HHS confirmed the FDA blocked publication of studies that supported Covid and shingles vaccine safety, saying the conclusions went beyond the data.
The Food and Drug Administration blocked publication of several recent studies that supported the safety of Covid and shingles vaccines, a Health and Human Services Department spokesperson confirmed to CNBC.
The studies, involving FDA scientists and data firms, analyzed millions of patient records and found side effects from the shots were rare, The New York Times first reported Tuesday, according to CNBC. The episode places new scrutiny on how federal health officials are handling vaccine research and public communication about vaccine safety.
The HHS spokesperson told CNBC the studies were “withdrawn because the authors drew broad conclusions that were not supported by the underlying data.” The spokesperson 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.”
According to the report, FDA scientists were directed in October to withdraw two Covid vaccine studies that had already been accepted for publication in medical journals. In February, senior FDA officials did not approve submitting abstracts on Shingrix, a shingles vaccine, to a drug safety conference, CNBC reported, citing the Times.
Asked about the shingles vaccine research, the HHS spokesperson said the study design “fell outside the agency’s purview.”
The withdrawals come during a broader shift in federal vaccine policy under HHS Secretary Robert F. Kennedy Jr. CNBC reported that federal health agencies have softened Covid vaccine recommendations, scaled back vaccine-development research and attempted to overhaul the childhood immunization schedule.
The immediate scientific impact of the withdrawn work remains unclear from the available report, including whether any of the studies will be revised, resubmitted or released in another form.
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