The Food and Drug Administration on Tuesday released an analysis of Pfizer and BioNTech’s COVID-19 vaccine in which it found the vaccine “met the prescribed success criteria” and showed “no specific safety concerns identified that would preclude issuance of” an emergency-use authorization.
On Thursday a group of independent experts will meet to review the two analyses, one from the FDA’s staff scientists and the other from the vaccine’s manufacturers, and to advise the agency whether to grant a EUA. If the panel recommends the approval, the FDA could formally grant the authorization of the vaccine as early as this weekend.
The FDA’s analysis highlighted a number of “known benefits” of the vaccine, including “reduction in the risk of confirmed severe COVID-19 any time after dose 1” and “reduction in the risk of confirmed COVID-19 occurring at least seven days after Dose 2.” Pfizer’s vaccine requires two doses for best results.
The company has reported its vaccine to be 95 percent effective at preventing symptomatic COVID-19. The U.K. began administering the vaccine on Tuesday.