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Pfizer, Moderna forced to update COVID-19 vaccine labels after FDA confirms heart inflammation risk highest in teenage boys

By isabelle // 2025-06-27

• FDA mandates stronger heart inflammation warnings for Pfizer and Moderna COVID-19 vaccines, especially for young males.
• New labels reveal 27 cases per million doses in males aged 12-24, with some patients showing lasting heart damage.
• FDA delayed action despite years of evidence, raising questions about accountability and transparency.
• CDC still recommends vaccines for all ages, ignoring disproportionate risks to young people.
• Critics demand full disclosure of vaccine risks and compensation for injured patients, as long-term effects remain uncertain.

In a long-overdue move to protect public health, federal regulators this week finally forced Big Pharma giants Pfizer and Moderna to update their COVID-19 vaccine labels with stronger warnings about life-threatening heart inflammation, particularly in young males. The Food and Drug Administration (FDA) announced on June 25 that the revised labels must now explicitly state that myocarditis and pericarditis occur "most commonly in males 12 years through 24 years of age," with alarming rates of 27 cases per million doses in this vulnerable group. While the FDA deserves some credit for this belated transparency, the question remains: Why did it take years of mounting evidence and irreversible harm to countless young people before regulators acted?

New warnings confirm long-suspected risks

The updated labels reflect disturbing 2024 FDA research showing that some patients suffered heart scarring months after vaccination, raising serious concerns about permanent cardiac damage. Although federal officials claim most cases resolve with treatment, the long-term consequences remain unknown, with manufacturers still conducting studies. The revised warnings also reveal that the estimated incidence of myocarditis or pericarditis within seven days of vaccination is eight cases per million doses in people ages 6 months through 64 but skyrockets to 27 cases per million in males ages 12 to 24. Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance, pointed to newer research, including a 2024 FDA study that found persistent heart abnormalities in myocarditis patients months after vaccination. "In most people who have had myocarditis or pericarditis after receiving an mRNA COVID-19 vaccine, symptoms have gone away a few days after receiving treatment," the labels state. Yet they also admit: "It is not known if these heart MRI findings might predict long-term heart effects."

A pattern of delayed accountability

This isn’t the first time regulators have dragged their feet. The FDA first added myocarditis warnings in June 2021, which was several months after officials first learned of cases, yet they continued pushing the shots for children and young adults. Even now, the CDC’s outdated webpage (last updated October 2023) still claims "COVID-19 vaccination is recommended for everyone ages 6 months and older," despite mounting evidence that healthy young people face disproportionate risks. Meanwhile, the Biden administration’s relentless vaccine mandates coerced millions into taking these experimental shots under the false pretense of absolute safety. How many parents, had they known the true risks, would have refused to subject their teenage sons to potential lifelong heart damage?

The fight for medical transparency isn’t over

While the FDA’s label update is a step toward accountability, it’s a small one. The agency still refuses to acknowledge the full scope of vaccine injuries, and Pfizer and Moderna—both of which ignored media inquiries—have yet to issue any public statements addressing these risks. Worse, the CDC continues to push COVID-19 shots for all age groups, ignoring data showing that myocarditis rates in young males far exceed the background rate. The truth is that this scandal is far from over. With studies still underway to assess long-term cardiac damage  and vaccine-injured patients struggling to get recognition—let alone compensation—from the government’s broken compensation system, the full consequences of this medical experiment may not be known for years. The FDA’s belated label changes confirm what independent researchers and courageous doctors have warned about for years: COVID-19 vaccines carry serious, potentially life-altering risks for young people. While regulators and pharmaceutical giants hope this minor concession will quiet critics, the American people deserve more than half-truths and bureaucratic foot-dragging. They deserve full transparency, real informed consent, and accountability for those who suppressed critical safety data. Until then, this fight is far from over. Sources for this article include: TheEpochTimes.com Newsweek.com APNews.com

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