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FDA Advisory Committee Recommends Approval of EUA for Pfizer-BioNTech COVID-19 Vaccine

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December 10, 2020

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine candidate, the first to be considered in the U.S. and following earlier approval in the United Kingdom and Canada. The proposed use “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older” was supported by a vote of 17-4, with one panel member abstaining. The panel's vote was based on the question of whether the benefits of the Pfizer-BioNTech COVID-19 vaccine candidate outweigh its risks for use in individuals 16 years of age and older. VRBPAC’s recommendation will now be taken up by the FDA. ASHP anticipates that the agency will issue a formal EUA shortly.

VRBPAC is a panel comprised of experts outside of the FDA charged with evaluating the safety, effectiveness, and appropriate use of vaccines and related biological products. In addition, panel members provide input on the quality and relevance of FDA’s research program for regulatory purposes. Over the course of the day, the panel discussed, among many topics, conditions for continuing blinded, placebo-controlled clinical trials, pursuing a biologic license application in the near future, addressing gaps in information for further evaluation of vaccine safety and effectiveness, and evaluating the safety in special populations such as those pregnant and lactating, pediatrics (under the age of 16), and those with a history of severe allergic reactions.

Vaccine shipment is expected to begin immediately. McKesson has already begun to mail out the supplies necessary to provide the vaccine. State and local organizations will make their own determinations about allocation based on the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommendations. ASHP has been advocating that all frontline healthcare workers, including pharmacists and pharmacy technicians, be considered for early administration of COVID-19 vaccine. We encourage members to alert ASHP immediately regarding any concerns related to their state’s allocation or tiering (e.g., who has priority for the vaccine) decisions.

ASHP’s principles for COVID-19 vaccine distribution, allocation, and mass immunization emphasize the need for a transparent and rigorous process for vaccine development, approval, and post-marketing surveillance. Although VRBPAC’s vote represents an important step toward advancing this critical countermeasure to the COVID-19 global pandemic, we will continue to call for robust research practices and comprehensive continued research and surveillance.

Because the Pfizer vaccine introduces new variables into traditional vaccine distribution, storage and handling, preparation, and administration that may raise questions, ASHP is offering a webinar on Thursday, Dec. 17 at 2 p.m. ET with Pfizer personnel. There will be no CE credits offered for the webinar.

We also encourage you to join us on Wednesday, Dec. 16 at 3 p.m. ET for the webinar, Authorization of First COVID-19 Vaccine: Details of the EUA. The webinar will discuss information needed for licensure, the makeup of the vaccine, distribution campaign, and standards for mass immunization programs.