The Food and Drug Administration plans to apply stricter standards to vaccine approvals after senior officials raised concerns about COVID-19 shots for children.
FDA Commissioner Marty Makary told Fox News the agency will stop “rubber-stamp[ing] new products that don’t work,” saying past practice made a “mockery of science.” His remarks followed an internal email from the agency’s top vaccine regulator, Dr. Vinay Prasad, that outlined several proposed changes to vaccine policy. NPR and other outlets reviewed the email, which said the FDA would revise its annual flu vaccine framework, update labels to be more “honest,” and alter review processes for vaccines.
Prasad told staff the agency would no longer authorize vaccines for pregnant women without stricter evidence. For pneumonia vaccines, he said manufacturers should prove they reduce clinical disease rather than rely on antibody levels as a surrogate. He also questioned the practice of giving multiple vaccines at the same time. Those shifts could make approvals more difficult and costly, possibly limiting access to vaccines that public health experts consider among the safest and most effective tools against infectious disease.
Makary and the email cite an FDA analysis linking COVID vaccines to 10 child deaths. Makary said on Fox News that 10 children “died from the COVID shot” during the Biden administration but provided no specifics about the analysis. According to Prasad’s email, the 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 may be higher. HHS and FDA officials did not immediately comment.
Several vaccine experts cautioned that Prasad has not shared the evidence behind the claimed 10 deaths. Dr. Paul Offit of the Children’s Hospital of Philadelphia said Prasad has not provided data and urged that the evidence be shared for independent review, warning that unsupported claims will only alarm the public. Dr. Jesse Goodman, who previously led the FDA’s vaccine center, defended the use of immunologic endpoints such as antibody levels for accelerated approvals of pneumonia and influenza vaccines, noting these approaches are followed by confirmatory studies after approval and have helped provide timely access to safe, effective vaccines.
University of Minnesota epidemiologist Michael Osterholm, after reviewing Prasad’s email, challenged the assertion that COVID-19 was never highly lethal for children and questioned the FDA’s analysis attributing 10 deaths to the vaccines. He noted 1,597 pediatric COVID deaths from 2020–2022 and said the 10 cases cited by the FDA have not been presented for peer review or published, arguing they should be reviewed by external experts before being accepted as vaccine-associated deaths.
The FDA posts data from the Vaccine Adverse Event Reporting System (VAERS), co-sponsored by the Centers for Disease Control and Prevention, but warns that reports do not establish cause-and-effect. Prasad noted in his email that causality in case reports is often assessed subjectively on a scale from certain to unlikely; categories such as certain, likely/possible, and probable are broadly considered related to the product.
Makary said the early COVID vaccines were valuable for people at high risk of severe disease but argued the risk-benefit calculus has changed. He questioned recommending repeated annual shots for children without stronger evidence of benefit.
The email and public comments come as the CDC’s Advisory Committee on Immunization Practices (ACIP) prepares for a two-day meeting Dec. 4–5 to review childhood vaccination policies. The committee is conducting a major reassessment of the schedule for diseases including measles, mumps, rubella, polio and hepatitis B. Some public health experts worry the review could delay or space out vaccinations, reformulate some vaccines, or otherwise reduce childhood coverage, risking the return of previously controlled diseases.
Moderna, whose COVID vaccine is approved for children as young as 6 months, said in a September statement that multiple peer-reviewed studies show its shot is safe and that the company is “not aware of any deaths in the last year or pertinent new information from prior years.” Moderna noted it monitors safety with regulators in more than 90 countries and that global surveillance has not reported new safety concerns in children or pregnant women. Pfizer did not immediately respond to requests for comment.
The policy shift follows earlier FDA actions: in August the agency restricted eligibility for updated COVID vaccines and said it would require more evidence about safety and effectiveness going forward. The current controversy has drawn attention from vaccine-skeptical figures in government, and public health leaders emphasize that while all vaccines carry some risk, the existing approval and post-approval surveillance systems are designed to ensure benefits outweigh harms. Independent review and transparent publication of evidence, experts say, will be essential if the FDA is to substantiate claims that the COVID shots caused pediatric deaths.