FDA's long-delayed myocarditis warning exposes vaccine safety failures
By avagrace // 2025-07-05
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  • The FDA has ordered Pfizer and Moderna to update their COVID-19 vaccine labels with clearer warnings about heart inflammation risks (myocarditis and pericarditis), particularly in young males aged 12 to 24.
  • New data shows that many patients, especially males aged 16 to 25, experience lingering heart damage – contradicting earlier claims that side effects were mild and temporary.
  • The FDA's updated warnings follow years of downplaying risks, with critics accusing agencies of suppressing data and acting too slowly to inform the public.
  • While the FDA now acknowledges risks, the CDC maintains that complications are rare and less severe than COVID-19 itself, fueling skepticism about official guidance.
  • Pfizer and Moderna must conduct further research, but results may take years. The delayed transparency has damaged public trust, raising concerns about politicized science and accountability.
The Food and Drug Administration (FDA) has ordered Pfizer and Moderna to update their Wuhan corona virus (COVID-19) vaccine labels with stronger warnings about heart inflammation risks, particularly in young males. The June 25 announcement follows mounting evidence linking mRNA vaccines to myocarditis and pericarditis, conditions involving dangerous swelling of the heart muscle and surrounding tissue. Boys and men aged 12 to 24 remain the most vulnerable, with at least 27 cases per million doses reported in the 2023-2024 vaccination period. The FDA now admits that long-term effects of these injuries remain unknown, raising urgent questions about transparency and accountability in the vaccine rollout. For years, federal health agencies downplayed concerns about vaccine-related heart complications, dismissing them as "rare" and "mild." But newly released data from a government-funded study confirms what independent researchers and parents have warned. Heart abnormalities persist for months in many patients, and nearly half suffer moderate to severe damage. (Related: Oxford study reveals COVID-19 mRNA vaccines as the sole cause of heart inflammation and heart failure in children.) The FDA's updated warning is now mandatory for both Comirnaty (Pfizer) and Spikevax (Moderna). It marks a stark reversal from earlier assurances that side effects were temporary and insignificant. The highest incidence of myocarditis occurs in males aged 16 to 25, with 38 cases per million doses – far exceeding initial estimates. MRI scans reveal lingering heart damage in many patients, contradicting claims by the Centers for Disease Control and Prevention (CDC) that most cases resolve quickly. The regulator insists long-term risks are still being studied. But critics argue the agency acted too slowly, leaving young Americans in the dark about potential dangers.

Why the warnings were delayed

In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. Its decision follows pressure from lawmakers and medical whistleblowers who accused health officials of suppressing data. The updated labels were finalized just hours before a Senate hearing on how federal agencies allegedly concealed vaccine injuries. Notably, Dr. Peter Marks – the FDA's former top vaccine regulator – departed that same month amid internal debates over how to present the risks. The timing suggests bureaucratic resistance delayed critical safety updates, a pattern seen throughout the pandemic. While the FDA now acknowledges myocarditis risks, the CDC maintains its stance that complications are rare and less severe than those caused by COVID-19 itself. This contradiction fuels skepticism about government health guidance. Independent studies, however, show vaccine-induced myocarditis can lead to chronic heart issues, challenging the CDC's optimistic assessments. Pfizer and Moderna must conduct long-term studies on heart risks, but results could take years. With trust in public health institutions eroding, the FDA's belated transparency may be too little, too late for families already affected. Watch this segment from "Get Facts-inated" with Del Bigtree that discusses whether vaccine-induced myocarditis is worse than the myocarditis from contracting COVID-19. This video is from the Informed Consent channel on Brighteon.com.

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Study: COVID-19 vaccines increase risk of heart attack by 127%. New study confirms link between COVID-19 vaccines and serious heart problems. Hong Kong medical experts find evidence suggesting COVID-19 vaccines cause heart disease. Sources include: TheNationalPulse.com CBSNews.com ABCNews.go.com Brighteon.com
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