May 7, 2021 -- Pfizer and BioNTech announced on Friday that they have started a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their messenger RNA (mRNA) vaccine to prevent COVID-19 in individuals ages 16 years and older.
The vaccine is currently available in the U.S. under an emergency use authorization (EUA) granted by the FDA on December 11, 2020. The BLA is supported by analyses from phase III clinical results, where the vaccine's efficacy and safety were observed up to six months after the second dose.
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.
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