FDA Deviated From Normal Process in Pfizer Vaccine Approval, Documents Show

The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

U.S. drug regulators acknowledged deviating from the normal vaccine approval process when dealing with Pfizer’s COVID-19 shot, according to newly disclosed documents.

Weeks after Pfizer and its partner BioNTech announced they started a rolling submission of documents for approval of their COVID-19 vaccine, a U.S. Food and Drug Administration official penned a memorandum authorizing the release of a Biologics License Application (BLA) number for the shot even as regulators weighed whether to approve the BLA, one of the documents shows.