.

Women with endometriosis may have difficulty becoming pregnant.

The cause of endometriosis is unknown. Women are at higher risk of developing it if they have a mother, aunt, or sister with endometriosis, started their period before age 11, have short monthly cycles (less than 27 days), and have heavy menstrual cycles that last more than seven days.

Women who have never given birth, went through menopause at an older age, and/or have any disorders of the reproductive tract are at higher risk.

Primary symptoms of endometriosis are pelvic pain often during periods, excessive menstrual cramps, abnormal or heavy menstrual flow, and pain during intercourse. Other symptoms are fatigue, diarrhea, constipation, spotting between periods, and bloating or nausea, especially during menstruation.

Endometriosis is sometimes mistaken for pelvic inflammatory disease or ovarian cysts. It may be confused with irritable bowel syndrome (IBS), which causes bouts of diarrhea, constipation, and abdominal cramping. IBS can accompany endometriosis, which can complicate the diagnosis.

Laparoscopy, a minimally invasive surgical procedure, can definitively diagnose endometriosis.

Endometriosis has no cure, but its symptoms can be managed. The U.S. Office of Women’s Health Talk recommends talking to your doctor about hormonal birth control methods such as pills, patches, or rings with lower doses of estrogen. Exercise regularly (more than four hours weekly), lower body fat, and avoid large amounts of caffeinated beverages and alcohol.

Treatment options are pain medications, hormone therapy, hormonal contraceptives, conservative surgery, and hysterectomy. Finding a support group may help. For more information, call 1-800-994-9662 or visit https://www.womenshealth.gov.

Page 3 of 3 47

www.fic.nih.gov www.fic.nih.gov www.fic.nih.gov

GLOBAL GLOBAL HEALTH GLOBAL HEALTH M HEALTH M AT AT TERS TERS M AT TERS

Inside this issue Inside this issue Former Fogarty Fellow Inside this issue JAN/FEB 2022 JAN/FEB 2022

Former Fogarty Fellow discovers omicron variant Former Fogarty Fellow discovers omicron variant in Botswana . . . . . p. 4 discovers omicron in Botswana . . . .variant . p. 4

FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF HEALTH OF HEALTH in Botswana . . . . .AND p. 51 4 HUMAN SERVICES JAN/FEB 2022 • DEPARTMENT FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF HEALTH • DEPARTMENT OF HEALTH AND HUMAN SERVICES

NIH unveils framework for climate change initiative NIH unveils framework for climate change initiative NIH unveils framework for climate change initiative

FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF HEALTH • DEPARTMENT OF HEALTH AND HUMAN SERVICES

NIH has announced the strategic framework for its new $100has million climate the change and health initiative.

NIH announced strategic framework for itsThe new project is intended to reduce health threats from climate $100 million climate change and health initiative. The NIH has announced the strategic framework for its new change across the lifespan and buildthreats health from resilience in project is intended to reduce health climate $100 million climate change and health initiative. The individuals, communities around the world, change across the lifespanand andnations build health resilience in project is intended to reduce health threats from climate especially those at the highest risk. individuals, communities and nations around the world, change across the lifespan and build health resilience in especially those at the highest risk. individuals, communities and nations around the world, The NIH-wide effort is being co-chaired by Fogarty and especially those at the highest risk. the National Environmental Health Sciences The NIH-wideInstitute effort is of being co-chaired by Fogarty and (NIEHS), in collaboration with 23 Institutes, Centers and the National Institute of Environmental Health Sciences The NIH-wide effort is being co-chaired by Fogarty and Offices.

The concept was endorsed by the NIEHS advisory (NIEHS), in collaboration with 23 Institutes, Centers and the National Institute of Environmental Health Sciences council November 2021.

Offices. in The concept was endorsed by the NIEHS advisory (NIEHS), in collaboration with 23 Institutes, Centers and council in November 2021.

Offices. The concept was endorsed by the NIEHS advisory “It is clear that climate change greatly elevates threats to council in November 2021. human health wide range of illnesses injuries “It is clear thatacross climatea change greatly elevates and threats to that arehealth being studied NIEHSand Director human across athroughout wide range NIH,” of illnesses injuries “It is clear that climate change greatly elevates threats to Dr. Rick Woychik said during a presentation to council that are being studied throughout NIH,” NIEHS Director human health across a wide range of illnesses and injuries members.

Woychik chairs the aclimate changetoinitiative’s Dr. Rick Woychik said during presentation council that are being studied throughout NIH,” NIEHS Director members. Woychik chairs the climate change initiative’s Dr. Rick Woychik said during a presentation to council members. Woychik chairs the climate change initiative’s

executive committee, which includes six peers from participating I/Cs, including Fogarty.six peers from executive committee, which includes participating I/Cs, including Fogarty. executive committee, which includes six peers from “There is no other issue that is as global as climate change,” participating I/Cs, including Fogarty. stressed Dr. is Roger I. Glass.

“It affects “There is Fogarty no otherDirector issue that as global as climate change,” absolutely everyone, everywhere.” stressed Fogarty Director Dr. Roger I. Glass. “It affects “There is no other issue that is as global as climate change,” absolutely everyone, everywhere.” stressed Fogarty Director Dr. Roger I. Glass. “It affects Echoing the sentiment, Fogarty advisory board member Dr. absolutely everyone, everywhere.”

Judith Wasserheit suggested climate change is the poster Echoing the sentiment, Fogarty advisory board member Dr. child forWasserheit global health.

“Done climate right, this couldisbe one of Judith suggested change the poster Echoing the sentiment, Fogarty advisory board member Dr. the most impactful initiatives that NIH ever child for global health.

“Done right, thishas could belaunched,” one of Judith Wasserheit suggested climate change is the poster she said.

The University of Washington professor noted the most impactful initiatives that NIH has ever launched,” child for global health. “Done right, this could be one of there has The beenUniversity little intervention research relatednoted to climate she said. of Washington professor the most impactful initiatives that NIH has ever launched,” change to been date and theresearch team forrelated incorporating there has littleapplauded intervention to climate she said. The University of Washington professor noted implementation science and capacity building into the change to date and applauded the team for incorporating there has been little intervention research related to climate initiative. “If we’re really and committed tobuilding addressing implementation science capacity intoequity the change to date and applauded the team for incorporating issues, we“If have to really acknowledge thattothe impacts are already initiative. we’re committed addressing equity implementation science and capacity building into the . . impacts continued p. 2 issues, we have to acknowledge that .the areon already initiative. “If we’re really committed to addressing equity . .. . .. continued p. page 2 continued onon next issues, we have to acknowledge that the impacts are already . . . continued on p. 2

Fogarty recently convened the recipients of awards designedrecently to help convened low- and middle-income country Fogarty the recipients of awards(LMIC) scientiststo develop or strengthen policies and procedures designed help lowand middle-income country (LMIC) Fogarty recently convened the recipients of awards to reduce sexual at their institutions.

Particiscientists developharassment or strengthen policies and procedures designed to help low- and middle-income country (LMIC) pants shared lessons learned at and different approaches to reduce sexual harassment their institutions.

Particiscientists develop or strengthen policies and procedures used to address the common One-year funding pants shared lessons learned problem. and different approaches to reduce sexual harassment at their institutions. Particiwas to 10 recipients, supported the usedprovided to address theLMIC common problem.

One-yearbyfunding pants shared lessons learned and different approaches NIH Office of AIDS Research. was provided to 10 LMIC recipients, supported by the used to address the common problem. One-year funding NIH Office of AIDS Research. was provided to 10 LMIC recipients, supported by the “I am incredibly impressed by what this program has NIH Office of AIDS Research. accomplished,” Fogarty Director Dr. Roger “I am incrediblyobserved impressed by what this program hasI. Glass. “The measures youFogarty are putting intoDr. place willI.create accomplished,” observed Director Roger “I am incredibly impressed by what this program has a safe environment foryou science, help women advance into Glass.

“The measures are putting into place will create accomplished,” observed Fogarty Director Dr. Roger I. leadership positionsfor and ensurehelp we don’t lose some ofinto the a safe environment science, women advance Glass. “The measures you are putting into place will create best and brightest minds in science.” leadership positions and ensure we don’t lose some of the a safe environment for science, help women advance into best and brightest minds in science.” leadership positions and ensure we don’t lose some of the . . . continued on p. 2 best and brightest minds in science.” . . . continued p. 2 . . . continued on nexton page . . . continued on p. 2

FOCUS FOCUS FOCUS 48 Delaware Journal of Public Health - March 2022

PhotoPhoto courtesy courtesy Photo of IDI/Makerere courtesy of IDI/Makerere of IDI/Makerere University University University

Grantees share methods to reduce sexual harassment Grantees share methods to reduce sexual harassment Grantees share methods to reduce sexual harassment

Fogarty provided supplemental funding for grantees to develop or strengthen sexual harassment policies and practices.

Fogarty provided supplemental funding for grantees to develop or strengthen sexual harassment policies and practices.

Fogarty provided supplemental funding for grantees to develop or strengthen sexual harassment policies and practices.

Focus on the importance of including men in research Focus on the importance including in research • Targeting male refugees forofmental healthmen support interventions

• Studying differences in immunity, behavior that in impact men’s health Targeting male refugees forofmental healthmen support interventions Focus on the importance including research • Examining masculine norms to prevent intimate partner violence Studying differences in immunity, behavior that impact men’s health • Targeting male refugees for mental health support interventions • Examining masculine norms to prevent intimate partner violence Read Moremen’s on pages pages 53-56 Read more on 6 –9 • Studying differences in immunity, behavior that impact health Readpartner more on pages 6 – 9 • Examining masculine norms to prevent intimate violence Read more on pages 6 – 9

JANUARY/FEBRUARY 2022 JANUARY/FEBRUARY 2022

NIH unveils framework for climate change initiative NIH unveils framework for climate change initiative

. .. .. continued fromfrom previous . continued p.1 page . . . continued from p.1

Fogarty board member Dr. Judy Wasserheit made the case for health in member the new NIH climate change made initiative Fogartyfocus board Dr. Judy Wasserheit theand casesaid for for its success. health focus in the new NIH climate change initiative and said

academic scientists to collect, analyze and synthesize academic scientists collect, analyze and synthesize diverse views, needsto and opportunities.

Core elements diverse views, opportunities.

Core elements include healthneeds effectsand research, health equity, intervention include health effects research, health equity, intervention research, and training and capacity building. research, and training and capacity building.

The research plan is based on the following objectives: The research plan is based on the following objectives: • Identify risks and optimize benefits to the health of • individuals, Identify risks and optimizeand benefits to the health of communities populations from actions individuals, and populations from actions to mitigate orcommunities adapt to climate change. to mitigate or adapt to climate change.

• Develop the necessary research infrastructure and a strong global she will be cheering a strong global she will be cheering

for its success. hitting populations in low- and middle-income countries hitting populations in low- and middle-income countries disproportionately,” Wasserheit said. “Indeed, there is disproportionately,” Wasserheit said.

“Indeed, there little recognition that soon climate change is likely toisstart little recognition soon climate change is likely to start undoing decadesthat of progress in global health in many of undoing decades of progress in global health in many of these countries.” these countries.”

Funding for the plan is included in the President’s Fiscal Funding forbudget the plan is included the President’s Fiscal Year 2022 request for thein agency.

The initiative’s Year aim 2022 budget the agency.

The initiative’s first will be to request leveragefor existing grant programs, cohorts first networks aim will be leverage existing grant cohorts and toto support projects that canprograms, be implemented and networks to support projects cansubstantial be implemented effectively in the near term, while that leaving effectivelyfor in the near term, while leaving substantial flexibility subsequent years.

The framework reflects flexibility for subsequent years. The framework reflects extensive input and coordination with organizations and extensive input and coordination with organizations and

• workforce Develop the infrastructure and to necessary enable theresearch generation of timely and relevant workforce todrawing enable the generation of timelyofand relevant knowledge, from the full spectrum biomedical knowledge, drawing from the full spectrum of biomedical disciplines.

• disciplines.

Leverage partnerships with other scientific and social • disciplines Leverage partnerships with other scientific social and organizations to achieve theand most impactdisciplines and organizations to achieve the most impactful results. results.

• ful Innovate across the research translation continuum to • ensure Innovate across are the credible, researchaccessible translationand continuum to findings actionable ensure findings aregoals. credible, accessible and actionable for achieving these for achieving these goals.

Fogarty is represented on the initiative’s steering committee Fogarty is represented the initiative’s steering committee by Drs. Flora Katz and on Joshua Rosenthal.

by Drs. Flora Katz and Joshua Rosenthal.

RESOURCES RESOURCES www.nih.gov/climateandhealth www.nih.gov/climateandhealth

Grantees share methods to reduce sexual harassment Grantees share methods to reduce sexual harassment . continued p.1 page . .. .. continued fromfrom previous . . . continued from p.1 Many of the LMIC grantee institutions had existing sexual Many of the LMIC grantee institutions had existingreported sexual harassment policies but a number of participants harassment policies but a number of participants reported that the policies were not widely promoted nor were that the policies were not promoted nor were there clear procedures for widely reporting and investigation. there clearshared procedures for reporting andapproached investigation.

Speakers how their institutions policy Speakers shared their institutions approached policyA development, staffhow training and publicity for their efforts. development, staff training publicity their efforts.

A number conducted surveys and to help informfor the process.

For number conducted surveys to help inform (IDI) the process.

For example, the Infectious Diseases Institute at Makerere example, the Infectious Diseases Institutesurvey (IDI) atthat Makerere University in Uganda found in a baseline only University in community Uganda found a baseline survey 32% of their saidinthey were aware of that IDI’s only 32% of harassment their community said they were aware of IDI’s sexual policy.

After IDI’s program training sexual harassment policy.poll After IDI’sabout program training and promotion, a second found 90%ofwere and promotion, secondsaid pollDr. found aboutCastelnuovo.

90% were She familiar with theapolicy, Barbara familiar with the policy, said Dr.their Barbara Castelnuovo.

She also reported respondents said likelihood of reporting also reported respondents said their likelihood of reporting sexual harassment incidents went from 8% initially to sexual 80% harassment went from 8% Promotional initially to nearly after theincidents program’s completion. nearly 80% after“zero the program’s efforts included tolerance”completion. sweatshirts.Promotional efforts included “zero tolerance” sweatshirts.

At the University of Lagos (UL) in Nigeria, the supplement At the University of Lagos (UL) in Nigeria, the supplement

2 2

helped to create awareness of sexual harassment guidelines helped to create of Women’s sexual harassment and establish theawareness Equity and Center. Theguidelines funding and establish the Equity and Women’s Center.

The catalyzed efforts across the three UL campuses andfunding serves as catalyzed efforts across the three said UL campuses andOgunsola. serves as a model for regional universities, Dr. Folasade a model for regional universities, said Dr. Ogunsola.

Students were included in the project andFolasade were responsible Students were slogans includedasinpart the of project and were responsible for developing the promotional campaign, for developing slogans as part the promotional campaign, such as “The fight is ours!

Theof struggle is ours!” and “Don’t such as “Theoffight ours! The struggle is ours!” and “Don’t be ashamed yourisstory…it will help inspire others.” be ashamed of your story…it will help inspire others.”

The supplemental funding program is one way NIH The funding is one way and supplemental Fogarty are working toprogram ensure grantees andNIH their and Fogarty are working ensure their institutions—wherever into the worldgrantees they are and located— institutions—wherever in the world they are located— meet the agency’s requirements for providing a workplace meetisthe agency’s requirements for providing workplace that free from sexual harassment, bullying a and racial that is free fromSince sexual harassment, and 215 racial discrimination.

2018, NIH has bullying investigated discrimination.

2018, has investigated 215 individuals and Since removed 75 NIH principal investigators due to individualsofand removed 75 principal investigators due tothe instances misconduct.

Issues can be reported through instances of misconduct. Issues reported hotline at 1-833-224-3829 or viacan the be NIH websitethrough https://the hotline at 1-833-224-3829 or via the NIH website https:// hr.nih.gov/working-nih/civil/intake-form hr.nih.gov/working-nih/civil/intake-form 49

JANUARY/FEBRUARY JANUARY/FEBRUARY 2022 2022

Former Former Fogarty Fogarty trainees trainees enlisted enlisted for for COVID-19 COVID-19 trials trials By

By Mariah Mariah Felipe Felipe

As Asscientists scientistswatched watchedthe theSARS-CoV-2 SARS-CoV-2outbreak outbreakspread spread globally globallyin inlate late2019, 2019,ititbecame becameevident evidentthis thispathogen pathogenhad had the thepotential potentialto tobecome becomethe thenext nextpandemic. pandemic.NIH NIHquickly quickly enlisted enlistedthe theexpertise expertiseof ofinfectious infectiousdisease diseaseresearchers researchers worldwide, worldwide,forming formingthe theCOVID-19 COVID-19prevention preventionnetwork network (CoVPN) (CoVPN)and andtasking taskingititwith withconducting conductingPhase Phase33efficacy efficacy trials trialsfor forCOVID-19 COVID-19vaccines vaccinesand andmonoclonal monoclonalantibodies. antibodies.

“The “Theshovel-ready shovel-readysites siteswith withinfrastructure infrastructureand and investigators investigatorsthat thatwere werewell-trained well-trainedand andknew knewhow how to toconduct conductclinical clinicalresearch, research,all allsprung sprungfrom fromthese these relationships relationshipswith withthe thenetworks networksbuilt builtwith withFogarty Fogarty over overdecades,” decades,”said saidDr. Dr.Myron MyronCohen, Cohen,HPTN HPTNprincipal principal investigator investigatorand anddirector directorof ofglobal globalhealth healthat atthe theUniversity University of ofNorth NorthCarolina.

Carolina.

CoVPN CoVPNinvestigators investigatorsinitially initiallyexamined examinedthe theeffectiveness effectivenessof of face facemasks masksand andsocial socialdistancing distancingin inreducing reducingthe thespread spread of ofSARS-CoV-2.

SARS-CoV-2.The Thenetwork networkalso alsostudied studiedNovavax, Novavax, AstraZeneca AstraZenecaand andModerna Modernavaccines, vaccines,as aswell wellas asthe theLily Lily and andRegeneron Regeneronmonoclonal monoclonalantibody antibodycombinations. combinations.CoVPN CoVPN recently recentlylaunched launchedthe thefirst firstU.S. U.S.government-supported government-supportedtrial trial measuring measuringthe theefficacy efficacyof ofthe theModerna ModernamRNA mRNAvaccine vaccinein in adults adultsliving livingwith withHIV. HIV.The Thescientists scientistsexpect expectto toenroll enrollabout about 14,000 14,000volunteers volunteersat at54 54clinical clinicalresearch researchsites sitesin inEast Eastand and Southern SouthernAfrica.

Africa.

“Vaccination “Vaccinationand andtreatment treatmentare arecritical criticalfor forthose thosewho whoface face the thedual dualthreat threatof ofHIV HIVand andCOVID-19, COVID-19,as asthey theyremain remainat at high highrisk riskof ofacquisition acquisitionand andtransmission transmissionand andpotentially potentially can canbe bethe theorigin originof offuture futurevariants,” variants,”according accordingto toDr. Dr. Larry LarryCorey, Corey,aaCoVPN CoVPNprincipal principalinvestigator. investigator.Although Although researchers researchersstress stressthey theymust mustnot notfurther furtherstigmatize stigmatizeHIV, HIV, there thereare aresome someimportant importantquestions questionsthat thatmerit meritstudy. study.

How Howwell welldo dopeople peoplewith withHIV HIVrespond respondto tovaccination? vaccination?Are Are monoclonal monoclonalantibodies antibodiesrequired requiredfor forprevention preventionof ofCOVID COVID among amongpeople peopleliving livingwith withHIV? HIV?

Numerous Numerousformer formerFogarty Fogartytrainees traineeshave havebeen beenusing usingtheir theirexpertise expertisetotostudy studythe the effectiveness effectivenessof ofCOVID-19 COVID-19vaccines vaccinesand andmonoclonal monoclonalantibody antibodytreatments treatmentsatatlowlowand andmiddle-income middle-incomecountry countrytrial trialsites. sites.

It’s It’simportant importantfor forNIH NIHto tosupport supportglobal globalresearch researchprojects projects like likethose thoseconducted conductedby byCoVPN CoVPNfor foraanumber numberof ofreasons, reasons, according accordingto toCohen.

Cohen.Increasing Increasingthe thenumber numberof ofresearch research subjects subjectsbeing beingstudied studiedspeeds speedsdiscovery discoveryand andallows allows scientists scientiststo tostudy studydiseases diseasesthat thatare areprevalent prevalentelsewhere. elsewhere.

“We “Wesee seethat thatwhen whenCOVID-19 COVID-19strikes, strikes,we wecan’t can’tpredict predict where whereit’s it’sgoing,” going,”Cohen Cohensaid. said.“I“Ithink thinkSARS-CoV-2 SARS-CoV-2shines shines aalight lighton onthe theabsolutely absolutelyessential essentialnature natureof ofhaving havingaaglobal global research researchnetwork.” network.”

One OneFogarty Fogartyalum alumplaying playingaaleadership leadershiprole rolein inCoVPN CoVPNis is its itsdirector directorof ofoperations—Dr. operations—Dr.Jim JimKublin—who Kublin—whoreceived receivedaa Fogarty Fogartycareer careerdevelopment developmentaward awardto toadvance advancehis hismalaria malaria research researchin in2000.

2000.Now Nowaaprincipal principalinvestigator investigatorat atthe theFred Fred Hutchinson HutchinsonCancer CancerResearch ResearchCenter, Center,Kublin Kublinsaid saidthe thegrant grant was was“instrumental” “instrumental”in inenabling enablinghim himto toprogress progressin inhis his career careerand andthat thathis hisearly earlystudies studiesof ofthe themolecular molecularevolution evolution and andepidemiology epidemiologyof ofmalaria malariahave haveapplications applicationsto toCOVID-19 COVID-19 today. today.“I“Ithink thinkFogarty Fogartyand andNIH NIHare areamong amongthe theleastleastappreciated appreciatednational nationalresources resourceswe wehave,” have,”he hesaid. said.“Both “Both have haveaacritical criticalrole roleto toplay playin inpandemic pandemicpreparedness.” preparedness.”

CoVPN CoVPNleaders leadersagree agreethat thatthe theSARS-COV-2 SARS-COV-2pandemic pandemic has hashighlighted highlightedthe theimpact impactof ofFogarty’s Fogarty’sresearch researchcapacity capacity building buildingprograms programsand andthe theneed needto toexpand expandthe thepipeline pipelineof of global globalhealth healthresearchers. researchers.

“The “Thesites, sites,the theinfrastructure, infrastructure,and andthe theinvestigators investigatorsthat that were werewell-trained well-trainedand andknew knewhow howto toconduct conductclinical clinical research researchare areall allaaresult resultof ofthe thenetworks networksbuilt builtwith withFogarty Fogarty support. support.ItItwould wouldhave havebeen beenimpossible impossibleto tohave havethis thiswithout without the theinvestments investmentsthat thatwere weremade madeover overdecades,” decades,”said saidCohen.

Cohen.

“It “Itcould couldnot nothave havehappened.” happened.”

RESOURCES RESOURCES https://bit.ly/COVID_19_Trials https://bit.ly/COVID_19_Trials

50 Delaware Journal of Public Health - March 2022

Photo courtesy courtesy of of UNC UNC Photo

Many ManyCoVPN CoVPNinvestigators investigatorsbased basedin inthe theU.S. U.S.and andin in lowlow-and andmiddle-income middle-incomecountries countries(LMICs) (LMICs)have havereceived received significant significanttraining trainingthrough throughFogarty Fogartyprograms programsover overthe the last lastthree threedecades decadesand andhad hadgained gainedexpertise expertisein ininfectious infectious disease diseaseresearch researchwith withaaparticular particularfocus focuson onending endingthe the HIV/AIDS HIV/AIDSepidemic. epidemic.CoVPN CoVPNis ismade madeup upof oflongstanding longstanding research researchorganizations organizationsincluding includingthe theHIV HIVPrevention PreventionTrial Trial Network Network(HPTN), (HPTN),HIV HIVVaccine VaccineTrial TrialNetwork Network(HVTN), (HVTN),the the AIDS AIDSClinical ClinicalTrials TrialsGroup Group(ACTG) (ACTG)and andthe theInfectious Infectious Diseases DiseasesClinical ClinicalResearch ResearchConsortium Consortium(IDCRC).

(IDCRC).CoVPN CoVPN was wasestablished establishedand andis isfunded fundedby bythe theNIH’s NIH’sNational National Institute Instituteof ofAllergy Allergyand andInfectious InfectiousDiseases Diseases(NIAID).

(NIAID).

33

PROFILE Fogarty Fogarty Fellow Fellow recognized recognized for for omicron omicron discovery discovery After After decades decades spent spent using using genomic genomic sequencing sequencing to to study study HIV/AIDS HIV/AIDS and and other other diseases, diseases, former former Fogarty Fogarty Fellow Fellow Dr. Dr. Sikhulile Sikhulile Moyo Moyo was was well-prepared well-prepared to to pivot pivot to to COVID-19 COVID-19 when when itit struck struck Botswana.

Botswana. Invited Invited to to join join his his country’s country’s presidential presidential pandemic pandemic task task force, force, Moyo Moyo helped helped establish establish national national guidelines guidelines for for testing testing and and genomic genomic surveillance. surveillance.

Adhering Adhering to to aa policy policy of of daily daily sampling sampling and and weekly weekly sequencing, sequencing, Moyo’s Moyo’s Botswana Botswana Harvard Harvard AIDS AIDS Institute Institute lab lab team team found found an an intriguing intriguing pattern pattern of of mutations mutations among among the the SARS-CoV-2 SARS-CoV-2 samples samples collected collected in in mid-November mid-November 2021.

2021. “So “So many many mutations!,” mutations!,” he he noted. noted. “We “We checked checked the the international international databases databases and and realized realized they they had had not not been been seen seen anywhere anywhere before.” before.”

He He immediately immediately alerted alerted Botswana’s Botswana’s health health department, department, which which sent sent him him more more information. information. Sifting Sifting through through this this data, data, Moyo Moyo discovered discovered that that the the four four individuals individuals who’d who’d provided provided samples samples with with the the mutations mutations had had traveled traveled and and entered entered the the country country together. together. Moyo’s Moyo’s team team quickly quickly deposited deposited the the sequences sequences into into the the international international GISAID GISAID database. database. Later Later that that same same day, day, South South African African scientists scientists reported reported their their own own six six sequences sequences while while aa Hong Hong Kong Kong team team posted posted aa single single sequence. sequence. Within Within aa week, week, the the WHO’s WHO’s virus virus working working group group had had classified classified Moyo’s Moyo’s discovery discovery as as aa “variant “variant of of concern.” concern.”

Moyo Moyo said said he he leveraged leveraged his his skills skills in in next-generation next-generation sequencing sequencing and and bioinformatics bioinformatics that that he he acquired acquired with with support support from from Fogarty Fogarty HIV HIV research research training training grants. grants. “I“I was was able able to to establish—from establish—from ground ground zero—sequencing zero—sequencing of of SARS-CoV-2 SARS-CoV-2 here here in in Botswana Botswana using using the the same same technology technology I’d I’d used used for for HIV.” HIV.” Previously, Previously, Moyo Moyo translated translated his his HIV HIV knowledge knowledge to to tackle tackle diseases diseases such such as as hepatitis, hepatitis, human human papillomavirus, papillomavirus, noroviruses noroviruses and and tuberculosis. tuberculosis. He He also also mentors mentors students, students, helping helping them them use use sequence sequence data data to to better better understand understand pathogens. pathogens. Indirectly, Indirectly, Fogarty Fogarty played played an an important important role role in in his his omicron omicron discovery discovery story, story, said said Moyo.

Moyo. He He serves serves as as aa mentor mentor on on aa Fogarty Fogarty COVID-19 COVID-19 supplemental supplemental grant grant that that is is supporting supporting two two of of the the scientists scientists who who helped helped with with the the discovery. discovery.

Some Some of of Moyo’s Moyo’s Ph.D. Ph.D. work work took took place place at at the the Harvard Harvard School School of of Public Public Health, Health, where where he he designed designed aa research research study study from from scratch, scratch, and and learned learned about about the the project project submission submission process, process, the the intricacies intricacies of of informed informed consent, consent, methods methods for for storing storing biological biological specimens specimens and and how how to to design design

44

Sikhulile Sikhulile Moyo, Moyo, Ph.D., Ph.D., MPH MPH Fogarty FogartyFellow: Fellow:

2017-18 2017-18

US USInstitution: Institution:

Harvard HarvardT.H. T.H.Chan ChanSchool Schoolof ofPublic PublicHealth Health

Foreign ForeignInstitution: Institution: Stellenbosch StellenboschUniversity, University,South SouthAfrica Africa Research Researchinterest: interest: Evolutionary Evolutionarytrends trendsof ofHIV HIVininBotswana Botswana

his his own own protocols. protocols. This This work, work, which which was was supported supported by by the the NIH’s NIH’s National National Institute Institute of of Mental Mental Health, Health, led led to to six six publications publications and and new new research research collaborations. collaborations.

As As aa participant participant in in Fogarty’s Fogarty’s Fellows Fellows and and Scholars Scholars program, program, Moyo Moyo came came to to the the NIH NIH campus campus in in 2017 2017 for for orientation, orientation, where where he he presented presented his his elevator elevator pitch pitch to to the the NIH NIH Director Director and and attended attended aa lecture lecture by

by Dr. Dr. Anthony Anthony Fauci, Fauci, head head of of NIH’s NIH’s National National Institute Institute of of Allergy Allergy and and Infectious Infectious Diseases.

Diseases. It’s It’s these these kind kind of of informal informal learning learning opportunities opportunities facilitated facilitated by

by Fogarty Fogarty that that prove prove invaluable, invaluable, said said Moyo.

Moyo. Through Through presentations presentations and and by by networking networking with with his his peers, peers, Moyo Moyo said said he he gained gained aa new new perspective. perspective.

“You “You meet meet people people who who have have few few resources, resources, yet yet they they do do quite quite impactful impactful translational translational research. research. That That changed changed my my mindset. mindset. Everything Everything II do do now, now, II ask ask myself: myself: What What is is in in itit for for public public health? health? What What is is in in itit for for the the ordinary ordinary person? person?

Is Is itit contributing contributing or or changing changing lives lives and and making making things things better?” better?”

The The omicron omicron discovery discovery led led to to aa “roller “roller coaster” coaster” of of negative negative and and positive positive effects, effects, said said Moyo.

Moyo. “We “We were were transparent, transparent, we we alerted alerted the the world world to to aa useful useful signal. signal. But, But, within within days, days, aa few few hours hours really, really, some some borders borders were were closed, closed, flights flights were were canceled canceled and and our our countries countries were were blacklisted.” blacklisted.”

Such Such aa negative negative response response encourages encourages dishonesty, dishonesty, Moyo Moyo suggested. suggested. “There “There is is great great value value in in scientific scientific transparency. transparency.

For For example, example, the the ability ability to to immediately immediately design design aa new new vaccine vaccine or or new new therapy therapy is is based based on on sharing sharing sequences.” sequences.”

Besides, Besides, closing closing aa border border may may incorrectly incorrectly assume assume that that the the virus virus has has not not already already begun begun to to circulate circulate within within other other regions. regions. Still, Still, the the discovery discovery also also led led to to positive positive effects, effects, including including more more PCR PCR kits kits for for his his lab. lab. Moyo Moyo believes believes that that this this bittersweet bittersweet experience, experience, in in the the end, end, will will spur spur increased increased scientific scientific collaboration collaboration with with global global partners. partners.

RESOURCES RESOURCES https://bit.ly/SikhulileMoyo https://bit.ly/SikhulileMoyo

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Q&A

MICHELLE GROOME, MBBCH, MSC, PHD

Dr. Michelle Michelle Groome Groome is is head head of of the the Division Division of of Public Public Health Health Surveillance Surveillance and and Response Response at at the the National National Dr. South Africa and a senior clinical researcher at the Institute for Communicable Diseases (NICD) in South University of of Witwatersrand.

Witwatersrand. She She began began her her career career as as a a medical medical doctor doctor in in 1997 1997 and and moved moved into into University development award award from from Fogarty Fogarty in in 2016 2016 to to study study research in 2005. Groome received a career development rotavirus vaccination vaccination in in South South Africa, Africa, specifically, specifically, the the safety safety of of the the vaccine vaccine and and factors factors influencing influencing immune immune rotavirus response. Her research results may inform vaccine policy decisions and rotavirus vaccine development.

Why did you choose to study rotavirus?

Rotavirus is is one one of of the the most most common common causes causes of of morbidity morbidity Rotavirus and mortality mortality amongst amongst children children under under five five in in South South Africa Africa and and can can cause cause severe severe diarrhea, diarrhea, vomiting vomiting and and fever. fever. Other Other and than pneumonia, pneumonia, it it is is one one of of the the most most important important causes causes than of infections and hospitalizations in young children here. of infections and hospitalizations in young children here.

My Ph.D. Ph.D. work work involved involved looking looking at at the the effectiveness effectiveness My and impact impact of of the the oral oral rotavirus rotavirus vaccine vaccine and and how how it it and reduced diarrheal diarrheal hospitalizations hospitalizations in in South South Africa.

Africa. reduced My Fogarty Fogarty grant grant allowed allowed me me to to look look closer closer at at those those My findings and and expand expand on on them. them. One One of of the the issues issues is is findings that oral oral rotavirus rotavirus vaccines vaccines had had aa significantly significantly lower lower that efficacy in in lowlow- and and middle-income middle-income countries countries (LMICs) (LMICs) efficacy compared to high-income countries (HICs).

My project compared to high-income countries (HICs). My project allowed me to unpack some of the factors surrounding allowed me to unpack some of the factors surrounding this lower lower efficacy efficacy to to try try to to improve improve immune immune responses responses this to oral oral vaccines. vaccines. There There were were also also safety safety issues issues as as the the to first licensed licensed rotavirus rotavirus vaccine vaccine was was associated associated with with aa first rare condition condition called called intussusception, intussusception, aa cause cause of of bowel bowel rare obstruction in in young young children. children. My My project project found found that that the the obstruction vaccine’s health health benefits benefits outweighed outweighed the the risks, risks, alleviating alleviating vaccine’s some of of those those concerns. concerns. We We also also looked looked at at how how genetic genetic some factors may may influence influence immune immune response. response. factors

What inspired your work?

On a a personal personal level, level, my my first first daughter daughter was was born born in in 2001 2001 On and contracted contracted rotavirus rotavirus as as aa small small child. child. II remember remember and thinking she she would would not not survive survive the the night night if if we we did did not not get get thinking her to to aa hospital. hospital. Thankfully, Thankfully, we we had had access access to to aa hospital hospital her nearby and and she she recovered. recovered. That’s That’s something something that's that's nearby always been been very very close close to to my my heart. heart. There There are are so so many many always people in in the the world world today today who who do do not not have have access access to to aa people hospital nearby. nearby. With With that that level level of of severe severe dehydration, dehydration, hospital young children children can can deteriorate deteriorate so so quickly. quickly. II went went on on to to young have two two more more daughters. daughters. My My youngest youngest had had the the rotavirus rotavirus have vaccine, and and it it really really hit hit home home for for me. me. Something Something as as vaccine, simple as as aa vaccine vaccine and and the the prevention prevention of of severe severe diarrhea diarrhea simple can significantly significantly impact impact regions regions without without easy easy access access to to can hospitals. hospitals.

There’s aa lot lot more more work work to to be be done done in in understanding understanding There’s the role role of of rotavirus rotavirus vaccines, vaccines, developing developing new new vaccines vaccines the 52 Delaware Journal of Public Health - March 2022

and studying studying combination combination schedules schedules with with the the oral oral and vaccines and the newer vaccines.

I am currently involved vaccines and the newer vaccines. I am currently involved in a rotavirus clinical trial, assessing a new injectable in a rotavirus clinical trial, assessing a new injectable rotavirus vaccine, vaccine, which which some some arms arms of of the the study study are are rotavirus receiving in conjunction with an oral vaccine.

If we’re receiving in conjunction with an oral vaccine. If we’re able to to expand expand and and improve improve the the vaccine vaccine effectiveness, effectiveness, able especially in in LMICs, LMICs, that that would would be be very very beneficial beneficial in in especially terms of of further further reducing reducing mortality mortality from from diarrheal diarrheal terms disease. These These research research findings findings could could provide provide guidance guidance disease. to countries countries that that haven’t haven’t yet yet introduced introduced the the vaccine. vaccine. to

How did you benefit from the Fogarty award?

When II applied applied for for the the Emerging Emerging Global Global Leader Leader Award, Award, When II didn't didn't realize realize the the impact impact it it would would have have on on my my career. career.

Having the the funding funding to to develop develop my my research research was was pivotal pivotal Having to helping helping me me progress progress in in my my career career as as aa rotavirus rotavirus to researcher and and getting getting to to where where II am am today. today. The The award award researcher allowed me me to to gain gain basic basic science science skills, skills, learn learn about about allowed immunology, and and study study research research methodologies methodologies and and immunology, statistical analysis. analysis. I’m I’m aa clinician clinician and and had had done done aa statistical master’s in in epidemiology epidemiology but but II didn’t didn’t have have many many insights insights master’s into the the lab lab side side of of research. research. II was was able able to to become become more more into familiar with with assays assays and and how how they they worked. worked. familiar The grant grant also also enabled enabled me me to to collaborate collaborate with with international international The partners that that were were critical critical to to the the project. project. As As part part of of this this partners award, II had had mentors mentors in in South South Africa Africa and and the the U.S. U.S. II had had award, the opportunity opportunity to to visit visit the the CDC CDC each each year year of of the the project project the and build build relationships relationships there. there. Being Being able able to to collaborate collaborate and with the the CDC CDC team team and and to to access access their their analytical analytical and and with lab resources resources was was highly highly beneficial beneficial to to the the project. project. These These lab relationships have have been been instrumental instrumental in in my my career career relationships advancement and and rotavirus rotavirus research. research. advancement Today, II have have aa much much more more far-reaching far-reaching public public health health Today, influence in in South South Africa Africa with with my my current current position position at at the the influence NICD. My My award award from from Fogarty Fogarty played played aa substantial substantial role role in in NICD. helping me me achieve achieve that. that. helping

RESOURCES RESOURCES https://bit.ly/MichelleGroome https://bit.ly/MichelleGroome

5

FOCUS

Men left behind by global health research

D

in the daytime when men are at work.

Dovel’s project to study a home-based intervention for men living with HIV is supported by a five-year Fogarty International Research Scientist Development Award (IRSDA), which provides an intensive, mentored LMIC research experience for U.S. early-stage investigators. Dovel and the larger team are exploring how best to reach men who are living with HIV but not engaged in care. Those randomized to the intervention arm will receive homebased treatment and one-on-one counseling. The team expects to see an improvement in treatment retention and viral suppression.

Courtesy Courtesy of of Partners Partners in in Hope/Malawi Hope/Malawi

espite significant achievements in global health over the past few decades, men have not benefited equally and have a life expectancy that is about five years less than women’s, according to WHO data. That gap is widening in Africa and South-East Asia. Work commitments and stigma prevent many men from visiting health clinics. They’re less likely to be tested and treated for HIV, less likely to adhere to treatment and more likely to die from AIDS. In many parts of the world, men tend to smoke and consume alcohol more often than women, which creates additional health risks. Also, men are less often included in interventions to address depression, mental health issues or intimate partner violence.

In Peru, the HIV epidemic is concentrated among men who Historically, men’s health concerns have sex with men (MSM), where have often been sidelined by there is a 12.2% prevalence rate global health programs in lowcompared to 0.4% among the and middle-income countries general population. All too often (LMICs) to prioritize studies aimed MSM living with HIV discontinue at reducing maternal and child treatment, said Dr. Luis Menacho mortality, said Dr. Kathryn Dovel of Universidad Peruana Cayetano of UCLA. For the last decade, Heredia. Menacho is testing an she’s done HIV research in Malawi A Fogarty-funded Fogarty-funded project project is is targeting targeting men men with with aa home-based home-based mHealth intervention that delivers where women may have hundreds Aintervention to encourage encourage them them to to continue continue treatment treatment for for HIV. HIV. intervention to interactive text messages to help of health care appointments increase care retention, with funding during their reproductive years, from a Fogarty Emerging Global Leader Award. Menacho’s more than 10 times the number of visits a man might team has completed the pre-developental phase and will make. “Men lack a systematic exposure to the health now launch the six-month intervention. Many participants system,” said Dovel. This has created an “uncomfortable will adhere to treatment and attend appointments on and unexpected paradox,” she said. “There is so much their own but up to a quarter may require assistance inequity for women in society generally, but there’s a very from nurses. Some participants have said they worry the clear gap, and inequity, regarding engaging men in health medicine won’t work to lower their viral load and that services.” hearing a bad result would be traumatic, said Menacho. As he attempts to address these concerns, Menacho is hopeful Yet men play a critical role in ending the HIV epidemic the intervention will improve retention. and must be included in scientific research for progress to be made. For example, only 63% of west and central Dovel—a social scientist by training—said she is excited by African men had tested for HIV compared to 77% of the progress being made to include men in global health women, according to 2019 data published in The Lancet. research. “If we develop a better understanding of men’s In Malawi, Dovel said men want to be involved in health experiences, and how men perceive their own health and services and to be seen as individuals whose health health systems, we can make adjustments to address their matters, yet they are often approached in suboptimal needs and improve men’s health.” ways. For example, home-based surveys usually happen

6

Resources: https://bit.ly/MenGlobalHealthResearch 53

FOCUS ON THE IMPORTANCE OF INCLUDING MEN IN ON RESEARCH FOCUS COVID AWARDS

Scientists study refugee families’ mental health needs Researchers investigating how best to provide mental health services to Syrian refugees wanted to ensure entire families were targeted in their approach. That meant including men, who can be difficult to reach since they spend much of their time working at low-wage jobs to provide for their families.

“Most have been displaced as families and Syrian culture is very family-oriented. So why not deliver mental health services that try to help the entire family?” Men are integral to his research because of the power they wield within patriarchal family structures, said Weine. “If you want to be able to impact the family, you have to go through the person in power.” Cultural sensitivities which prohibit men or even women from talking to wives and daughters also necessitate a father’s participation. Weine’s exploratory research grant was awarded through Fogarty’s global brain disorders program, with funding from the NIH’s National Institute of Mental Health.

Weine said his project aims to strengthen family members’ ability to communicate with each other, help them discuss difficult subjects, and improve their capacity to support each other’s emotional and mental health needs. “These are issues around which there’s a lot of stigma, a lot of shame, a sense of personal failure and weakness, so it helps to be able to have those discussions with the whole family,” Weine noted.

Applying lessons learned in previous work with Bosnian refugees, the research team developed a multi-family group model intervention to provide a safe space for families living in similar circumstances to interact.

“Imagine a room with six or eight families together, eating pastries, drinking coffee or tea, like they would be in a cafe in their village or city,” said Weine. “It's a comfortable atmosphere that we’re trying to create, instead of the feeling of a clinic or hospital, which has negative associations.”

54 Delaware Journal of Public Health - March 2022

Fogarty grantees are developing family-focused interventions—that include men— designed to reduce post-traumatic stress disorder, anxiety and depression among Syrian refugees.

Working with groups of families instead of just one also increases potential positive effects. “Frequently refugee families are isolated and don't want other families to know their troubles. In these meetings they overcome their fears and end up becoming friends,” Weine observed. They learn to listen to one other and sometimes offer advice. “It’s empowering when you have the ability to help somebody else. This becomes an important part of their own recovery.” In the pilot study, Weine collaborated with the Turkish Red Crescent and other organizations to recruit 72 families that attended four gatherings each, usually on weekends. To run the sessions, Weine enlisted Syrian refugees with the “people” skills necessary to lead conversations on painful topics, engage children in the discussion and create an atmosphere where everyone felt able to participate. He provided the hosts with 30 hours of training, including how to teach breathing exercises and other stress-reduction techniques.

Nearly 90% of families attended all four meetings, while fathers, “under pressure to work all the time,” came to half, said Weine. “We specifically spoke to the fathers at the beginning—we told them we wanted and needed them here because they’re important in the family.” Fathers who could not make the sessions, watched with their families videos recorded in Arabic that conveyed key lessons. At the program’s conclusion, Weine’s research team recorded significant decreases in emotional distress and post-traumatic stress disorder, as well as increases in mental health literacy.

Looking ahead, Weine believes adapting this intervention for others would not be difficult. Having worked with refugees in different countries for 30 years, he noted that “their experiences are more similar than different.”

7

Photo by Adam Patterson/Panos/DFID

About 3.6 million Syrian refugees now live in Turkey, many of them in Istanbul. Dr. Stevan Weine of the University of Illinois is conducting research in several urban neighborhoods there to determine how best to provide services to refugees who may be at risk of posttraumatic stress disorder, anxiety and depression.

FOCUS ON THE IMPORTANCE OF INCLUDING MEN IN RESEARCH

Projects examine sex, behavior differences that impact men’s health

“The field of sex-based biology is rapidly expanding with strong evidence showing that men and women respond differently to microbial challenges, therapeutics and vaccines,” observed Dr. Djeneba Dabitao of the University of Sciences, Techniques and Technologies of Bamako.

Dabitao’s Global Emerging Leader Award from Fogarty is enabling her to examine the sex differences of TB in Mali.

Dabitao hypothesizes that sex hormones influence immune responses to TB. “When you look at immune cells, most, if not all, have a receptor for hormones and we think that there is crosstalk between hormonal responses and immune responses.” Sex hormones can play a protective role in some contexts yet a pathogenic role in certain diseases. “Teasing out those different effects will provide new strategies to develop sex-specific therapies to treat or prevent infectious diseases. This means that doses of vaccines and drugs could become sex-specific in the near future,” said Dabitao.

In Mali, the rate of TB is 52 per 100,000 people, according to the WHO. Dabitao and her team have screened more than 300 people for TB and have enrolled 120 in the study. More than half have completed the protocol, which consists of a baseline visit, a check at two months after beginning treatment and a final examination at six months corresponding to the end of TB treatment. Dabitao also think that hormonal responses may not be the only explanation of the observed male bias in TB. “There could be a genetic component, too. Some immune genes located on the sex chromosomes have been involved in the pathogenesis of TB and we do not know whether they could be influencing disease outcomes in a sex-specific manner,” said Dabitao. She believes her study is proof of concept that can be used to examine pathogenesis of other major infectious diseases, such as HIV and COVID-19.

Across the globe in Vietnam, gender is a huge determining factor for tobacco consumption, behavior that poses health risks. About half of men in the country

8

In Mali, Dr. Djeneba Dabitao is using a Fogarty career development award to study the role sex hormones play in immune responses to TB.

smoke, compared with only 2% of women. In the Red River Delta region, Dr. Rajani Sadasivam of the University of Massachusetts has conducted a randomized control trial of an mHealth intervention that provided smokers with counseling, Quitline phone support and nicotine replacement therapy (NRT). Imbalanced smoking rates rendered men’s participation essential to this research funded through Fogarty’s tobacco research program, with additional support from the NIH’s Office of the Director and the National Cancer Institute.

Enlisting men to participate in the study was easy, said Jessica Wijesundara, project director. “There was a lot of interest being able to access NRT.” Co-investigator Dr. Hoa Nguyen said volunteers believe their participation helps themselves and their community. Recruitment efforts relied on trusted community health workers.

“They are also helpful in terms of follow-up, which reached 99%,” she said.

The intervention included six months of text messaging.

“Texting is attractive to us because it's low tech and most people can access it,” explained Sadasivam. Messages are written by both experts and peers. “Peers talk about their own experiences and are direct: ‘You will die from this.’ ‘You will get seriously ill.’ Experts cannot say things that way.”

To build capacity, the team developed a program for the Vietnamese Quitline counselors that included training with their U.S. counterparts. “We were lucky that Vietnam did a great job managing COVID-19 in their alpha period. Thus, we only had to pause for brief periods before we could resume our data collection.” said Sadasivam. Having completed data collection and qualitative interviews, the team is working on analysis and preparing results for publication. They’ve also begun another Vietnamese mHealth intervention for people living with HIV who smoke. “We will try to address not only smoking-cessation but also stigma related to HIV,” said Nguyen.

55

Photo courtesy of Ibrahima Dia/UCRC

Certain infectious diseases prevalent in low- and middleincome countries affect men in greater numbers than women. Such is the case with tuberculosis (TB), a public health concern in West Africa where incidence among men averages two to three times higher than among women.

FOCUS ON THE IMPORTANCE OF INCLUDING MEN IN RESEARCH

Grantees study masculine norms to reduce violence In India, one in three married women has experienced intimate partner violence (IPV), which is escalating in newly settled rural areas nearest the cities. A U.S.Indian collaboration funded by Fogarty is developing male-focused strategies to reduce IPV in Bangalore’s peri-urban neighborhoods. “Instead of seeing men as perpetrators, they must be included in the conversation and become part of the solution,” said Dr. Nancy Angeline Gnanaselvam of Saint John’s Medical College, coPrincipal Investigator (PI) of the project.

To create an intervention that will shift masculine norms, especially among youth, the researchers are first gathering information about the underlying concepts of masculinity and how they are formed. This is done by interviewing youth and adults and holding group discussions about who they look up to and how they learned to behave as a husband or wife. In patriarchal societies, men often have greater power in marital relationships, something their male children observe and may model, the researchers noted.

Engaging men in research involves recruiting them, a difficult task in India, said Gnanaselvam. “They ask so many questions: Why are you doing this study? Who is funding the study? Why should I take part?” Each man is aware that others may criticize him for participating so researchers are careful to conduct interviews in privacy, she added.

Beyond recruitment, there’s the broader issue of health professionals becoming involved in IPV, a hot-button issue. In a busy practice, rarely, if ever, do doctors or nurses address couples whose relationships are marked by violence to try and prevent it, said Gnanaselvam.

“It’s the need of the hour for health care professionals to come into the picture. In the spectrum of gender-based violence, there are multiple outcomes including homicide and suicide. The legal system penalizes and criminalizes

56 Delaware Journal of Public Health - March 2022

An important prerequisite to the research is capacity building, said Gnanaselvam. “Health care workers in India don’t have adequate knowledge of preventive measures or the necessary skills to address IPV.” The team from Iowa has taught faculty and staff at St. John’s about different aspects of intimate partner violence, including gender norms, masculine identity and mental health factors. During interaction with couples, the research team also learned about emotional, psychological and economic violence—“milder” mistreatment some see as acceptable within marriage.

“A workshop gave us a practical step-by-step approach when addressing a sensitive topic or approaching individuals who have experienced IPV or abuse,” said Gnanaselvam. They also explored ethical issues. “Both our knowledge and our research skills improved.”

While the pandemic has slowed progress, a COVID-19 supplement is enabling them to examine how the pandemic is impacting IPV. The team looks forward to coming up with community-accepted strategies that can actually prevent IPV, said Gnanaselvam. “Ultimately, we want to make sure men advocate and promote women’s health and children’s health as much as possible because around the globe where we see women and children thriving, we usually see communities that are really thriving,” said Story.

The project is funded through an exploratory research grant from Fogarty’s Global Noncommunicable Diseases and Injuries Across the Lifespan program.

Researchers in India are examining the cultural norms of masculinity—especially among male youths—to see if they can find ways to reduce intimate partner violence.

Photo by Dr. William Story, University of Iowa College of Public Health

“Both men and women uphold masculine norms. Men have an idea of what a man should be, but women also have an idea. And those ideas are embedded within every culture,” said Co-PI Dr. William Story of the University of Iowa. Swift urbanization in the neighborhoods they are studying has led to substantial income disparities, a threat for many men. “We’re wondering if this challenge to masculine identity is causing some men to act out in ways that may be harmful to women?” said Story. “This is why peri-urban areas interest us. Bangalore is not the only place seeing rapid urbanization—it’s happening everywhere.”

the act, however the health care system should focus on provision of mental health support to both the husbands and wives.”

OPINION

By Dr. Roger I. Glass, Director, Fogarty International Center

Pandemic truths: “none are safe until all are safe” In the hundred years since the great influenza pandemic of 1918, little has changed in terms of basic control measures—masking and social distancing. Yet the introduction of new science has been momentous for diagnostics, global tracking and modeling, new drugs and of course, vaccines. During the current SARSCoV-2 pandemic, more than 9 billion doses of COVID-19 vaccine have been manufactured and administered in little over a year, a remarkable achievement.

Yet, the distribution of these vaccines highlights the troubling issue of global inequities. Only 8% of vaccines have gone to Africa, the second most populous continent on earth. The 55 constituent countries of the African Union not only depend on the international community for vaccines but also diagnostics, drugs and PPE. Last April, the African Union, the African CDC and the Coalition for Epidemic Preparedness Innovations (CEPI) launched Partnerships for Vaccine Manufacturing in Africa, which, among other goals, aims to locally produce 60% of vaccines by 2040, while developing African universities as R&D hubs.

Undoubtedly, the pandemic has been a wake-up call.

Still, there are many reasons for hope. I recently visited Rwanda, where I was heartened to see lower rates of COVID in Kigali than in many places in the U.S. People wore masks everywhere and free screening was widespread. This country of just under 13 million had vaccinated more than 90% of its Kigali population, and 70% nationwide.

Another reason for optimism: international collaboration has characterized this pandemic from the start. The open science spirit began with the Chinese publishing in January 2020 the first SARS-CoV-2 sequence, which served as the blueprint for most vaccines. Since then, scientists have posted more than three million genomic sequences on open international databases.

Only three African sites had the ability to sequence strains in the earliest weeks of the pandemic, yet training—some of which was provided by Fogarty and its partners—has helped enable sequencing of more than 60,000 African strains to date. Just as international data

10

sharing is currently possible, global surveillance can soon become a reality.

One positive lesson from COVID has been the importance of investing in people. Many foreign scientists trained by NIH and Fogarty programs are leaders in their country’s pandemic response: Dr. John Nkengasong, who leads the African CDC; Dr. Christian Happi, who sequenced the first SARS-CoV-2 strain identified in Nigeria; and Dr. Sikhulile Moyo, who discovered the omicron variant in Botswana. We never anticipated their training, which has enabled them to adapt and address the pandemic, would be so valuable. Developing leaders in Africa, incubating their talents and building on them will be essential activities going forward.

Throughout the pandemic, global partners—including WHO, CEPI and GAVI—have demonstrated best practices in fostering a global response. Free exchange of ideas helped us all conclude that new vaccines, to be most effective, need to be distributed worldwide within 100 days. If we accelerate research on the 20-plus major virus groups, we can develop prototype vaccines and drugs for each class well in advance of future outbreaks. We also need regional centers for local production of vaccines, drugs, supplies and devices; this necessitates establishing supply chains with multiple providers for key ingredients.

The past two years have revealed to every person—and every world leader—the shortcomings of global outbreak preparation and response. Each of us now sees that “none are safe until all are safe.” Our global society can seize this moment by establishing more effective governance and improving partnerships between industry, universities, financial institutions and philanthropic foundations.

Most importantly, we must address inequities within existing and proposed systems.

These goals are not fantasies. Another tragic pandemic, HIV/AIDS, also provided lessons—lessons we studied and learned. No longer an automatic death sentence, HIV is now a chronic disease thanks to the many collaborative scientific discoveries funded by global partnerships. With sufficient investment and a concerted global effort, we can ensure we are better prepared when the next pandemic strikes.

RESOURCES https://bit.ly/PandemicTruths

57

PEOPLE Dr. Paul Farmer dies suddenly in Rwanda Humanitarian, physician and global health advocate Dr. Paul Farmer has died. Farmer was co-founder of Partners in Health, professor at Harvard and chief of global health equity at Brigham and Women’s Hospital. Farmer brought his message of health equity to NIH in 2016, when he delivered the David E. Barmes Global Health Lecture.

Former Fogarty grantee and advisor dies unexpectedly Longtime NIH grantee Dr. Bonnie Stanton died suddenly in January. An early experience in Bangladesh informed the rest of her career, which was devoted to improving health in underserved communities. Since 2016, she was founding dean of the SetonHall Hackensack Meridian School of Medicine. Stanton authored 350 peer-reviewed publications and edited several books.

Renowned “disease detective,“ Dr. Sherif Zaki dies CDC Pathologist Dr. Sherif Zaki died recently after suffering a fall in his home. Zaki founded and had led the CDC's infectious diseases pathology branch since the early 1990s. The Egyptianborn scientist and his team successfully identified the culprits of infectious disease outbreaks worldwide, including Ebola, Zika, leptospirosis and many others.

Califf confirmed as FDA Commissioner Former FDA Commissioner Dr. Robert Califf has been confirmed again to lead the agency—a role he previously held from 20162017. Califf has served on advisory boards and committees at several NIH institutes. Previously, he was a practicing cardiologist and professor of medicine at Duke University.

Gawande confirmed as USAID's global health chief Renowned surgeon, public health expert and former NIH grantee Dr. Atul Gawande has been confirmed as the Assistant Administrator for Global Health at USAID. Previously, Gawande was a surgeon at Brigham and Women's Hospital, and professor at Harvard Medical School and Harvard T.H. Chan School of Public Health.

Mubuuke receives inaugural James Hakim award Former Fogarty Fellow Dr. Roy Mubuuke Gonzaga was named recipient of the inaugural James G. Hakim Global Health Award for having submitted the highest ranked abstract to the 2022 Consortium of Universities for Global Health (CUGH) annual meeting. The award—established by Fogarty, CUGH and AFREhealth—will provide travel support to CUGH meetings.

Webster-Cyriaque named NIDCR’s Deputy Director Dr. Jennifer Webster-Cyriaque has joined the NIH’s National Institute of Dental and Craniofacial Research (NIDCR) as deputy director. Webster-Cyriaque previously was on faculty at the University of North Carolina’s schools of dentistry and medicine, where she led the UNC Malawi project and aided in founding Malawi's first dental school in 2019.

58 Delaware Journal of Public Health - March 2022

Global HEALTH Briefs US benefits from foreign STEM talent

A White House-commissioned study to quantify the economic costs and benefits of international science, technology, engineering and mathematics (STEM) talent in the U.S. found that foreign workers contribute nearly 2% to the country’s gross domestic product, adding as much as $409 billion annually to the economy.

Full report: https://bit.ly/STEM_benefits

NIH releases pandemic preparedness plan The NIH’s National Institute of Allergy and Infectious Diseases has announced it will direct its preparedness efforts on two fronts. Researchers will identify “prototype pathogens”—viruses within viral families that have the potential to cause significant human disease—and use these to build a framework for a rapid research and product development response.

Website: https://bit.ly/NIH_preparedness

Scientific integrity should be strengthened The White House has released a report identifying ways to strengthen policies and practices to restore public trust in government through scientific integrity and evidence-based policymaking. The assessment is intended to ensure governmentfunded science is conducted, managed, communicated, and used in ways that preserve accuracy and objectivity and prevent political interference.

News release: https://bit.ly/Scientific_integrity

Academy calls for global science focus

The U.S. should take bold and meaningful steps to strengthen connections in an increasingly global network of science and technology, according to a report from the American Academy of Arts and Sciences. To fully participate in this new landscape, the U.S. must support additional talent pipelines and foster sustainable, equitable partnerships.

Full report: https://bit.ly/Academy_global

GHTC celebrates 15th anniversary

The Global Health Technology Coalition is marking 15 years of advocacy to advance policies that support innovations to improve the health of the world’s poorest people. GHTC has produced a website that reviews its history, impact and some of the breakthrough innovations its members have brought to market.

Website: https://bit.ly/GHTC_15

11

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An Informed Approach to Vaccine Hesitancy and Uptake in Children Jonathan M. Miller, M.D., F.A.A.P. Chief, Primary Care; Medical Director, Value Based Care, Nemours Children’s Health; Clinical Associate Professor, Pediatrics; Sidney Kimmel Medical College, Thomas Jefferson University Ricki Carroll, M.D., M.B.E. Attending Physician, Divisions of Orthogenetics & Palliative Medicine, Nemours Children’s Health; Clinical Associate Professor, Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University

ABSTRACT The tremendous success of vaccination programs worldwide over the past two centuries has produced a paradoxical effect whereby a lack of exposure to the devastating consequences of vaccine-preventable diseases has created an environment in which fear of the side effects of vaccines can overshadow concerns about the impact of the diseases they are meant to prevent. As vaccine hesitancy grew over the past twenty years, states passed legislation, such as non-medical exemptions from vaccination, that have cultivated pockets of poor vaccine uptake allowing for the return of vaccine-preventable diseases such as measles and pertussis. The COVID-19 pandemic has further intensified mistrust of vaccines, impacting both the reasons for vaccine hesitancy and the attributes of vaccine hesitant parents. Because unimmunized children are at increased risk for vaccine-preventable diseases and associated cancers, as well as reduced access to adequate healthcare, they are a particularly vulnerable population warranting special protections and support. A comprehensive approach to combat vaccine hesitancy and promote uptake should include a focus on evidence-based initiatives at the legislative, practice, and provider levels. These strategies can substantively inform health policy, from upstream legislation strengthening school mandates and eliminating non-medical exemptions to downstream policies that impact provider conversations about immunization.

INTRODUCTION The World Health Organization (WHO) considers immunization to be “one of modern medicine’s greatest success stories,” and the Centers for Disease Control and Prevention (CDC) listed vaccination at the top of the list of the “Ten Great Public Health Achievements” of the 20th century.1,2 Despite the estimated 2-3 million deaths prevented each year by immunizations, vaccine hesitancy has been growing over the past 25 years, leading to the WHO naming vaccine hesitancy as one of “ten threats to global health” in 2019.3 The COVID-19 pandemic has intensified the backlash against vaccination programs and highlighted disparities in vaccination access and uptake.

Fundamental to a fully informed immunization debate is an understanding of the efficacy and significance of vaccines.

Global vaccination programs are responsible for the eradication of smallpox, the loss of endemic status for measles and polio in many countries around the world, including the eradication of wild-type polio from the African continent, and the saving of countless lives from vaccine-preventable diseases.4 The majority of immunizations recommended for routine use in children in the United States have efficacy of over 90%, with some, such as polio and measles, approaching 99%.5 The side effect profiles of these immunizations are quite favorable, typically encompassing local reactions or transient systemic symptoms such as fever. Fortunately, the vaccinations routinely recommended for children have no serious, long-term side effects. The serious adverse effects of these vaccines, such as 60 Delaware Journal of Public Health - March 2022

anaphylaxis or febrile seizures, are rare and not associated with long-term sequelae when treated appropriately. Studies have repeatedly failed to demonstrate a link between immunizations and developmental changes such as autism, but that has not prevented the anti-vaccination movement from continuing to gain momentum.6

HISTORY OF VACCINE HESITANCY Anti-vaccination sentiment rose shortly after the advent of vaccination, beginning with Edward Jenner’s smallpox vaccine in England at the turn of the 18th century. Smallpox outbreaks led to vaccination campaigns in the United States, stimulating the founding of the Anti Vaccination Society of America in 1879.7 During a smallpox outbreak in Cambridge, Massachusetts in 1902, the US Supreme Court ruled in support of the city’s right to mandate the vaccine in the context of a local outbreak, setting a precedent for the role of the government in public health emergencies.7 As the smallpox vaccine was demonstrating remarkable success around the world, the Salk polio vaccine was brought to market to prevent the devastating impact of polio on children. The polio vaccine was also extraordinarily successful, leading to the eradication of wild-type polio from most nations around the globe. However, the early roll-out of this vaccine was not without missteps. In 1955, Cutter Laboratories produced some batches of polio vaccine that were not inactivated, therefore containing live polio virus and leading to over 200 cases of paralysis and 10 deaths. The “Cutter Incident” led to many DOI: 10.32481/djph.2022.03.009

lawsuits against vaccine manufacturers and ultimately inspired the creation of an improved process for the oversight and regulation of vaccine manufacturing.8 During the 1970s and 1980s, the Diphtheria Pertussis Tetanus (DPT) vaccine was in widespread use. This vaccine was associated with more substantial side effects than those associated with the Diphtheria Tetanus acellular Pertussis (DTaP) vaccine that we use today. Along with the known side effects of DPT, there were a number of unsubstantiated reports of neurologic damage related to the vaccine, leading to an increase in lawsuits targeting vaccine manufacturers.7 These lawsuits ultimately chased several companies from the market, and, by 1984, there was only one US company still manufacturing DPT. A growing concern for vaccine shortages led to the creation of the National Childhood Vaccine Injury Act (NCVIA) in 1986. This act paved the way for improved vaccine program regulatory processes, including the National Vaccine Injury Compensation Program (NVICP) in 1988, the Vaccine Adverse Events Reporting System (VAERS) in 1990, and the creation of Vaccine Information Statements (VIS) in 1991.9 Then, in 1998, the anti-vaccination movement was ignited by the publication of a study in The Lancet authored by former British physician Andrew Wakefield that proposed a link between the Measles Mumps Rubella (MMR) vaccine and autism.7 This paper was subsequently retracted by The Lancet due to falsification of data and financial conflicts of interest, and Wakefield was barred from practicing medicine in the UK.7 Unfortunately, the damage was already done. This now infamous article unleashed a new wave of anti-vaccination sentiment due to unsubstantiated fear that this vaccine would cause autism, leading to a decrease in uptake of immunizations and, ultimately, a number of vaccinepreventable disease outbreaks around the world. Celebrities and media became an echo chamber for anti-vaccination sentiment.

During the years following the Wakefield article, anti-vaccine legislation targeting school vaccine mandates led to a trend toward more non-medical exemptions from vaccination.10 Despite a declaration of measles eradication in the US in 2000, worsening vaccination coverage led to outbreaks of measles, such as the Disneyland outbreak in 2015. By 2019, the US experienced the most cases of measles since 1992, indicating a growing problem that showed no signs of relinquishing. In the wake of the various measles outbreaks, several states (California, Maine, New York, and Connecticut) passed legislation to eliminate nonmedical exemptions, joining West Virginia and Mississippi as the only states without non-medical exemptions. However, there are still 44 states that allow non-medical exemptions from vaccination.

Historically, the emergence of a dangerous communicable disease has been largely met with widespread support for the corresponding vaccine. For example, families lined up with their children to get the polio vaccine in the 1950s. The COVID-19 pandemic has proved to be an anomaly in this respect, as this vaccination was met with a great deal of skepticism, and vaccine confidence has waned over the course of the pandemic.

IMPACT OF COVID-19 ON VACCINE CONFIDENCE Leading up to the COVID-19 pandemic, there was growing evidence that vaccine hesitancy was gaining a foothold as a pivotal issue in US politics. For example, in 2018 antivax political action committees (PACs) played a large role influencing which candidates were on the ballot, and their lobbying prevented the passage of legislation intended to strengthen public health vaccination programs in many states.11 A 2018 study demonstrated that Russian Twitter bots and trolls were amplifying anti-vaccine messaging to fuel the fire and erode vaccine confidence during that political cycle.12 Over the subsequent year, it became clear that social media giants, such as Facebook and YouTube, were being used to spread misinformation and propaganda about vaccines, laying the groundwork for the public health misinformation campaigns that plagued the COVID-19 pandemic.13 By the end of 2020, the first COVID-19 vaccine – created using cutting edge messenger RNA technology but with the unfortunate name of “Operation Warp Speed” – was rolled out in the US. As with polio in the 1950s, many people were clamoring to get the vaccine; however, many others met this vaccination with skepticism and mistrust, citing the speed of development and approval, concern about “new” technology, and fear of long-term side effects as rationale for delaying or refusing the vaccine. A study published in October 2021 by the Kaiser Family Foundation found that only 27% of parents were willing to get their 5- to 11-year-old vaccinated as soon as it was available for that age group.14 Studies have demonstrated an increase in overall childhood vaccine hesitancy over the course of the COVID-19 pandemic in addition to hesitancy regarding the COVID-19 vaccine specifically.15,16 Notably, the face of the anti-vaxxer has changed during this pandemic. There is a striking difference between populations regarding uptake of COVID-19 vaccine, with Democrats, college graduates, urban residents, women, and people age 65 and up being far more likely to receive the vaccine than Republicans, rural residents, men, and people age 30-49.14 The pandemic and political climate have stimulated the “anti-vax movement’s radical shift from crunchy granola purists to far-right crusaders.”17 There are also significant sociodemographic disparities in intention to vaccinate, with caregivers of Black children and from rural and disadvantaged neighborhoods being more hesitant to vaccinate their child against COVID-19.18 Furthermore, different vaccines engender hesitance in different populations. For example, people who refuse the MMR vaccine are not the same as the ones refusing the COVID-19 vaccine, and the principles impacting this decision are different.19

UNDER-IMMUNIZED POPULATIONS In order to establish comprehensive, evidence-based interventions to improve childhood vaccine uptake, it is crucial to understand the influence of sociodemographic and political disparities as well as the populations directly impacted: children and their surrogate 61

decision-makers (usually the parents). Vaccine hesitant parents typically fall into one of four categories: 1) no specific objection but concern due to external factors such as media; 2) concern about specific vaccines e.g., MMR or COVID-19; 3) concern about the timing of the recommended vaccine schedule; or 4) opposed to all vaccines (including for religious or philosophical reasons). Different interventions will have varying success with each of these groups of caregivers, so a comprehensive approach should include a variety of culturally sensitive strategies aimed at all groups.

The result of the vaccination decision that is in the hands of the surrogate decision-maker is the potential for a child to be underimmunized. Like other populations in society warranting special protections, such as disabled persons, the socioeconomically disadvantaged, racial and ethnic minorities, children in foster care, and the underinsured, underimmunized children are a vulnerable population.

Vulnerable status stems from economic, cultural, ethnic, or health characteristics that lead to disparate healthcare access and outcomes.20 In the case of underimmunized children, there are four main contributors to vulnerable status. First, they have surrogate decision-makers that are making inadvisable decisions on their behalf. Regarding the COVID-19 vaccine, there is some evidence that vaccine confidence is related to practice of other preventative behaviors; so, it can be extrapolated that inadvisable medical decisions may extend to other areas of health.21 Second, underimmunized children have a relative immunodeficiency compared with their appropriately immunized peers; they are at greater risk for serious, life-threatening, vaccine-preventable diseases such as measles, pertussis, pneumonia, and meningitis.

Third, they are at higher risk for certain cancers, specifically HPV-related malignancies such as cervical and oropharyngeal cancer as well as hepatocellular carcinoma related to Hepatitis B. Finally, they have decreased access to adequate medical care due to a significant increase in pediatric practices dismissing or refusing to care for these families.22 This practice can force underimmunized patients to cluster at practices that will accept them, which can put these practices at risk for disease outbreak, or transition to a “vaccine friendly” provider who is unlikely to promote vaccination by catering to the needs of vaccine hesitant families.23 The decrease in access to adequate healthcare is often compounded by recurrent adversarial confrontations with the healthcare system experienced by vaccine hesitant parents, further leading them to avoid contact with conventional healthcare providers.

Along with children and their parents, there are other key stakeholders that are affected by the underimmunized child.

They include populations at risk of serious illness from vaccinepreventable diseases, other children at school or in the waiting room of a practice, teachers, and healthcare workers. An ethical analysis of vaccine hesitancy should balance the best interest of the patient with that of society, autonomy of patients and preferences of parents, emerging autonomy of adolescents, potential for harm from the vaccines and harm from being underimmunized, protection of the vulnerable, and distribution of limited resources.

62 Delaware Journal of Public Health - March 2022

VACCINE CONTROVERSIES There are several common vaccine concerns that have strong evidence to discredit them. For example, the evidence is strong that there is no causal link between MMR or thimerosal, the mercury-based preservative, and neurodevelopmental disorders such as autism.6 Studies have failed to show evidence linking autoimmune disease and vaccines. Aluminum adjuvants are safe and effective. And while certain vaccinations, such as varicella, rubella, and hepatitis A are made by growing viruses in fetal embryo fibroblast cells first obtained in the 1960s, the Vatican has issued a statement on immunization promoting the use of these vaccines.24 Some vaccine hesitancy is related to the sheer number of vaccinations and the young age of children upon initiation: the “too many too soon” concern. In the United States, the number of diseases recommended for prevention by childhood immunization has increased from five in 1960 (smallpox, polio, diphtheria, tetanus, and pertussis) to 17 in 2022 (including COVID-19).25 During the same time period, improvements in vaccine science led to a decrease in the total number of antigens contained in those vaccines from >3000 in five vaccines to <200 in the 17 current vaccines,25 which is thought to be responsible for the significant decrease in side effects with the current recommended vaccine schedule.

Further, the recommended schedule was studied at the suggested ages to maximize benefit while minimizing harm; any deviation from the evidence-based schedule is likely to come at the cost of reduced immune response.

APPROACH TO VACCINE HESITANCY A comprehensive approach to vaccine hesitancy requires intervention at many different levels and must be informed by an evidence-based understanding of the risks and benefits of immunization as well as techniques to improve uptake at the individual and population level. Upstream approaches are the most effective strategies to improve vaccine uptake but tend to be the most difficult to execute. At the state level, the single most effective strategy has been school and childcare mandates for vaccines. Vaccines required for school entry have uptake exceeding 94%, and only 2.5% of children had an exemption for at least one vaccine.26 Another upstream approach, the elimination of non-medical exemptions, has led to a significant decrease in the number of children entering school underimmunized.27 Finally, targeting access for immunizations to underserved communities with disparities in vaccine uptake can help support health equity.

At the practice level, a formalized protocol for the management of underimmunized patients and families can improve uptake and protect both patients and staff. This protocol should be transparent to families and staff from the establishment of the provider-patient relationship. Potential policies for the underimmunized patient can include mandating regular well visits, eliminating walk-in visits, masking the patients and accompanying caregivers, avoiding the waiting room when sick,

and using a refusal to vaccinate form. Practices can maintain a registry of underimmunized patients, which can be used in the event of a regional outbreak to notify families of the heightened need for vaccination. Along with practice-level policy changes, practices can engage in quality improvement initiatives to improve vaccination coverage, including the use of registries to identify gaps in care, standing orders, and provision of vaccines at all opportunities.

manner to lead patients and caregivers to be internally motivated to follow recommendations.29 Finally, persistence after initial resistance can demonstrate the importance of vaccination for families and influence their decision.30 Providers should strive to make a strong recommendation and then persist in their recommendation later during the same encounter but also over time at future encounters, knowing that with time and trust, many families will change their minds.

Some providers refuse to see underimmunized patients or dismiss them from their care, a practice that is both controversial and ethically problematic.28 While dismissal of vaccine refusing families does have the benefits of reducing the number of underimmunized children in the office and waiting room while also decreasing the time and potential frustration of working with families that are not following medical guidance, there is no evidence that this practice improves vaccine uptake. However, this practice does lead to mistrust and decreased access to healthcare, leading to increasing health inequities and vulnerable status.

Furthermore, this is a missed opportunity for trust building, continued education about vaccination, and preventative counseling in the event of a disease exposure or outbreak.

CONCLUSION

At the provider level, it is most beneficial to continue to engage with a hesitant family, recognizing that they have the potential to change their minds about immunization over time. Many studies have demonstrated the importance of the trusted provider’s recommendation on the immunization decision.18 Providers should work hard to establish rapport, trust, and a therapeutic alliance that is not solely focused on the immunization decision, but the whole patient. Families want providers to listen carefully, respectfully, and non-judgmentally to their concerns, and providers should elicit the reasons and supporting evidence for these concerns. Information gathering can help the provider to better understand what type of hesitant parent they are dealing with, which can inform the approach. For instance, parents who have no specific objection but are concerned due to word-of-mouth are often amenable to a strong provider recommendation, while parents who are opposed to all vaccines tend to not be as flexible. The provider should educate the surrogate decision-maker in a culturally sensitive manner about what is known (and not known) about the risks and benefits of immunization, including correcting misperceptions and misinformation, providing resources, and sharing real life stories. It can be helpful to directly compare the risks of the vaccine with the risk of being unimmunized. The provider can also work with the family, using shared decisionmaking, to vaccinate the child at a different pace than the recommended schedule to engender trust and confidence.

There is growing evidence for several specific techniques to improve vaccine uptake. Providers can use a presumptive approach to offering vaccines, stating “your child is due for her vaccines today,” rather than an opt-in approach, such as asking “what do you think about doing vaccines today?” Another technique is motivational interviewing, where providers can guide conversations in a non-confrontational, non-paternalistic

Vaccination programs have been the victims of their own overwhelming success, as fading memories of terrifying vaccinepreventable diseases are accompanied by intensifying vaccine hesitancy and mistrust. The false equivalency between the severity of vaccine side effects and the diseases they are meant to prevent opens the door for vaccine hesitancy, which has been amplified by social media, political agents, immoral influencers acting in bad faith, and the COVID-19 pandemic.

Vaccine hesitancy is influenced by sociodemographic factors, highlighting the importance of developing culturally sensitive approaches for different populations, which must be informed by an understanding of the different types of vaccine hesitant parents as well as the vulnerable status of underimmunized children. Strategies to improve immunization uptake can include upstream approaches, such as school mandates and elimination of non-medical exemptions, practice-level approaches such as thoughtful protocols for the management of underimmunized children and their families as well as quality improvement initiatives, and provider-level techniques such as the presumptive approach, motivational interviewing, and a strong and persistent recommendation. Protecting children from vaccine-preventable diseases is a challenging yet admirable endeavor that requires a multi-level strategy with a focus on health equity and the protection of the vulnerable.

Dr. Miller can be contacted at jonathan.miller@nemours.org

REFERENCES 1. World Health Organization. (2019, Dec 5). Immunization. https://www.who.int/news-room/facts-in-pictures/detail/immunization 2. Centers for Disease Control and Prevention. (1999). Ten great public health achievements – United States, 1900-1999.

MMWR Mob Mortal Wkly Rep, 48(12), 241-264. https://www.cdc.gov/mmwr/pdf/wk/mm4812.pdf 3. World Health Organization. (2019). Ten threats to global health in 2019. https://www.who.int/news-room/spotlight/ten-threats-to-global-healthin-2019 4. World Health Organization. (2020, August 25). Global polio eradication initiative applauds WHO African region for wild polio-free certification. https://www.who.int/news/item/25-08-2020-global-polio-eradicationinitiative-applauds-who-african-region-for-wild-polio-free-certification 5. Kimberlin, D. W., Barnett, E. D., Lynfield, R., & Sawyer, M. H. (Eds.). (2021). Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics.

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6. DeStefano, F., Bodenstab, H. M., & Offit, P. A. (2019, August 1). Principal controversies in vaccine safety in the United States. Clin Infect Dis, 69(4), 726–731. https://doi.org/10.1093/cid/ciz135 7. The College of Physicians of Philadelphia. (2018, Jan 10).

History of anti-vaccination movements. https://www.historyofvaccines.org/content/articles/history-antivaccination-movements 8. Centers for Disease Control and Prevention. (2020, Sep 4).

Historical vaccine safety concerns. https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html 9. Centers for Disease Control and Prevention. (2020, Sep 9).

Overview, history, and how the safety process works. https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html 10. Bednarczyk, R. A., King, A. R., Lahijani, A., & Omer, S. B. (2019, February). Current landscape of nonmedical vaccination exemptions in the United States: Impact of policy changes. Expert Review of Vaccines, 18(2), 175–190. https://doi.org/10.1080/14760584.2019.1562344 11. Molteni, M. (2018, Nov 5). How antivax PACs helped shape midterm ballots. WIRED. https://www.wired.com/story/vaccine-choice-pacs-shaping-the-ballot/ 12. Broniatowski, D. A., Jamison, A. M., Qi, S., AlKulaib, L., Chen, T., Benton, A., . . . Dredze, M. (2018, October). Weaponized health communication: Twitter bots and Russian trolls amplify the vaccine debate. American Journal of Public Health, 108(10), 1378–1384. https://doi.org/10.2105/AJPH.2018.304567 13. Wong, J. C. (2019, February 1). How Facebook and YouTube help spread anti-vaxxer propaganda. The Guardian. https://www.theguardian.com/media/2019/feb/01/facebook-youtubeanti-vaccination-misinformation-social-media 14. Hamel, L., Lopes, L., Sparks, G., Stokes, M., & Brodie, M. (2021, May 6). KFF COVID-19 vaccine monitor: April 2021.

Kaiser Family Foundation. https://www.kff.org/coronaviruscovid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/ 15. He, K., Mack, W. J., Neely, M., Lewis, L., & Anand, V. (2022, February). Parental perspectives on immunizations: Impact of the COVID-19 pandemic on childhood vaccine hesitancy.

Journal of Community Health, 47(1), 39–52. https://doi.org/10.1007/s10900-021-01017-9 16. de Albuquerque Veloso Machado, M., Roberts, B., Wong, B. L. H., van Kessel, R., & Mossialos, E. (2021, September 28). The relationship between the COVID-19 pandemic and vaccine hesitancy: A scoping review of literature until August 2021.

Frontiers in Public Health, 9, 747787. https://doi.org/10.3389/fpubh.2021.747787 17. Butler, K. (2020, June 18). The anti-vax movement’s radical shift from crunchy granola purists to far-right crusaders.

Mother Jones. https://www.motherjones.com/politics/2020/06/the-anti-vaxmovements-radical-shift-from-crunchy-granola-purists-to-far-rightcrusaders/ 18. Phan, T. T., Enlow, P. T., Wong, M. K., Lewis, A. M., Kazak, A. E., & Miller, J. M. (2021, December). Disparities in delaware caregiver beliefs about the COVID-19 vaccine for their children. Delaware Journal of Public Health, 7(5), 64–71. https://doi.org/10.32481/djph.2021.12.015 64 Delaware Journal of Public Health - March 2022

19. Phan, T. T., Enlow, P. T., Wong, M. K., Lewis, A. M., Kazak, A. E., & Miller, J. M. (2022, April). Medical factors associated with caregiver intention to vaccinate their children against COVID-19. Vaccine: X, 10, 100144. https://doi.org/10.1016/j.jvacx.2022.100144 20. Waisel, D. B. (2013, April). Vulnerable populations in healthcare. Current Opinion in Anaesthesiology, 26(2), 186– 192. https://doi.org/10.1097/ACO.0b013e32835e8c17 21. Latkin, C. A., Dayton, L., Yi, G., Colon, B., & Kong, X. (2021, February 16). Mask usage, social distancing, racial, and gender correlates of COVID-19 vaccine intentions among adults in the US. PLoS One, 16(2), e0246970. https://doi.org/10.1371/journal.pone.0246970 22. Hough-Telford, C., Kimberlin, D. W., Aban, I., Hitchcock, W. P., Almquist, J., Kratz, R., & O’Connor, K. G. (2016, September). Vaccine delays, refusals, and patient dismissals: A survey of pediatricians. Pediatrics, 138(3), e20162127. https://doi.org/10.1542/peds.2016-2127 23. Buttenheim, A. M., Cherng, S. T., & Asch, D. A. (2013, August). Provider dismissal policies and clustering of vaccinehesitant families: An agent-based modeling approach. Human Vaccines & Immunotherapeutics, 9(8), 1819–1824. https://doi.org/10.4161/hv.25635 24. Pontifical Academy for Life. (2017, July 31). Note on Italian vaccine issue. https://www.academyforlife.va/content/pav/en/the-academy/activityacademy/note-vaccini.html 25. Iannelli, V. (2020, December 16). Antigen counts in vaccines.

Vaxopedia. https://vaxopedia.org/2016/09/07/antigens-in-vaccines/ 26. Seither, R., McGill, M. T., Kriss, J. L., Mellerson, J. L., Loretan, C., Driver, K., . . . Black, C. L. (2021, January 22). Vaccination coverage with selected vaccines and exemption rates among children in kindergarten – United States, 2019-20 School Year.

MMWR. Morbidity and Mortality Weekly Report, 70(3), 75–82. https://doi.org/10.15585/mmwr.mm7003a2 27. Delamater, P. L., Pingali, S. C., Buttenheim, A. M., Salmon, D. A., Klein, N. P., & Omer, S. B. (2019, June). Elimination of nonmedical immunization exemptions in california and school-entry vaccine status. Pediatrics, 143(6), e20183301. https://doi.org/10.1542/peds.2018-3301 28. Diekema, D. S. (2015, Fall). Physician dismissal of families who refuse vaccination: An ethical assessment. J Law Med Ethics, 43(3), 654–660. https://doi.org/10.1111/jlme.12307 29. Limaye, R. J., Opel, D. J., Dempsey, A., Ellingson, M., Spina, C., Omer, S. B., . . . Leary, S. O. (2021, May-June).

Communicating with vaccine-hesitant parents: A narrative review. Academic Pediatrics, 21(4S), S24–S29. https://doi.org/10.1016/j.acap.2021.01.018 30. Opel, D. J., Heritage, J., Taylor, J. A., Mangione-Smith, R., Salas, H. S., Devere, V., . . . Robinson, J. D. (2013, December).

The architecture of provider-parent vaccine discussions at health supervision visits. Pediatrics, 132(6), 1037–1046. https://doi.org/10.1542/peds.2013-2037

The DPH Bulletin

From the Delaware Division of Public Health

February 2022 Who’s eligible for booster doses All Delawareans 12 and older are eligible for a booster if: • You received Pfizer or Moderna as your primary series and it has been five months since you completed it; or

As COVID-19 hospitalizations decrease, DPH urges booster doses for ages 12+ Delaware seems to be on the downward side of its unnerving January peak of COVID-19 cases and hospitalizations. As of February 6, 2022, the sevenday average for new positive cases was 501.6, down from 759 on January 12, 2022.

“When you look at our case data, our hospitalizations, and COVID-19-like illness, it shows we are heading down in a good way,” said Division of Public Health Director Dr. Karyl Rattay during Governor John Carney’s February 1, 2022 briefing, posted to de.gov.

Delawareans who are eligible for vaccine are urged to get it, complete the vaccine series, and get a booster dose. According to My Healthy Community, in Delaware during the week of January 24 to January 30, 2022, the unvaccinated and partially vaccinated represented 56 percent of cases, 58 percent of hospitalized cases, and 65 percent of COVID-19 deaths. In the same period, individuals who did not receive a booster dose represented 84 percent of Delaware’s cases, 86 percent of hospitalized cases, and 85 percent of COVID-19 deaths.

“Absolute effectiveness” against COVID-19 is 90 percent with two doses and 99 percent to 100 percent with a booster, Dr. Rattay said. She shared the results of four studies. According to the Centers for Disease Control and Prevention, among adults ages 50 to 64, the unvaccinated are 44 times more likely to be hospitalized than their fully vaccinated peers who also got booster doses. According to Moderna, their booster elevated antibodies against the Omicron variant 37 times above the response from completing the primary series; Pfizer says its booster elevated antibodies 25 times higher.

• You received Johnson & Johnson as your primary series, and you are two months past that one dose.

If you are 18 or older, you can choose any of the vaccines as your booster, but if you are 12–17, Pfizer is your only choice for a booster.

If you had COVID-19 and are no longer in quarantine or isolation, you can get your first dose, second dose, or booster dose.

Many primary care providers, health systems, and Federally Qualified Health Centers are administering the vaccine. You can also find vaccine at DPH Standing Vaccine sites or the DPH clinics. Visit de.gov/getmyvaccine or vaccines.gov for a location near you. Or text GETVAX for English and VACUNA for Spanish and receive three vaccine sites near you.

Pediatric vaccine news The U.S. Food and Drug Administration announced on February 1, 2022 that its Vaccines and Related Biological Products Advisory Committee will on February 15 discuss Pfizer-BioNTech’s request for emergency use authorization (EUA) of its COVID-19 vaccine for use in children 6 months through 4 years of age.

Follow this news at www.fda.gov.

Isolation and Quarantine For Isolation and Quarantine guidance and materials, visit de.gov/quarantine. An infographic is available in English, Spanish, and Haitian Creole.

Flyers are also available.

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Governor lifts universal indoor mask mandate effective February 11 On February 7, 2022, Governor John Carney announced he lifted Delaware’s universal indoor mask mandate effective at 8:00 a.m. on February 11.

He also temporarily extended the mask requirement in public and private K-12 schools and child care facilities to March 31 at 11:59 p.m. That requirement applies to children kindergarten-age and older.

The temporary extension gives parents time to get their school-age children vaccinated before the expiration of the statewide requirement.

The March 31 date also allows districts and schools time to consider local mask requirements and gives the Division of Public Health and the Department of Education time to work with schools on updates to quarantine and contact tracing guidance.

His actions were through a revision to the State of Emergency order.

The mask mandate remains in effect in state buildings, Long Term Care facilities, and certain medical facilities (hospitals and some physician offices). Businesses and medical providers may choose to keep a mask mandate in place as part of a management decision.

Some individuals may still need to, or prefer to, wear a mask. The Centers for Disease Control and Prevention provides these recommendations: • Masks should fit snugly over your nose, mouth, and chin.

• Select a mask with layers.

• Choose a mask with a nose wire, a metal strip at the top of the mask. Bend it over your nose to fit close to your face.

• If you can tolerate it, an N95 respirator (non-medical) provides the best protection, though proper fit may be a challenge. A well-fitting disposable mask that you can wear correctly and consistently is better than a poorly fitting respirator.

Source: https://www.cdc.gov/coronavirus/2019ncov/your-health/effective-masks.html

The DPH Bulletin – February 2022 66 Delaware Journal of Public Health - March 2022

Computer-aided architectural design of an expanded Delaware Public Health Laboratory on Sunnyside Road in Smyrna.

Bernardon is the architect. Artwork from Wohlsen Construction.

Delaware Public Health Laboratory holds expansion groundbreaking On January 19, 2022, the Delaware Public Health Laboratory (DPHL) held a groundbreaking for an expansion that will nearly double its size. DPHL is located on Sunnyside Road in Smyrna, on the property of the Delaware Department of Health and Social Services’ Hospital for the Chronically Ill. DPHL is increasing its capacity for routine and outbreak testing to accommodate advanced technical laboratory staff and the infectious disease epidemiology program. Despite space and staffing constraints, DPHL has performed up to 10 percent of COVID-19 testing in Delaware since the pandemic began. The laboratory reached a high of 6,085 COVID-19 tests processed between December 2 and December 8, 2021.

The project involves 24,954 square feet of additions to the east and west sides of the existing 26,165square-foot facility building. DPHL will gain two emerging infectious disease laboratories, new administrative office areas, an expanded warehouse, and increased mechanical/electrical space. The 40-person Infectious Disease Epidemiology Program will relocate from Dover.

Site work also includes 4,386 square feet of renovations in the main building.

As a reference laboratory for the State of Delaware, DPHL supports hospitals and other clinical and environmental laboratories. If a laboratory requires enhanced testing methodology, it can request DPHL’s assistance.

Grant awards from State Public Works, Centers for Disease Control and Prevention, and the American Rescue Plan Act will fund the $35 million project.

Most work is anticipated to be completed by the summer of 2023.

Page 2 of 3

Prevent heart disease and Alzheimer’s disease with a healthy lifestyle

Valentine’s Day reminds us to celebrate ourselves and take care of our heart. Heart disease is a leading health concern, particularly among women.

According to the 2020 Delaware Behavioral Risk Factor Surveillance System, 4.8 percent of Delaware adults reported having been told they had angina or coronary heart disease. In the same year, 5.5 percent of Delaware adults reported having had a heart attack and survived, and 3.4 percent of Delaware adults reported having a stroke (including “mini” stroke) and survived.

Heart disease covers many conditions and can lead to serious, even fatal, cardiac events such as heart attack and stroke. According to the Centers for Disease Control and Prevention (CDC), risk factors for heart disease are high blood pressure, high blood cholesterol, smoking, diabetes, being overweight or obese, having an unhealthy diet, getting little physical activity, and drinking alcohol excessively.

One way to improve blood pressure control is to check out the Division of Public Health’s Healthy Heart Ambassador Blood Pressure Self-Monitoring Program. For more information about this program, visit www.healthydelaware.org or call 302-208-9097 for eligibility requirements and enrollment.

Eating a heart-healthy diet and getting regular physical exercise will help keep your heart strong and lower your risk for heart disease. These same activities can help protect your brain. Some practical steps include: • Get at least 30 minutes daily of moderate movement.

• Eat heart-healthy, with plenty of fruits, vegetables, and whole grains. Reduce salt intake.

• Self-monitor your blood pressure per your health care provider’s recommendations.

• Be socially active. Maintain strong social relationships.

• Keep mentally active. Read books, do puzzles, take a class, and learn something new.

For more information, visit the CDC at https://www.cdc.gov/chronicdisease/resources/infogr aphic/healthy-aging.htm and the Alzheimer’s Association at alz.org/delval or 800-272-3900.

The DPH Bulletin – February 2022

DPH and UD conducting community health assessments through March The Division of Public Health (DPH) and the University of Delaware's Partnership for Healthy Communities and Epidemiology Program are conducting community health assessments to better understand the concerns and needs of communities during the COVID-19 pandemic and guide future public health interventions.

The assessments are part of Delaware's State Health Improvement Plan (SHIP), which helps to prioritize areas such as chronic disease, maternal and child health, mental health, and substance use disorder, and identify where more work is needed to make Delawareans healthier.

Randomly selected households will receive a postcard in the mail about the voluntary survey, followed by a packet for completion online or by mail. The first set of survey packets was mailed to Kent County households at the end of January.

In late February, teams of students and community volunteers will canvas Kent County neighborhoods to knock on the doors of those selected households who haven't completed the survey by mail or online.

Similar assessments will occur for New Castle and Sussex counties over the next two months.

Incentives will be provided for completed surveys.

To learn more about SHIP, visit www.DelawareSHIP.org. To find out when the survey teams will be coming to your area, visit https://delawareship.org/delaware-ship-log.

Page 3 of 3 67

Vaccines for COVID-19 Stephen C. Eppes, M.D.

SARS-CoV-2, the virus that causes COVID-19, was first identified in patient specimens in China in January 2020. Within 3 days, the RNA of the virus was sequenced. Twenty-five days after that, the first mRNA vaccine had been developed, and in 63 days it was ready to give to volunteers in a large clinical trial. On December 11, 2020 the Pfizer mRNA vaccine, with an efficacy of 95%, was given Emergency Use Authorization (EUA) by the FDA, and on December 19 the Moderna vaccine, with an efficacy of 94%, had EUA approval. After a phased rollout across the country, these vaccines, along with the Johnson & Johnson vaccine, became widely available in the spring of 2021. In the following months, through the time of this writing, we have learned about waning efficacy after the primary vaccine series, reduced efficacy in immunocompromised populations, unanticipated side effects (e.g. mild myocarditis cases mostly in adolescent and young adult males), the effectiveness of vaccines against the delta and omicron variants of SARS-CoV-2, and the impressive efficacy after a booster dose. As the science has evolved, so have the recommendations for vaccine use. The following are the current CDC recommendations for COVID-19 vaccines.

SUMMARY OF RECENT CHANGES (LAST UPDATED FEBRUARY 22, 2022)1 • Added considerations for an 8-week interval between the first and second doses of a primary mRNA vaccine schedule

Key Points

• COVID-19 vaccines currently approved or authorized

by FDA are effective in preventing serious outcomes of coronavirus disease 2019 (COVID-19), including severe disease, hospitalization, and death.

68 Delaware Journal of Public Health - March 2022

• COVID-19 primary series vaccination is recommended for everyone ages 5 years and older in the United States for the prevention of COVID-19.

• A 3-dose primary mRNA COVID-19 vaccine series is recommended for people ages 5 years and older who are moderately or severely immunocompromised, followed by a booster dose in those ages 12 years and older.

• In most situations, Pfizer-BioNTech or Moderna COVID-19 Vaccines are preferred over the Janssen COVID-19 Vaccine for primary and booster vaccination.

• A booster dose of COVID-19 vaccine is recommended for everyone ages 12 years and older.

Timing of a booster dose varies based on COVID-19 vaccine product and immunocompetence.

• Efforts to increase the number of people in the United States who are up to date with their COVID-19 vaccines remain critical to preventing illness, hospitalizations and deaths from COVID-19.

• These clinical considerations provide additional information to healthcare professionals and public health officials on use of COVID-19 vaccines.

REFERENCES 1. Centers for Disease Control and Prevention. (2022, Feb).

Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States.

Retrieved from https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html

DOI: 10.32481/djph.2022.03.010

COVID-19 Vaccine

Interim COVID-19 Immunization Schedule for Ages 5 Years and Older COVID-19 vaccines are recommended for persons 5 years of age and older within the scope of the Emergency Use Authorization or Biologics License Application for the vaccine. The table below provides guidance for COVID-19 vaccination schedules based on age and medical condition. Detailed information can be found in CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States (link below).

Table 1. Immunization schedule for persons 5 years of age and older Recipient Age

Product*†

Persons Who ARE NOT Moderately or Severely Immunocompromised Primary Series‡§

Booster Dose‡¶

Persons Who ARE Moderately or Severely Immunocompromised Primary Series‡§

Booster Dose‡¶

Type: mRNA vaccine Not recommended

3 doses. Separate: Dose 1 and 2 by at least 3 weeks.

Dose 2 and 3 by at least 4 weeks.

Not recommended

At least 5 months after Dose 2

3 doses. Separate: Dose 1 and 2 by at least 3 weeks.

Dose 2 and 3 by at least 4 weeks.

At least 12 weeks after Dose 3

2 doses.

Separate: Dose 1 and 2 by at least 3 - 8 weeks.**

At least 5 months after Dose 2

3 doses. Separate: Dose 1 and 2 by at least 3 weeks.

Dose 2 and 3 by at least 4 weeks.

At least 12 weeks after Dose 3

2 doses.

Separate: Dose 1 and 2 by at least 4 - 8 weeks.**

At least 5 months after Dose 2

3 doses. Separate: Dose 1 and 2 by at least 4 weeks.

Dose 2 and 3 by at least 4 weeks.

At least 12 weeks after Dose 3

5–11 years

Pfizer-BioNTech Ages: 5–11 years Orange cap

2 doses.

Separate: Dose 1 and 2 by at least 3 weeks **

12–17 years

Pfizer-BioNTech Ages: 12 years and older Gray cap or Purple cap

2 doses.

Separate: Dose 1 and 2 by at least 3 - 8 weeks.**

Pfizer-BioNTech Ages: 12 years and older Gray cap or Purple cap

Moderna

18 years and older

Recipient Age

Product*†

Persons Who ARE NOT Moderately or Severely Immunocompromised Primary Series†§

Booster Dose‡¶

Persons Who ARE Moderately or Severely Immunocompromised Primary Series‡§

Booster Dose‡¶

Type: Viral vector vaccine 18 years and older

Janssen††

1 dose

At least 8 weeks after Dose 1

2 doses. Separate: Dose 1 and 2 by at least 28 days‡‡ Dose 2 MUST be a mRNA vaccine

At least 8 weeks after Dose 2

* Administer the appropriate COVID-19 vaccine product based on the recipient’s age. † COVID-19 vaccines may be administered on the same day as other vaccines. If multiple vaccines are administered at a single visit, administer each in a separate injection site. ‡ Administer doses as close as possible to the recommended interval. It is not necessary to restart the series if the dose is given after the recommended interval. § Complete the primary series using the same product. Every effort should be made to determine which vaccine product was received as the first dose. If the vaccine product previously administered cannot be determined or is no longer available, any age-appropriate mRNA COVID-19 vaccine product may be administered at least 28 days after the first dose. ¶ A different COVID-19 vaccine product than the primary series may be administered. An mRNA COVID-19 vaccine is preferred. ** An 8 week interval may be optimal for some people, including males 12-39 years of age because of the small risk of myocarditis associated with mRNA COVID-19 vaccines. Vaccine effectiveness may also be increased with an interval longer than 3 (or 4 depending on document) weeks. See Interim Clinical Considerations for COVID-19 Vaccines (link below) for detailed information. †† mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 Vaccine for all vaccine-eligible people. However, the Janssen COVID-19 Vaccine may be offered in some situations, see Interim Clinical Considerations for COVID-19 Vaccines (link below) for detailed information. ‡‡ Administer Moderna or Pfizer-BioNTech COVID-19 Vaccine only, which are allowed under Emergency Use Instructions (EUI) for this dose. Janssen COVID-19 Vaccine is not under EUI for this dose.

CDC Resources

CDC COVID-19 Vaccine clinical training and materials at: www.cdc.gov/vaccines/covid-19/info-by-product/index.html CDC Interim clinical considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States at: www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#primary-series 02/25/2022

CS321629-AV

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1

COVID-19 Vaccine

Interim COVID-19 Immunization Schedule for Ages 5 Years and Older

Table 2. COVID-19 Vaccine Products Summary Product

Age Indications

Diluent

Dosage (amount injected)

Type: mRNA vaccine Pfizer-BioNTech Orange cap and bordered label

Pfizer-BioNTech Gray cap and bordered label

Pfizer-BioNTech Purple cap

Moderna Red cap

Product

5 - 11 years

12 years and older

12 years and older

18 years and older

1.3 mL 0.9% sodium chloride (normal saline, preservative-free)

NONE

1.8 mL 0.9% sodium chloride (normal saline, preservative-free)

NONE

Age Indications

Doses 1 and 2

0.2 mL

Dose 3*

0.2 mL

Booster dose

Not recommended

Doses 1 and 2

0.3 mL

Dose 3*

0.3 mL

Booster dose

0.3 mL

Doses 1 and 2

0.3 mL

Dose 3*

0.3 mL

Booster dose

0.3 mL

Doses 1 and 2

0.5 mL

Dose 3*

0.5 mL

Booster dose

0.25 mL

Diluent

Dosage (amount injected)

Type:Viral Vector Vaccine Janssen† Blue Cap

18 years and older

NONE

Dose 1

0.5 mL

Dose 2*

Dose 2 Administer mRNA vaccine only ‡

Booster dose

0.5 mL

* For moderate or severely immunocompromised persons only † mRNA vaccines are preferred. ‡ Additional dose for moderate or severely immunocompromised persons only: Administer Moderna or Pfizer-BioNTech COVID-19 Vaccine ONLY. Administer the correct product based on the recipient's age. If administering Moderna COVID-19 Vaccine, administer 0.5 mL.

CDC Resources

CDC COVID-19 Vaccine clinical training and materials at: www.cdc.gov/vaccines/covid-19/info-by-product/index.html CDC Interim clinical considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#primary-series

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COVID-19 Vaccine Hesitancy and Refusal: The Same But Different?

Neil Rellosa, M.D. Division of Infectious Disease, Department of Pediatrics, Nemours Children’s Hospital-Delaware

ABSTRACT Pediatric providers deal with vaccine hesitancy and vaccine refusal for routine childhood vaccinations on a regular basis. However, the COVID-19 pandemic has brought challenges for pediatricians including COVID-19 vaccine hesitancy and refusal. Some of the issues surrounding COVID-19 vaccine hesitancy are similar to those associated with routine vaccines, however some are unique to COVID-19. Much of COVID-19 vaccine hesitancy has been because of both the fear of the known and unknown. Identifying these issues and reasons for hesitancy is important to devising strategies and approaches pediatric providers can use to address patient and parent concerns, and hopefully convince them to vaccinate against COVID-19

INTRODUCTION Vaccine hesitancy and vaccine refusal are not new issues in pediatrics. On a regular basis, pediatricians face vaccine hesitancy from their patients and families for well-established routine immunizations such as the measles, mumps and rubella (MMR) vaccine; pneumococcal vaccine; and the seasonal influenza vaccine. Reasons for hesitancy or refusal can vary from religious or cultural to mistrust of medicine or fear of side effects. Most pediatricians are very familiar with not only encountering vaccine hesitancy, but also how to deal with families who refuse or hesitate to vaccinate their children.

Many families who refuse or delay vaccination for children fit a common profile and for many pediatricians identifying those parents who may hesitate may be easy.

However, while the COVID-19 vaccine has brought some of the same issues seen with other routine vaccines in terms of hesitancy and refusal, many pediatric providers are facing new and different challenges and are surprised by families where vaccine hesitancy or refusal was never before an issue. Many pediatricians are perplexed by this and are struggling to convince families to get their children vaccinated against COVID-19.

In the United States, COVID-19 vaccine became available for persons aged 16 years old and older in early December of 2020.

Children and adolescents, aged 12 to 15 years, could receive the COVID-19 vaccine starting in May of 2021. By November 2, 2021, children 5 to 11 years of age became eligible to receive the COVID-19 vaccine. National data from the Centers for Disease Control and Prevention (CDC) report that in the United States, approximately 54% of children and adolescents are either vaccinated or report they will “definitely get vaccinated.” However, specifically in the 5 to 11 age group, only approximately 21 percent of children in this group are vaccinated. Additionally, approximately 29 percent of parents surveyed for this younger age group report they “probably or definitely” will not get vaccinated.1 In the State of Delaware, the Division of Public Health reports that only approximately 32% of the 5 to 11 year old age group are vaccinated, as opposed to the 12 to 17 year old age group that has approximately 65 percent vaccinated.2 The path out of this pandemic relies heavily on getting as many people vaccinated as possible, including children. COVID-19 72 Delaware Journal of Public Health - March 2022

vaccine for children less than 5 years of age has yet to be become available but based on our current vaccination rates for children the prospect of having impactful immunization rates in children overall is worrisome. Why are parents hesitant to vaccinate their children against COVID-19? How are the reasons for COVID-19 vaccine hesitancy the same or different than other childhood vaccine hesitancy? What can pediatric providers do to convince families to vaccinate against COVID-19, and is it a different approach than other vaccines?

THE FEAR OF THE “UNKNOWN” AND THE “KNOWN” Much of parental vaccine hesitancy in general stems from the fear of side effects and adverse reactions related to the vaccine.

Parents can fear true, known side effects or reactions, such as allergic reactions, injection site reactions, reactions that mimic the acute illness, and even psychologic or mental anguish caused by administration of vaccines. Parents fear even reactions that may be unfounded or untrue but are perceived as real, such as vaccine causing autism or certain vaccines causing the very infection for which they provide protection. Nevertheless, despite these fears, per CDC data, for most routine vaccines more than 80 percent of US children are vaccinated by age 24 months.3 What has been somewhat different for the COVID-19 vaccine for many parents has been the fear of the unknown. Many parents feel “comfortable” with most routine vaccines; those vaccines are familiar. Even for relatively newer routine vaccines such as the varicella, conjugated pneumococcal, and human papillomavirus vaccines, many parents feel because the possible side effects are known and because there is long-term experience, these vaccines are safe. However, for the COVID-19 vaccine, many parents are hesitant because they believe that both the short-term and longterm adverse effects of this vaccine are still unknown because of how new the COVID-19 vaccine is and because it developed with “new” technology that has not previously been used.

Additionally, families have concerns that the clinical trial testing and the scientific and regulatory vetting of this vaccine was rushed given the urgency of the pandemic. Their fear comes from a lack of knowledge or understanding of clinical trials and the regulatory process. Many families have never before been faced DOI: 10.32481/djph.2022.03.011

with considering what regulatory terms such as “Emergency Use Authorization” or “EUA” or “FDA approved” meant to the health of their child.

What many families fail to realize is that the mRNA technology used in COVID-19 vaccine has existed for decades, and was developed to improve both vaccine efficacy and safety. And while these COVID-19 vaccines are the first mRNA vaccines to be used clinically, there is no mystery of how they work or their potential.

While many people understand the need and urgency to expedite COVID-19 vaccines availability to the American public, the US Food and Drug Administration (FDA) regulatory process in terms of clinical trial and approval for use of COVID-19 vaccines for children was the same exact process that has been used in all vaccines, and no exceptions or short cuts were made.

ADVERSE EFFECTS Many vaccine-hesitant parents do not realize that most shortterm adverse effects develop within the first six weeks after immunization, and would likely be observed during clinical trials. Thus, it is rare that unknown side effects occur once a vaccine has been approved for use.4 Even when a short-term side effect is identified, data and information from surveillance and reporting allows for not only good risk stratification for vaccine administration, but also awareness and quick, decisive intervention when these short-term adverse events occur.

Historically, US medical and regulatory institutions have good track records on picking up on short-term adverse effects with vaccines, including for such vaccines against polio and rotavirus.

Despite these past events, vaccination rates for these infections remains high among US children.

Post-vaccination myocarditis has been a major deterrent for parents to vaccinate their child against COVID-19. In a recent study that reported on myocarditis cases after mRNA-based COVID-19 vaccination in the US from December of 2020 to August of 2021, rates are highest among adolescent males aged 12 to 15 years (70.7 per million doses) and aged 16 to 17 yeas (105.9 per million doses).5 However, these numbers are still relatively rare and death associated with myocarditis has also been rare. Most patients have had relatively quick resolution of symptoms with conservative treatments such as non-steroidal anti-inflammatory medications.6 Knowing this information has allowed for identification of people who may be at higher risk, informed decision making for parents, and swift and effective diagnosis and treatment of people when post-vaccination myocarditis has occurred. Even now with a year of experience with the COVID-19 vaccine and better knowledge on short-term outcomes, vaccination rates remain low in eligible children.

Much of the concern of parents for long-term effects from COVID-19 vaccination has been due to not only to the concern of the unknown, but also to misinformation. Historical experience with other routine childhood immunizations has shown that long-term side effects are unlikely. However, similar to the false autism scare with the MMR vaccine, long-term effects such as infertility due to COVID-19 vaccination has been driven by medical implausibility and misguided theoretical science. Even when these outlandish concerns have been entertained, they have been debunked. Lu-Culligan et al. showed that claims that circulating levels of specific antibodies produced following COVID-19 mRNA vaccination were not increased and unlikely to

contribute to infertility and adverse birth outcomes.7 Additionally, a study performed at the University of Miami showed no significant decreases in any sperm parameters in men after receiving two doses of COVID-19 mRNA vaccine.8 Like many aspects of the COVID-19 pandemic, vaccine hesitancy and refusal has been fueled by myths and misconceptions.

An interesting anecdotally observed phenomenon during the COVID pandemic is parental willingness to give their child acute COVID-19 infection treatments (i.e. antiviral medications such as remdesivir, or monoclonal antibodies) despite previous vaccine refusal. While these therapies for children may be relatively new, have limited clinical experience and carry only a FDA EUA similar to the COVID-19 mRNA vaccines, some parents inexplicably are able to overlook the “unknown” of these medications and request these therapies when their children get infected. Perhaps for these parents, the fear of severe infection outweigh the fear of the unknown of these medications.

At the beginning of the pandemic, there was a wide-spread notion that COVID-19 did not significantly affect children and adolescents. It was “known” that children did not get infected with COVID-19 and if they did get infected, they were unlikely to significantly spread COVID-19 or have severe symptoms or complications associated with infection. While parents vaccinated themselves for fear of the COVID-19-related morbidity and mortality, this perception that children were unaffected by COVID-19 likely lead many parents to not vaccinate their children once COVID-19 vaccine became available. However, as schools opened and new variants such as Delta and Omicron emerged in late 2021, the impact of COVID-19 on children became more apparent. Mounting evidence proved that children and adolescents contributed to COVID-19 transmission. Not only did the number of infections increase, pediatric hospitalizations associated with COVID-19 infection sky-rocketed. While parents readily vaccinate their children against diseases they have never seen or have little first-hand knowledge of (i.e. diphtheria, polio, tetanus), they continue to hesitate to vaccinate their children even in the midst of the most recent COVID-19 surge. Death and severe complications like respiratory failure, hematologic abnormalities, and cardiac problems such as myocarditis seen in the adult population are rare among children but have been seen.

Regardless, the fear of these complications may not be enough for some parents to vaccinate.

One COVID-19-related complication that has disproportionally effected children as compared to adults has been Multisystem Inflammatory Syndrome in Children or MIS-C. MIS-C has been a newly discovered condition in children during the pandemic, and presumed to occur 4 to 6 weeks following acute COVID-19 infection. Often, children with MIS-C had no known previous COVID-19 infection or acute COVID-19 infection that was asymptomatic or mildly symptomatic. MIS-C causes inflammation in different areas of the body including the heart, lungs, brain and gastrointestinal system, very similar to other childhood systemic inflammatory diseases like Kawasaki Disease.

Many patients have presented in cardiogenic shock due to severe ventricular dysfunction. Data from the CDC reports that 6,851 children have had MIS-C in the US with 59 reported deaths.

Recent studies that looked at the association of MIS-C and COVID-19 mRNA vaccination have shown that the majority of children who had MIS-C were unvaccinated.9 In data reported 73

in a January Morbidity and Mortality Weekly Report, 95% of cases reported were unvaccinated.10 The lack of wide-spread knowledge and highlighting of this aspect of the pandemic has likely contributed to the slowed uptake of vaccination in children and adolescents.

PUBLIC HEALTH Parental instinct may prompt parents to vaccinate their children for individual protection of their child from infection and complications. However, conversely, the idea of reducing the risk of transmission in the community may not be compelling enough for parents to vaccinate. While public health reasons to vaccinate may seem less important in rarer diseases where only local pockets of outbreaks occur (i.e. measles or mumps), during a life-threatening global pandemic, public health interest should seemingly be reason enough to vaccinate. For many parents, it has not.

Finally, political, cultural, and socioeconomic factors have always played into parental vaccine hesitancy and refusal, and the COVID-19 vaccine is no exception. However, given the era of social media and the ease of how information and misinformation can be spread, COVID-19 vaccine hesitancy and refusal may be the most affected by misinformation compared to other vaccines.

Social health disparities that existed prior to the pandemic have only been more apparent. In terms of infection rates, access to care, hospitalizations and death, disparities have significantly been shown in people of color and those of lower socioeconomic status.

This has also been seen in childhood COVID-19 infection and vaccination. Additionally, while the epidemic of childhood obesity rages on (and likely worsened by the COVID-19 pandemic), what has been less emphasized has been how obesity impacted the severity of COVID-19 disease in children. Obesity has been the leading underlying medical condition seen in COVID-19-related hospitalization in children.11 The efforts and strategies to change COVID-19 vaccine hesitancy likely need to occur not only at the individual parent level, but also at the community level.

BRIDGING THE UNKNOWN AND KNOWN GAP Prior to the COVID-19 pandemic, many providers were already honing their skills to handle vaccine hesitancy and refusal in their practice. However, the different and unique aspect of COVID-19 vaccine hesitancy has created different and unique challenges for pediatric providers. Parents who had never hesitated to give other vaccines now have new questions and concerns, and are trying to make thoughtful decisions on the health of the children. What can providers due to help convince parents and families that the right decision is to vaccinate?

Previous approaches to vaccine hesitancy should still be employed. Pediatric providers need to arm themselves with accurate information and feel confident to talk with families regarding the benefits of vaccination. Many families are invested in the advice and recommendations of their medical providers, and their confidence in vaccination can be directly tied to providers’ confidence. Asking families about their fears and concerns, validating their feelings without judgment, and genuinely showing emotional investment in the health of their child and family will likely go a long way. Respectfully discussing 74 Delaware Journal of Public Health - March 2022

the facts—including the risks and complications of infection, and the risks and benefits of vaccination—and dispelling misinformation in language that parents can easily understand is essential. These discussions should be true to the known medical science, but not overwhelming or filled with too much data and scientific information. When there is discordance between the child’s opinion and parents’ decision on getting vaccinated, providers should validate the autonomy of child, address their questions and concerns, and attempt to negotiate a shared decision between parents and child. Finally, providers should give patients and families space and time to decide without feeling pressured or rushed.

Specific to the COVID-19 vaccine, pediatricians should inform families about the true individual risk of COVID-19 infection and risks due to vaccination (e.g. myocarditis), especially to those patients at higher risk. Highlighting the risk for associated conditions such MIS-C is also important. Discussing the community benefits of COVID-19 vaccination, not just the individual benefits, may be helpful in convincing families.

Emphasis should be made on the secondary protective effects for the highest at risk for COVID-19 infection complications (the elderly and immunocompromised). Additionally, medical providers can show families that getting as many people vaccinated as possible—including children—is a larger part of ending the COVID-19 pandemic.

Providers can make available trusted and reliable resources— local and national public health and government websites, and fair and unbiased social media sites that give accurate and updated information—available to families. Finally, providers can help organize, participate in, or support broader programs that provide education and access to the COVID-19 vaccine, especially to underserved or unrepresented communities.

Dr. Rellosa may be contacted at neil.rellosa@nemours.org

REFERENCES 1. Centers for Disease Control and Prevention. (2022, Mar 1).

COVID data tracker. Retrieved from: https://covid.cdc.gov/covid-data-tracker 2. Community, M. H. Delaware Environmental Public Health Tracking Network. (2022, Mar 1). Vaccine tracker. Retrieved from: https://myhealthycommunity.dhss.delaware.gov/locations/state/ vaccine-tracker 3. Centers for Disease Control and Prevention. (2022, Mar 1).

Fast facts: immunize. Retrieved from: https://www.cdc.gov/nchs/fastats/immunize.htm 4. Suran, M. (2022, January 4). Why parents still hesitate to vaccinate their children against COVID-19. JAMA, 327(1), 23–25. https://doi.org/10.1001/jama.2021.21625 5. Oster, M. E., Shay, D. K., Su, J. R., Gee, J., Creech, C. B., Broder, K. R., . . . Shimabukuro, T. T. (2022, January 25).

Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021.

JAMA, 327(4), 331–340. https://doi.org/10.1001/jama.2021.24110

6. Gargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., . . . Oliver, S. E. (2021, July 9). Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: Update from the Advisory Committee on Immunization Practices-United States, June 2021. MMWR. Morbidity and Mortality Weekly Report, 70(27), 977–982. https://doi.org/10.15585/mmwr.mm7027e2 7. Lu-Culligan, A., Tabachnikova, A., Tokuyama, M., Lee, H. J., Lucas, C., Monteiro, V. S., . . . Iwasaki, A. (2021, Dec 8). No evidence of fetal defects or anti-syncytin-1 antibody induction following COVID-19 mRNA vaccination. BioRxiv. Preprint. https://doi.org/10.1101/2021.12.07.471539

10. Zambrano, L. D., Newhams, M. M., Olson, S. M., Halasa, N. B., Price, A. M., Boom, J. A., . . . Randolph, A. G., & the Overcoming COVID-19 Investigators. (2022, January 14). Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA vaccination against multisystem inflammatory syndrome in children among persons aged 12-18 years-United States, JulyDecember 2021. MMWR. Morbidity and Mortality Weekly Report, 71(2), 52–58. https://doi.org/10.15585/mmwr.mm7102e1 11. Centers for Disease Control and Prevention. (2022). COVIDNET. Retrieved from: https://gis.cdc.gov/grasp/covidnet/covid19_5.html

8. Gonzalez, D. C., Nassau, D. E., Khodamoradi, K., Ibrahim, E., Blachman-Braun, R., Ory, J., & Ramasamy, R. (2021, July 20). Sperm parameters before and after COVID-19 mRNA vaccination. JAMA, 326(3), 273–274. https://doi.org/10.1001/jama.2021.9976 9. Yousaf, A. R., Cortese, M. M., Taylor, A. W., Broder, K. R., Oster, M. E., Wong, J. M., . . . Campbell, A. P. (2022).

Reported cases of multisystem inflammatory syndrome in children aged 12-20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation. Advance online publication.

Lancet Child-Adolescent. https://doi.org/10.1016/S2352-4642(22)00028-1

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Meningococcal Vaccination: An Update on Meningococcal Vaccine Recommendations for the Primary Care Physician Justin Nichols, M.D. PGY-4 Internal Medicine-Pediatrics Resident, ChristianaCare Stephen Eppes, M.D. Director, Pediatric Infectious Disease; Director, Quality Assurance and Performance Improvement, ChristianaCare; Co-Chair, Immunization Coalition of Delaware

ABSTRACT Neisseria meningitidis is an aerobic, gram-negative, diplococcus bacterium that is a leading cause of meningitis and sepsis in the United States. Particularly at-risk groups include those with complement deficiencies, people using complement inhibitors, individuals with anatomic or functional asplenia, patients with HIV infection and travelers to endemic countries. There are currently three quadrivalent meningococcal vaccines (Serogroups A, C, W, Y) and two recombinant serogroup B vaccines available for use in the United States, and recommendations for vaccine use have changed rapidly in the past 10-15 years. This article summarizes updated ACIP recommendations for meningococcal vaccination for the primary care provider.

INTRODUCTION Neisseria meningitidis is an aerobic, gram-negative, diplococcus bacterium with a polysaccharide capsule that is a leading cause of meningitis and sepsis in the United States (figure 1).

There are twelve unique polysaccharide capsules that have been discovered that define specific serogroups of the bacteria.

There are six serogroups—A, B, C, W, X and Y—that cause the vast majority of invasive meningococcal disease around the world.2 The capsule of the bacterium allows N. meningitidis to evade typical immune responses such as phagocytosis and complement-mediated destruction.

of meningococcal disease peaked in the late 1990s in the United States and has been declining since (figure 2). In 2019, the total incidence of meningococcal disease cases in the United States was 0.11 per 100,000 persons4 (a total of 375 cases). Ninety-nine of these cases (26.4%) were caused by serogroup B infection, while C was the second-most common serogroup with 85 cases (22.7%).

Among the 41 cases in the 18-24 year old age group, about half (51.2%) were attending college at the time. Serogroup B infection caused 12 out of the 21 cases identified among college attendees.

Amongst cases of serogroup B in college attendees, 56.3% had received one or more does of MenB vaccine.4 There are several important risk factors that increase the risk of meningococcal infection. General risk factors include smoking, a preceding viral infection, and crowded living conditions (including dorm rooms, military members). Particularly at risk groups include those with complement deficiencies (as complement-mediated destruction is an important defense mechanism against invasive disease), people using complement inhibitors (such as eculizumab), individuals with anatomic or functional asplenia, patients with HIV infection and travelers to endemic countries.5

TYPES OF VACCINATIONS Figure 1: N. meningitidis colonies on a chocolate agar plate1

There are currently three quadrivalent meningococcal vaccines (Serogroups A, C, W, Y) and two recombinant serogroup B vaccines available for use in the United States.2

In the United States, meningitis is the most common clinical presentation of invasive meningococcal disease, occurring in about 50% of cases; other presentations include bacteremia and pneumonia.2 Invasive meningococcal disease caries a high mortality (10-15%) and morbidity (20%) rate despite appropriate treatment.2 Common co-morbidities include hearing loss, vision loss, neurologic deficits and amputation. The incidence

MenACWY-D (Menactra, Sanofi Pasteur, licensed in 2005) is a polysaccharide diphtheria toxoid conjugate vaccine for use in nine months to 55 years of age. MenACWY-CRM (Menveo, GlaxoSmithKline, 2010) is an oligosaccharide diphtheria CRM197 conjugate vaccine approved for ages two months to 55 years old.

Lastly, MenACWY-TT (MenQuadfi, Sanofi Pasteur, 2020) is a polysaccharide tetanus toxoid conjugate approved for use in any patient two years or older.5

76 Delaware Journal of Public Health - March 2022

DOI: 10.32481/djph.2022.03.012

Figure 2. Meningococcal Disease Incidence, United States, 1970-20193

MenB-FHbp (Trumenba, Pfizer, 2014) and MenB-4C (Bexsero, GlaxoSmithKline, 2015) are the two meningitis B vaccines available in the United States. Both vaccines are approved for use in 10-25 year old patients.5 Notably, due to low incidence of meningococcal disease in the U.S., vaccine licensing approval has been based off demonstration of laboratory immune response to vaccine and not on randomized trials assessing clinical efficacy.

MENACWY VACCINATION RECOMMENDATIONS The Advisory Committee on Immunization Practices (ACIP) acts as an advisory committee for the Centers for Disease Control and Prevention in providing immunization recommendations.5

Routine Vaccination

Routine vaccination with any MenACWY vaccine is recommended for all adolescents 11-12 years old with a booster dose given at 16 years old if the first dose was received before their 16th birthday. Booster doses were recommended due to laboratory evidence of waning immunity in older adolescents.

Routine vaccination is only recommended for adolescents 11-18 years old, but MenACWY may be given to patients 19 to 21 years old who have not yet received a dose after their 16th birthday.

Minimum interval between doses is eight weeks.5

Special Circumstances

Vaccination for individuals two months old or greater is recommended for those at increased risk of meningococcal disease. These include persons with anatomic or functional asplenia, patients with complement deficiencies or use of complement inhibitors, or people with HIV. Additional reasons for early vaccination include those exposed to an outbreaks of meningococcal disease or travel to an endemic country. Notably, only MenACWY-CRM (Menveo) is approved for use in the two to less than nine months age group.

For those with complement deficiencies, use of a complement inhibitor, asplenia (including sickle cell disease), or HIV infection, primary vaccination should start with MenACWY-CRM (Menveo) at two months of age with four doses at 2, 4, 6 and 12 months. Dosing schedule varies if initial vaccination occurs at three or more months of age. For those who complete a primary series in this age group, a booster is recommended as a single dose for those less than seven years old three years after primary vaccination and every five years afterward. If vaccination starts at nine months or later, then MenACWY-D (Menactra) can be used.

Menactra can be used as a 2-dose series starting at nine months for those with complement deficiency; however, for those with anatomic or functional asplenia or HIV infection, Menactra is not recommended from 9-23 months of age, but may be used at age 24 months or older as a 2-dose series at least eight weeks apart.

Notably, Menactra must be administered at least four weeks after completion of PCV13 series.5 Various catch up schedules and primary vaccination schedules for this population are available from the CDC.5

SEROGROUP B MENINGOCOCCAL VACCINE RECOMMENDATIONS

Routine Vaccination

Both MenB vaccines MenB-FHbp (Trumenba) and MenB4C (Bexsero) are licensed for use in patients ≥10 years of age.

Trumenba is a 2-dose series (0 and 6 months), although a 3-dose series (0, 1-2 and 6 months) is recommended for those at increased risk of meningococcal disease. Bexsero is a 2-dose series at least one month apart. The same vaccine type should be used for a patient’s entire vaccine series.

MenB series is recommended as a primary vaccination for those 16-23 years old on the basis of shared decision making.

While no definitive recommendation exists for administration for college freshman or military recruits, it is important to note that serogroup B infections, while rare, are currently the most 77

common individual serogroup for invasive meningococcal disease in college attendees.4 A 2019 study published in the journal Pediatrics examined the incidence and relative risk of meningococcal disease in college-aged young adults (18 to 24 years old) from 2014-2016. In that time period, 166 cases of disease occurred with an annual incidence of 0.17 cases per 100,000 population. The relative risk of serogroup B disease in college versus non-college students was 3.54 (95% CI: 2.21-5.41) driven by six MenB disease outbreaks on college campuses during that time. The authors conclude that incidence of disease is low, but college students do have an increased risk for MenB disease.6 The AAP estimates that universal routine adolescent MenB vaccination would prevent 15 to 29 cases per year and 2 to 5 deaths per year.7 The AAP policy statement on MenB vaccination encourages pediatricians to educate families regarding the availability of MenB vaccines while acknowledging low incidence of disease and lack of efficacy data (as trials were based on antibody response).7

Special Circumstances

For those with complement deficiencies, complement inhibitor use or anatomic or functional asplenia (including sickle cell disease), primary vaccination with either vaccine type should be started at age 10. The ACIP recommends booster vaccines to be given at one year after completion of primary vaccination, then every 2-3 years. However, only primary vaccine series are licensed for use in the United States and booster dose use is off label.5 Healthy persons deemed to be at risk due to a local MenB disease outbreak should receive the MenB vaccine series. This decision should be make in consultation with state or local health departments.

The American Academy of Pediatrics released a policy statement in 2016 stating their agreement with the ACIP on MenB vaccine recommendations.7

VACCINE SAFETY The most common adverse events with MenACWY-D (Menactra) vaccination were injection site pain, erythema, swelling, myalgias, fatigue, headache and gastrointestinal symptoms. Post-vaccine cases of Guillain-Barre syndrome were reported to VAERS (vaccine adverse events reporting system) after initial licensing; however, subsequent analyses have not shown an increased risk of GBS and ACIP removed precautions for patients with a history of GBS from their recommendations, though the package insert still has this precaution listed.5 MenACWY-CRM (Menveo) side effects include injection site pain, erythema, headaches, myalgias and fatigue. Post-licensing data showed a statistically significant increased risk for Bell’s palsy in patients 11-21 years old when Menveo was given with other vaccines but not when given alone. However, among the eight patients noted to have Bell’s palsy, several may have had other conditions that could be associated with Bell’s palsy. In the 2 month to 10 years age group, no increased risk was noted.

Subsequent VAERS data did not show an increased signal of Bell’s palsy risk.5 MenACWY-TT (MenQuadfi) is a newly licensed vaccine and showed common adverse effects of erythema, swelling, infection site pain, malaise, myalgias, and fever. Adverse events were mild to moderate and no major adverse safety signals were identified.5 In clinical trials, most common MenB vaccine side effects were pain at injection site, fever, headache, fatigue, muscle pain and 78 Delaware Journal of Public Health - March 2022

joint pain.7 MenB-FHbp (Trumenba) did not show any obvious safety signals for autoimmune or renal disease. No major adverse safety concerns were identified. MenB-4C (Bexsero) also did not show any major safety concerns in post-marketing VAERS data.5 Bexsero did show mild increase in symptoms of underlying disease in patients taking complement inhibitors (as the vaccine itself can activate complement). Vaccination is recommended to occur prior to administration of complement inhibitors when possible. Neither of the MenB vaccines have been evaluated in pregnancy or breastfeeding.7

CONCLUSION Though overall incidence is declining, invasive meningococcal disease still carries a high morbidity and mortality and often affects young, healthy adults. Individuals with complement deficiency, complement inhibitor use, anatomic or functional asplenia, patients with HIV, and persons living in crowded conditions are at particularly high risk. Vaccination is an important preventative modality to help alleviate the burden of disease. Two major subtypes of vaccine exist which cover five of the six major serotypes that cause disease in humans. MenACWY vaccines are recommended as part of the routine adolescent vaccination schedule, while MenB vaccines can be given as part of a shared decision making process with patients and their families.

Dr. Nichols can be contacted at Justin.nichols@christianacare.org

REFERENCES 1. Centers for Disease Control and Prevention. (2011). Chapter 7: Identification and Characterization of Neisseria meningitidis. In Mayer L., Laboratory Methods for the Diagnosis of Meningitis, 2nd ed. Centers for Disease Control and Prevention. https://www.cdc.gov/meningitis/lab-manual/chpt07-id-characterization-nm.html 2. Mbaeyi, S., Duffy, J., & McNamara, L. A. (2021). Chapter 14: Meningococcal Disease. In Hall E., Wodi A.P., Hamborsky J., et al., Epidemiology and Prevention of Vaccine-Preventable Diseases, 14th ed (pp. 207-224). Centers for Disease Control and Prevention. Washington, D.C. Public Health Foundation.

3. Centers for Disease Control and Prevention. Meningococcal Disease. 2021. https://www.cdc.gov/meningococcal/images/ meningococcal-disease-incidence.jpg 4. Centers for Disease Control. (2019). National Center for Immunization and Respiratory Diseases, Office of Infectious Diseases. Enhanced Meningococcal Disease Surveillance Report, 2019. https://www.cdc.gov/meningococcal/downloads/ NCIRD-EMS-Report-2019.pdf 5. Mbaeyi, S. A., Bozio, C. H., Duffy, J., Rubin, L. G., Hariri, S., Stephens, D. S., & MacNeil, J. R. (2020, September 25).

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.

MMWR Recom Rep, 69(9), 1–41. https://doi.org/10.15585/mmwr.rr6909a1 6. Mbaeyi, S. A., Joseph, S. J., Blain, A., Wang, X., Hariri, S., & MacNeil, J. R. (2019, January). Meningococcal disease among college-aged young adults: 2014-2016. Pediatrics, 143(1), e20182130. https://doi.org/10.1542/peds.2018-2130 7. COMMITTEE ON INFECTIOUS DISEASES. (2016, September). Recommendations for serogroup B meningococcal vaccine for persons 10 years and older. Pediatrics, 138(3), e20161890. https://doi.org/10.1542/peds.2016-1890

Controlling Blood Pressure in Delaware As the lead agency of the Hypertension Control Network (HCN), the American Heart Association convenes health center, hospital and private practice representatives along with advocates, community-based organizations, and large employers throughout Delaware who have a stake in community health.

The group’s priority is to reduce heart disease with an emphasis on hypertension control for individuals with low socioeconomic status (SES).

The three key areas of focus for the Delaware Hypertension Control Network are:

Increase Hypertension control through screening and followup focusing on individuals with low SES.

Establish best practices at primary care offices, HRSA funded health centers and other health care organizations (HCOs).

Identify community/clinical data and metrics that are meaningful to improve patient quality around hypertension in our region.

DELAWARE HYPERTENSION CONTROL NETWORK Goal: Achieve >70% or greater hypertension control for adults across Delaware by 2024.

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American Heart Association

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AmeriHealth Caritas

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Bayhealth

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Beebe Healthcare

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Chi Eta Phi Sorority, Inc.

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ChristianaCare

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Delaware Department of Public Health

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Delaware Division of Libraries

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Food Rescue Heroes

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Healthy Communities Delaware

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Henrietta Johnson Medical Center

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La Red Health Center

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Medical Society of Delaware

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Mid-Atlantic Association of CHCs

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Mountaire Farms

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Quality Insights of Delaware

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TidalHealth

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Trinity Health Mid-Atlantic: St. Francis

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University of Delaware

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Westside Family Healthcare

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YMCA of Delaware

The Hypertension Control Network is an initiative of the American Heart Association of Delaware with generous funding and support from: E. Thomas Harvey & Robin Adair Harvey, The Happy Difference Foundation, Highmark Blue Cross Blue Shield Delaware, The Longwood Foundation, M&T Charitable Foundation, and the WSFS CARES Foundation. Additional funding to support our work in achieving blood pressure control comes from local sponsorships and donations.

Updated 02/14/2022

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Dispelling COVID-19 Myths: Implications of Vaccination Acceptance by African Americans and Others in Marginalized Communities Marlene A. Saunders, D.S.W., L.M.S.W., M.S.W.

HISTORY: VACCINATION HESITANCY IS NOT A NEW PHENOMENON Over the last 200 years since the first vaccine was used in the U. S. to prevent smallpox, some Americans have been fearful and mistrustful about inoculation as a means of protection from lethal viruses.1 Historically, Delawareans have been no less suspicious. For instance, despite the efficacy of vaccination for smallpox, opponents to inoculation continued throughout the 1920s. Opposition was especially fierce when compulsory vaccination was enacted. In fact, in 1926, while at a health office in Georgetown, Delaware to vaccinate residents, a retired Army lieutenant and a city councilman led a violent and armed mob to run the vaccinators out of town.2

DISPELLING MYTHS ABOUT COVID-19 VACCINES Myth: The risks of vaccines outweigh their benefits.

Today, one in four individuals believes that vaccines cause autism, even though sixteen methodologically sound and controlled epidemiological studies, conducted in different countries between 1991-2019, show no relationship between vaccines and autism.3 Furthermore, other research demonstrates there is no association between the measles, mumps, and rubella (MMR) vaccine and autism.3 Data show that the COVID-19 vaccines are among the safest and most efficacious ways to reduce the number of new infections, decrease the likelihood of severe infections, reduce death as an outcome if infection occurs, and slow the progression of the pandemic. The evidence is clear that “[v]accines are inarguably the most important medical advance in human history. Scientists can attest to the fact that ten historically fatal diseases have been reduced by 92% to 100% percent since the 20th century.

Smallpox has been eradicated and polio is nearly gone.” Moreover, epidemiological data show “…vaccines have saved literally tens of millions of lives and prevented hundreds of millions of cases of disease, if not more.”1

Myth: The COVID-19 vaccines were developed too quickly to be safe.

Kizzmekia C. Corbett is African American. She is also the scientific lead for the Coronavirus Vaccines and Immunopathogenesis Team at the National Institutes of Health, National Institute of Allergy, and Infectious Diseases. One of her precise and clear explanations clarified the speedy process that lead to the development and introduction of the COVID-19 vaccines to the public. Her very instructive presentation is a perfect way to address the average person’s concerns about the vaccines’ rollout to the public.

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“The tremendous amount of research that went into understanding how to make an effective and safe vaccine before the pandemic occurred essentially explains how the COVID-19 vaccines were available for administration so quickly. Prior to the pandemic, hundreds of scientists had already studied the development of vaccines, including, mutations, while simultaneously learning about other coronaviruses.

The end product of researchers working side by side is a messenger mRNA vaccine that teaches human cells how to make a special protein that triggers an immune response inside the human body. Following tests on mice, and adherence to other ethical research protocols, Moderna was able to make a COVID-19 vaccine in four days and ship it in 41 days for Phase 1 clinical trials which began March 16, 2020, and Phase 2 trials which started on May 29, 2020. Phase 3 trials, the purpose of which was to determine if the vaccine really worked, began on July 27, 2020.”4 Myth: COVID-19 vaccines change the internal makeup and functioning of the body.

The mRNA vaccines cannot change a person’s DNA or interfere with fertility. Further, none of the COVID-19 vaccines used in America contain the live COVID-19 virus. Rather, the vaccines contain an mRNA strand that codes for the protein that activates an immune response in the body.4 The mRNA strand does not enter the nucleus of the cell—it stays in the cytoplasm and is degraded within a few hours—not only can it not affect a person’s DNA, long term side effects from the vaccine are very unlikely.

Myth: COVID-19 was blown out of proportion; recovery from the illness could have occurred without vaccination.

The two-dose Pfizer-BioNTech COVID-19 and Moderna COVID-19 vaccines were approved for emergency use by the Federal Drug Administration (FDA) in 2020 and phased rollout began in December 2020. The Johnson & Johnson single-dose COVID-19 vaccine received the same emergency approval by the FDA in 2021. According to data reported by the National Institutes of Health (NIH), during the period from December 21, 2020 to May 9, 2021, COVID-19 vaccines prevented more than 139,000 deaths. Considering the approximately 570,000 persons who died due to COVID-19 by May 9, NIH researchers estimated about 709,000 deaths would have occurred without the vaccines. In addition to saving lives, the vaccines produced positive outcomes. Researchers estimated that the economic value of preventing these deaths was between $625 billion and $1.4 trillion.5 DOI: 10.32481/djph.2022.03.013

Myth: COVID-19 vaccines are not safe or effective for all populations because African Americans and other People of Color were not represented in the clinical trials.

During an interview with CNN in July 2020, Dr. Anthony Fauci was asked about diversity in the clinical trials for the Moderna vaccine. He responded saying it is desirable to have “…representation in the trial of those who are most at risk for adverse consequences of getting infected… African Americans and Latinx are at greater risk of not only getting infection but of having deleterious, negative severe consequences from getting infected.”6 Speaking to the special importance of African American participation in the clinical trials, Oliver T. Brooks, MD, president of the National Medical Association emphasized, Black people “…participating in trials could build vaccine confidence in communities that are most vulnerable to the virus by generating data that demonstrate safety and efficacy for people like them.”7 At the time the clinical trials were underway, African Americans constituted 12 percent of the total U.S. population.

Of the 30,000 study participants in the Moderna trials and the 43,000 in the Pfizer/BioNTech trials, Black people accounted for 10% of study participants in both study samples.

Hispanic or Latinx people accounted for 18% of the total American population. This group comprised 20% of the study participants for the Moderna for trials, and 26% of trial sample for the Pfizer/BioNTech trials. The percentage for Asian clinical trial participants was 5% for Pfizer/BioNTech and Moderna, and 6% for Johnson & Johnson’s clinical trials.8 These figures show that the number of African American and Latinx individuals who volunteered for the clinical trials for Pfizer/BioNTech, Moderna and Johnson & Johnson was not exactly equal to the share of each group’s proportion of the national population. However, these proportions were very close to (and sometimes exceeded) the proportion in the nation, and provided an informed basis for the safety of the vaccines in these populations.

REFRAMING VACCINE HESITANCY AMONG AFRICAN AMERICANS Recruiting and accepting greater numbers of people of color in studies for the COVID-19 vaccines will not necessarily eliminate doubts among African Americans that scientists, researchers, physicians and pharmaceutical companies motivated by profit will act in their best interests, even during a pandemic. For example, a review of protocols in Operation Warp Speed (federal guidelines for developing safe and effective vaccines by January 2021) did not include any guidelines specifying preferred samples sizes for minority groups.9 This is the case for the Federal Drug Administration as well.7 Several studies have found high rates of COVID-19 vaccine hesitancy among African Americans and other marginalized populations. Numerous studies report vaccination rates in Blacks that are below the rates of White people.10 For example, a Kaiser Health News report reveals that Black Americans were vaccinated at rates 2 to 3 times lower than White Americans in January of 2021.11

However, this and other studies with similar findings require “deep dive” questions reflecting the social and structural determinants of health on which the health inequalities that were so prevalent in Black communities before and during the pandemic are necessary. These analyses may uncover external factors, such as structural racism, that provide explanations regarding differences in vaccination rates among marginalized people of color and other populations. Such questions include but are not limited to: • Are there factors other than race/ethnicity that explain vaccine reluctance within the Black population?

• What are the implications of these factors for decision making relevant to accepting or rejecting the COVID-19 vaccine?

Bauer defines vaccine hesitancy as “…a nebulous phase that refers to the black box of assorted reasons people cite for not getting the COVID-19 vaccine.” Continuing, she makes the crucial point that the term singles out persons in a negative way, thereby suggesting that the possible decision to remain unvaccinated describes individuals who are uncaring or even meanspirited, when such characterizations do not apply.12 If the true aim of America’s and Delaware’s health care systems is to mitigate the factors that prevent persons from making sound, informed decisions regarding COVID-19 vaccination, then scientists, researchers, and physicians must broaden the lens through which to gain an accurate understanding of factors outside the person that explain behaviors and decisions relative to getting vaccinated.

IMPACT ON VACCINE MISTRUST AMONG AFRICAN AMERICANS Past Atrocities in Medical Research Black people who are informed about the Tuskegee Experiment wondered if COVID-19 vaccinations provided the government an opportunity to take advantage of a crisis to again intentionally expose and infect large members of group with a deadly virus in the name of medical research (even though we recognize the COVID vaccines cannot infect people with the virus).

Sandra Crouse Quinn, a professor at the University of Maryland School of Public Health in College Park correctly observed that recollections, including the government’s notorious Tuskegee syphilis study, are “still alive and well in people’s memories.”7 In fact, polls show that Black individuals are less trusting of medical research than White or Hispanic people, including their attitudes about vaccines. Hence, health care policy makers and health providers cannot overlook the historical basis of the cynicism and mistrust toward the health professionals.

The public should be able to expect the health care system to employ every measure to protect every American from medical research abuses. While the U.S Code of Federal Regulations allows a waiver of the informed consent requirements of 45 CFR 46 in certain narrowly defined types of research in emergency situations,13 bypassing the informed consent process presents potential harm to not only African Americans, but all Americans.

Institutionalized Racism in Health Care The fact that health care leaders are acknowledging that structural determinants of health are casting a dark shadow over public 81

health in Delaware is somewhat encouraging. After listening to the stories of a Delawarean who experienced implicit bias by her health care provider, Dr. Kara Odom Walker, former Delaware Secretary of Health and Social Services said, “[t]heirs and others’ stories, including my own, underscore the reality of health disparities that will continue to exist unless we all contribute understanding and work to eliminate systemic racism.”14 Medical organizations and Delaware legislators are acknowledging race as a social determinant of health. In 2021, Dr. Rochelle P. Walensky, Director of the Centers for Disease Control and Prevention (CDC) declared that the inequalities the pandemic exposed, “… were not a result of COVID-19. Instead, the pandemic illuminated inequities that have existed for generations and revealed for all of America a known, but often unaddressed, epidemic impacting public health: racism.”15 Research conducted in Delaware before the pandemic clearly highlighted the interconnection of race and the health status of African Americans. The findings in one study showed that non-Hispanic Black Delawareans had the highest adjusted mortality rate for seven of the top ten causes of death between 2014 and 2018. The most common comorbidities associated with COVID-19 were hypertension, obesity, and diabetes, all of which disproportionately impacted Black and Hispanic/Latinx Americans in the U.S. and Delaware.

Director Walensky’s powerful statement challenges Delaware’s health care system to organize Delaware’s response to the health inequalities that impacted African Americans before and following COVID-19 with the goal of redressing the social injustices apparent in public health in the State. Accepting this orientation as a framework for designing and delivering health care would make public health in Delaware an arbiter for social justice. The consequences of such an approach could appreciably reduce or even eliminate the institutionalized racism in health care regularly encountered by African Americans, as well as repair the group’s mistrust of the health system.

Being Black should not be a predictor for vaccine hesitancy.

Rather, an analysis of this phenomenon should be expanded to include a consideration of the ways social and structural determinants of health could explain the choices African Americans and other marginalized groups make relative to vaccination for COVID-19.

Consistent with this perspective, a recent study with a sample of 1200 American adults hypothesized that Black individuals would show less willingness to agree with vaccination when COVID-19 vaccines were first introduced.16 The decision to get vaccinated would increase more rapidly over time in this population compared with White individuals. The study found that COVID-19 vaccine hesitancy decreased more rapidly among Black individuals than among White individuals since December 2020. A key factor associated with this pattern seemed to be the fact that Black individuals more rapidly came to believe that vaccines and vaccinations were necessary to protect themselves and their communities.

The researchers described a major outcome of the study in the following manner: “Black individuals in the U. S. are cautious in their use of novel medical technologies for good reason—the history of abuse by medical and research communities is real—but they are just as likely as White individuals to embrace 82 Delaware Journal of Public Health - March 2022

vaccination once they are convinced that vaccines are safe, effective, and necessary. Vaccine mistrust grounded in community experiences of racism might therefore be characterized not as resistance to protective health behavior but instead as an expression of commitment to protective health behavior.”16

CONCLUSION The COVID-19 vaccine provides opportunities and challenges to the nation and Delaware to improve the health care system, and for it to eliminate barriers to health and well-being for African Americans.

The aim of this commentary was to dispel some of the popular misconceptions surrounding the COVID-19 vaccines that continue fuel the debate and controversy about their safety, effectiveness and necessity. It can be used to address misconceptions held by patients, members of the community, and others who interact with Persons of Color who have questions about the COVID-19 vaccines, or are unwilling to be vaccinated.

There are many methods of addressing the extant health disparities that existed before, and were exacerbated by, the pandemic; repairing the mistrust harbored by African Americans and other marginalized communities towards the health care systems and the professionals with whom they interface; and insuring protection from unethical medical research practices.

These methods include: 1. Increase the number African American and Hispanic/Latinx health care staff, including doctors, nurses, and boots on the ground community workers. A paper written by Delaware physicians and researchers advocating a proactive initiative to diversify health care staff noted that doctors who are African American, or represent other racial ethnic groups, increase the likelihood that high quality care will be provided to underserved populations and people of color.17 2. Develop and mobilize a corps of frontline, boots on the ground community workers to enhance access to COVID-19 vaccines and related services. Assignments include, but are not limited to, disseminating clearly presented information regarding the COVID-19 vaccines (e.g., safety, effectiveness) to residents and in community settings where target populations come together for church, recreation, etc.; distributing masks and test kits; and providing transportation to testing sites.

3. Connect researchers to the community in ways modeled by the Community and Engagement Outreach Core “(CEO), a component of the DE-CTR ACCEL project. The CEO is a mechanism and structure that gives priority to the voice of the community and patient. This and similar programs that bring community and researchers together can go a long way in diminishing the mistrust between African Americans and other people of color and the health system.

4. Involve the community in conducting research (experimental, quasi experimental, qualitative, quantitative, etc.) that examines the accessibility of healthcare. Study questions should include: how has accessibility of health services in the past impacted specific groups? What are the health impacts associated with barriers to access (transportation, shortage of healthcare staff related to COVID-19 specific health needs, etc.)? Are COVID-19 vaccines available in accordance with demand? For whom?

Since when? Who is distributing them? Location?18

5. Assess and develop cultural competence and awareness among health care staff through special required programs.

In a presentation sponsored by the Washington Thoracic Society, Dr. Benjamin Danielson made this statement, “[a] s we look into and understand the history of vaccination, we trace a lot of those back to the African continent and the lessons learned about inoculation that have come from practices that go back many centuries. African Americans hold their own strong history in the promotion and development of vaccines in different ways.”19 An enslaved African, Onesimus, is generally credited with introducing the process of inoculation (or variolation) to Cotton Mather as a method to prevent smallpox. Mather is regarded as the person who introduced inoculation to the colonies, setting the stage for vaccination against smallpox in the 1721 epidemic.20 6. Provide training about the culture-based healing practices of the diverse ethnic and racial populations most impacted

by COVID-19, and methods for integrating this content into health care practices and medical research.

7. Establish community engagement programs in each county to obtain input from community members regarding effective strategies for increasing access to heath care services and mitigating health disparities. Community members should not only hold major roles in designing, implementing and evaluation such an initiative but, should also receive compensation.3 8. Work with institutional review boards at every level, and include community members, with the specific purpose of ensuring an informed consent process that does not allow subject participation in a research project without his or her implicit, informed consent.

Dr. Saunders can be contacted at marlenesaunders145@gmail.com

REFERENCES 1. Pennington, M. (2021, Jul). Vaccine hesitancy: a story as old as vaccines themselves. Eureka A Dose of Science. Retrieved from https://www.criver.com/eureka/vaccine-hesitancy-story-old-vaccines-themselves 2. The College of the Physicians of Philadelphia. (n.d.). The history of vaccines. Retrieved https://www.historyofvaccines.org/timeline 3. Solomon, D. (2021, Feb). Vaccine refusal in the time of COVID-19: Opportunities for community engagement & research [Presentation]. Community Research Exchange, Newark, DE. 4. Centers for Disease Control and Prevention. (2021, March).

Everything you should know about the COVD-19 vaccines [Video]. https://youtu.be/pL-B30EXBEc

8. Goldon, S. H. (2022, Mar 10). COVID vaccines and people of Color. Johns Hopkins Medicine. https://www.hopkinsmedicine.org/health/conditions-and-diseases/ coronavirus/covid19-vaccines-and-people-of-color 9. Government Accountability Office. (2021, Feb 11). Operation warp speed: Accelerated COVID-19 vaccine development status and efforts to address manufacturing challenges. GAO 21-319. https://www.gao.gov/products/gao-21-319 10. Wang, S. X., Bell-Rogers, N., Dillard, D., & Harrington, M. A., & the FNP-c. (2021, September 27). COVID-19 vaccine hesitancy in Delaware’s underserved communities. Delaware Journal of Public Health, 7(4), 168–175. https://doi.org/10.32481/djph.2021.09.022 11. Recht, H., & Weber, L. (2021). Black Americans are getting vaccinated at lower rates than White Americans. Kaiser Health News. https://khn.org/news/article/black-americans-are-getting-vaccinated-atlower-rates-than-white-americans/ 12. Blauer, B. (2021). Vaccine hesitancy involves more than distrust in science & government. Johns Hopkins University & Medicine. https://coronavirus.jhu.edu/pandemic-data-initiative/data-outlook/ vaccine-hesitancy-involves-more-than-distrust-of-science-andgovernment 13. Waiver of Informed Consent Requirements in Certain Emergency Research, 45 CFR § 46. (1996).

14. Bo, C. (2020, Nov 17). Racism is a public health crisis – and Delaware must confront it. The News Journal. https://www.delawareonline.com/story/opinion/2020/11/17/delawaremust-confront-racism-public-health-crisis/6313931002/ 15. Milken Institute School of Public Health. (2021, Oct 22).

Racism is a public health crisis. https://onlinepublichealth.gwu.edu/resources/racism-public-health-crisis/ 16. Padamsee, T. J., Bond, R. M., Dixon, G. N., Hovick, S. R., Na, K., Nisbet, E. C., . . . Garrett, R. K. (2022, January 4). Changes in COVID-19 vaccine hesitancy among Black and White individuals in the US. JAMA Network Open, 5(1), e2144470. https://doi.org/10.1001/jamanetworkopen.2021.44470 17. Mitchell, K., Iheanacho, F., Washington, J., & Lee, M. (2020, August 13). Addressing disparities in Delaware by diversifying the next generation of Delaware’s physicians. Delaware Journal of Public Health, 6(3), 26–28. https://doi.org/10.32481/djph.2020.08.008

5. National Institutes of Health. (2021, August). Vaccines prevented up to 140,000 COVID-19 deaths. https://www.nih.gov/news-events/nih-research-matters/vaccinesprevented-140000-covid-19-deaths-us

18. Knight, K. (2022, Feb 10). Stop conflating COVID-19 vaccine access with ‘hesitancy:’ Government can protect the right to health care by removing barriers. Human Rights Watch. https://www.hrw.org/news/2022/02/10/stop-conflating-covid-19vaccine-access-hesitancy

6. CNN. (2020, July). Here’s what Fauci thinks about the latest COVID-19 vaccine trial [Video]. https://youtu.be/NK3W5IPE9Oc

19. Danielson, B. (2020). COVID-19 vaccine hesitancy in BIPOC communities. Presentation at the WA Thoracic Society [Video]. https://youtu.be/L3t_2iBCAPM

7. Jaklevic, M. C. (2020, September 1). Researchers strive to recruit hard-hit minorities into COVD-19 vaccine trials. JAMA, 324(9), 826–828. https://doi.org/10.1001/jama.2020.11244

20. Blakemore, E. (2021, Apr 8). How an enslaved African man in Boston helped save generations from smallpox. History.com. https://www.history.com/news/smallpox-vaccine-onesimus-slavecotton-mather 83

Towards Eliminating Nonmedical Vaccination Exemptions Among School-Age Children Neal D. Goldstein, Ph.D. Department of Epidemiology and Biostatistics, Drexel University Dornsife School of Public Health Joanna S. Suder, J.D. Civil Division, Delaware Department of Justice

ABSTRACT The increase in childhood vaccine hesitancy and corresponding use of nonmedical exemptions to abstain from vaccination has deleteriously impacted the public’s health. This has many in the field calling for widespread elimination of nonmedical school-entry exemptions, as has been done in six states to date: West Virginia, Mississippi, California, New York, Maine, and Connecticut. By eliminating nonmedical exemptions, vaccination rates can be improved, with the corresponding decline in vaccine-preventable disease incidence. Yet the path towards widespread adoption of these policies presents legislative and judicial implications which evolve with the changing political landscape. In this this article, we discuss legislative actions concerning the expansion of exemptions, whether the widespread elimination of nonmedical exemptions would be effective from a practical and legal end, and how the COVID-19 pandemic has influenced such legislation, with specific focus on Delaware.

INTRODUCTION The COVID-19 pandemic combined with the re-emergence of childhood vaccine-preventable infectious diseases in the past few decades has exemplified the impact that vaccine hesitancy has on the public’s health (we use the term “hesitancy” in this article broadly to include individuals who are unsure about vaccinating themselves or others, as well as individuals who refuse to vaccinate themselves or others.).1–3 While hesitancy is not the only reason for vaccine-preventable disease outbreaks (e.g., waning host immunity following immunization), from a public health perspective this is perhaps the most important criterion, because outbreaks are often started and sustained by persons choosing not to vaccinate.1 Indeed, following the scale up of COVID-19 vaccination during the pandemic, the highest hospitalization and mortality rates have been among those unvaccinated.4 Further, hesitancy surrounding COVID-19 vaccination has been widespread across the U.S.,5 especially among parents vaccinating their children.6 A January 2022 survey found that only 1 in 3 children aged 5-11 had received at least their first COVID-19 shot7; the proportion was higher, though far from perfect, among adolescents aged 12-17 at 3 in 5. For the 2022 school year, both California and Louisiana instituted COVID-19 vaccination school entry requirements for students.8,9 Modifying state childhood vaccination exemption laws through legislation including removing nonmedical exemptions or making them more difficult to obtain is one frequently proposed strategy for increasing vaccination rates.2,3 Major national medical organizations have endorsed this strategy for several years now.10–12 Although the public health agenda of eliminating nonmedical exemptions has an intuitive appeal, changing state law across the U.S. raises substantial challenges on legislative and judicial fronts. In addition to gathering adequate support from voters and lawmakers, both state and federal legislatures must ensure that any law that restricts citizens’ choice concerning vaccinations is consistent with state and federal constitutions, state and federal laws and, in turn, legal precedent established by state and federal 84 Delaware Journal of Public Health - March 2022

courts. It is our intention with this article to explore these areas in more detail. Our audience is not only policymakers considering this approach, but also public health practitioners to supplement their knowledge in this controversial area.

EXEMPTING FROM VACCINATION As many childhood diseases require a high proportion of the population to be immunized to achieve community-wide protection (typically >80%, depending on the pathogen),13 exempting from vaccination may jeopardize community health, particularly if non-immune individuals cluster together.14 All states require vaccination of children enrolling in public schools, state-funded day care, and often private schools, and allow parents to exempt their children from vaccination for medical reasons. All but six states (West Virginia, Mississippi, California, New York, Maine, and Connecticut) allow exemptions for religious and, in some, ideological or philosophical reasons.15 Procedures to exempt one’s children vary by state, and the ease with which exemptions are obtained is positively correlated with lower vaccination coverage.16 Specific to Delaware, the process to obtain a religious or medical exemption for children in public schools is found in 14 Del. C. § 131 and 14 Del. Admin. C. § 804, 7.0. Families seeking a medical exemption for a child in public school must supply “a written statement from a physician, i.e., medical doctor or doctor of osteopathy, stating that the enrollee should not receive the prescribed immunization or immunizations required in the basic series because of the reasonable certainty of a reaction detrimental to that person.”17 Further, “[t]he asserted cause of medical exemption may be subject to review and approval by the Division of Public Health.”17 Families seeking a religious exemption for a child in public school must submit an affidavit of religious belief as codified in 14 Del. C. § 131. Further, “the school shall offer information regarding the benefits of immunization and the risks of not being fully immunized.”18 The process for obtaining a religious or medical exemption for children in private DOI: 10.32481/djph.2022.03.014

schools and child care facilities is found in 16 Del. Admin. C. §4202, 7.0. Families may be granted a medical exemption for a child enrolled in private school or a child care program if their “physicians have submitted, in writing, that a specific immunizing agent would be detrimental to that child.”19 Families may be granted a religious exemption for a child enrolled in private school or a child care program if “the parents or guardians present a notarized document that immunization is against their religious beliefs.”19 Regardless of the educational environment, unvaccinated children may be excluded from school or child care “in the event the Division of Public Health declares an outbreak of a vaccine preventable disease or determines the student has had or is at risk of having an exposure to a vaccine preventable disease. The Division of Public Health shall determine when the student may return to school.”19 Among the states that allow only medical exemptions, vaccination rates are markedly higher. For example, with national median receipt for all recommended doses by kindergarten of measles, mumps, and rubella; diphtheria tetanus and acellular pertussis; and varicella vaccines at 95%, 94%, and 95% respectively for the 2019-2020 school year, both West Virginia and Mississippi exceed this indicator with 98%, 99%, and 98% respectively in West Virginia and >99% for all three vaccines in Mississippi.20 Correspondingly, disease rates have decreased. Pertussis and varicella, both of which occur in relatively large numbers nationally, had among the lowest reported incidences in 2019 in West Virginia and Mississippi.21 Given the preponderance of evidence, from a public health perspective it is only natural to seek widespread elimination of nonmedical vaccination exemptions through state, and possibly federal, action. However, attempts towards widespread elimination of nonmedical exemptions have faced substantial challenges for a variety of reasons with some states even attempting to add exemptions into law.

A LEGISLATIVE BACKLASH

BY ADDING EXEMPTIONS There are numerous examples of state legislatures proposing bills to expand exemption law. In 2017, three bills were proposed in West Virginia–HB2945, SB359, and SB537–to add nonmedical exemptions into the state. In New York, Senate Bill S1536 was proposed in the 2016 legislative session to add philosophical exemptions. Across the river in New Jersey in the same year, a legislator sought to add philosophical exemptions in Senate Bill S1864. In fact, New Jersey has been particularly active in this area with 24 proposed bills to broaden exemptions or remove existing requirements between 2011-2017.22 Across all states in the U.S., there were 78 bills proposed during this time to broaden exemptions or remove existing requirements suggesting this is an active legislative area.22 What all these proposed bills have in common is the failure to become law, although that is not always the case. In 2003, Arkansas successfully added philosophical exemptions to school entry requirements. While there was the expected uptick in exemptions there was not the associated rise in vaccine-preventable diseases.23 Driven by the pandemic, there has been increasing activity in this area of late, for example, Ohio HB435 was introduced to allow student exemption from COVID-19 vaccination mandates. In Delaware, HB209 was introduced on June 3, 2021, which seeks to prohibit any political

subdivision of the State of Delaware (including schools) from requiring immunization against COVID-19. As of this writing, the bill is currently in committee with no movement.

THE FALSE-PREMISE OF FEDERAL ACTION Intuitively, the easiest way towards widespread elimination of nonmedical exemptions would be federal congressional action, such as a non-vaccination tax deterring use of exemptions.

Such action must be within the Constitutional jurisdiction of the Federal government. Under the Tenth Amendment to the Constitution, the power to legislate for the health and welfare of citizens falls under state jurisdiction, and because vaccine laws have traditionally been within a state’s jurisdiction, the U.S. Supreme Court could deem this action to be an unconstitutional exercise of power. However, it is worth exploring whether certain education funds could be tied to state vaccine rates, incentivizing states to increase their vaccination rates without coercing them into changing well-established laws.

LEGAL PRECEDENT AND POSSIBLE CHALLENGES Even if state statutes were passed eliminating nonmedical exceptions, those statutes may be challenged in the courts under the grounds that these laws violated Constitutional rights. In the well-known court case of Jacobson v. Massachusetts, the U.S. Supreme Court upheld a mandatory smallpox vaccination, stating that the Constitution “does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint.”24 In other words, liberty is not absolute: one cannot falsely yell “fire” in a crowded theater as it jeopardizes the safety of others. In 1922, Zucht v. King challenged the constitutionality of a Houston, Texas ordinance requiring vaccination for schoolchildren, which the Court upheld reinforcing Jacobson.25 Prince v. Massachusetts, decided in 1944, challenged child labor laws, and the Court held “[t]he right to practice religion freely does not include the liberty to expose the community or the child to communicable disease or the latter to ill health or death.”26 These three cases make up the historical federal vaccination precedent; but precedent evolves over time.

During the COVID-19 pandemic, the Supreme Court of the United States has weighed in on the Federal government’s authority to mandate vaccination. In National Federation of Independent Business v. Department of Labor, the Supreme Court blocked the Occupation Safety and Health Administration’s proposed soft vaccine mandate for all large employers.27 Conversely, in Biden v. Missouri, the Supreme Court upheld the Centers for Medicare and Medicaid Services’ vaccine requirement for facilities that agree to the Centers’ conditions of participation.28 Unsurprising to many public health law practitioners, the Supreme Court upheld state vaccine mandates in New York and Maine.29,30 In the scenario of a state eliminating all nonmedical exemptions, a parent may hypothetically challenge this action as an infringement upon their, and their child’s, civil liberties. Courts below the U.S. Supreme Court have taken up similar issues and have held against a right to decline vaccinations, namely Phillips v. City of New York, Workman v. Mingo County Board of Education, Boone v. Boozeman, and Brown v. Stone.31–34 In Brown v. Stone, the Mississippi Supreme Court examined, and 85

overturned, a statute expansion to include religious exemptions.34 Although the Supreme Court has not weighed in specifically on this matter, the Court has issued many decisions supporting a citizen’s ability to make private decisions related to procreation, child-bearing and family. While the precedent set in Jacobson makes it unlikely the Court would find that parents have a right to not vaccinate their children, this case is now over 110 years old and the 21st century Supreme Court has expanded fundamental individual rights in a way the 20th century Court could never have imagined, particularly through the same-sex marriage cases of U.S. v. Windsor and Obergefell v. Hodges.35,36 The Court has also repeatedly upheld the interests of religious freedom over public health during the COVID-19 pandemic, specifically in Tandon v.

Newsom and Roman Catholic Diocese of Brooklyn v. Cuomo.37,38 As an alternate and perhaps more plausible scenario, the elimination of only religious exemptions may have implications under the First Amendment. Laws requiring mandatory vaccination are often seen as neutral and generally applicable because they do not demonstrate a denominational preference.

However, an Arkansas court ruled in Boone v. Boozman that the State’s religious exemption showed preference to established religion, and struck down the law, thereby limiting the ability to opt out of vaccination.33 If states have adopted their own Religious Freedom Restoration Acts – Delaware has not – then these states must show that there are no less restrictive means to improving vaccinate rates and preventing communicable illness than eliminating religious exemptions.

OVERCOMING POLITICAL IDEOLOGIES Perhaps the greatest challenge to removing nonmedical exemptions is not judicial, but legislative. That is, legislation must be written, voted, and executed into law. There is emerging evidence about the alignment of legislative bills being proposed in the states and their impact on vaccination. Goldstein, Suder, and Purtle observed a concerning increase of bills being proposed in state legislatures between 2011 and 2017 that would undermine vaccination efforts through broadening exemptions.22 Bills that would broaden exemptions were more likely to be proposed

by Republican lawmakers or come from states in the South or Northeast. Fortunately, these bills were less likely to become enacted into law. In a follow-up study, these authors correlated bills that would impact vaccine exemption law with vaccinepreventable diseases and found that an increase in reported diseases brought about an increase in bills that would restrict the ability to exempt, perhaps suggesting that lawmakers will respond to disease outbreaks among their constituency.39 The partisan nature of public health legislation has also been studied. Congressional party affiliation predicts voting patterns on public health legislation.40 States that voted Democratic in the 2012 Presidential election were correlated with higher vaccination coverage.41 A comprehensive examination of vaccine-related legislation between 1995 and 2020 has found an increase in the polarization of proposed bills during recent years; whereas vaccination law used to be more bipartisan, today it is not.42 In short, any law that proposed to eliminate nonmedical exemptions will be subject to the political climate of that state, with some states, particularly those in the South or under Republican leadership, less amenable to change.

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ENTER ALTERNATIVES TO LEGISLATION The premise underlying the elimination of nonmedical exemptions, or at least making them more difficult to obtain, is that most parents will have no option but to immunize their children prior to school entry. However, these efforts can still be undermined by fringe practitioners granting medical exemptions or an increase in home schooling, a potentially selfdamaging scenario to the public’s health.43 In fact, the increase in medical exemptions was observed in California following their elimination of personal belief exemptions in 2015.44 Proposed alternatives to eliminating exemptions include stricter exemption policies, financial disincentives, increasing voluntary compliance, and more effective vaccines. Internationally, Australia limited childcare benefits for parents who philosophically object to vaccinating their children.45 For states here in the U.S., an annual nonmedical exemption fee has been proposed for parents who seek such exemptions.46 In a recent article tailored towards the legal community, Reiss and Weithorn present a table of various tools states can use to increase vaccination rates, some of which have yet to be tried, such as tort liability for failure to vaccinate.47

CONCLUSIONS In this article, we have presented a legal and judicial analysis of eliminating nonmedical vaccination exemptions, and further argued that federal action is unlikely. The road to widespread elimination of nonmedical exemptions is filled with long, drawn-out legislation with many political hurdles. Nonmandated alternatives may be the path of least resistance. Regardless, the current and changing state of exemptions will serve as a useful case study in the future as we continue to strive for control and eradication of vaccine-preventable infectious diseases in Delaware and beyond.

Dr. Goldstein can be contacted at ng338@drexel.edu

ACKNOWLEDGEMENTS The authors would like to thank Stephen C. Eppes, MD, ChristianaCare, for a helpful critique of a draft version of this manuscript.

DISCLAIMER The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the Delaware Department of Justice.

REFERENCES 1. Phadke, V. K., Bednarczyk, R. A., Salmon, D. A., & Omer, S. B. (2016, March 15). Association between vaccine refusal and vaccine-preventable diseases in the United States: A review of measles and pertussis. JAMA, 315(11), 1149–1158. https://doi.org/10.1001/jama.2016.1353 2. Gostin, L. O. (2015, March 17). Law, ethics, and public health in the vaccination debates: Politics of the measles outbreak.

JAMA, 313(11), 1099–1100. https://doi.org/10.1001/jama.2015.1518 3. Yang, Y. T., & Silverman, R. D. (2015, January 20). Legislative prescriptions for controlling nonmedical vaccine exemptions.

JAMA, 313(3), 247–248. https://doi.org/10.1001/jama.2014.16286

4. Moghadas, S. M., Vilches, T. N., Zhang, K., Wells, C. R., Shoukat, A., Singer, B. H., . . . Galvani, A. P. (2021, December 16). The impact of vaccination on coronavirus disease 2019 (covid-19) outbreaks in the United States. Clin Infect Dis, 73(12), 2257–2264. https://doi.org/10.1093/cid/ciab079 5. Centers for Disease Control and Prevention. (2022, Feb).

Estimates of vaccine hesitancy for COVID-19. Retrieved from: https://data.cdc.gov/stories/s/Vaccine-Hesitancy-for-COVID-19/cnd2-a6zw 6. Beleche, T., Kolbe, A., Bush, L., & Sommers, B. D. (2022, Feb). Parents’ intentions to vaccinate children ages 12-17 for COVID-19: Demographic factors, geographic patterns, and reasons for hesitancy. Retrieved from: https://aspe.hhs.gov/reports/hesitancy-vaccinate-children 7. Hamel, L., Sparks, G., Lopes, L., Stokes, M., & Brodie, M. (2022). KFF COVID-19 Vaccine Monitor: January 2022 parents and kids update. Retrieved from: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19vaccine-monitor-january-2022-parents-and-kids-update/ 8. State of California Office of the Governor. (2021, Oct).

California becomes first state in nation to announce covid-19 vaccine requirements for schools. Retrieved from: https://www.gov.ca.gov/2021/10/01/california-becomes-first-state-innation-to-announce-covid-19-vaccine-requirements-for-schools/ 9. State of Louisiana Office of the Governor. (2021, Dec). House health letter. Retrieved from: https://gov.louisiana.gov/assets/docs/househealthletter.pdf 10. American Medical Association. (2015). AMA supports tighter limitations on immunization opt outs. Retrieved from: https://www.ama-assn.org/press-center/press-releases/ama-supportstighter-limitations-immunization-opt-outs 11. American College of Physicians. (2015, Jul). Elimination of non-medical exemptions from state immunization laws.

Retrieved from: https://www.acponline.org/acp_policy/policies/non_medical_ exemptions_policy_2015.pdf 12. American Academy of Pediatrics. (2016). Eliminate nonmedical immunization exemptions for school entry, says AAP. Retrieved from: http://www.aappublications.org/news/aapnewsmag/2016/08/29/ VaccineExemptions082916.full.pdf 13. Anderson, R. M., & May, R. M. (1990, March 17).

Immunisation and herd immunity. Lancet, 335(8690), 641–645. https://doi.org/10.1016/0140-6736(90)90420-A 14. Omer, S. B., Enger, K. S., Moulton, L. H., Halsey, N. A., Stokley, S., & Salmon, D. A. (2008, December 15). Geographic clustering of nonmedical exemptions to school immunization requirements and associations with geographic clustering of pertussis. American Journal of Epidemiology, 168(12), 1389– 1396. https://doi.org/10.1093/aje/kwn263 15. National Conference of State Legislators. (2022, Jan 20). States with religious and philosophical exemptions from school immunization requirements. https://www.ncsl.org/research/health/ school-immunization-exemption-state-laws.aspx

16. Wang, E., Clymer, J., Davis-Hayes, C., & Buttenheim, A. (2014, November). Nonmedical exemptions from school immunization requirements: A systematic review. American Journal of Public Health, 104(11), e62–e84. https://doi.org/10.2105/AJPH.2014.302190 17. 14 Del. C. § 131 18. 14 Del. Admin. C. § 804, 7.1.2.

19. 16 Del. Admin. C. §4202, 7.1.4.1 20. Seither, R., McGill, M. T., Kriss, J. L., Mellerson, J. L., Loretan, C., Driver, K., . . . Black, C. L. (2021, January 22). Vaccination coverage with selected vaccines and exemption rates among children in kindergarten - United States, 2019-20 school year.

MMWR. Morbidity and Mortality Weekly Report, 70(3), 75–82. https://doi.org/10.15585/mmwr.mm7003a2 21. Centers for Disease Control and Prevention. (2021). National Notifiable Diseases Surveillance System, 2019 Annual Tables of Infectious Disease Data. https://www.cdc.gov/nndss/datastatistics/infectious-tables/index.html 22. Goldstein, N. D., Suder, J. S., & Purtle, J. (2019, January).

Trends and characteristics of proposed and enacted state legislation on childhood vaccination exemption, 2011-2017.

American Journal of Public Health, 109(1), 102–107. https://doi.org/10.2105/AJPH.2018.304765 23. Safi, H., Wheeler, J. G., Reeve, G. R., Ochoa, E., Romero, J. R., Hopkins, R., . . . Jacobs, R. F. (2012, June). Vaccine policy and Arkansas childhood immunization exemptions: A multiyear review. American Journal of Preventive Medicine, 42(6), 602–605. https://doi.org/10.1016/j.amepre.2012.02.022 24. Jacobson v. Mass., 197 U.S. 11 (1905).

25. 260 U.S. 174 (1922).

26. 321 U.S. 158 (1944).

27. 142 S.Ct. 661 (2022).

28. Biden v. Missouri, 142 S. Ct. 647 (2022) 29. Howe, A. (2021). Court rejects religious challenge to New York’s vaccine mandate for health care workers. https://www.scotusblog.com/2021/12/court-rejects-religious-challengeto-new-yorks-vaccine-mandate-for-health-care-workers/ 30. John Does 1-3 v. Mills, 142 S. Ct. 581 (2021) 31. Phillips v. New York, 775 F.3d at 544.

32. Workman v. Mingo County, 419 Fed.Appx. at 354 33. 217 F.Supp.2d 938, 956 (Ar. E.D., 2002).

34. 378 So.2d 218 (Ms. 1979).

35. 570 U.S. 744 (2013).

36. 576 U.S. 644 (2015).

37. Tandon v. Newsom, 141 S. Ct. 1294, 209 L. Ed. 2d 355 (2021) 38. Roman Cath. Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 208 L. Ed. 2d 206 (2020) 39. Goldstein, N. D., Purtle, J., & Suder, J. S. (2020, January 1).

Association of vaccine-preventable disease incidence with proposed state vaccine exemption legislation. JAMA Pediatrics, 174(1), 88–89. https://doi.org/10.1001/jamapediatrics.2019.4365 87

40. Purtle, J., Goldstein, N. D., Edson, E., & Hand, A. (2016, December 23). Who votes for public health? U.S. senator characteristics associated with voting in concordance with public health policy recommendations (1998-2013). SSM Population Health, 3, 136–140. https://doi.org/10.1016/j.ssmph.2016.12.011 41. Bernstein, S., North, A., Schwartz, J., & Niccolai, L. M. (2016, October). State-level voting patterns and adolescent vaccination coverage in the United States, 2014. American Journal of Public Health, 106(10), 1879–1881. https://doi.org/10.2105/AJPH.2016.303381 42. Estep, K., Muse, A., Sweeney, S., Goldstein, N.D. (n.d.).

Partisan polarization of childhood vaccination policies, 19952020. Manuscript under review.

43. Mohanty, S., Buttenheim, A. M., Joyce, C. M., Howa, A. C., Salmon, D., & Omer, S. B. (2018, November). Experiences with medical exemptions after a change in vaccine exemption policy in California. Pediatrics, 142(5), e20181051. https://doi.org/10.1542/peds.2018-1051

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44. Delamater, P. L., Leslie, T. F., & Yang, Y. T. (2017, September 5). Change in medical exemptions from immunization in California after elimination of personal belief exemptions.

JAMA, 318(9), 863–864. https://doi.org/10.1001/jama.2017.9242 45. BBC News. Australia to stop welfare cash of anti-vaccine parents. April 12, 2015. http://www.bbc.com/news/world-australia-32274107. Accessed February 4, 2022.

46. Billington, J. K., & Omer, S. B. (2016). Use of fees to discourage nonmedical exemptions to school immunization laws in US States. American Journal of Public Health, 106(2). https://doi.org/10.2105/AJPH.2015.302967 47. Reiss, D.R., Weithorn, L.A. (2015). Responding to the childhood vaccination crisis: legal frameworks and tools in the context of parental vaccine refusal. 63 Buff. L. Rev. 881.

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SPOTLIGHT

Mid-Atlantic Public Health Partnership Conference

Isabelle Raynard Intern, Maryland Public Health Association; Undergraduate, American University Jody Gan, M.P.H., C.H.E.S. Professional Lecturer, Health Studies, American University; President, Maryland Public Health Association

This year’s second annual Mid-Atlantic Public Health Partnership Conference used a virtual platform to bring together public health professionals and students from Maryland, Delaware, and Pennsylvania to explore “Strengthening Communities Through Trauma-Informed Public Health,” this year’s conference theme. This “newish” partnership recognizes that public health challenges do not observe state lines and that coming together as a region can do more to move the needle on common public health opportunities and threats than to address them as individual states. Occurring in the midst of the fourth wave of the pandemic (January 13-14, 2022), the conference focus emphasized that a strong public health infrastructure that is trauma-informed and equitable is crucial to address healing and rebuilding at the local, regional and national levels.

their respective states and spotlighted promising programs.

Dr. Kathleen Brewer-Smyth, a professor at the University of Delaware, painted a vivid portrayal of how ACEs haunt women throughout their lives gleaned from her research with inmates at a women’s prison.

A warm salute from Kaye Bender, President of the American Public Health Association, kicked off 1.5 days of thoughtful programming around the many ways trauma impacts individuals and communities, the importance of developing systems that respond with trauma-informed care promoting healing and resilience, and how we can prevent future trauma from challenges before us (including climate change). From a ninth-grade student presenting research on the impact of climate change to a New York Times best-selling author, Rachel Louise Snyder, sharing a harrowing expose of domestic violence and the many holes in our medical, social service and law enforcement systems (No Visible Bruises), a diverse group of panelists shared their insights related to the importance of ensuring that public health infrastructures are traumainformed and preparing for future threats to public health.

The last panel of the conference focused on the experiences of individuals living with intellectual disabilities. Panelists Sara Molina-Robinson (Pennsylvania), Mark Salzer (Pennsylvania), Charmaine Wright (Delaware) and Adriane Griffen (Maryland) shed light on the needs of these individuals and the intensified impact of trauma, with an important reminder to include this vulnerable population group in public health program planning, coalition building, and resource allocation, as all too often the narratives of those with disabilities are left out of the conversation.

Keynote speaker, Senator Sarah McBride of Delaware, a member of the LGBTQ+ community and the first transgender member of a state legislature, delivered a heartbreaking yet inspiring speech on her personal struggles, and how she rose above to become the influential woman she is today.

Sacoby Wilson, Associate Professor at the University of Maryland Institute for Applied Environmental Health, gave a dynamic talk that revved up listeners regarding the threat of climate change in Maryland, and the dramatic consequences here in the mid-Atlantic area and the rest of the world. Dr. Wilson was joined by Deepa Manikar from the National Nurse-Led Care Consortium (Delaware) and Dan Early from Booz Allen Hamilton (Pennsylvania), who elaborated on both the physical health and mental health effects of climate change that we are currently seeing and will continue to see.

The conference also focused on the lasting effects of adverse childhood experiences (ACES). Logan Herring (Delaware), Malcolm Yates (Pennsylvania), Aileen Fink (Delaware), and Claudia Remington (Maryland), shared data from 90 Delaware Journal of Public Health - March 2022

Friday’s forum began with a speech delivered by Mike Africa Jr., writer, activist, and subject of the HBO Max documentary “40 Years A Prisoner” about the aftermath of the 1978 storming of the MOVE compound in Philadelphia. When Africa was six years old, he saw a police bomb detonate in his familial home, killing his uncle, cousin, and nine other family members. After 25 years, Africa was able to free his parents from jail and continues to lead others in the pursuit of justice, exhibiting impressive resilience as he “moved forward,” despite the unspeakable trauma he experienced as a youngster.

The conference program also included time to acknowledge the stress that we as public health workers have endured during the ongoing pandemic. Participants were treated to a relaxing, mindfulness exercise led by psychologist Christine Runyan that was tailored to the needs of those working on the frontlines and all of us who have been on heightened alert since the beginning of the pandemic in March 2020.

The second annual Mid-Atlantic Public Health Conference successfully provided another opportunity for public health folks from three states to learn from one another--this time examining trauma-informed public health practice.

Conference participants had the opportunity to network and get to know one another a bit in a fun afternoon virtual social. The conference also gave students the opportunity to present their related research. One student attendee shared that this year’s meeting not only helped her professionally in that she has a better understanding of the future challenges that those in the public health field can expect, but also found the meeting to be personally therapeutic. The conference organizers (Stephanie Shell, Joshua Miller-Myers, Brooke Spencer, Tim Gibbs, Kate Smith, Jody Gan, Suparna Navale) look forward to continuing the partnership and offering an in-person or hybrid gathering in 2023.

Ms. Raynard may be contacted at ir8808a@student.american.edu DOI: 10.32481/djph.2022.03.015

The future of health begins with you.

The All of Us Research Program is inviting one million people across the U.S. to help build one of the most diverse health databases in history. We welcome participants from all backgrounds. Researchers will use the data to learn how our biology, lifestyle, and environment affect health. This may one day help them find ways to treat and prevent disease.

JOIN NOW! https://allofus.nih.gov 91

All of Us Research Program

a program of the National Institutes of Health

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Too often, is one size fits all. meant for the “average” patient may not work wellwork for individual Toohealth often,care health care is one sizeTreatments fits all. Treatments meant for the “average” patient may not well people. for Health care providers may find it difficult to coordinate care among specialists or to access all of a patient’s individual people. Health care providers may find it difficult to coordinate care among specialists or health information.

Researchers may spend lots of time and resources creating new databases for every study. to access all of a patient’s health information. Researchers may spend lots of time and resources

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92 Delaware Journal of Public Health - March 2022

DOI:

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94 Delaware Journal of Public Health - March 2022

It gets better with All of Us.

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Encouraging women to participate in clinical research: American Heart Association’s Go Red For Women and Verily’s Project Baseline address gender disparities in research.

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From the Archives: the Healing Arts in History

“Of the Importance of General Vaccination and the Groundlessness of the Prejudices Against It” Sharon Folkenroth Hess, M.A. Historian and Archivist, Delaware Academy of Medicine/Delaware Public Health Association

The 1870s and 1880s smallpox epidemics in the United States can be attributed to the successful mass vaccination efforts in the first century. As cases became rare toward the mid-century, vaccine use decreased. Out of sight, out of mind. With the population susceptible to the ravages of the disease once more, physicians and governments pushed for a return to former immunization rates by enforcing existing mandates or creating new ones. The pushback was immediate. Inspired by their counterparts in Europe, anti-vaccination activists railed against the laws, citing concerns regarding the safety and efficacy of vaccinations as well as violations of their civil liberties.1 With smallpox cases on the rise, the Board of Health of the State of Delaware called upon Dr. John K. Kane, Jr, M.D., to address the public’s concerns.

John K. Kane Jr. was born in Philadelphia in 1833. He attended University of Pennsylvania and received his medical degree from Jefferson College. After passing an examination before the Naval Commission, he sailed on the polar expedition sent out in 1854 to search for his brother, Dr. Elisha Kent Kane. The expedition was successful and Dr. John K. Kane accompanied his brother to Cuba, remaining with him until he died. He continued his medical studies in Paris, and then returned to Philadelphia to practice. During the American Civil War, he served as an army surgeon in Cairo, Illinois and Chester, Pennsylvania. In l868, he was appointed surgeon of the Philadelphia, Wilmington, and Baltimore Railroad Company and in 1879 Dr. Kane was elected president of the Delaware Medical Society.

In addition to his position as president of the Delaware Medical Society, the Board likely selected Dr. Kane because of his minor celebrity and family name recognition (Figure 1). Dr. Kane’s 1882 report, “Vaccination. Of the Importance of General Vaccination and the Groundlessness of the Prejudices Against It,” was initially presented to the Board and was printed in its entirety in the Wilmington newspaper, The News Journal.2 The Delaware Academy of Medicine Archives has an 1883 reprint of the report on display in the Lewis B. Flinn Library.

Late nineteenth-century immunizations involved more than the quick ‘shot’ we enjoy today. In a “vaccine operation,” a small spot on the patient’s upper arm is scored with a needle or lancet.

Then a small amount of “lymph” containing live cowpox or vaccinia virus is applied to the wound. After a few days of mild discomfort, the lesion produced a blister-like vesicle. Once healed, a tell-tale cicatrix scar appeared and served as permanent proof of vaccination. Immunity would last between five to ten years if done correctly.

96 Delaware Journal of Public Health - March 2022

Before the mid-century, cowpox lymph was collected from an infant or young child. As demand for vaccines increased, health departments and entrepreneurs created stock farms for the sole purpose of supplying the cowpox virus in large quantities.

Cowpox lymph was often harvested directly from cows and dried onto ivory points, injected into goose quills, or sold as scabs. Even though the city council elected official ‘vaccination doctors’ who were required to provide the service to all at low or no cost to the patient,3 vaccine points and quills were available from the corner druggist or apothecary. As Dr. Kane complains, these vaccines were not always reliable:

“The demand for [the vaccine] has become so great that, either the vendors, not content with the very great profit that must have accrued to them legitimately, have used a spurious imitation (nothing could be easier than to stain a quill or ivory point with mucilage or cochineal), or else that the retailers sell stale points which have become inert.” 2 Even if the vaccines were prepared correctly, transportation and storage conditions could significantly impact the product’s efficacy. Some of the vaccines would not produce a strong enough reaction in the patient to provide them with immunity. These faulty products helped to spread doubt regarding the protective power of immunization.

In 1881, the Board of Health and the city vaccination doctors unanimously resolved to discontinue the use of quills and points and rely on arm-to-arm transmission.4 With this method, a physician would collect material directly from a human pustular cowpox lesion and immediately apply it to the prepared wound on the patient. In his report, Dr. Kane does not specify how the supplier of the lymph was selected, only that it be taken from “healthy children with well-formed vesicles.”2 However, during the vaccine physician’s caucus of 1892, Republican nominees argued that scabs should be used instead of fresh lymph and created turmoil within the city council.5 The election of the vaccine physicians was a matter of politics rather than merit well into the twentieth century.

DOI: 10.32481/djph.2022.03.016

One primary objection to the use of humanized lymph and scabs was that other communicable diseases like syphilis or scrofula would be transmitted in the humanized lymph. Dr. Kane scoffs at these ‘groundless’ fears, stating that it is impossible to even accidentally transmit disease this way.2 Although later disproved, he was not alone in this belief and the practice continued for another two decades. Arm-to-arm transmissions were later banned after cases of hepatitis and syphilis were connected to smallpox inoculations.

Delaware concluded that the benefits of inoculation outweighed the risks. According to Dr. Kane, “those who die from SmallPox the average is only 3 ½ to 4 per cent in the vaccinated, as contrasted with 30 to 50 per cent of those who were unprotected by vaccination.”2 On March 21, 1881, Delaware passed a law that required all children attending public schools to be vaccinated unless already protected from smallpox by vaccination or by an attack of smallpox.6 It is difficult to overstate how vital smallpox inoculation and vaccination have been to the health and well-being of

Delawareans and the world. Still, some of the efforts to promote these public health measures may have done more harm than good. The suspicions born in this period linger today.

Ms. Hess can be contacted at shess@delamed.org

REFERENCES 1. Is Vaccination Dangerous, I. V. (1879, May 18). The News Journal, 2.

2. Kane, J. K. (1882, June 15). Vaccination. Of the Importance of General Vaccination and the Groundlessness of the Prejudices Against It. The News Journal, 4.

3. The Question of Vaccination. (1881, May 12). Daily Republican, 1.

4. Down on Bovine Quills. (1881, July 9). The Daily Gazette, 1.

5. Vaccine Physician Caucus. (1892, January 1). The Evening Journal, 1.

6. An Important Move: School Children Must Be Vaccinated.

(1883, October 9). The Daily Gazette, 1.

Figure 1. The Kane Family 97

VACCINES – LEXICON Anaphylaxis A severe, potentially life-threatening allergic reaction that can occur within seconds or minutes of exposure to an allergen. Symptoms include a skin rash, nausea, vomiting, difficulty breathing, and shock. If not treated right away, usually with epinephrine, it can result in unconsciousness or death.

Antigen A toxin or other foreign substance which induces an immune response in the body, especially the production of antibodies.

Antimicrobial Resistance The development by a disease-causing microbe, through mutation or gene transfer, of the ability to survive exposure to an antibacterial agent that was previously an effective treatment.

Asplenia Without a spleen.

Bacteremia The presence of bacteria in the blood.

Cardiomyopathy Chronic disease of the heart muscle.

Congestive Heart Failure (CHF) A chronic condition in which the heart does not pump blood as well as it should. It may be due to systolic (pumping) or diastolic (filling) problems.

Conjugate Vaccine A type of vaccine which combines a weak antigen with a strong antigen as a carrier so the immune system has a stronger response to the weak antigen.

Complement Deficiency An immune deficiency of absent or suboptimal functioning of one of the complement system proteins.

Complement System A group of proteins within the blood, cells, and tissues important in infection prevention.

Contraindication A condition that serves a reason not to take a certain medical treatment, technique, or drug, due to the harm it would cause (the opposite of indication, or a reason to use a certain treatment, technique, or drug).

Chronic Obstructive Pulmonary Disease (COPD) A chronic inflammatory lung disease causing an obstructed airflow leaving the lungs. Symptoms include breathing difficulty, cough, mucus production, and wheezing.

Endemic A disease or condition regularly found among particular people or in a certain area.

Gastroenteritis Inflammation of the stomach and intestines, typically due to bacteria, toxins, or viral infection. Symptoms include vomiting and diarrhea.

Hemoglobinopathy A group of inherited disorders in which there is abnormal production or structure of the hemoglobin molecule.

Iatrogenic Immunosuppression The unintentional suppression of the immune system due to injury or illness occurring as a result of medical care.

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VACCINES – LEXICON Immunocompetent Having a normal immune response.

Immunocompromised Having a weakened immune system.

Immunogenicity The ability of a foreign substance (antigen) to provoke an immune response.

Meningitis Inflammation of the brain and spinal cord membranes (meninges) caused by viral or bacterial infection. Symptoms include intense headache and fever, sensitivity to light, and muscular rigidity, leading (in severe cases) to convulsions, delirium, and death.

Myalgia Pain in a muscle or group of muscles.

Non-Inferiority Study A study that tests whether a new treatment or procedure is not worse than an active treatment or procedure it is being compared to.

Oliogosaccharide A carbohydrate (e.g. starch, cellulose, or glycogen) whose molecules are composed of a relatively small number of monosaccharide units.

Osteomyelitis Inflammation of bone or bone marrow, usually due to infection.

Otitis Media Inflammation of the middle ear, usually distinguished from otitis externa (of the passage of the outer ear) and otitis interna (of the inner ear; labyrinthitis).

Polysaccharide A carbohydrate (e.g. starch, cellulose, or glycogen) whose molecules consist of a number of monosaccharide molecules bonded together.

Quadrivalent Vaccine A vaccine that works by stimulating an immune response against four different antigens.

Serotype A distinct variation within a species of bacteria or virus, or among immune cells of different individuals.

Sequelae A pathological condition resulting from a disease, injury, therapy, or other trauma.

Sinusitis Inflammation or swelling of the tissue lining the sinuses (four paired spaces within the skull). Symptoms include nasal congestion and facial pain.

Toxoid A toxin from a bacteria that has been chemically altered to be no longer toxic, while still producing an immune response.

Tympanostomy The surgical procedure to insert ear tubes.

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VACCINES – RESOURCES Delaware Resources Immunization Coalition of Delaware - http://immunizedelaware.org/

State of Delaware COVID-19 Response - https://coronavirus.delaware.gov/ DelVAX Public Access Portal - https://delvax.dhss.delaware.gov/delvax_public/Application/PublicPortal Immunization Program - https://dhss.delaware.gov/dhss/dph/dpc/immunize.html Influenza Response - https://dhss.delaware.gov/dhss/dph/flu.html Vaccines for Children Program - https://dhss.delaware.gov/dhss/dph/dpc/immunize-vfc.html

National Resources Advisory Committee on Immunization Practices (ACIP) https://www.cdc.gov/vaccines/acip/index.html Current COVID-19 Recommendations - https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html Vaccine Recommendations and Guidance - https://www.cdc.gov/vaccines/hcp/acip-recs/index.html

Centers for Disease Control and Prevention (CDC) 2022 Immunization Schedules Birth to 18 Years - https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html 19 Years and Older - https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html COVID-19 Vaccination Resources - https://www.cdc.gov/vaccines/covid-19/ Epidemiology and Prevention of Vaccine-Preventable Diseases (“Pink Book”) https://www.cdc.gov/vaccines/pubs/pinkbook/

Influenza 2021-2022 Season Burden Estimates - https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm Weekly Surveillance Report - https://www.cdc.gov/flu/weekly/ Pregnancy and Vaccination - https://www.cdc.gov/vaccines/pregnancy/index.html

Travel Vaccines General Information - https://wwwnc.cdc.gov/travel/page/travel-vaccines Yellow Book, 2020 - https://wwwnc.cdc.gov/travel/page/yellowbook-home-2020 Vaccines and Immunizations - https://www.cdc.gov/vaccines/ Immunization Action Coalition - https://www.immunize.org/ Immunization Coalitions Network - https://www.immunizationcoalitions.org/

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Index of Advertisers The Nation's Health. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 American Public Health Association 2022 Evelyn R. Hayes Innovations in Healthcare Symposium. . . . . . . . . . . . . . . . . . . . . . . . . . . 17 University of Delaware Health Sciences Save The Date - 92nd Annual Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Delaware Journal of Public Health The DPH Bulletin - March 2022. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Delaware Division of Public Health The DPH Bulletin - February 2022. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Delaware Division of Public Health Making the Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Public Health Communications Collaborative Controlling Blood Pressure in Delaware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 American Heart Association Get Down With Your Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 American Heart Association All Of Us Research Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 National Institutes of Health Go Red for Women® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Verily’s Project Baseline Submission Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Delaware Journal of Public Health

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Delaware Journal of

Public Health

Submission Guidelines

updated April, 2020

About the Journal Established in 2015, The Delaware Journal of Public Health is a bi-monthly, peer-reviewed electronic publication, created by the Delaware Academy of Medicine/Delaware Public Health Association. The publication acts as a repository of news for the medical, dental, and public health communities, and is comprised of upcoming event announcements, past conference synopses, local resources, peer-reviewed content ranging from manuscripts and research papers to opinion editorials and personal interest pieces, relating to the public health sector. Each issue is largely devoted to an overarching theme or current issue in public health.

The content in the Journal is informed by the interest of our readers and contributors. If you have an event coming up, would like to contribute an Op-Ed, would like to share a job posting, or have a topic in public health you would like to see covered in an upcoming issue, please let us know.

If you are interested in submitting an article to the Delaware Journal of Public Health, or have any additional inquiries regarding the publication, please contact DJPH Deputy Editor Elizabeth Healy at ehealy@delamed.org, or the Executive Director of The Delaware Academy of Medicine and Delaware Public Health Association, Timothy Gibbs, at tgibbs@delamed.org

Information for Authors Submission Requirements The DJPH accepts a wide variety of submission formats including brief essays, opinion editorials pieces, research articles and findings, analytic essays, news pieces, historical pieces, images, advertisements pertaining to relevant, upcoming public health events, and presentation reviews. If there is an additional type of submission not previously mentioned that you would like to submit, please contact a staff member.

Cover Letters must address the following four article requirements: 1. A description of what the paper adds to current knowledge, in particular with respect to material previously published in DJPH, and if systematic reviews exist on the topic.

2. The public health importance of the paper.

3. One sentence summarizing the main message(s) of the paper, which may be used to disseminate the paper on social media.

The initial submission should be clean and complete, without edits or markups, and contain both the title and author(s) fulls name(s). Submissions should be 1.5 or 4. For individual or group randomized trials, provide the double spaced with a font size of 12. Initial submissions date of trial registration and the NCT number from must also contain a cover letter with concise text www.Clinicaltrials.gov or other approved registry. (maximum 150 words). Once completed, articles In the cover letter only, not in the paper. Do NOT should be submitted via email to Elizabeth Healy at include the trial registration or NCT number in the ehealy@delamed.org as an attachment. Graphics, images, abstract or the body of the manuscript during the info-graphics, tables, and charts, are welcome and initial submission. encouraged to be included in articles. Please ensure that all pieces are in their final format, and all edits and track All manuscripts must be submitted via email to Elizabeth Healy at ehealy@delamed.org. changes have been implemented prior to submission.

102 Delaware Journal of Public Health - March 2022

To view additional information for online submission requirements, please refer to the website for the Delaware Journal of Public Health: https://djph.org/sample-page/submit-an-article/.

Submission Length While there is no prescribed word length, full articles will generally be in the 2500-4000-word range, and editorials or brief reports will be in the 1500-2500-word range. If you have any questions regarding the length of a submission, or APA guidelines, please contact a staff member.

Copyright Opinions expressed by contributors and authors do not necessarily reflect the opinions of the DJPH or affiliated institutions of authors. Copying for uses other than personal reference or interest without the consent of the DJPH is prohibited. All material submitted alongside written work, including graphics, charts, tables, diagrams, etc., must be referenced properly in accordance with APA formatting.

Conflicts of Interest Any conflicts of interest, including political, financial, personal, or academic conflicts, must be declared prior to the submission of the article, or in conjunction with a submission. Conflicts of interest are any competing interests that may leave readers feeling misled or deceived, and/or alter their perception of subject matter. Declared conflicts of interest may be published alongside articles in the final electronic publication.

Additional Documents and Information for Authors Please Note: All authors and contributors are asked to submit a brief personal biography (3 sentences maximum) and a headshot along submissions. These will be published alongside final submissions in the final electronic publication. For pieces with multiple authors, these additional documents are requested for all contributors.

Abstracts Authors must submit a structured or unstructured abstract along with their article.

The word limit is 200 words, including headings. A title page should be submitted with this abstract as well.

Structured abstracts should employ 4-5 headings: Objectives (begins with “To…”) Methods Results Conclusions A fifth heading, Policy Implications, may be used if relevant to the article.

Trial Registration information is required for clinical trials and must be included in the final version abstract All abstracts should provide the dates(s) and location(s) of the study is applicable.

Note: There is no Background heading.

Nondiscriminatory Language Use of nondiscriminatory language is required in all DJPH submissions. The DJPH reserves the right to reject any submission found to be using sexist, racist, or heterosexist language, as well as unethical or defamatory statements.

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Delaware Academy of Medicine / DPHA 4765 Ogletown-Stanton Road Suite L10 Newark, DE 19713

www.delamed.org | www.djph.org Follow Us:

The Delaware Academy of Medicine is a private, nonprofit organization founded in 1930. Our mission is to enhance the well being of our community through medical education and the promotion ofpublic health. Our educational initiatives span the spectrum from consumer health education tocontinuing medical education conferences and symposia.

The Delaware Public Health Association was officially reborn at the 141st Annual Meeting of the American Public Health Association (AHPA) held in Boston, MA in November, 2013. At this meeting, affiliation of the DPHA was transferred to the Delaware Academy of Medicine officially on November 5, 2013 by action of the APHA Governing Council. The Delaware Academy of Medicine, who’s mission statement is “to promote the well-being of our community through education and the promotion of public health,” is honored to take on this responsibility in the First State.

ISSN 2639-6378