A newly released interim report by the Senate Permanent Subcommittee on Investigations alleges that federal health agencies, under the Biden administration, withheld timely warnings about a known risk of myocarditis associated with mRNA COVID-19 vaccines. The report, based on thousands of pages of unredacted records obtained via subpoena, outlines a detailed timeline showing internal awareness of the heart condition, especially among young people, and a failure to formally alert the public until months later.
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Key documents reveal that by early 2021, officials at the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) were aware of increasing reports of myocarditis, particularly among males aged 16 to 24, following vaccination with Pfizer and Moderna’s COVID-19 vaccines. Despite internal discussions and draft alerts, including a planned nationwide Health Alert Network (HAN) message, a formal warning was never issued. Instead, limited information was quietly added to the CDC’s website in late May 2021, just weeks after the vaccine was authorized for adolescents.
CDC emails show that officials were aware of underreporting of adverse events in the Vaccine Adverse Event Reporting System (VAERS) and considered issuing a formal alert to health providers, many of whom were reportedly unaware of the myocarditis link. Internal records also show the CDC shared early drafts of safety guidance with Pfizer and Moderna, while the broader public remained uninformed. Notably, FDA officials including then-Acting Commissioner Janet Woodcock expressed opposition to the draft HAN, influencing the decision to halt its publication.
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Additionally, the Defense Health Agency warned in April 2021 that the government’s V-safe monitoring system was inadequate in identifying cardiac events, yet no substantive updates were made to address these concerns. Revised guidance instead restricted follow-up calls to only the most severe cases. Communications reviewed by the Subcommittee also show that White House officials circulated talking points in May 2021 downplaying the severity and frequency of myocarditis cases.
The interim report underscores that a formal warning from federal health authorities did not materialize until June 25, 2021, when the FDA updated vaccine labels to acknowledge the risk. The Subcommittee continues to investigate why key communications and warnings were delayed, and why pharmaceutical companies appeared to receive more timely updates than the medical community or the public.
Associated documents for this story are available in our Public Information Archive.
Article by multiple RFHC contributors, based upon information from the U.S. Senate Permanent Subcommittee on Investigations interim report, May 21, 2025.
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