The Food and Drug Administration may revoke authorization for Pfizer’s COVID-19 vaccine for healthy children under age 5, the pharmaceutical company confirmed, potentially narrowing parents’ vaccine choices ahead of the winter respiratory virus season.
This possibility follows months after the Department of Health and Human Services under President Donald Trump began restricting COVID-19 vaccines. For four years, updated vaccines have been available each fall for most Americans before colder weather.
The FDA informed Pfizer it may not renew the emergency use authorization for the Pfizer-BioNTech vaccine Comirnaty for children ages 6 months to 4 years, according to a statement sent to USA TODAY.
“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 company spokesperson said. “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.”
HHS spokesperson Andrew Nixon would not say what action the agency might take. “We do not comment on potential, future regulatory changes,” he said. “Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.”
In July, Moderna received full FDA approval for its COVID-19 vaccine Spikevax for children 6 months to 11 years old who face higher risk of infection. Spikevax is expected to be available to eligible groups in the 2025-26 season.
The Centers for Disease Control and Prevention still advises vaccination for older individuals and those with weakened immune systems from illness or medical treatments such as chemotherapy. Without Pfizer’s EUA, parents would lose the option to vaccinate healthy young children.
HHS Secretary Robert F. Kennedy Jr. has questioned many vaccines, while saying parents should have the right to choose their children’s vaccinations.
In late May, he announced the removal of the COVID-19 vaccine for healthy children and pregnant women from the CDC’s immunization schedule. “There’s no evidence healthy kids need it today,” Dr. Marty Makary, FDA commissioner, said in a May 27 announcement on X.
The American Academy of Pediatrics opposed the change, saying it “ignores independent medical experts and leaves children at risk.”
Ending vaccination access for healthy young children would take away choice, Dr. Sean O’Leary, chair of the academy’s infectious diseases committee, said in a May statement. “Those who want to vaccinate may no longer be able to, as the implications for insurance coverage and access remain unclear,” he said.
