FDA expected to convert Pfizer and BioNTech COVID-19 vaccine EUA to full approval within months

19 July 2021

The US Food and Drug Administration (FDA) has granted Priority Review designation for the Biologics License Application (BLA) for the BNT162b2 COVID-19 vaccine from Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX).

Approval for the full application would build on the emergency use authorization that was granted to the jab, now named Comirnaty in Europe, in December 2020.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision on whether the FDA will grant permanent approval is January 2022, although the agency is expected to approve Comirnaty in a matter of months.

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