The Food and Drug Administration (FDA) has been accused of suppressing vaccine safety research after career scientists were directed to withdraw two studies that had already been accepted by peer-reviewed journals. The studies, which examined millions of vaccine recipients, were completed, peer-reviewed, and accepted by the journals Drug Safety and Vaccine, but political appointees declined to sign off, leading to their withdrawal.
Details of the Suppressed Studies
One study analyzed records of 7.5 million Medicare beneficiaries for adverse outcomes after the 2023-2024 Covid-19 vaccination. It found only one signal—anaphylaxis at roughly one per million Pfizer-BioNTech doses—that exceeded statistical noise. A second study examined 4.2 million recipients aged six months to 64 years for more than a dozen outcomes, identifying rare febrile-seizure and myocarditis signals already on the label. Additionally, a Shingrix safety analysis confirmed the elevated but low Guillain-Barré risk that has been on the package insert for years.
Political Interference in Science
The agency stated that the authors “drew broad conclusions that were not supported by the underlying data,” a criticism that would normally be addressed through peer review. However, the withdrawal of accepted manuscripts by political appointees is unprecedented and raises concerns about scientific integrity. This asymmetry is compounded by the release of a memo linking deaths of 10 children to Covid-19 vaccination, a claim the agency has not substantiated, while reassuring safety findings are withheld.
Implications for Public Health
The suppression of vaccine safety data occurs amid a regional measles resurgence and the upcoming FIFA World Cup, which will draw millions of attendees to the US. The Centers for Disease Control and Prevention (CDC) has lost a quarter of its workforce and faces editing directives, weakening the public health surveillance system. Physicians like Dr. Robert B. Shpiner, a clinical professor at UCLA, express concern that the system may no longer be free to report what it sees, potentially endangering public health.
Dr. Shpiner notes that he could not inform a patient about the suppressed Shingrix safety analysis, and he fears that the federal public health system may not be able to detect outbreaks during the World Cup. The integrity of vaccine safety communication and disease surveillance is at stake, highlighting the need for transparency and independence in scientific research.
