COVID VACCINE 101

COVID-19 VACCINE ADMINISTRATION 101

By GREGG S. POTTER, Ph.D., B.S. Pharm., R.Ph., MPA Professional Affairs Committee; professor of pharmacology, Ferris State University College of Pharmacy; pharmacist, Rowe Pharmacy Care Clinic Healthcare providers’ success in controlling the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections significantly improved with the emergency use authorization (EUA) of the first COVID-19 vaccine in the United States on Dec. 20, 2020.1 Since then, due to the gravity of the public health emergency and the novelty of the vaccines, COVID-19 vaccinators are expected to keep informed of all aspects concerning vaccine administration and potential adverse effects.

Increased Vaccinator Demand

With the increased demand for vaccinations, there has developed an increased demand for vaccinators. In many practice settings across the country, pharmacists and pharmacy technicians have significantly shifted their roles to primarily being involved with the handling, preparation and administration of the COVID-19 vaccines. Additional responsibilities have included being prepared to respond to the vaccine recipients’ questions and concerns before and after vaccination. Due to the rapidly changing nature of the COVID-19 pandemic, different strategies are often required to maintain clinical preventative services. Beyond the initial training that was attained by each vaccine provider, there is an evolving need for updated information and training as healthcare professionals learn more about COVID-19 and the vaccines used to improve the fight against the disease. Vaccine providers within pharmacy can help to improve the vaccination process by contributing to the reporting systems established by the U.S. Department of Health and Human Services (HHS).2 Reporting systems, both required and voluntary, are in place to track the occurrence of adverse effects associated with the use of each of the authorized COVID-19 vaccines.2 Likewise, when errors in administration occur, vaccine providers are able to report the events to the Centers for Disease Control and Prevention (CDC).2 Reporting of adverse effects educates vaccinators, thereby providing more effective counseling tools for patients. Reporting of vaccine administration errors leads to the development of strategies to prevent future occurrences by healthcare providers.2

The COVID-19 vaccines are reactogenic, meaning they will cause some adverse effects in most people that receive them. Because of this, vaccinators should counsel patients about possible local and systemic adverse effects that can occur in the first one to two days following vaccine administration. Table 1 lists the most common adverse effects reported to the CDC, based on clinical trials from the EUAs.3,4,5 The patient should be reassured that these adverse effects are normal signs that the body is building protection against SARS-CoV-2.6 COVID-19 EUA Fact Sheets provide specific information on each of the COVID-19 vaccines.7,8,9 These are to be given to each patient who receives a COVID-19 vaccine. The fact sheets can provide more detail of the potential adverse effects that occur with each approved vaccine. Severe adverse effects such as anaphylaxis have been documented with the COVID-19 vaccines but occur much less frequently.10 For more Table 1: Most Common Adverse Effects from COVID-19 vaccines

Adverse Effect

Janssen % (Johnson and Johnson) Moderna %

PfizerBioNTech %

Pain at injection site 48.6 92 84.1 Fatigue 38.2 70 62.9 Headache 38.9 64.7 55.1

Muscle pain 33.2 61.5 38.3 Chills/fever 12.8 45.4 31.9

detailed instructions on what to do for COVID-19 anaphylaxis prevention and treatment, refer to www.cdc.gov/vaccines/covid-19/clinicalconsiderations/managing-anaphylaxis.html.

Table 2: Common Vaccination Errors (> 10%) received by CDC December 14, 2020 to February 28, 2021

Error Type Example % of Topics received

Lower-than authorized dose administered

Administered to younger than authorized age Administered by incorrect route Dose leaked out of syringe, arm Aged < 16 year (Pfizer-BioNTech) or < 18 years (Moderna) Subcutaneous 35.2%

18.5%

12.3%

Administered at incorrect anatomic site Into shoulder bursa, into gluteal muscle of buttock 10.2%

12.8 45.4

Due to the rapidly changing nature of the COVID-19 pandemic, different strategies are often required to maintain clinical preventative services.

COVID-19 Vaccination Errors

Proper administration techniques are necessary to achieve the greatest degree of COVID-19 vaccination effectiveness. Pharmacy vaccinators are required to participate in general vaccination training prior to delivering COVID-19 vaccines. Many organizations, including the Michigan Pharmacists Association (MPA) (www.MichiganPharmacists.org/ immunization) and the American Pharmacists Association (APhA) (www.pharmacist.com/Education/Certificate-Training-Programs/ Immunization) have training courses designed for attendees to receive vaccination administration certification. Due to the complexities of SARS-CoV-2, organizations such as the CDC and the Immunization Action Coalition (IAC) (www.immunize.org) provide healthcare professionals with up-to-date information and guidance regarding best practices with the COVID-19 vaccines as new information becomes available.11 During the first months of the COVID-19 vaccine use, a variety of errors in vaccine administration were reported to the CDC.12 Table 2 provides a partial listing of the frequency of the more than 400 vaccination errors reported.12 The CDC provides clinical guidance on how to handle vaccination administration errors. This information can be found at www.cdc.gov/vaccines/covid-19/onfo-by-product/clinicalconsiderations.html#Appendix-A.

Assessing Safety of COVID-19 Vaccines

this purpose, including the Vaccine Adverse Event Reporting System (VAERS) and the after-Vaccination Health Checker (V-Safe). In addition, the National Healthcare Safety Network has a monitoring system for healthcare providers and long-term care facility residents. VAERS is an online surveillance system in which vaccine providers and patients can report adverse events. Vaccine providers are required to report all COVID-19 vaccine administration errors to VAERS, whether or not the error was associated with an adverse event. Additionally, serious adverse effects (i.e. death, life-threatening adverse effects, cases that result in hospitalization, significant incapacity) and cases of multisystem inflammatory syndrome must be reported. Vaccine providers or patients can report the occurrence of adverse effects at vaers.hhs.gov/index. V-safe is primarily a smartphone-based reporting system set up to aid patients in informing the CDC if any adverse effects have occurred following COVID-19 vaccination. Patients can submit reports at vsafe. cdc.gov. After registering and entering data, vaccination information via email updates can be provided to the patient along with direct calls from the CDC depending on responses to web-based surveys. These national vaccine reporting systems help the CDC and the U.S. Food and Drug Administration (FDA) monitor adverse events reported by healthcare providers or the general public throughout the vaccination experience and are intended to lead to improvements in the vaccination process.