An advisory committee to the U.S. Food and Drug Administration (FDA) voted late on Thursday to recommend that emergency use authorization (EUA) be given to Pfizer's (PFE 0.12%) and BioNTech's (BNTX 2.42%) COVID-19 vaccine BNT162b2. The FDA doesn't have to go along with the committee's recommendation but is widely expected to do so after both Canada and the U.K. authorized emergency use of the vaccine.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) consists of independent industry vaccine experts. The members of the committee spent hours on Thursday discussing Pfizer's and BioNTech's EUA filing for BNT162b2. In particular, the committee focused on the vaccine's safety profile.
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Ultimately, it all came down to one question presented to the members of the VRBPAC committee. They were asked, "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older?" And the committee voted 17 to four with one abstention that the answer to that question was "yes."
The positive vote wasn't surprising. Earlier this week, the FDA released briefing documents for the advisory committee to review that appeared to be in favor of the efficacy and safety profile of BNT162b2. These documents revealed that Pfizer's and BioNTech's vaccine achieved 52.4% efficacy after the first dose.
Now, the ball is in the FDA's court. Alex Azar, the Secretary of the Department of Health and Human Services has publicly stated that the agency will make its decision "within days" after the advisory committee's recommendation. The world is staying tuned.
