Officials at the Food and Drug Administration blocked the publication of several government-funded studies supporting the safety of Covid-19 and shingles vaccines in recent months, according to current and former officials familiar with the decisions, raising concerns among scientists about political interference in federal health research.
The studies, conducted by FDA scientists using millions of patient records, found that serious side effects linked to the vaccines were rare and that the benefits of vaccination continued to outweigh the risks.
The Department of Health and Human Services defended the decisions. Andrew Nixon, an HHS spokesman, told the Times that the Covid studies were withdrawn because "the authors drew broad conclusions that were not supported by the underlying data." He added that the FDA acted "to protect the integrity of its scientific process."
But outside experts who reviewed the studies disputed that characterization. Dr. Caleb Alexander, a drug safety expert at Johns Hopkins University, said the reports contained "nothing inherently problematic" while Jeffrey Morris, director of the University of Pennsylvania's biostatistics division, described the studies as "generally well done."
One withdrawn study examined approximately 7.5 million Medicare beneficiaries over age 65 who received updated Covid vaccines during the 2023 and 2024 vaccination campaigns. Researchers analyzed 14 potential health outcomes, including strokes, heart attacks and Guillain-Barré syndrome, comparing rates immediately after vaccination to later periods.
The only statistically significant elevated risk identified was anaphylaxis associated with the Pfizer vaccine, occurring in roughly one per million recipients.
A second study involving 4.2 million recipients between six months and 64 years old identified rare cases of myocarditis and fever-related seizures already known to be associated with Covid vaccines. The study concluded that "the benefits of vaccination outweigh the risks."
The blocked publications come amid broader changes to federal vaccine policy under Health Secretary Robert F. Kennedy Jr., a longtime vaccine critic. Last month HHS canceled nearly $500 million in grants and contracts related to mRNA vaccine development, including projects overseen by the Biomedical Advanced Research and Development Authority.
Scientists and former federal health officials said suppressing large-scale safety research could undermine public trust rather than restore it. Dr. Jeanne Marrazzo, former acting director of the National Institute of Allergy and Infectious Diseases, called the withdrawal of the papers "a pretty active act of sabotage."
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