finance
FDA Withdraws Studies on Safety of COVID-19 and Shingles Vaccines
The U.S. Food and Drug Administration blocked the publication of research finding rare side effects from COVID and shingles vaccines. The studies were withdrawn due to broad conclusions not supported by data, amid broader efforts by the Trump administration to challenge vaccine recommendations. This action involved analyses of millions of patient records.
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The U.S. The agency acted in recent months, blocking publication after determining the authors' broad conclusions exceeded what the underlying data supported. This move aligns with ongoing changes under the current administration. FDA scientists and data contractors reviewed millions of patient records for these studies, which aimed to affirm vaccine safety.
The research found serious side effects to be uncommon, but officials halted their release to maintain scientific integrity. The spokesperson emphasized that the FDA ensures all associated work meets high standards.
In October, agency scientists were directed to pull back two COVID vaccine studies already accepted for publication in medical journals. Earlier, in February, top FDA officials declined to approve submission of study abstracts on Shingrix, the shingles vaccine, to a drug safety conference. The HHS spokesperson noted that the shingles study design fell outside the agency's purview.
“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.”
These actions occur under Health and Human Services Secretary Robert F. Kennedy Jr., who has expressed skepticism toward vaccines. Federal health agencies have recently softened COVID shot recommendations and reduced research on vaccine development. Efforts also include attempts to revise the childhood immunization schedule.
The withdrawals represent part of a pattern where the Trump administration has challenged established vaccine policies. Multiple sources confirm the studies' findings on rare side effects, but the agency prioritized data limitations over publication.
