Announcement on COVID-19 Vaccines for Children Coming Soon: FDA Commissioner

Dr. Marty Makary says there’s no evidence supporting additional doses in healthy children.

Dr. Marty Makary, commissioner of the Food and Drug Administration. in Washington on May 5, 2025. Anna Moneymaker/Getty Images

Health officials are poised to make an announcement on COVID-19 vaccines, the commissioner of the Food and Drug Administration (FDA) said.

“That is something that’s being discussed right now,” Dr. Marty Makary, the commissioner, said in an interview, released on May 12, after being asked by political activist Charlie Kirk about whether COVID-19 vaccines will remain on the childhood vaccination schedule.

“I think you’re going to see some announcement on that in the coming weeks, but I know they are trying to review all of the scientific data.”

The Centers for Disease Control and Prevention and the Department of Health and Human Services, which maintains the schedule, did not respond to a request for comment.

Makary told Kirk that there’s no evidence available at this time that supports giving healthy children additional COVID-19 vaccine doses.

“That evidence does not exist, and so we’re not going to rubberstamp things at the FDA,” he said. “I don’t think you’re going to see the CDC pushing COVID shots in young, healthy children.”

The FDA commissioner, who expressed concern before joining the agency about vaccinating children, noted that there is no data from randomized, controlled trials for the COVID-19 vaccines that are currently available. The regulatory agency cleared the vaccines from Moderna, Pfizer, and Novavax in 2024, pointing to animal testing and data from previous versions of the shots.

“There’s no good randomized control data that the current version, the latest formulation, of the COVID shot, is necessary for young, healthy children. Other leading countries in Europe have recommended against it,” Makary said. “So I think you’re going to hear something forthcoming.”

The CDC, in 2023, added the COVID-19 vaccines to the vaccination schedule, following a recommendation from its vaccine advisory panel.

The same panel said in April that it is leaning toward narrowing the current universal recommendation for COVID-19 vaccination. In the same meeting, officials noted that the United Kingdom and Australia are among the countries that do not recommend COVID-19 vaccine boosters for healthy children.

Health Secretary Robert F. Kennedy Jr. said that same month that officials were considering removing the COVID-19 vaccines from the schedule. Makary has said he would support that move.

The CDC, which has an acting director at present, has not commented on the prospect of the schedule being adjusted.

The American Academy of Pediatrics is among the organizations that support the current COVID-19 vaccine recommendations. The group says on its site that the vaccines are safe and effective.

The FDA is set to meet with its vaccine advisers on May 22 to discuss selecting updates to the COVID-19 vaccines, with Novavax saying it plans to participate in the meeting. Pfizer and Moderna have not responded to queries.