The Food and Drug Administration plans to raise standards for vaccine approvals after senior agency officials questioned risks of COVID-19 vaccines for children. FDA Commissioner Marty Makary told Fox News the agency will stop routinely approving products without stronger scientific evidence, saying past practice allowed ineffective products to move forward.
The statements followed an internal email from the FDA’s top vaccine regulator, Dr. Vinay Prasad, which was reviewed by NPR and other outlets. Prasad outlined several proposed changes: revising the annual flu vaccine framework, rewriting labels to be more precise, and altering how vaccines are reviewed. He said the agency would impose stricter requirements before authorizing vaccines for pregnant women, ask makers of pneumonia vaccines to prove they reduce disease rather than rely only on antibody responses, and reconsider the practice of giving multiple vaccines at once.
Those shifts could make approvals harder, slower and more expensive, and could affect vaccine availability. Public health experts emphasize that vaccines remain among the safest and most effective tools against infectious disease and note that current U.S. processes — including preapproval trials, post-approval studies and surveillance systems such as the Vaccine Adverse Event Reporting System (VAERS) — generally support the conclusion that benefits outweigh risks.
Makary said the FDA’s internal analysis linked 10 child deaths to COVID vaccination during the Biden administration, but the agency has not publicly detailed the methodology. According to Prasad’s email, the FDA biostatistics and pharmacovigilance team reviewed 96 reported pediatric deaths from 2021 to 2024 and determined that 10 represented deaths caused by the COVID vaccine; Prasad added that the true number could be higher. HHS and FDA officials did not immediately respond to requests for comment.
Several vaccine experts urged transparency and careful review. Dr. Paul Offit of the Children’s Hospital of Philadelphia said evidence supporting the claim of 10 vaccine-related child deaths has not been shared and that failing to publish data could needlessly alarm the public. Jesse Goodman, a Georgetown professor and former FDA vaccine official, defended the use of immunologic endpoints such as antibody levels for accelerated approvals of pneumonia and influenza vaccines, noting these measures are validated and followed by confirmatory studies that have enabled timely access to effective vaccines.
Epidemiologist Michael Osterholm, who reviewed Prasad’s email, questioned attributing the 10 deaths to vaccines without public review and said COVID-19 did cause fatalities in children, citing about 1,597 pediatric COVID deaths from 2020–2022. He called for independent expert review because the individual cases described in the email have not been presented to medical or public health communities or published in the scientific literature.
The FDA publishes VAERS data but cautions that reports are not proof of causation. Prasad noted that causality in case reports is often judged on a subjective scale ranging from certain to unlikely and that several categories are commonly treated as related to the product.
Makary acknowledged that COVID vaccines initially provided major benefits for people at high risk of severe disease but argued the risk-benefit balance has shifted for children. He said routine annual COVID shots for young children should be supported by clear scientific evidence rather than automatic approvals.
The agency’s moves come amid broader scrutiny of vaccines from current administration health officials. Health Secretary Robert F. Kennedy Jr. has expressed long-standing skepticism about vaccine safety, and the FDA in August narrowed eligibility for updated COVID vaccines while requesting additional evidence about their safety and effectiveness.
Prasad’s email arrives ahead of a two-day meeting of the CDC’s Advisory Committee on Immunization Practices on Dec. 4–5, which will review childhood vaccination policies. Public health experts worry that recommendations to delay or space some inoculations, or to change formulations, could reduce coverage and increase the risk of outbreaks of measles, mumps, rubella, polio and hepatitis B.
Moderna, whose COVID vaccine is approved for children as young as 6 months, pointed to peer-reviewed studies showing its vaccine is safe and said it was not aware of any pediatric deaths in the past year or new information from prior years. The company added that safety monitoring across more than 90 countries has not identified undisclosed concerns for children or pregnant women. Pfizer did not immediately respond to requests for comment.
Experts across disciplines have called for the FDA to publish the evidence behind its internal findings and for independent review so policymakers, clinicians and the public can assess any proposed changes to vaccine policy.