Senator Ron Johnson (R-Wis.), chairman of the Senate’s Permanent Subcommittee on Investigations (PSI), released a bombshell interim report on Wednesday exposing how federal health agencies under the Biden administration suppressed early warnings about heart inflammation linked to mRNA Covid vaccines.
In a press release, his office stated:
The report, which follows Chairman Johnson’s Jan. 28, 2025 subpoena to the Department of Health and Human Services (“HHS”), reveals how federal health officials who were aware of reports of heart inflammation conditions associated with mRNA COVID-19 vaccines delayed notifying the public while downplaying the risks.
The report includes over 2,400 pages of subpoenaed records. These documents show that U.S. officials were warned by Israeli counterparts as early as February 2021. The warnings involved cases of myocarditis following Pfizer’s vaccine, especially in young men.
Key Findings
With the release of the interim report and subpoenaed documents obtained from the Trump administration, the public now has access to a far more complete record, said the senator. Unlike the heavily redacted productions released by the Biden administration under the Freedom of Information Act, these materials reveal, in detail, how federal health officials concealed risks linked to Covid-19 vaccines.
According to the Permanent Subcommittee on Investigations, the records show a pattern of delay, suppression, and coordinated messaging aimed at avoiding public alarm.
The report outlines the following findings:
Federal health officials knew of myocarditis risks early
As early as February 28, 2021, Israel’s Ministry of Health warned the CDC about “large reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine.”
Centers for Disease Control and Prevention (CDC) and Defense officials discussed safety signals in April 2021
A Defense Health Agency consultant warned that key monitoring systems like V-safe were not capable of detecting cardiac-related side effects. “If you do not ask, you will not see it,” the consultant said, questioning the absence of myocarditis tracking.
CDC and the Food and Drug Administration (FDA) acknowledged a safety signal by late May 2021
Internal meeting notes confirm that both agencies saw a signal for myopericarditis among 16- to 24-year-olds. The CDC considered issuing a Health Alert Network (HAN) warning, but never followed through.
The White House issued talking points instead
On May 25, 2021 — just one day after the myocarditis safety signal was confirmed — officials distributed guidance downplaying the risks. The message was clear: Keep pushing the vaccine, assure the public the adverse event is “rare,” and avoid fueling hesitancy.
FDA blocked a formal warning
Then-acting FDA Commissioner Janet Woodcock explicitly rejected the CDC’s draft HAN message. Officials chose instead to post “clinical considerations” on the CDC website, with no national alert.
Internal concerns were suppressed
Dr. Peter Marks of the FDA’s Center for Biologics Evaluation and Research (CBER) expressed hesitation even about publishing the clinical guidance. Dr. Demetre Daskalakis advised “walking back” statements warning against physical activity after myocarditis.
Pfizer and Moderna were kept better informed than the public
Internal emails show that vaccine manufacturers received detailed updates about the myocarditis discussions. Doctors and patients remained in the dark, though.
Label changes were delayed
It was not until late June 2021 that the FDA formally added myocarditis and pericarditis warnings to the Pfizer and Moderna products, long after internal records confirmed the safety signal.
Senator Johnson stated that the documents “offer a simple, yet troubling, answer” to why this information was withheld: Officials feared vaccine hesitancy more than they valued informed consent.
“They weren’t finding what they weren’t looking for,” Johnson said in his statement. He added,
They did not want the public or Congress to ever know the complete extent of their awareness of and lack of response to mRNA COVID-19 vaccine adverse health events.
The report concludes that the Biden administration knowingly downplayed cardiac-related risks to protect vaccine rollout momentum. The subcommittee promises continued oversight as more redacted and hidden documents are released.
FDA Orders Label Update for Heart Risks
Amid growing scrutiny over vaccine safety, the FDA — now under new Trump administration leadership — has formally directed Pfizer/BioNTech and Moderna to revise the warning labels on their Covid vaccines. The agency cited new safety data showing ongoing cardiac abnormalities linked to mRNA shots.
The FDA sent letters to both companies on April 17, but they were not publicized until May 21. In them, the agency flagged the “persistence of abnormal cardiac magnetic resonance imaging findings” as signs of myocardial injury in vaccinated individuals. It labeled this “new safety information” that requires an immediate label update.
Pfizer and Moderna were given 30 days to comply or challenge the order. The deadline passed on May 17.
Current labels already warn of myocarditis and pericarditis. However, the FDA has asked both companies to revise the affected age range. Pfizer currently lists the highest risk as males 12-17, and Moderna as 18-24. The new requirement is to state that “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age.”
These cardiac complications have long been associated with mRNA vaccines, especially after second doses.
HHS continues to endorse Covid vaccinations for “everyone 6 months and older” as “the best way to help protect people from COVID-19.”
What Comes Next?
The PSI report does more than expose a bureaucratic failure. It opens a series of urgent questions about accountability, ethics, and public safety.
Will any officials face consequences for suppressing myocarditis warnings? If a private company hid these risks, there would be criminal investigations. Should federal officials be held to a lower standard?
Were the laws broken? Could this qualify as fraud, negligence, or a violation of informed-consent protections under U.S. and international law?
What about Pfizer and Moderna? Internal emails show they were kept better informed than the public. Did they knowingly stay silent — or were they simply protected by regulators?
Under the Trump administration, the FDA — now led by Dr. Marty Makary — is demanding tighter warnings and reshaping future vaccine approvals focusing on “high-risk” groups. But will the new leadership go further and pursue real accountability?
And then there’s the question many now ask: Should the Covid vaccination program be paused altogether?
With suppressed safety signals, incomplete guidance, no meaningful long-term safety trials, and trust in public health at a low point, continuing mass vaccination with products shielded from liability — especially for low-risk individuals — may no longer be defensible.
Setting aside for the moment the crucial point that the federal government’s involvement in healthcare is completely unconstitutional, the fact is that informed consent cannot exist when key risks are hidden. If the government wants to rebuild trust, it must start by telling the full truth — and proving that no one is above accountability.
