The Food and Drug Administration is considering revoking the emergency use authorization for Pfizer's COVID-19 vaccine in healthy children under 5 years old, a move that could significantly limit vaccination options for parents seeking to protect their young children ahead of the upcoming respiratory virus season.
Pfizer confirmed that the FDA has indicated it might not renew the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine Comirnaty for children ages 6 months through 4 years. The three-dose shot for this age group has been available under EUA since its initial 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," a Pfizer spokesperson stated. The company emphasized that "these deliberations are not related to the safety and efficacy of the vaccine, which continues to demonstrate a favorable profile."
Limited Alternatives for Young Children
The potential revocation comes as vaccination options for the youngest children remain restricted. In July, Moderna received full FDA approval for its COVID-19 vaccine Spikevax for children 6 months to 11 years old, but only for those at increased risk of contracting severe COVID-19. Novavax has never been approved for children younger than 12.
If Pfizer's authorization is withdrawn, healthy children younger than 5 years old would have no official vaccination options, as Moderna's approval is limited to high-risk children. This would force pediatricians to offer Moderna's vaccine "off label" for healthy children, with no guarantee of insurance coverage.
"We're hopeful that the clinical decisionmaking allows them to request the vaccine and get it and have it covered by insurance. But it's just complicated," said Claire Hannan, executive director of the Association of Immunization Managers, which represents state and local officials.
Policy Shifts Under New Administration
The potential authorization revocation follows significant policy changes implemented by the Trump administration's Department of Health and Human Services. In May 2025, HHS Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines for healthy children and healthy pregnant women were removed from the Centers for Disease Control and Prevention's immunization schedule.
"There's no evidence healthy kids need it today," stated Dr. Marty Makary, FDA commissioner, in a May 27 video announcement. The CDC subsequently updated its immunization schedule to reflect that children with no underlying health condition "may receive" COVID-19 vaccines after consulting with a health care provider.
Kennedy has previously expressed skepticism about mRNA vaccines, calling the Moderna and Pfizer shots dangerous and unreliable. HHS also recently announced it was pulling back from funding research involving the mRNA technology used to develop these vaccines.
Access Concerns and Clinical Implications
Pediatric advocates have raised significant concerns about the potential impact on vaccine access. Fatima Khan, co-founder of Protect Their Future, which advocates for vaccine access for children, warned of worsening access issues.
"Parents already were struggling. We had parents, even last year, they had to drive two to three hours to get [COVID] vaccines for their kids. So already, access was an issue. Now it's just going to be abysmal," Khan said. "You're abandoning children right now … this is something that's so safe and so easy for them to just administer to our kids. Why can we not get it?"
Infectious disease experts and CDC data indicate that children younger than age 2 are at risk for severe COVID-19 infection even if they are otherwise healthy. Dr. Ayanna Bennett, director of the District of Columbia's Department of Health, emphasized the importance of prevention.
"I want kids to not miss two weeks of school. I want kids not to be hospitalized, or in urgent care and miserable. We want them to be able to live their lives when there's no reason why they shouldn't," Bennett said. "If I can prevent something, I should do it, and this is something where we absolutely have prevention available."
Medical Community Response
The American Academy of Pediatrics has pushed back against the policy changes, stating that the removal of COVID-19 vaccines from the immunization schedule "ignores independent medical experts and leaves children at risk."
Dr. Sean O'Leary, chair of the academy's committee on infectious diseases, warned that ending access to vaccination for healthy young children would strip families of choice. "Those who want to vaccinate may no longer be able to, as the implications for insurance coverage and access remain unclear," he said.
State health officials report that Moderna is ramping up supplies of its vaccine for the fall season and will be able to meet demand if Pfizer's vaccine becomes unavailable for the youngest children. Providers who have already preordered Pfizer shots for the coming season will likely be able to switch to Moderna, though the regulatory complexities around off-label use remain a concern.
The FDA's decision on Pfizer's EUA renewal is expected before the 2025-2026 respiratory virus season begins, with significant implications for pediatric vaccination strategies nationwide.
