U.S. gives full approval to Pfizer-BioNTech COVID vaccine

SILVER SPRING, MARYLAND – The U.S. Food and Drug Administration (FDA) has given its full approval to the Pfizer-BioNTech COVID-19 vaccine.

The agency says people can be “very confident” that the drug meets its high standards for effectiveness, safety and manufacturing quality. Over 200-million Pfizer doses have already been administered in the United States, as well as hundreds of millions more across the world, since emergency use of the drug started in December.

The FDA says the vaccine will now be marketed as Comirnaty, for the prevention of COVID-19 in people aged 16 years and older.

Additionally, the vaccine continues to be available under emergency use authorization, including for individuals aged 12 through 15, and for the administration of a third dose in certain immunocompromised people.