On Aug. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application 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 United States under Emergency Use Authorization since Dec. 11, 2020.