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FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY

Grants first full approval for COVID vaccine.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer and BioNTech announced that the U.S. FDA approved the Biologics License Application (BLA) for COMIRNATY (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.   The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 vaccine). The EUA permitted essential rollout of vaccine doses across the U.S. to hel...

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