FDA Vaccine Safety Studies Withdrawn After Peer Review, Doctor Reports

The Story

An opinion piece published by a UCLA doctor reports that safety studies of Covid-19 and shingles vaccines, completed by Food and Drug Administration scientists and accepted by peer-reviewed journals, were withdrawn after political appointees declined to sign off. The author states that the agency’s objection was that authors “drew broad conclusions that were not supported by the underlying data,” but that the procedural removal of accepted manuscripts is unusual.

Key Facts

• The New York Times and Washington Post reported a case of data suppression at the FDA, according to the article.
• In October, FDA scientists were directed to withdraw two Covid-19 vaccine safety studies that had been accepted by the journals Drug Safety and Vaccine.
• In February, top officials declined to sign off on submitting Shingrix safety abstracts to a drug-safety conference.
• One Covid study examined 7.5 million Medicare beneficiaries for 14 pre-specified adverse outcomes after 2023–2024 vaccination; only anaphylaxis at roughly one per million Pfizer-BioNTech doses exceeded statistical noise.
• A second Covid study examined 4.2 million recipients aged six months to 64 years and identified rare febrile-seizure and myocarditis signals already on the label.
• The Shingrix safety analysis confirmed the elevated but low Guillain-Barré risk already on the package insert.
• In late November, a memo from the same FDA center linked deaths of 10 children to Covid-19 vaccination, a claim the agency has not substantiated, the article states.
• The article notes upcoming FIFA World Cup (June 11) and a regional measles resurgence: over 9,000 confirmed cases in Mexico since February 2025, Canada losing measles elimination status, and U.S. vaccination coverage below 95%.
• The CDC has lost approximately a quarter of its workforce in the past year, the article reports.

Conflicting Reports

No conflicting reports identified in the source article.

Still Unclear

No open questions identified in the source article.

Misconceptions

No widespread misconceptions addressed in the source article.

Key Figures

• Robert B Shpiner, clinical professor of medicine and associate professor of neurosurgery at UCLA, author of the opinion piece.

Sources: The Guardian