The Food and Drug Administration plans to tighten standards for vaccine approvals as senior officials questioned the risks of COVID-19 vaccines for children. FDA Commissioner Marty Makary said on Fox News the agency would stop “rubber-stamp[ing] new products that don’t work,” calling past practice “a mockery of science.”
The remarks followed an internal email from the agency’s top vaccine regulator, Dr. Vinay Prasad, that NPR and other outlets reviewed. Prasad told staff the FDA would revise its annual flu vaccine framework, update vaccine labels to be more “honest,” and change how it reviews vaccines. He said the agency would no longer authorize vaccines for pregnant women without stricter requirements, would require pneumonia vaccine makers to show they reduce disease rather than only generate antibodies, and would reexamine the practice of giving multiple vaccines at once.
Those shifts could make approvals more difficult and costly and might limit vaccine availability. Public health experts note that vaccines remain among the safest, most effective tools against infectious disease and that the current U.S. process—preapproval studies, post-approval studies and surveillance systems such as the Vaccine Adverse Event Reporting System (VAERS)—has long supported the conclusion that benefits generally outweigh risks.
Makary told Fox News the FDA’s analysis linked 10 child deaths to COVID vaccination during the Biden administration but offered no public details on the methodology. According to Prasad’s email, the FDA’s biostatistics and pharmacovigilance team reviewed 96 reported deaths from 2021 to 2024 and determined 10 children died “after and because of” the COVID vaccine, though Prasad suggested the true number might be higher. HHS and FDA officials did not immediately respond to requests for comment.
Several vaccine experts urged transparency and caution. Dr. Paul Offit of the Children’s Hospital of Philadelphia said Prasad has not shared evidence to support claims that vaccines killed 10 children and that failing to publish data will needlessly frighten people. Jesse Goodman, a Georgetown professor who once led the FDA’s vaccine center, defended using immunologic endpoints like antibody levels for accelerated approvals of pneumonia and influenza vaccines, noting they are validated and confirmed with follow-up studies and have enabled timely access to effective vaccines.
Epidemiologist Michael Osterholm, who reviewed Prasad’s email, challenged assertions that COVID-19 was never highly lethal in children and questioned attributing the 10 deaths to vaccines without public review. Osterholm noted that 1,597 children died of COVID from 2020–2022 and said the cases cited by Prasad have not been presented to medical or public health communities or published in the literature; he called for independent expert review before accepting they are vaccine-associated.
The FDA publishes VAERS data but cautions that reports do not establish cause and effect. Prasad wrote that causality in case reports is typically judged on a subjective scale—ranging from “certain” to “unlikely”—and that “certain, possible/likely, and probable are broadly considered as related to the product.”
Makary acknowledged COVID vaccines initially provided major benefit for people at high risk of severe disease but argued the risk-benefit balance has shifted for children: “Back in 2020, we saw a reduction in the severity of illness and lives saved, but now recommending that a 6-year-old girl get another 70 million COVID shots—one each year for the rest of her life—is not based on science. And so we’re not going to just rubber stamp approvals without seeing some scientific evidence.”
The moves come amid broader scrutiny of vaccines by the current administration’s health officials. Health Secretary Robert F. Kennedy Jr. has long questioned vaccine safety, and the FDA in August restricted eligibility for updated COVID vaccines after announcing it would require more evidence about their safety and effectiveness.
The timing of Prasad’s email coincides with an upcoming two-day meeting (Dec. 4–5) of the CDC’s Advisory Committee on Immunization Practices (ACIP), which is reviewing childhood vaccination policies. Public health experts worry the committee could recommend delaying or spacing some inoculations or reformulating vaccines—changes that could lower coverage and allow reemergence of diseases such as measles, mumps, rubella, polio and hepatitis B.
Moderna, whose COVID vaccine is approved for children as young as 6 months, pointed to a September statement saying multiple peer-reviewed studies show its shot is safe and that it is “not aware of any deaths in the last year or pertinent new information from prior years.” Moderna said monitoring systems across more than 90 countries have not reported new or undisclosed safety concerns in children or pregnant women. Pfizer did not immediately respond to requests for comment.