FDA political appointees blocked vaccine safety studies, op-ed reports

The Story

According to a recent op‑ed in The Guardian, the New York Times and the Washington Post reported that FDA political appointees withdrew vaccine safety studies after they had been accepted by peer‑reviewed journals. The author describes two COVID‑19 vaccine safety studies and a Shingrix safety analysis that were blocked from publication. The op‑ed also contrasts the suppression of these studies with the release of an unsubstantiated memo linking 10 child deaths to COVID‑19 vaccination.

Key Facts

• In October, FDA scientists were directed to withdraw two COVID‑19 vaccine safety studies accepted by the journals Drug Safety and Vaccine.
• One study examined records of 7.5 million Medicare beneficiaries and found only one signal – anaphylaxis at roughly one per million Pfizer‑BioNTech doses – exceeded statistical noise.
• A second study examined 4.2 million recipients aged six months to 64 years and identified rare febrile‑seizure and myocarditis signals already on the label.
• In February, top officials declined to sign off on submitting Shingrix safety abstracts to a major drug‑safety conference; the analysis confirmed elevated but low Guillain‑Barré risk already on the package insert.
• In late November, a memo from the same FDA center linked the deaths of 10 children to COVID‑19 vaccination, a claim the agency has not substantiated; that memo was released and widely covered.
• The op‑ed states that vaccine‑critical claims have moved through the agency at low evidentiary thresholds, while reassuring safety findings have been held to standards no peer‑reviewed paper could realistically meet.

Conflicting Reports

The source article describes a conflict within the FDA’s handling of vaccine safety information: an unsubstantiated memo linking 10 child deaths to COVID‑19 vaccination was released and widely covered, while two large safety studies that found serious adverse effects to be very rare were withdrawn by political appointees after acceptance by peer‑reviewed journals.

Still Unclear

The article does not name the political appointees who blocked the studies, nor provide exact dates beyond “October” and “February.” It also does not clarify why the agency’s stated objection – that authors “drew broad conclusions that were not supported by the underlying data” – was treated as a reason for withdrawal rather than as ordinary peer‑review feedback.

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, and author of the op‑ed.

Sources: The Guardian