FDA Advisers Recommend Authorization of Pfizer COVID-19 Vaccine

An FDA advisory committee voted on Thursday that the potential benefits of the Pfizer and BioNTech COVID-19 vaccine outweigh its risks for people ages 16 years and up.

The committee voted 17 to 4, with one abstention, in favor of the mRNA vaccine known as BNT162b2. The FDA could act on this recommendation and issue its first emergency use authorization for a COVID-19 vaccine within days.

The FDA has asked the manufacturers to add potential anaphylactic reactions to its pharmacovigilance plan, which attempts to identify new safety risks. At least two people in the U.K. with a history of allergic reactions had reactions after receiving the vaccine.

Committee members noted the dearth of data on preventing severe COVID-19, on long-term safety outcomes, and on safety in pregnant women. The vote followed a discussion about whether to include 16- and 17-year-olds in the recommendation because there are little efficacy data in this group.

Results of the vaccine’s phase 3 study were published in the New England Journal of Medicine earlier on Thursday. Roughly 43,000 people ages 16 and older were randomized to receive two doses of either the BNT162b2 vaccine or placebo 21 days apart. The vaccine had an overall efficacy of 95% in preventing COVID-19 at least 7 days following the second dose. Protection began around 12 days after the first dose, with an efficacy of 52% between doses. This particular study did not examine whether vaccination prevented asymptomatic infection.

Roughly 16% of younger vaccine recipients and 11% of older recipients had a fever after the second dose.

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577