FDA grants full approval to Pfizer-BioNTech COVID vaccine

Aug. 23, 2021

The U.S. FDA has granted full approval to the Pfizer-BioNTech COVID-19 vaccine for people age 16 and older — making it the first coronavirus vaccine approved by the FDA.

In the U.S., more than 92 million have already received the shot, which will now be marketed as Comirnaty.

The vaccine has been authorized for emergency use in the U.S. since mid-December for people age 16 and older. The authorization was later extended to those 12 and older. Back in May, Pfizer was the first drugmaker to submit its BLA for full approval. A month later, Moderna filed for full approval of its vaccine.

According to the FDA, Comirnaty's BLA builds on the extensive data previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.

Now with full approval for those 16 and up, the vaccine will continue to be available under emergency use authorization for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.