The Food and Drug Administration has blocked the publication of multiple scientific studies funded by American taxpayers that concluded Covid-19 and shingles vaccines were safe, according to a Department of Health and Human Services official.
Agency scientists conducted the research by analyzing millions of medical records and determined that serious vaccine side effects were rare. The studies, which cost several million dollars, examined vaccine safety in 2023 and 2024.
HHS spokesperson Andrew Nixon confirmed the withdrawals, stating that the studies were pulled 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."
One Covid-19 study reviewed the safety of vaccines in seniors by examining medical records from 7.5 million Medicare beneficiaries. The research looked at health outcomes during the 21 days after vaccination and the subsequent 20 days, comparing rates of 14 potential serious conditions including heart attacks, strokes, and Guillain-Barré syndrome, a rare autoimmune disorder.
That study found anaphylaxis was the only notable concern, occurring in roughly one in a million people who received the Pfizer vaccine. As the researchers concluded, "No other statistically significant elevations in risk were observed." The paper had been accepted by the peer-reviewed journal Drug Safety before being withdrawn.
A second Covid-19 study examined safety data from 4.2 million people aged six months to 64 years, assessing more than a dozen health conditions including brain swelling, blood clots, and heart attacks. It documented rare cases of fever-related seizures and myocarditis, or inflammation of the heart muscle. The study noted that "given the available evidence, FDA continues to conclude the benefits of vaccination outweigh the risks."
Beyond the Covid-19 research, the FDA also prevented publication of shingles vaccine studies. Administration officials did not approve the work in time for staff to submit abstracts on two Shingrix studies to a drug safety conference in February.
Dorit Reiss, a law professor at UC Law San Francisco who specializes in vaccine policy, said the decision was troubling. "The fact that in one case these were accepted by a journal and that they are open about not liking the conclusion makes it more jarring," she said.
Janet Woodcock, former FDA Principal Deputy Commissioner, criticized the pattern. "There is a pattern here for not letting information out that might support the general safety of vaccines, with methodological rationales given by non-scientist spokespersons," she said.
The disclosure arrives as the HHS faces mounting questions about its leadership. FDA Commissioner Marty Makary has reportedly clashed with administration officials, and biotech firms have expressed frustration over what they view as an inconsistent drug review process. The decision to halt the vaccine studies did not reach either Makary or HHS Secretary Robert F. Kennedy Jr.
Author James Rodriguez: "Blocking studies that confirm vaccine safety, then offering weak methodological defenses, corrodes public trust in institutions already fractured by years of politicized health messaging."
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