The Food and Drug Administration says it will adopt stricter standards for vaccine approvals after senior officials raised concerns about COVID-19 shots for children and proposed broader policy changes.
FDA Commissioner Marty Makary told Fox News the agency will stop “rubber-stamping” products he views as ineffective and said past practices had made a “mockery of science.” His comments followed an internal email from Dr. Vinay Prasad, a senior vaccine official, outlining proposed changes to vaccine policy that NPR and other outlets have reviewed. The memo recommends revising the annual flu vaccine framework, making labeling more candid, and altering vaccine review processes.
Prasad told staff the FDA should require stronger evidence before authorizing vaccines for pregnant women and said manufacturers of pneumonia vaccines should demonstrate reductions in clinical disease rather than rely solely on antibody levels as a surrogate. He also questioned the routine practice of administering multiple vaccines at once. Those shifts could lengthen and raise the cost of approvals, potentially affecting access to vaccines that public health officials regard as safe and effective.
Both Makary and Prasad’s memo cite an FDA biostatistics and pharmacovigilance review that the memo says examined 96 reported pediatric deaths from 2021 to 2024 and concluded 10 children died “after and because of” COVID vaccination. Prasad suggested the true number could be higher. The agency and the Department of Health and Human Services did not immediately comment, and the review underlying the memo has not been published.
Several vaccine experts urged that the evidence behind the claimed 10 deaths be released for independent evaluation. Dr. Paul Offit of the Children’s Hospital of Philadelphia said the data have not been provided and warned that unsubstantiated assertions could alarm the public. Dr. Jesse Goodman, a former FDA vaccine center director, defended using immunologic endpoints such as antibody levels to expedite approvals for influenza and pneumonia vaccines, noting those pathways are followed by confirmatory studies and have enabled timely access to vaccines.
University of Minnesota epidemiologist Michael Osterholm, after reviewing Prasad’s email, disputed the suggestion that COVID-19 was never highly lethal for children and questioned the FDA’s attribution of 10 deaths to the vaccines. He pointed out that 1,597 pediatric COVID deaths were recorded from 2020–2022 and said the 10 vaccine-linked cases have not been peer-reviewed or published; he argued external review is needed before accepting them as vaccine-associated deaths.
The FDA posts Vaccine Adverse Event Reporting System (VAERS) reports, which are co-sponsored by the Centers for Disease Control and Prevention, but warns those reports do not establish causality. Prasad noted that causality in case reports is often judged subjectively using categories from “certain” to “unlikely,” and that categories such as certain, likely/possible, and probable are generally treated as related to a product.
Makary said earlier COVID vaccines were valuable for people at high risk of severe disease but argued the risk-benefit balance has shifted, questioning the routine recommendation of repeated annual shots for children without stronger evidence of benefit.
The internal memo and public comments arrive as the CDC’s Advisory Committee on Immunization Practices (ACIP) prepares a two-day meeting Dec. 4–5 to review childhood vaccination policies. The committee is conducting a major reassessment of schedules for diseases including measles, mumps, rubella, polio and hepatitis B. Some public health experts worry the review could delay or space out vaccinations, alter formulations, or otherwise reduce childhood coverage, increasing the risk that controlled diseases could resurface.
Moderna, whose COVID vaccine is approved for children as young as 6 months, said in September 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 said it monitors safety with regulators in more than 90 countries and that global surveillance has not identified new safety concerns in children or pregnant women. Pfizer did not immediately respond to requests for comment.
This policy shift follows an August FDA decision to restrict eligibility for updated COVID vaccines and to require more evidence of safety and effectiveness going forward. Public health leaders emphasize that while all vaccines carry some risk, approval and post-approval surveillance systems are designed to ensure that benefits outweigh harms. Experts say independent review and transparent publication of the data will be essential if the FDA’s analysis is to substantiate claims that COVID shots caused pediatric deaths.