U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine

Pfizer

16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license application for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. 

The Prescription Drug User Fee Act goal date for a decision by the FDA is in January 2022.

Read Pfizer press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Dossier , COVID-19