A newly released interim report from the U.S. Senate’s Permanent Subcommittee on Investigations has revealed that top federal health agencies, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), received early warnings about potential heart inflammation risks tied to COVID-19 mRNA vaccines but withheld that information from the public for months.

Senator Ron Johnson (R-Wis.), chairman of the subcommittee, released over 2,400 pages of documents along with a non-final report titled “Failure to Warn: How Federal Health Agencies Downplayed the Risk of Myocarditis and Other Adverse Events Following COVID-19 Vaccination.”

The findings were announced ahead of a Senate hearing held on Wednesday.

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The report concludes that federal officials were first notified in February 2021—barely two months after the Pfizer and Moderna vaccines received emergency use authorization—of a possible link between mRNA vaccinations and myocarditis, particularly among younger individuals.

Despite that early notification, the CDC did not publicly acknowledge the potential risk until late May 2021.

According to the documents, Israeli health officials reached out to the CDC and FDA in February 2021 after observing an uptick in myocarditis cases, especially among teenagers and young adults, following Pfizer vaccinations.

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Israel had at that time launched an aggressive national vaccination campaign, including individuals aged 16 and older.

One CDC official described the Israeli inquiry in an internal message: “The Israeli National Focal Point is noticing a large number of reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine.”

Following the Israeli contact, internal meeting notes from the CDC’s Vaccine Safety Technical Work Group dated February 26, 2021, revealed early reports of deaths associated with cardiovascular issues after vaccination.

Among the 470 death reports from long-term care facilities, cardiovascular causes were frequently cited.

Despite increasing data and concern from international and domestic sources, the FDA authorized Pfizer’s mRNA vaccine for children as young as 12 in early May 2021.

Around that time, CDC Director Rochelle Walensky received additional internal updates regarding similar myocarditis cases being reported in Europe.

By mid-May, health officials began drafting a Health Alert Network (HAN) notice to inform U.S. medical providers about the developing myocarditis concerns.

Draft notes show that the CDC vaccine safety group determined that the vaccine surveillance system was showing “signals” for myopericarditis in the 16–17 and 18–24 age groups.

However, the FDA intervened. Then-Commissioner Janet Woodcock and Peter Marks, Director of the Center for Biologics Evaluation and Research, expressed reservations about releasing an alert that could generate public alarm.

The HAN alert was subsequently canceled. Instead, the CDC quietly posted a “clinical considerations” notice on its website on May 28, 2021, which did not include stronger language or recommendations from the original draft.

One recommendation that was removed from the final web-posted version suggested doctors advise patients recovering from myocarditis to avoid strenuous physical activity, such as competitive sports, for at least three months due to the potential for cardiac complications.

The Senate subcommittee also examined communications from the Biden-Harris administration.

The report claims the White House distributed a 17-page document of talking points to senior officials at HHS, CDC, and FDA days before the CDC’s public notice.

These internal documents downplayed myocarditis risks as rare and promoted a narrative of continued transparency, despite internal memos acknowledging underreporting and data limitations.

Sen. Johnson criticized the administration for what he called a pattern of avoiding accountability.

“After facing four years of the Biden administration’s efforts to undermine the public’s access to information and my oversight work, I immediately issued a subpoena to HHS when I became chairman of this committee,” he said at Wednesday’s hearing.

🚨 DR DREW: “Senator Ron Johnson just had a hearing where he revealed the extraordinary evidence of myocarditis in young males and that the [Biden] administration and the FDA and the NIH knew about it and suppressed this information, leading God knows how many kids to serious… pic.twitter.com/jdVT0oMTfN

— Chief Nerd (@TheChiefNerd) May 23, 2025

The report suggests that what was once dismissed as conspiracy theory has become the basis for an active Senate investigation and may lead to new standards in vaccine monitoring and public health communications.

Further hearings and a final report are expected later this year.

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