A 53-page review published as a Food & Drug Administration briefing document today confirms that the vaccine from Pfizer (PFE) and BioNTech (BNTX) meets the agency’s standards for emergency use authorization. The briefing document is the result of two weeks of study of the Pfizer/BioNTech data by scientists at the FDA and confirms the companies’ own data showing that the vaccine was 95% effective in preventing Covid-19. The document says two months of follow-up on 38,000 participants in the trial provide evidence of “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].”
On Thursday, a group of advisers to the FDA will meet for a full-day public meeting to discuss the data and make recommendations on whether the vaccine merits authorization for immediate use. A decision, informed but not dictated by that meeting, is expected from the FDA within days of the meeting. The first doses are expected to be shipped immediately after FDA approval with a target of 6.4 million doses distributed in the first week.
Shares of Pfizer closed up 3.18% today.