Pfizer and BioNTech seek full vaccine approval for those ages 12-15

Pfizer and BioNTech announced on Thursday evening that they had submitted an application to the Food and Drug Administration (FDA) seeking full approval for the administration of their two-dose COVID-19 vaccine in children aged between 12 and 15.

The companies said in a release that their application included follow-up data from their Phase 3 clinical trial, which showed that two doses of the vaccine were 100 percent effective against COVID-19 among 12 to 15-year-olds. 

The Phase 3 clinical trial observed 2,228 participants. All 30 symptomatic cases of the coronavirus that were observed in the trial were found among the placebo group.

Pfizer and BioNTech also intend on filing this data with international regulatory authorities, including the European Medicines Agency, the companies said.

In May, the FDA granted Pfizer’s and BioNTech’s vaccine emergency use authorization for those between 12 and 15. The Pfizer vaccine, marketed as Comirnaty, is currently approved for use in all U.S. residents ages 5 and up.

The FDA granted full approval to the vaccine in August for recipients aged 16 and up, making it the first and only COVID-19 vaccine to gain complete authorization in the U.S.

Acting FDA Commissioner Janet Woodcock said at the time that granting full authorization to the Pfizer vaccine meant that “the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

The Pfizer vaccine is the most widely administered COVID-19 shot in the U.S., according to the Centers for Disease Control and Prevention (CDC), with over 285 million doses administered so far.