The Food and Drug Administration stopped publication of studies about the safety of vaccines to protect against covid-19 and shingles in recent months, a spokesman for the Health and Human Services Department said.
One covid vaccine safety study examined the association between people who received the 2023–24 vaccine and their later experience with more than a dozen health conditions, including those that affect the heart, blood, brain and nervous system. The study, whose authors included FDA scientists, was going through a peer review process but the authors withdrew it from the journal Vaccine in October, according to Angela Rasmussen, one of journal’s editors in chief.
Journal manuscripts are confidential, she said. But she noted that an abstract of the study was presented at a conference last year and is online. “No new safety concerns were found following 2023–2024 COVID-19 vaccination among U.S. health plan enrollees aged 6 months–64 years,” the abstract said.
The New York Times reported Tuesday on two covid vaccine studies and abstracts about studies of a shingles vaccine that were blocked. STAT previously reported on the withdrawal of one of the covid papers.
Speaking in her personal capacity as a virologist at the University of Saskatchewan, Rasmussen said the withdrawal of the study came months after the FDA’s then-top vaccine official, Vinay Prasad, and FDA Commissioner Marty Makary, unveiled a new approach to approving coronavirus vaccines. The new plan resulted in the agency narrowing its approval for updated shots to high-risk Americans such as older adults and people with at least one underlying health condition.
Prasad, who served as the FDA’s vaccine chief until the end of last month, did not immediately respond to a request for comment. He had a rocky, nearly year-long tenure at the agency, facing backlash for initially declining to review a Moderna application for the first mRNA-based flu vaccine and a plan to tighten vaccine approvals.
In a statement, Andrew Nixon, an HHS spokesman, said the studies were withdrawn “because the authors drew broad conclusions that were not supported by the underlying data.” He added: “The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”
The Times reported that the FDA did not sign off in time for staff to submit abstracts on studies of Shingrix, a shingles vaccine, to a drug safety conference.
News of the papers getting pulled comes after The Washington Post reported that the CDC had also blocked a vaccine-related study for publication. A report showing that the covid vaccinereduced emergency department visits and hospitalizations among healthy adults by about half this past winter was blocked from being published in the CDC’s flagship scientific journal. The report had been scheduled for publication March 19 in the Morbidity and Mortality Weekly Report.
Initial publication of the report was delayed because Jay Bhattacharya, who is temporarily overseeing the CDC, had raised concerns about “the observational method used in the study to calculate vaccine effectiveness,” according to HHS spokesman Nixon.
When the agency decided not to publish the report at all, Nixon said: “The MMWR’s editorial assessment identified concerns regarding the methodological approach to estimating vaccine effectiveness and the manuscript was not accepted for publication,” a characterization that differs from accounts by people familiar with the report’s review.
Attention on how HHS agencies have been handling such reports comes as the Trump administration has sought to soften its public stance on vaccine actions ahead of the midterm elections. Republican pollsters have warned that policies supporting vaccine skepticism carry political risks amid Health Secretary Robert F. Kennedy Jr.’s efforts to overhaul the vaccine schedule.
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