The Food and Drug Administration (FDA) has halted the publication of multiple studies examining the safety of COVID-19 and shingles vaccines, a move confirmed by a Department of Health and Human Services (HHS) spokesperson and first reported by The New York Times. The decision has sparked a political firestorm, with critics accusing the agency of suppressing potentially sensitive data.
HHS spokesperson Andrew Nixon stated that the studies were withdrawn because the authors drew broad conclusions not supported by the underlying data. “The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards,” Nixon said.
The blocked research included two papers on COVID-19 vaccines and abstracts of studies on the Shingrix shingles vaccine. The COVID-19 studies involved FDA scientists as co-authors and analyzed data from millions of Medicare beneficiaries. One study, which examined the 2023-2024 COVID-19 vaccine formulas, found a rare elevation in anaphylaxis rates following Pfizer-BioNTech vaccination, affecting about 1 in 1 million people, but noted no other statistically significant risks among the elderly population.
Another study reviewed records of individuals aged 6 months to 64 years and identified an elevated risk of febrile seizures in children aged 6 months to 5 years after Moderna vaccination. However, it found no new safety concerns for the broader group. That study was withdrawn from the journal Vaccine in October, according to Angela Rasmussen, one of the journal’s editors in chief.
The FDA’s actions come amid heightened scrutiny of vaccine safety and government transparency. The controversy echoes recent tensions, such as the acting CDC chief blocking a COVID vaccine study, which also drew sharp criticism. The agency’s decision to block the shingles vaccine abstracts from a drug safety conference was attributed to study design issues outside the FDA’s purview, though Nixon provided no further details.
Political analysts see this as part of a broader pattern of government agencies limiting public access to vaccine data, especially amid ongoing debates over pandemic-era policies. The move has intensified calls for greater transparency, with some lawmakers demanding a full accounting of the FDA’s review process.
Meanwhile, the scientific community is divided. Some researchers argue that the FDA’s intervention undermines public trust, while others defend the agency’s commitment to rigorous standards. The blocked studies’ preprints remain available online, allowing independent scrutiny.
The controversy also intersects with other COVID-era accountability issues, such as the indictment of former Fauci aide David Morens for allegedly hiding records. As the political landscape shifts ahead of the midterms, the FDA’s actions are likely to remain a flashpoint in debates over vaccine safety and federal oversight.
