FDA Withdraws Studies That Found Rare Vaccine Side Effects

“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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 The New York Times first reported on the withdrawn Covid-19 studies, detailing the methodologies and findings.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.