Washington, D.C. — The Food and Drug Administration halted publication of multiple studies examining the safety of COVID-19 and shingles vaccines, according to statements from the Department of Health and Human Services and reporting first published by The New York Times.
An HHS spokesperson said the studies were withdrawn because researchers allegedly made broader conclusions than the underlying data supported. Officials stated the agency acted to protect scientific standards and preserve the integrity of FDA-reviewed research.
One of the blocked studies analyzed health outcomes among roughly 7.5 million Medicare beneficiaries who received updated 2023-2024 COVID-19 vaccines. According to a preprint version still available online, researchers found a possible but extremely rare increase in anaphylaxis cases following Pfizer-BioNTech vaccination, estimated at approximately one case per one million vaccinated individuals. The study reported no other statistically significant safety concerns among the Medicare population.
Another study involving people ages 6 months to 64 years identified some elevated risks tied to previously documented rare adverse events, including febrile seizures among certain young children who received Moderna vaccines. Researchers said no new major safety concerns were identified across the broader study population.
FDA officials also reportedly delayed publication of abstracts involving the Shingrix shingles vaccine. The agency did not publicly detail why those studies were blocked, though officials said one study design fell outside the FDA’s regulatory scope.
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