FDA orders stricter cardiac inflammation warnings for Pfizer and Moderna’s COVID-19 vaccines

05/24/2025 / By Ramon Tomey

The FDA ordered Pfizer and Moderna to add warnings to their COVID-19 vaccines due to new evidence of persistent heart muscle damage (myocarditis) in young males months after vaccination.
The highest incidence of myocarditis and pericarditis now applies to males aged 16-25, broadening previous age brackets (12-17 for Pfizer, 18-24 for Moderna).
A Lancet study found abnormal cardiac MRI findings in young vaccine recipients, with 60% of a 333-person cohort still showing myocardial injury markers five months post-diagnosis, though most cases improved over time.
The FDA took 13 months to act on the Lancet findings, raising concerns about incomplete safety surveillance (VAERS/V-Safe) and deferred reporting deadlines for subclinical myocarditis.
The FDA’s delayed action and unresolved questions about long-term risks intensify skepticism, forcing a reevaluation of vaccine benefits vs. risks – especially for young males (38 myocarditis cases per million doses in high-risk groups).

The Food and Drug Administration (FDA) has mandated updated warning labels for Pfizer and Moderna’s mRNA vaccines for the Wuhan coronavirus (COVID-19), citing new evidence of persistent heart muscle damage in young males months after vaccination.

The regulator outlined this instruction in two letters dated April 17 and addressed to Pfizer representative Heather Hufnagel and Moderna representative Brady Nesbitt. The letters, which were only made public on Wednesday, May 21 – were signed by Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance under the Center for Biologics Evaluation and Research.

The correspondence followed a landmark study published in The Lancet revealing abnormal cardiac MRI findings in adolescents and young adults diagnosed with post-vaccine myocarditis, a potentially fatal inflammation of the heart muscle. The move raises urgent questions about long-term risks, transparency and why federal agencies delayed public disclosure of these findings for over a year after initial detection.

The FDA’s letters to both manufacturers, obtained by the Epoch Times, revealed a critical shift. The highest incidence of myocarditis and pericarditis now applies to males aged 16 to 25, up from previous age brackets of 12 to 17 for Pfizer and 18 to 24 for Moderna.

Forshee cited data showing that nearly 60 percent of patients in a 333-person cohort still exhibited myocardial injury markers five months post-diagnosis. “The clinical and prognostic significance of these findings is not known,” he wrote, albeit emphasizing that most cases showed improvement over time.

FDA’s 13-month delay on heart risk study sparks outrage

The Centers for Disease Control and Prevention maintains a “causal association” between mRNA vaccines and heart inflammation. However, it reported no spike in myocarditis for COVID-19 vaccine formulations released between 2023 and this year.

Yet critics highlight gaps. They pointed to the FDA’s 13-month silence on the Lancet study, incomplete VAERS and V-Safe surveillance systems and Pfizer’s deferred deadlines for subclinical myocarditis reporting. (Related: Emails reveal FDA refused to monitor select COVID-19 vaccine injuries from select vaccine manufacturers.)

A spokesperson for the Department of Health and Human Services defended the process in an email to the Epoch Times. “Americans deserve radical transparency around the safety and efficacy of COVID vaccines, and the FDA is delivering on their promise to do just that,” they wrote.

Historical parallels abound. The 1976 swine flu vaccine debacle, halted after 450 Guillain-Barré syndrome cases, underscores the stakes of rapid vaccine rollouts without robust post-market scrutiny.

Moderna and Pfizer now face a 30-day deadline to update labels or risk penalties, but the FDA’s delayed action has fueled skepticism. With 38 myocarditis cases per million doses in high-risk males and unresolved questions about cardiac outcomes, the updated warnings mark a pivotal moment in the pandemic’s legacy – one where trust in public health institutions hinges on candor about known risks.

As the FDA pledges stronger monitoring, the burden falls on providers and patients to weigh vaccination benefits against emerging evidence. For young males, the calculus just grew more complex.

Watch Dr. Peter McCullough warning that vaccine-induced myocarditis is much more serious than myocarditis as a result of COVID-19 infection.

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