Full Breakdown
FDA Blocks Publication of COVID-19 and Shingles Vaccine Safety Studies
5/7/2026, 12:09:39 AM
FDA Blocks Vaccine Safety Studies
In recent months, the Food and Drug Administration (FDA) halted publication of several studies on COVID-19 and shingles vaccine safety, according to HHS spokesperson Andrew Nixon. The agency withdrew the papers because authors, including FDA scientists, drew broad conclusions not supported by the data. FDA officials said the action protects the integrity of the scientific process and ensures work meets high standards.
Policy Context and Recent Agency Shifts
The move occurs amid policy shifts linked to U.S. Health Secretary Robert F. Kennedy Jr., noted as a vaccine critic. HHS has wound down nearly $500 million in mRNA vaccine development, canceling 22 projects overseen by the Biomedical Advanced Research and Development Authority. A Centers for Disease Control and Prevention panel backed by Kennedy voted to drop thimerosal from flu shots. The Pentagon also revoked a mandatory flu-shot requirement for service members, with Secretary Pete Hegseth describing the change as restoring freedom and strength.
Key Studies and Findings
One study of about 7.5 million Medicare recipients of 2023-2024 COVID-19 vaccines found a rare increase in anaphylaxis—approximately one case per 1 million after Pfizer-BioNTech—without other significant risk signals. A second study of individuals aged six months to 64 years reported a statistically significant rise in febrile seizures among children six months to five years after Moderna vaccination, with no new safety concerns in the broader group. The manuscript was withdrawn from *Vaccine* in October. An abstract on the Shingrix shingles vaccine was also blocked, with officials saying its design fell outside the agency’s purview.
Official Statements & Agency Response
Andrew Nixon said the withdrawals resulted from conclusions deemed unsupported by the data and stressed the FDA’s role in safeguarding scientific rigor. He added that the Shingrix study’s methodology was outside the agency’s jurisdiction, without further detail.
Criticism & Opposition
Critics view the withdrawals as part of a broader effort to limit vaccine access, citing recent funding cuts and policy changes under Health Secretary Robert F. Kennedy Jr.
Conflicting Reports & Gaps
The sources do not specify which conclusions were judged unsupported, nor the criteria for deeming the Shingrix study outside the FDA’s purview. No alternative explanations are offered.
Verbatim Quotes
- “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.” — Andrew Nixon, HHS Spokesperson
- “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
- “The design of that study fell outside the agency’s purview,” — Andrew Nixon, HHS Spokesperson
- “restore freedom and strength” — Pete Hegseth, Secretary of the Pentagon
What’s Next
The Medicare safety preprint remains publicly available, and the FDA has not set a timeline for reconsideration. Monitoring of vaccine safety data will continue through other channels.
