Tags: covid | vaccine | fda | full approval | pfizer | ages 12 to 15

FDA Grants Full Approval to Pfizer COVID Vaccine for Ages 12-15

close up of vial of Pfizer COVID-19 vaccine, held by a hand in blue gloves
(Dreamstime)

Friday, 08 July 2022 04:08 PM EDT

The U.S. Food and Drug Administration said on Friday it has granted full approval to Pfizer and BioNTech's COVID-19 vaccine for adolescents aged between 12 and 15 years.

The vaccine, sold under the brand name Comirnaty for adults, has been available under an emergency use authorization since May 2021 for the 12-15 age group. It will now be sold under the same brand name for adolescents as well.

The FDA said on Friday the full approval follows a rigorous analysis and evaluation of the safety and effectiveness data. The vaccine was approved for use in those aged 16 and older in August last year.

Roughly 67% of the total U.S. population has been fully vaccinated against COVID-19, according to federal data.

The FDA last month had asked vaccine manufacturers, including Pfizer and rival Moderna Inc, to change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus. 

© 2025 Thomson/Reuters. All rights reserved.


Health-News
The U.S. Food and Drug Administration said on Friday it has granted full approval to Pfizer and BioNTech's COVID-19 vaccine for adolescents aged between 12 and 15 years. The vaccine, sold under the brand name Comirnaty for adults, has been available under an emergency use...
covid, vaccine, fda, full approval, pfizer, ages 12 to 15
163
2022-08-08
Friday, 08 July 2022 04:08 PM
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