FDA blocked studies finding Covid and shingles vaccines safe, HHS official says
Summary
The US Food and Drug Administration (FDA) blocked the publication of several government-funded studies that found Covid-19 and shingles vaccines to be safe. Agency officials said the studies drew conclusions not fully supported by data, but some experts and insiders criticized the decision, noting the research showed few serious side effects.Key Facts
- The FDA blocked several studies on Covid-19 and shingles vaccine safety funded with taxpayer money.
- These studies analyzed millions of patient records, including 7.5 million people over 65 and 4.2 million people aged six months to 64 years.
- Researchers found serious side effects from the vaccines were rare; one study found only a rare risk of anaphylaxis at about one in a million for the Pfizer vaccine.
- Studies were withdrawn after publication acceptance because officials said conclusions were broader than data supported.
- The decisions did not involve the FDA commissioner or the HHS secretary directly.
- Some officials and experts said this pattern limits the release of information showing vaccine safety.
- Public criticism has increased amid concerns about management at the FDA and statements by HHS Secretary Robert F. Kennedy Jr., who has expressed anti-vaccine views.
- The FDA continues to say the benefits of vaccination outweigh the risks despite the withdrawn studies.
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