The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee has voted in favor of granting Emergency Use Authorization (EUA) to Pfizer and BioNTech’s mRNA-based vaccine BNT162b2 for the prevention of coronavirus disease 2019 (COVID-19).
The EUA recommendation was based on data from an ongoing phase 3 double-blind, placebo-controlled study in approximately 44,000 participants. Final efficacy data, which was recently published in The New England Journal of Medicine and included 36,523 participants, showed that the vaccine was 95% effective (P <.0001) in people without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as well as in those with or without evidence of infection before vaccination, based on the breakdown of cases in the BNT162b2 (n=8) and placebo arms (n=162). The data also included 10 severe cases, 9 of which occurred among participants in the placebo group.
Additionally, subgroup analysis revealed consistent efficacy across age, gender, race and ethnicity demographics. Among participants over 65 years of age, vaccine efficacy was observed to be over 94%.
As for safety, the vaccine was found to be well tolerated, with no serious adverse events reported. Fatigue and headache were noted to be the only grade 3 solicited adverse events greater than or equal to 2% in frequency. Conclusions as to the safety of the vaccine in subpopulations such as children under 16 years of age, pregnant or lactating women, and immunocompromised individuals could not be made due to insufficient data.
Based on these findings, the panel voted 17 yes, 4 no, with 1 abstention on whether the totality of the available scientific evidence supports the effectiveness of the vaccine in preventing COVID-19 in individuals 16 years of age and older. The committee decided that the potential benefits of the vaccine outweigh its known and potential risks for this patient population. Four committee members voted against authorizing the vaccine over concerns about including 16- and 17-year olds due to limited safety data.
In meeting documents, it was noted that more data will be needed to determine the duration of protection, the effectiveness of the vaccine in certain populations at high risk of severe disease (ie, those with HIV/AIDS), as well as in those with prior SARS-CoV-2 infection. Additionally, no data are available on the efficacy of the vaccine in children 15 years of age and younger. Vaccine effectiveness against asymptomatic infection, long-term effects of COVID-19 disease, mortality, and transmission also remain unclear at this time.
Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval. In a press statement, the FDA has informed the sponsor that the agency will rapidly work toward finalization and issuance of an Emergency Use Authorization.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic.”
The BNT162b2 (30μg) vaccine is administered intramuscularly as a 2-dose series spaced 21 days apart. The preservative-free product is supplied as a multi-dose vial that contains 5 doses; the frozen suspension requires thawing and diluting prior to administration and must be used within 6 hours of dilution.
1. Pfizer and BioNTech receive FDA advisory committee vote supporting potential first emergency use authorization for vaccine to combat COVID-19 in the U.S. [press release]. New York, NY & Mainz, Germany; Pfizer, Inc and BioNTech SE; December 10, 2020.
2. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. Published online December 10, 2020. doi: 10.1056/NEJMoa2034577.