Pfizer, BioNTech start licence application for FDA approval of COVID-19 vaccine

May 7, 2021

Pfizer Inc. and BioNTech SE announced the initiation of a 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 16 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 Dec. 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.

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age. The Companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data 6 months after the second vaccine dose are available.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the FDA but has been authorized for emergency use by FDA under an EUA to prevent COVID-19 for use in individuals 16 years of age and older.

BioNTech has the release.

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