The studies cost millions of taxpayer dollars. They combed through more than 11 million patient records. And they found what public health officials have been saying for years: COVID-19 and shingles vaccines are safe.

Then the FDA blocked them from being published.

The Department of Health and Human Services confirmed this week that several FDA-conducted vaccine safety studies were withdrawn from publication. HHS spokesperson Andrew Nixon said the studies were pulled because “the authors drew broad conclusions that were not supported by the underlying data.” The FDA acted “to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards,” he said.

The scientists who conducted the research might quibble with that framing. So would the peer reviewers who accepted at least one of the papers.

What the Studies Found

The largest study examined COVID-19 vaccine safety in adults over 65 by analyzing records from 7.5 million Medicare beneficiaries. Researchers compared health outcomes in the 21 days after vaccination against the subsequent 20 days, screening for 14 adverse events including heart attacks, strokes, and Guillain-Barré syndrome.

Anaphylaxis — a severe allergic reaction — was the only concerning signal, affecting roughly one in a million Pfizer recipients. “No other statistically significant elevations in risk were observed,” the study concluded, according to the New York Times.

A second study reviewed 4.2 million people between six months and 64 years, assessing more than a dozen conditions including brain swelling, blood clots, and heart attacks. It found rare cases of fever-related seizures and myocarditis. Even so, the researchers wrote that “the benefits of vaccination outweigh the risks.”

One study was accepted by the peer-reviewed journal Drug Safety before being withdrawn. The second paper, submitted to the journal Vaccine, was withdrawn by its authors. The Drug Safety paper was later withdrawn, and the editor-in-chief of Vaccine confirmed to the Times that the second paper was withdrawn by its authors. In addition, two shingles vaccine studies were blocked when agency officials failed to sign off in time for researchers to submit abstracts to a drug safety conference, according to people familiar with the matter.

Methodological Concern or Political Filter

Nixon, the HHS spokesperson who issued the statement, is a communications official, not a scientist. That detail has not gone unnoticed.

Janet Woodcock, the FDA’s former principal deputy commissioner, said 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.”

Dorit Reiss, a law professor at UC Law San Francisco, pointed to a deeper problem: “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.”

Dr. Fiona Havers, a former CDC official, was more direct. “HHS leaders now have a clear pattern of blocking high-quality studies that include results that don’t support their overall anti-vaccine narrative,” she told ABC News. “This censorship of taxpayer-funded science is extremely concerning.”

The decision reportedly did not reach FDA commissioner Marty Makary or HHS secretary Robert F. Kennedy Jr., according to the Times. But the institutional context is difficult to separate from the outcome.

A Strategy That Defeats Itself

Kennedy has called the COVID-19 vaccine “the deadliest vaccine ever made” — a claim contradicted by extensive clinical evidence. Since taking office, he has cancelled at least $500 million in federally funded mRNA vaccine research, removed all 17 members of the CDC’s vaccine advisory committee and replaced them with new members, many of whom have expressed vaccine-skeptic views. A federal judge has since stayed their votes.

Inside the FDA, Dr. Vinay Prasad — who heads the agency’s Center for Biologics Evaluation and Research — sent an internal email in late 2025 claiming COVID vaccines had caused the deaths of “at least 10 children.” That claim relied on VAERS, a crowdsourced reporting system that scientists emphasize cannot establish causation. Twelve former FDA commissioners published a response in the New England Journal of Medicine calling Prasad’s claims “a threat to evidence-based vaccine policy and public health security.”

The result is an agency whose leadership publicly questions vaccine safety while simultaneously suppressing studies that could reassure the public. The stated rationale is scientific rigor. The effect is the opposite of transparency.

When a government agency hides safety data, it invites suspicion about what that data might contain. People who distrust vaccines will not be reassured by silence — they will assume the worst. People who trusted the FDA will wonder what else is being withheld.

The studies in question were funded by the public, conducted by government scientists, and accepted through peer review. Whether the conclusions were too broad is a scientific question that science — not a communications office — should settle.

Sources