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.
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.
Yet, Comirnaty is not available in the U.S for any age group and is not the same formula as the Pfizer-BioNTech vaccine currently authorized under EUA and being distributed as a “fully approved” vaccine.
“The approval of Comirnaty for adolescents 12 to 15 is head-spinning,” said Mary Holland, president and general counsel for Children’s Health Defense.
“The FDA failed to convene an expert committee and failed to appropriately weigh the risk-benefit profile of this vaccine for this age group. Even Vaccine cheerleader Dr. Paul Offit acknowledged FDA decisions are being made based on political pressure, not science when, in commenting on the agency’s vote last week to allow reformulated booster shots, he said it felt like ‘the fix was in.’”