FDA blocked studies finding Covid and shingles vaccines safe, HHS official says | Trump administration
The U.S. Food and Drug Administration blocked the release of several studies showing that Covid-19 and shingles vaccines were safe, according to a Department of Health and Human Services spokesperson.
Agency scientists conducted these studies by analyzing millions of patient records and found that serious side effects from vaccines were rare, the spokesperson confirmed. The studies – funded by taxpayer money and costing several million dollars – included research examining the safety of Covid-19 vaccines in 2023 and 2024.
Andrew Nixon, an HHS spokesperson, confirmed the withdrawals in a statement, saying: “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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 met its high standards.”
One of the Covid-19 studies examined vaccine safety in people over 65 by reviewing the medical records of 7.5 million Medicare beneficiaries, The New York Times first reported.
The researchers focused on the 21-day period after vaccination and the following 20 days, comparing rates of health problems immediately after vaccination. They evaluated 14 potential outcomes, including heart attacks, strokes and Guillain-Barré syndrome, a rare autoimmune disease, the Times said.
Researchers said anaphylaxis was the only outcome of concern, affecting about one in a million people who received the Pfizer vaccine. The study stated, “No other statistically significant increases in risk were observed,” according to the Times. Although it was accepted by Drug Safety, a peer-reviewed journal, the study was later retracted, people familiar with the matter told the Times.
“The fact that in one case these conclusions were accepted by a journal and they are openly saying they don’t like the conclusion makes it even more shocking,” said Dorit Reiss, a law professor at UC Law San Francisco who focuses on vaccine-related legal and policy issues.
Janet Woodcock, former principal deputy commissioner of the Food and Drug Administration, said that “there is a pattern here of withholding information that might support the general safety of vaccines, with methodological justifications given by non-scientific spokespeople,” likely referring to Nixon.
Another withdrawn study reviewed by The New York Times examined the safety of the Covid-19 vaccine in 4.2 million people aged six months to 64 years.
This study evaluated more than a dozen health problems — including brain swelling, blood clots and heart attacks — and found rare cases of fever-related seizures and myocarditis, or inflammation of the heart muscle.
“Given the available evidence, FDA continues to conclude that the benefits of vaccination outweigh the risks,” the study said, adding that Angela Rasmussen, editor-in-chief of the journal Vaccine, confirmed to the Times that the article had been retracted by its authors.
In addition to studies on Covid-19, several studies on shingles have also been prevented from publishing. People familiar with the matter told The New York Times that agency officials failed to sign off in time in February for staff to submit summaries of two Shingrix studies to a drug safety conference. A senior administration official also said studies were not moving forward at the agency.
In a statement to the Times, Nixon said that “the design of this study was not within the agency’s purview.” The newspaper adds that the decision to stop publication of the studies did not reach FDA Commissioner Marty Makary or HHS Secretary Robert F Kennedy Jr.
The latest Times report follows a growing backlash against HHS and its secretary, Robert F Kennedy Jr, who has repeatedly pushed anti-vaccine rhetoric and significantly limited funding and accessibility to Covid-19 and other vaccines.
Meanwhile, staffers have raised concerns about the FDA’s management under Makary’s leadership, with Bloomberg recently reporting that Makary frequently clashed with administration officials while biotech companies grew disillusioned with what they saw as an inconsistent drug review process.
Melody Schreiber contributed reporting
