FDA Advisory Committee Recommends Approval of Pfizer COVID-19 Vaccine
The US Food and Drug Administration advisory committee has voted 17 to 4 in favor of recommending the authorization the Pfizer/BioNTech COVID-19 mRNA vaccine (BNT162b2), saying that the potential benefits outweigh the risks for individuals aged 16 years and older.1
The recommendation was based upon data including the results of a Phase 3 clinical study that found a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection. The efficacy of the vaccine was found to be consistent across all demographics.
The randomized, observer-blinded trial, which is still ongoing, has involved over 44,000 participants, most of whom have received two doses of the vaccine.
The recommendation comes a day after the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning to individuals with a history of serious allergic reactions to medicines or food, prompted by serious anaphylactic reactions observed in two NHS staff members who received the vaccine during the country’s mass vaccination rollout. Both patients had significant histories of allergic reactions and carried auto-injectors.2
—Michael Potts
References:
- Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S. News release. Pfizer. December 10, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-fda-advisory-committee-vote
- UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions. News release. Reuters. December 9, 2020. https://www.reuters.com/article/health-coronavirus-britain-vaccine/uk-issues-anaphylaxis-warning-on-pfizer-vaccine-after-adverse-reactions-idUSKBN28J1DK