FDA Withdrew Vaccine Safety Studies Finding Rare Side Effects, HHS Spokesperson Says

Vaccine Safety Studies Withdrawn The U.S.

Food and Drug Administration withdrew multiple studies that found serious side effects from Covid-19 and shingles vaccines to be rare, according to Andrew Nixon, a spokesperson for the Department of Health and Human Services. These studies, conducted by agency scientists and funded by taxpayer dollars at a cost of several million dollars, involved analyzing millions of patient records.

The research included examinations of Covid-19 vaccine safety in 2023 and 2024. One withdrawn Covid-19 study reviewed medical records of 7.5 million Medicare beneficiaries over age 65, comparing health issues in the 21 days after vaccination to the following 20 days.

Researchers assessed 14 potential outcomes, such as heart attacks, strokes, and Guillain-Barré syndrome, finding anaphylaxis as the only notable issue, affecting about one in a million recipients of the Pfizer vaccine. The study concluded no other statistically significant risks were observed, but it was pulled after acceptance by the peer-reviewed journal Drug Safety.

It identified rare cases of fever-related seizures and myocarditis, yet affirmed that vaccination benefits outweighed risks. This paper was also withdrawn by its authors, as confirmed by Angela Rasmussen, editor in chief of the journal Vaccine.

and Agency Response Andrew

Nixon stated that the studies were withdrawn because authors drew broad conclusions not supported by the data, emphasizing the FDA's action to protect scientific integrity and maintain high standards. , according to the report. Separately, FDA Commissioner Makary defended the agency's decision on a biotech company's drug, as reported by CNBC.

“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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 meets its high standards." — Andrew Nixon, HHS spokesperson In addition to Covid-19 research, several shingles vaccine studies were halted from publication. Agency officials did not approve abstracts for two studies on the Shingrix vaccine in time for a February drug safety conference submission. A senior administration official noted these studies were not advancing within the agency, with Nixon stating their design fell outside the FDA's purview.”

The withdrawals occur amid mounting concerns about FDA management under Marty Makary's leadership, including reports of clashes with administration officials and biotech firms' dissatisfaction with an inconsistent drug review process. Janet Woodcock, former FDA principal deputy commissioner, highlighted a pattern of withholding information that supports vaccine safety, with methodological rationales provided by non-scientist spokespersons.

Dorit Reiss, a law professor at UC Law San Francisco specializing in vaccine issues, described the situation as jarring, especially since one study was initially accepted by a journal. , who has limited funding and accessibility for Covid-19 vaccines.

Employees have raised issues about agency leadership, while the Trump administration oversees these developments. The New York Times first reported on the withdrawn Covid-19 studies, detailing the methodologies and findings.

Scientists involved analyzed large datasets to confirm vaccine safety, but the blocks prevented public dissemination of the results. For the shingles studies, the lack of approval delayed conference presentations, potentially impacting ongoing drug safety discussions.

No direct contradictions appear across sources on the core facts, though the Guardian highlighted criticisms of the decisions, while Reuters focused on Makary's defense in a separate drug-related matter. The studies emphasized rare side effects, such as anaphylaxis in one per million Pfizer doses and isolated cases of myocarditis.

Researchers maintained that overall benefits of vaccination exceeded risks, a conclusion the FDA disputed as overly broad. This episode underscores tensions in balancing scientific rigor with public health communication. Melody Schreiber contributed reporting to the coverage of these events.