FDA May Revoke Pfizer’s COVID-19 Vaccine for Young, Healthy Children

The U.S. Food and Drug Administration (FDA) may revoke Pfizer-BioNTech’s emergency use authorization (EUA) for its COVID-19 vaccine, Comirnaty, for children ages 6 months through 4 years. “We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,” said a Pfizer spokesperson. “It is important to note that these deliberations are not related to the safety and efficacy of the vaccine, which continues to demonstrate a favorable profile.”

In July, Moderna received full FDA approval for its COVID-19 vaccine for children 6 months to 11 years old who are at increased risk of contracting COVID-19. The vaccine, Spikevax, is expected to be available for eligible populations in the 2025-26 respiratory virus season.

In late May, Robert F. Kennedy, Jr., secretary of the U.S. Department of Health and Human Services, announced that the COVID-19 vaccine for healthy children and healthy pregnant women was removed from the Centers for Disease Control and Prevention’s immunization schedule, despite push back from the American Academy of Pediatrics, saying at the time that the removal “ignores independent medical experts and leaves children at risk.”