FDA approves Pfizer-BioNTech COVID vaccine for 12- to 15-year-olds

The FDA has authorized the COVID-19 vaccine from Pfizer and BioNTech for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer claimed to have demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine was also reportedly has favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” wrote Acting FDA Commissioner Janet Woodcock, MD, in prepared remarks. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

An advisory committee of the Centers for Disease Control and Prevention (CDC) plans to convene a meeting in the near future to provide recommendations for the vaccine’s use in 12- to 15-year-olds.

Assuming the CDC recommends the use of the vaccine for younger adolescents, distribution of the vaccine to 12- to 15-year-olds could follow swiftly.

CDC has tracked roughly 1.5 million COVID-19 cases in individuals aged 11 to 17 from March 1, 2020 to April 30, 2021.

Pfizer is currently testing the vaccine in children aged two to 11.

Moderna is currently conducting vaccine testing in 12- to 17-year-olds. Moderna recently announced that its vaccine was 96% effective in participants aged 12 to 17 in a Phase 2/3 trial.

The company is conducting a separate trial involving children from six months to 12 years of age.