FDA Announces Approval of Pfizer-BioNTech COVID-19 Vaccine

The Food and Drug Administration (FDA) today announced its full approval for the Pfizer-BioNTech COVID-19 vaccine — under the name Comirnaty — for individuals 16 and older, making it the first COVID-19 vaccine to go beyond emergency use authorization (EUA) in the U.S. 

The vaccine also continues to be available under EUA, including for individuals 12 through 15 and for the administration of a third dose in certain immunocompromised individuals. Additional details are available via FDA frequently asked questions and fact sheets.  

CHA is reviewing the FDA approval and will update members on any impacts on the California Department of Public Health (CDPH) health orders or guidance.