Just a week after the FDA updated its stance on new COVID-19 vaccine approvals, U.S. recommendations around the use of existing COVID shots are changing.
As of Tuesday, COVID vaccines are no longer on the list of immunizations recommended by the Centers for Disease Control and Prevention (CDC) for pregnant women and "healthy" children, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a video posted on his X account on Tuesday.
RFK Jr., who said he "couldn't be more pleased" about the change, said there's a lack of "clinical data to support the repeat booster strategy in children."
Joining RFK Jr. in his video statement were National Institutes of Health Director Jay Bhattacharya, M.D., Ph.D., and FDA Commissioner Marty Makary, M.D., Ph.D. Notably absent was an official representing the CDC, advocacy nonprofit Public Citizen pointed out.
"It's common sense and it's good science," Bhattacharya said of the change.
The abrupt change to the vaccine schedule has already attracted scrutiny, with Public Citizen Health Research Group Director Robert Steinbrook, M.D., lambasting RFK Jr. for "making arbitrary public health decisions," he said in a statement.
“For the CDC’s immunization schedule to be credible, it must be developed by CDC scientists through the well-established federal consultation process, not single-handedly by the HHS Secretary," Steinbrook said, adding that the decision may cause confusion and prompt insurers to stop covering the vaccines for impacted groups.
Makary, meanwhile, is firm that there's "no evidence that healthy kids need [a COVID booster] today, and most countries have stopped recommending it for children,” Makary noted in RFK Jr.'s video announcement, echoing some of the rationale laid out in his recent “evidence-based approach to COVID-19 vaccination” article published in The New England Journal of Medicine last week.
In the newly unveiled FDA policy stance, Makary and Center for Biologics Evaluation and Research head Vinay Prasad, M.D., cited a “need for evidence” on the benefits of repeated COVID vaccines. The officials declared that the FDA will demand “robust, gold-standard data” when approving new vaccines for use in those who are at a low risk for severe COVID outcomes.
Those data would come in the form of placebo-controlled clinical trial results with six months of follow-up and immunologic endpoints, Makary and Prasad explained.
The FDA’s position on new COVID vaccines has already been put into practice with the recent full approval of Novavax’s vaccine, which limits the shot's use to those 65 years and older and in people between the ages of 12 and 64 who have at least one underlying health condition that puts them at a high risk for severe COVID outcomes.
As for updated COVID vaccine formulas from Moderna and Pfizer, the new regulatory standards are a little murkier. Shortly after the FDA’s COVID vaccine policy framework dropped, the agency’s Vaccine and Related Biological Products Advisory Committee met to discuss updated vaccines designed to better match the current evolution of the COVID virus. The committee ultimately voted unanimously in favor of the reformulated vaccines.
As such, the FDA has advised the makers of approved COVID vaccines to go ahead with the updates for use in the fall 2025 virus season, the agency noted in a press release. During the meeting, some committee members voiced concerns that if a change to the vaccines were recommended, new testing requirements could delay that fall delivery, Stat reported. Such questions went largely unanswered by FDA leadership at the meeting, and the agency did not mention the new approval standard in its release.
Meanwhile, the CDC’s Advisory Committee on Immunization Practices is meeting next month to discuss vaccine recommendations. The CDC currently lists pregnancy or recent pregnancy as a factor that makes it more likely to get "very sick" from COVID infection.