FDA authorizes Moderna, Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age

Today, the US Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine to include use in children aged 6 months and above.

This announcement comes days after the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend emergency use authorization (EUA) of the Pfizer-BioNTech vaccine for children aged 6 months to 4 years and recommended to split the vote on 2 age groups of the Moderna vaccine due to dosing differences.

With the FDA authorization, the Moderna vaccine EUA is now amended to include use in individuals aged 6 months through 17 years. Before this amendment, the vaccine had only been authorized for use in adults 18-years and older.

The Pfizer-BioNTech vaccine will now include indication for individuals aged 6 months through 4 years. The vaccine had previously only been authorized for those aged 5 and older.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” said FDA commissioner Robert M. Califf, MD, in the press release announcing the decision. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death. Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

Key points the FDA evaluated before its authorization of the 2 vaccines included rigorous and comprehensive analysis of safety, effectiveness, and manufacturing data. The administration also concluded that the known and potential benefits of both vaccines outweigh the risks in pediatric populations now authorized for use.

The FDA noted that the VRBPAC recommendation also came into account when making the decision. Historically, both the FDA and CDC have followed VRBPAC endorsements for vaccine authorizations.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the release. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these 2 vaccines for pediatric populations.”

Watch the FDA’s virtual press conference discussing the authorization here.

Reference:

Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age. US Food and Drug Administration. Published June 17, 2022. Accessed June 17, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children