FDA Blocks Publication of Vaccine Safety Studies. Why Experts Are Concerned

The U.S. Food and Drug Administration (FDA) has withdrawn multiple studies on the safety of COVID-19 and shingles vaccines, preventing their publication despite prior peer review. The Department of Health and Human Services (HHS) confirmed the decision, which affects studies involving millions of patient records funded by taxpayer dollars. Two COVID-19 vaccine safety studies, accepted by medical journals in October 2025, were pulled before publication, while two Shingrix vaccine studies were blocked from submission to a federal drug safety conference without FDA approval. Experts argue the move undermines public trust, as both vaccines have robust safety records. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City, criticized the secrecy, stating it could worsen vaccine hesitancy. Similarly, Dr. Monica Gandhi, a professor at the University of California, San Francisco, emphasized the importance of transparency, noting the studies were peer-reviewed and could have reassured the public. The blocked COVID-19 studies analyzed side effects among millions using Medicare and insurance data, while the Shingrix studies assessed vaccine effectiveness. HHS cited concerns over study conclusions, though officials declined further comment. Dr. William Schaffner of Vanderbilt University Medical Center called the decision problematic, stressing that widespread vaccine use—both domestically and globally—requires public access to safety data for informed assessment. Critics suggest political influence may play a role, citing HHS Secretary Robert F. Kennedy Jr.’s known anti-vaccine stance. The FDA’s actions contrast with existing evidence supporting vaccine safety, raising alarms among medical professionals. Public health experts warn that suppressing such research could exacerbate distrust, particularly among already skeptical populations.