Report: FDA set to authorize Pfizer vaccine for those as young as 12

Report: FDA set to authorize Pfizer vaccine for those as young as 12
© Getty Images

The Food and Drug Administration (FDA) is poised to authorize Pfizer and BioNTech's coronavirus vaccine for adolescents as young as age 12 by early next week, The New York Times reported Monday.

The highly anticipated decision would be a major step toward ensuring middle and high schools can operate for full in-person learning next fall — and would be a major boon to parents concerned about the safety of summer activities.

Pfizer's vaccine is currently authorized for teenagers aged 16 and older. The other two vaccines on the market in the U.S., from Moderna and Johnson & Johnson, are only authorized for adults.

ADVERTISEMENT

An FDA spokeswoman declined to comment, saying only that the review is ongoing. 

"We can assure the public that we are working to review this request as quickly and transparently as possible," Stephanie Caccomo said. 

The agency has been reviewing the amended application from Pfizer and BioNTech for nearly a month. 

The companies cited research from their clinical trial in late March that found the vaccine was effective in the younger population, and produced strong antibody responses.

Once the FDA issues its decision, the Centers for Disease Control and Prevention vaccine advisory committee will still likely need to meet to vote on the recommendation. 

The U.S. has fully vaccinated more than 100 million adults, but the pace has dropped off significantly, and officials are trying to change strategy to reach the rest of the population.