The FDA is not required to follow the committee's advice, but it is expected to do so.
A panel of outside experts voted to recommend coronavirus disease 2019 (COVID-19) vaccine candidate BNT162b2 for widespread emergency use in the US, according to the FDA Advisory Committee meeting held on Thursday.1 The decision moves the Pfizer/BioNtech vaccine one step closer to receiving EUA from the FDA.
The FDA is not required to follow the committee’s advice, but it is expected to do so.
The FDA’s Vaccines and Related Biological Products Advisory Committee, which is composed of independent scientific and public health experts from around the US, met to discuss the request for EUA of the vaccine from Pfizer and BioNTech. The advisory panel voted 17 to 4, with 1 member abstaining, in favor of emergency authorization for individuals aged 16 years and older.1
Data from the phase 3 trial of BNT162b2 were also published today in the New England Journal of Medicine. Results from the 43,448 participants, half of whom received the vaccine candidate, showed that the vaccine was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Additionally, partial protection appeared to begin as early as 12 days after the first dose. These data were submitted to the FDA to support the request for EUA.2
BNT162b2 has already been authorized for emergency use in several countries, including the United Kingdom, Bahrain, and Canada.
1. US Food and Drug Administration YouTube page. Vaccines and Related Biological Products Advisory Committee – 12/10/2020. Accessed December 10, 2020. https://www.youtube.com/watch?v=owveMJBTc2I&%3Bfeature=emb_title
2. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine. December 10, 2020. Doi: 10.1056/NEJMoa2034577