Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine

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Pfizer and BioNTech SE today announced the initiation of Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent Covid-19 in individuals, years of age and older.

Data to support the BLA will be submitted by the Companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The Pfizer-BioNTech COVID-19 vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the Companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. 

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

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