Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Friday that they have initiated the Biologics License Application (BLA) process 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.
The companies initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine. The 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 BLA approval will be based on the pivotal Phase 3 trial and longer-term follow-up data.
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.
Pfizer and BioNTech also have submitted an application to expand the current Emergency Use Authorization (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 later.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an 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.
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 Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
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