COVID-19 Vaccine: Updates and Role of Pharmacists

Abstract

The 2019 novel coronavirus (SARS-COV-2 or 2019-nCoV) and coronavirus disease-2019 (COVID-19) pandemic is a global health crisis. As of December 31, 2020, there are over 83.5 million cases and 1.8 million deaths globally(1) and 2.2 million cases and 25,300 deaths in California.(2) The addition of a vaccine to prevent COVID-19 is an essential addition to the public health and safety toolkit alongside recommendations for physical distancing, hand hygiene, masks and face coverings, testing, tracing, quarantining or isolation, and therapeutics. There are currently two vaccines that have received emergency use authorization (EUA) in the United States to prevent COVID-19: the Pfizer-BioNTech mRNA COVID-19(3) and Moderna mRNA COVID-19 vaccines.(4) In the first 3 weeks since its authorization, the U.S. has distributed over 12.4 million and 2.7 million first doses had been administered.(5)The Pfizer-BioNTech (BNT162b2) vaccine, authorized on December 11, 2020, was reviewed and authorized or recommended by the US Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC)(6), and the Western States Scientific Safety Review Workgroup(7) for the prevention of COVID-19 in individuals 16 years and older. The Phase 3 trial for the BNT162b2 included 43,548 participants from the US, Argentina, Brazil, and South Africa.(8) BNT162b2 was found to be 95% effective in preventing COVID-19 with similar vaccine efficacy observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. The incidence of serious adverse events was low and the safety profile was characterized by local and systemic reactions. Following two reports of anaphylaxis in the United Kingdom, the CDC identified six cases after 272,001 doses were administered in the U.S. and continues to monitor through its surveillance programs.(9) See Table 1 for summary of vaccine characteristics, inducing information on dosing, storage, preparation, and administration.The Moderna (mRNA-1273) vaccine, authorized on December 18, 2020, was reviewed and authorized or recommended by the FDA, CDC(10), and the Western States Scientific Safety Review Workgroup(11) for the prevention of COVID-19 in individuals 18 years and older. The Phase 3 trial for the mRNA-1273 included 30,420 participants from the US.(12) The interim efficacy analysis of BNT162b2 demonstrated vaccine efficacy of 94.5% in preventing symptomatic COVID-19 with similar vaccine efficacy observed across subgroups defined by age, sex, race, ethnicity, and occupational risk factors. The incidence of serious adverse events was low and the safety profile was characterized by local and systemic reactions. See Table 1 for summary of vaccine characteristics, inducing information on dosing, storage, preparation, and administration.See Table 2 for list of clinical resources for both vaccines, including FDA fact sheets, CDC recommendations, and manufacturer resources.Vaccine distribution and allocation is largely being overseen at the federal level with subsequent delegated responsibility to the state, local, and provider level. Both the CDC(13,14,15) and the California Department of Public Health (CDPH)(16) have established guidelines for the phased distribution of COVID-19 vaccine to prioritized groups. The CDC and CDPH have identified populations for Phase 1A, 1B, and 1C while the remaining phases are still to be determined. See Table 3 for the list of phases and tiers of prioritized and sub-prioritized groups.The current phase and tier of allocation may vary on the local level. Generally, most California counties are currently in Phase 1A, tier 1 or 2.Pharmacists are playing a major role in the implementation and distribution of the COVID-19 vaccine. Pharmacists can order and administer the COVID-19 vaccine and intern pharmacists and pharmacy technicians can administer the COVID-19 vaccine.(17,18,19) Pharmacies can receive vaccine allocation through three methods: participation in the Federal Pharmacy Partnership for Long-Term Care (LTC) Program(20,21), participation in Federal Retail Pharmacy Partnership(22,23), or invitation from the local health department (LHD). For more information about provider enrollment through the local jurisdictions, visit the COVIDReadi Platform(24) and contact your LHD.(25)The current status of each program may vary on the local level. Generally, the federal LTC program has been activated and the federal retail and invitations to pharmacies from LHD have not yet been activated in California.The distribution and allocation of the COVID-19 vaccine are still in its initial stages. Ass vaccine supply increases, the remainder of the plans will be activated and pharmacies, pharmacists, pharmacy technicians, and intern pharmacists will play a crucial role in ensuring quick and equitable access to nearly 40 million Californians across all 58 counties.