FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children 6 Months and Up

The FDA authorized emergency use of Moderna and Pfizer-BioNTech's COVID-19 vaccines for use in children as young as 6 months old.

The US Food and Drug Administration (FDA) announced Friday that it authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children who are at least 6 months old.

The emergency use authorization (EUA) for Moderna’s COVID-19 vaccine (mRNA-1273) was amended to include use in children and adolescents aged 6 months to 17 years. The vaccine is already authorized for use in adults aged ≥18 years. For Pfizer-BioNTech’s vaccine—which had been authorized for use in individuals aged ≥5 years—the EUA will now include children aged 6 months to 4 years.

"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 Califf, MD, in a press release. "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."

The decision comes after 2 back-to-back meetings of the agency's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which unanimously recommended that both mRNA vaccines be authorized for use in patients as young as 6 months old.

A separate advisory panel to the Centers for Disease Control and Prevention (CDC) is scheduled to meet Friday and Saturday on the matter, after which CDC Director Rochelle P. Walensky, MD, MPH, will issue her own recommendation.

In April, Moderna was the first manufacturer to ask the FDA to authorize its vaccine for children, citing data from the phase 2/3 KidCOVE study. Interim results showed a “robust” neutralizing antibody response in participants aged 6 months to <6 years after a 2-dose primary series of mRNA-1273, as well as a favorable safety profile.

Topline data from a phase 2/3 clinical trial evaluating a third 3-µg dose of Pfizer’s COVID-19 vaccine showed that the vaccine produced a strong immune response and a favorable safety profile similar to placebo in participants aged 6 months to under 5 years.

"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 statement. “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 two vaccines for pediatric populations.”