FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Children Ages 12–15

• The FDA has approved a COVID-19 vaccine for younger adolescents.
• Until now, the Pfizer-BioNTech vaccine had only been approved for people over age 16.
• The FDA is also studying how the vaccine works for children as young as 6 months old.

The Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech COVID-19 vaccine for children and teens between 12 and 15 years old.

“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,” said acting FDA Commissioner Janet Woodcock, MD, in a statement. “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.”

In early April, Pfizer and BioNTech requested an amendment of the existing emergency use authorization (EUA) to expand use of the vaccine to this younger age group.

The companies reported at the end of March that a phase 3 clinical trial involving 2,260 12- to 15-year-olds showed that the vaccine had an efficacy of 100 percent in this age group. It was also well tolerated.

Adolescents who received the vaccine produced strong antibody responses, similar to what was seen in earlier trials among people 16 to 25.

“This is welcome news,” Dr. Christina Johns, senior medical adviser for PM Pediatrics, said last week when the news was leaked that the vaccine would likely be authorized. “Children, especially the 12- to 15-year-old group, are important to keep in mind, in terms of being at risk for not only getting, but also spreading, COVID-19 infection.”

The initial EUA for the vaccine was granted in December 2020 after a public meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Because the new request involves an amendment to an existing EUA, another meeting of the agency’s vaccine advisory committee isn’t expected.

After the FDA amends the EUA, the vaccine advisory committee of the Centers for Disease Control and Prevention will meet to decide whether to recommend use of the vaccine in 12- to 15-year-olds.

This meeting is likely to happen soon after the FDA’s decision.

Pfizer’s pediatric study is currently enrolling children 6 months to 11 years old. Moderna has an adolescent trial in progress and is recruiting children 6 months to 11 years old for another study.