FDA Grants Priority Review to Pfizer-BioNTech Vaccine BLA

July 19, 2021

The Food and Drug Administration granted priority review to the biologics license application (BLA) for the Pfizer-BioNTech mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older, the companies announced July 16. FDA has authorized the vaccine for emergency use to prevent COVID-19 in individuals ages 12 and older. 

The Prescription Drug User Fee Act (PDUFA) goal date for the agency’s decision is January 2022. However, FDA stated that the goal date does not mean approval will not happen before that time. “Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA goal date,” FDA said in its recent statement