Pfizer and BioNTech’s Vaccine BLA Secures FDA Priority Review

July 21, 2021

The FDA has granted priority review designation to Pfizer’s and BioNTech’s Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in people 16 years of older.

An approved BLA would replace the existing Emergency Use Authorization and allow the companies to advertise and market the vaccine directly to the public. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

The FDA gives a priority review designation to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. The agency’s goal for completing a priority review is six months, while the goal for standard reviews of new drugs is 10 months.

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