The Food and Drug Administration (FDA) is considering revoking the authorization of Pfizer’s COVID-19 vaccine for healthy children younger than 5 years old, a move that would add another barrier for parents who want to vaccinate healthy children ahead of the respiratory virus season.

Pfizer's three-dose shot for children between 6 months and 5 years old has long been available under an emergency use authorization (EUA). But according to the company, the FDA is weighing ending that authorization.

“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,” Pfizer told The Hill.

“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,” the company added.

Pfizer expects the FDA to approve its vaccine for children ages 5 to 11 with the same limitations as Moderna and Novavax.

The FDA in July approved Moderna's shot for children 6 months and older, but only if they have a health condition that puts them at increased risk for severe COVID-19. Novavax has never been approved for children younger than 12.

Pfizer has had full FDA approval for its COVID-19 vaccine for individuals age 12 and older since 2022.

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