Pfizer and partner BioNTech's COVID-19 vaccine meets expectations on agency guidance and is enough to spur an agency review, according to staff of the U.S. Food and Drug Administration.
The finding is one of several significant new results featured in the briefing materials, which span 53 pages of data analyses from the agency and from Pfizer.
On Thursday, F.D.A.'s vaccine advisory panel will discuss these materials in advance of a vote on whether to recommend authorization.
On the bright side, efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine was 95.0%.
the study sponsors "provided adequate information to ensure the vaccine's quality and consistency for authorization of the product under an EUA" agency reviewers said in briefing documents ahead of a Thursday panel.
Additionally, the study confirms that the vaccine worked well regardless of a volunteer's race, weight or age.