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In a move Children’s Health Defense President Mary Holland called “head-spinning,” the U.S. Food and Drug Administration on Friday granted full approval of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine for adolescents 12 through 15 years old.
The U.S. Food and Drug Administration (FDA) on Friday granted full approval of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine for adolescents 12 through 15 years old.
In an FDA press release, the agency said full approval of Comirnaty follows a “rigorous analysis and evaluation of the safety and effectiveness data,” and the Pfizer-BioNTech vaccine “has been, and will continue to be authorized for emergency use in this age group since May 2021.”
Pfizer’s press release announcing the approval said the Comirnaty vaccine has been available under Emergency Use Authorization (EUA) since May 2021 for the adolescent age group.