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A new U.S. Senate report alleges that senior officials in the Biden administration’s Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) delayed public warnings about cardiac side effects linked to mRNA COVID-19 vaccines for teenagers and young adults, despite receiving early alerts as early as February 2021.
The report, released Wednesday by the Senate Homeland Security and Governmental Affairs’ Select Permanent Subcommittee on Investigations, draws from more than 2,400 subpoenaed documents and email communications. It accuses Biden-era FDA leaders, including then-Center for Biologics Director Peter Marks and former Acting Commissioner Janet Woodcock, of casting doubt on myocarditis concerns and walking back draft advisories prepared by CDC staff.
According to the report, the CDC had planned to issue a formal Health Alert Network (HAN) bulletin in late May 2021 warning clinicians about the increased incidence of myocarditis and pericarditis — inflammation of the heart muscle or lining — in vaccinated individuals, especially young males. However, internal FDA objections led to the notice being scrapped.
Entire report pdf can be viewed and downloaded here
An internal email dated May 26, 2021, obtained by the committee, shows Woodcock writing to CDC Director Rochelle Walensky that the FDA did “not concur” with the advisory’s release. Additional emails reveal Marks questioning whether the data justified any formal guidance at all, writing, “We still have concerns here if myocarditis and pericarditis have not actually signaled.”
The CDC ultimately replaced the formal HAN bulletin with a less detailed “clinical considerations” page published on May 28, 2021 — omitting key language that would have urged clinicians to restrict young patients with myocarditis from intense physical activity, such as competitive sports, for at least three months.
That guidance had been supported by the CDC’s own Vaccine Safety Technical Work Group just five days earlier.
The delay followed earlier warnings from Israeli health officials, who on February 28, 2021, had alerted the CDC to a spike in myocarditis cases among young vaccine recipients. Additional alerts came from U.S. military health officials, including immunologist Renata Engler, who warned that the V-safe surveillance app failed to track cardiac symptoms like chest pain and palpitations.
“If you do not ask, you will not see it, but does that mean it does not exist?” Engler asked in a presentation obtained by the Senate subcommittee.
Despite mounting evidence, it wasn’t until June 25, 2021, that the FDA updated the official Pfizer and Moderna vaccine fact sheets to include myocarditis and pericarditis warnings. By then, the CDC had already been pressured to soften its own language.
FDA recently expanded those warnings to cover a broader age range: males aged 12 to 25 for both Pfizer and Moderna products, as CBS reported this week.
The Senate report sharply criticized the administration’s internal handling of the risk data. “The Biden administration’s decision to downplay the COVID-19 vaccine health risks and delay warning the public about cardiac-related adverse events associated with the mRNA vaccines jeopardized the public’s health,” the report concludes.
The Department of Health and Human Services only turned over the requested documents after a January 2025 subpoena from Sen. Ron Johnson (R-Wis.), following years of delay and partial responses under the Biden administration.