Pfizer + BioNTech receive FDA Advisory Committee vote supporting potential first emergency use authorization for vaccine (BNT162b2) to combat COVID-19 in the U.S.

Pfizer Inc. and BioNTech SE announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision. VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase III clinical study announced last month and published in The New England Journal of Medicine. The Phase III data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety. The FDA will take the advisory committee’s recommendation into consideration when it makes a final determination.