COVID-19 Vaccine

COVID-19 VACCINE DISTRIBUTION IN IOWA

The FDA issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020 and for the Moderna COVID-19 vaccine on December 18, 2020.1,2 However, planning for vaccine distribution in Iowa began long before December 2020. The Iowa Department of Public Health (IDPH) internal planning group began officially meeting in mid-August 2020 and reached out to partner organizations, including the Iowa Pharmacy Association and the Iowa Board of Pharmacy, in mid-September.3 IDPH communicated with partner organizations through weekly webinars and shared documents through the Iowa Health Alert Network (HAN).3 These communication strategies have remained throughout the vaccine rollout.

On December 2, 2020, the Advisory Committee on Immunization Practices (ACIP) released their recommendations for priority groups to receive vaccine. On December 4, IDPH announced that an Infectious Disease Advisory Council (IDAC) would be convened to provide clinical guidance for determining priority populations for vaccination in Iowa.3,4 Members of IDAC were intended to represent multiple perspectives with clinical and ethical expertise from across the state.3 Phase 1A in Iowa, as recommended by IDAC, aligned with ACIP recommendations to vaccinate healthcare personnel and residents of long-term care facilities.5 The first doses of Pfizer-BioNTech vaccine arrived at Iowa hospitals on December 14, and healthcare workers began receiving their first doses.6,7 David Conway, RN, an emergency room nurse at the University of Iowa Hospitals & Clinics, was the first Iowan to receive the vaccine.7 Long-term care residents began receiving their first doses of vaccine on December 28.8 Vaccinations of long-term care residents and staff in Iowa were provided through the Federal Long-Term Care Pharmacy Partnership Program using the Pfizer-BioNTech vaccine.9 The program assigned long-term care facilities to Walgreens, CVS, or Community Pharmacy to provide vaccinations to current staff and residents.9

IDPH has utilized a localized approach in working with local county public health agencies to directly allocate and distribute vaccine within each county. Each local county public health agency has autonomy to identify local partners for vaccine administration. To identify providers who wish to administer the COVID-19 vaccine, IDPH utilized a REDCap survey that was accompanied by the CDC’s COVID-19 Vaccination Program Provider Agreement.3 Vaccines providers had to be enrolled within the state’s immunization registry, which was a primary tool for capturing and reporting doses provided. Over 500 pharmacies in 96 of Iowa’s 99 counties are state-approved and able to administer COVID-19 vaccines.

On February 1, 2021, IDPH activated Phase 1B of vaccine distribution.11 Phase 1B will include individuals aged 65 years and older, and a tiered-approach for first responders, PreK-12 school staff and childcare workers, individuals living in congregate settings other than college dormitories, government officials, health and safety inspectors, and correctional facility staff.11 Since the number of eligible Iowans has exceeded the number of available vaccines, these populations were further divided into five tiers to accommodate continued short supply of vaccine.11

The vaccine rollout has brought criticism into the federal process as Iowa has received some of the smallest vaccine allocations in the nation.12 As the new Biden Administration announced plans to secure 200 million additional doses of vaccine, IDPH has reported that Iowa’s vaccine allocation would slowly begin to increase beginning in February.12 Given the increased population that will become eligible for vaccination in Phase 1B and anticipated increased vaccine supply, the Federal Retail Pharmacy Program is expected to be activated sooner than expected to improve vaccine distribution utilizing additional community pharmacy partners with direct allocation from the federal government.

IPA continues to work directly with IDPH and other key stakeholders across the state to ensure equitable and efficient distribution of the COVID-19 vaccine to all Iowans. Stay tuned to IPA communications for the latest information.

SOURCES:

1. Pfizer-BioNTech COVID-19 Vaccine. FDA. January 12, 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. 2. Moderna COVID-19 Vaccine. FDA. January 6, 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. 3. Iowa COVID-19 Vaccination Strategy Working Draft Version 2.0. Iowa Department of Public Health. December 4, 2020. https://idph.iowa.gov/Portals/1/userfiles/61/covid19/vaccine/V%202%20IOWA%20 COVID-19%20VACCINATION%20STRATEGY%2012_4_20_FINAL.pdf. 4. Infectious Disease Advisory Council (IDAC) COVID-19 Vaccine and Therapeutics Priority Distribution Framework. IDPH. December 4, 2020. https://idph.iowa.gov/Portals/1/userfiles/61/covid19/vaccine/ IDAC_Framework_Dec2020.pdf. 5. Vaccine Shortage Order. IDPH. December 14, 2020. https://idph.iowa.gov/Portals/1/userfiles/61/ covid19/vaccine/Vaccine%20Shortage%20Order%20Phase%201-A%20FIN.pdf. 6. COVID-19 vaccine arrives in Iowa, first doses administered. KCCI Des Moines. December 14, 2020. https://www.kcci.com/article/first-doses-of-pfizer-covid-19-vaccine-arrive-in-iowa/34962755. 7. Pfizer-BioNTech vaccine delivered to UI Hospitals & Clinics. UIHC. December 14, 2020. https://uihc. org/pfizer-biontech-vaccine-delivered-ui-hospitals-clinics. 8. Stein E. Vaccinations begin in long term care facilities in Iowa. KCRG Cedar Rapids. December 29, 2020. https://www.kcrg.com/2020/12/30/vaccinations-begin-in-long-term-care-facilities-in-iowa/. 9. COVID-19 Vaccine Update. Leading Age Iowa. https://www.leadingageiowa.org/lai-covid-19news---12-7-2020. 10. Iowa COVID-19 Vaccine Doses Administered Report. IDPH. January 25, 2021. https://idph.iowa. gov/Portals/1/userfiles/61/COVID19%20Vaccine%20Administration.pdf?utm_medium=email&utm_ source=govdelivery. 11. Phase 1-B Supplemental Vaccine Shortage Order. IDPH. January 21, 2021. https://idph.iowa.gov/ Portals/1/userfiles/61/covid19/vaccine/COVID%20Vaccine%20Shortage%20Order%20Phase%201-B%20 FINAL_1_21_21%20%281%29.pdf. 12. Price D. Iowa’s COVID-19 Vaccine Supply Will Increase Next Week, health Department Confirms. WHO13 Des Moines. January 26, 2021. https://who13.com/news/coronavirus/iowas-covid-19-vaccinesupply-will-increase-next-week-health-department-confirms/.

BE PREPARED FOR QUESTIONS:

HOW DOES THE MRNA VACCINE TECHNOLOGY WORK?

Two messenger RNA (mRNA) vaccines for COVID-19 have been granted emergency use authorization in the United States. These vaccines work by a novel mechanism, though mRNA technology has been studied for its potential application in healthcare for over thirty years. The first report of successful use of synthetic mRNA in mice was published in 1990.1 Instead of using a dead or weakened version of the virus to illicit an immune response, as traditional vaccines would, the mRNA vaccines instruct cells to produce a piece of the spike protein SARS-Cov-2 that enters cells to prompt the body to recognize that protein and produce antibodies to the virus.2 The mRNA vaccines are injected intramuscularly into the deltoid muscle on the upper arm. The mRNA is encapsulated in a layer of lipid nanoparticles to protect it from degradation as it makes its way to the lymph nodes near the injection site. Once in the lymph nodes, the mRNA enters the cytoplasm of dendritic cells and macrophages where it is transcribed to produce spike proteins. The dendritic cells and macrophages then break down the mRNA and display the spike proteins on their cell surfaces to activate T-cells and initiate antibody production. The mRNA never enters the cell’s nucleus and does not affect the patient’s DNA. It is also important to note that the vaccines do not provide instructions for the body to produce the full virus, and it is not possible to become infected from COVID-19 through the mRNA vaccines.2

Exogenous mRNA tends to cause a significant immune response, which leads to efficacy in providing protection from the virus but may also lead to adverse effects. Both the mRNA-1273 SARS-CoV-2 vaccine, produced by Moderna, and the BNT162b2 mRNA Covid-19 Vaccine, produced by Pfizer and BioNTech, reported high rates of efficacy in their phase 3 trials at 94.1% and 95%, respectively.3,4 In Moderna’s trial, no severe COVID-19 infections were reported in the vaccine group, compared to 30 severe infections including one fatality in the placebo group.3 Pfizer reported one severe COVID-19 infection in the vaccine group and nine in the placebo group following the first dose of vaccine.4 This data indicates that both vaccines are effective in preventing mild and/or symptomatic COVID-19 infections.

Trials for both vaccines reported local and systemic adverse effects. Injection site pain was the most common local adverse effect reported in both trials, though redness and swelling were also reported.3,4 The pain was typically reported as mild to moderate in intensity. Data from Moderna’s trial shows an incidence rate of >80% for injection site pain and patients reported that the pain resolved over 2-3 days.3 Pfizer’s trial found an incidence rate of >70% for injection site pain, and patients reported that pain resolved within 1-2 days.4 Headache and fatigue were the most common systemic adverse effects caused by both vaccines, though these effects were reported by a slightly higher percentage of the patients in the Moderna trial than the Pfizer trial.3,4 In both trials, systemic adverse effects were more pronounced after the second dose than after the first dose of vaccine and were more commonly reported by younger patients than older patients.3,4 In the Moderna trial, the incidence of patients in the vaccine group reporting headache was 32.7% after the first dose and 58.6% after the second dose. 37.2% of patients receiving Moderna vaccine reported fatigue after the first dose, and 65.3% reported fatigue after the second dose.3 34-47% of patients receiving the Pfizer vaccine reported fatigue after the first dose, and 51-59% reported fatigue after the second dose.4 25-42% experienced headache after the first dose, compared to 39-52% after the second dose.4 Muscle and joint pain, chills, and gastrointestinal effects were also reported to a lesser extent with both vaccines.3,4

Despite these adverse effects, the Food and Drug Administration (FDA) considers both vaccines to be safe and effective based on the available data. Both have been granted emergency use authorization and are being administered across the country. While they are both intramuscular injections, there are a few important differences in storage, stability, and administration. Pfizer’s vaccine requires ultracold storage at -80 to -60°C and must be diluted before use.4,5 It is only stable for five days in the refrigerator and must be used within six hours once brought to room temperature.5 Patients aged 16 years and older receive two doses of 0.3 mL 21 days apart.4 The Moderna vaccine remains stable at higher temperatures than the Pfizer vaccine for greater lengths of time.6 For longer periods of storage, it should be kept in a freezer between -25 and -15°C, but it may be stored in the refrigerator for up to 30 days.6 Patients aged 18 years and older receive two doses of 0.5 mL 28 days apart.3 The widespread use of these two vaccines is the result of significant progress in the evolution of mRNA vaccine technology. Though the vaccines present some challenges, they are highly effective in preventing symptomatic COVID-19 infections.

SOURCES:

1. Pardi N, Hogan MJ, Porter FW, Weissman D. mRNA Vaccines – A New Era in Vacinology. Nature Reviews. Drug Discovery. 2018; 17(4): 261. 2. Understanding and Explaining mRNA COVID-19 Vaccines. Centers for Disease Control and Prevention. Last reviewed November 24, 2020. https://www.cdc.gov/vaccines/covid-19/hcp/mrna-vaccine-basics.html. 3. Baden LR, El Sahly HM, Essink B, Kotloff K, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. NEJM. 2020. DOI: 10.1056/NEJMoa2035389. 4. Polack FP, Thomas SJ, Kitchin N, Absalon J, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. NEJM. 2020; 383: 2603-2615. 5. Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary. Centers for Disease Control and Prevention. December 22, 2020. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/ downloads/storage-summary.pdf. 6. Moderna COVID-19 Vaccine Storage and Handling Summary. Centers for Disease Control and Prevention. December 20, 2020. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/ downloads/storage-summary.pdf.

Both Written By: Maureen Martin, PharmD Candidate Class of 2021, University of Iowa College of Pharmacy