Pfizer applies for full FDA approval of its COVID-19 vaccine
Pfizer and BioNTech announced this morning that they have applied for full approval with the U.S. Food and Drug Administration for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
The companies initiated a Biologics License Application (BLA) with the FDA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to 6 months after the second dose.
The Pfizer-BioNTech COVID-19 vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on Dec. 11, 2020.
The companies also submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age. They intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data 6 months after the second vaccine dose is available.