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Senate Report Accuses Biden Administration of Delaying COVID Vaccine Heart Risk Warnings

A newly released Senate report alleges federal health agencies withheld myocarditis risk information from the public in early 2021, citing concerns over vaccine hesitancy.

The FDA is telling Pfizer and Moderna to expand warning labels about the risk of a rare heart condition after Covid-19 vaccination.
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Overview

  • The Senate Permanent Subcommittee on Investigations published an interim report claiming U.S. health officials delayed public warnings about myocarditis risks linked to mRNA COVID-19 vaccines until June 2021, despite being aware of the issue as early as February 2021.
  • The report alleges that the Biden administration prioritized minimizing vaccine hesitancy over transparency, distributing talking points to health officials that downplayed the risks of myocarditis.
  • Emails and internal documents reveal disagreements between the CDC and FDA over issuing a Health Alert Network (HAN) warning, with then-FDA Commissioner Janet Woodcock opposing the proposed alert in May 2021.
  • The Israeli Ministry of Health had alerted U.S. agencies to myocarditis cases in February 2021, prompting internal discussions and safety reviews, but formal warnings were delayed for months.
  • In April 2025, the FDA expanded myocarditis and pericarditis warnings for males aged 16–25, citing new safety data, while Senate hearings are now scheduled to examine the report's findings.