FDA vaccine safety studies withdrawn after political appointees decline sign-off

The Story

A Guardian opinion piece by UCLA professor Robert B Shpiner reports that the New York Times and Washington Post covered what it describes as data suppression at the FDA. According to the piece, career scientists completed studies on millions of vaccine recipients that were peer-reviewed and accepted by pharmacovigilance journals, but political appointees declined to sign off, leading to withdrawal. In October, FDA scientists were directed to withdraw two Covid-19 vaccine safety studies already accepted by the journals Drug Safety and Vaccine. In February, top officials declined to sign off on submitting Shingrix safety abstracts to a major conference. The piece notes that the FDA’s stated objection was that the authors “drew broad conclusions that were not supported by the underlying data.” The author expresses concern that this pattern, combined with CDC workforce cuts and a regional measles resurgence, could affect public health surveillance during the 2026 FIFA World Cup in North America.

Key Facts

• Two Covid-19 vaccine safety studies accepted by Drug Safety and Vaccine were withdrawn after FDA political appointees declined sign-off.
• Shingrix safety abstracts were not submitted to a major drug-safety conference after top officials declined sign-off.
• One Covid study examined records of 7.5 million Medicare beneficiaries for 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; it 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, an FDA memo linked deaths of 10 children to Covid-19 vaccination, a claim the agency has not substantiated; that memo was released and widely covered.
• The World Cup opens June 11 across North America with 48 teams, 11 U.S. host cities, and more than 6 million attendees over 39 days.
• A regional measles resurgence includes more than 9,000 confirmed cases in Mexico since February 2025, Canada’s loss of measles elimination status in November, and U.S. vaccination coverage below the 95% threshold.
• The CDC has lost approximately a quarter of its workforce in the past year and has been editing its weekly journal under directive.

Conflicting Reports

No conflicting reports identified in the source article.

Still Unclear

Whether the withdrawn studies contained findings beyond already known risks; whether the FDA’s objection was scientifically valid; whether CDC surveillance will be reliable during the World Cup.

Misconceptions

No widespread misconceptions addressed in the source article.

Key Figures

Robert B Shpiner – clinical professor of medicine (pulmonary and critical care) and associate professor of neurosurgery (neurocritical care) at the David Geffen School of Medicine at UCLA.

Sources: The Guardian