Pfizer and BioNTech initiate FDA rolling BLA submission for their COVID-19 vaccine

US pharma giant Pfizer (NYSE: PFE) and German partner BioNTech (Nasdaq: BNTX) have announced the initiation of a Biologics License Application (BLA) with the US Food and Drug Administration for approval of their mRNA vaccine to prevent COVID-19 – called Comirnaty or BNT162b2 - 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.

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 six months after the second vaccine dose are available.