The FDA’s announcement follows evidence that mRNA COVID-19 vaccines carry a risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the pericardium, the sac-like membrane surrounding the heart). This is particularly the case in males aged 16 to 25, for whom analysis of insurance data has found that cases of myocarditis occur as frequently as one in 250 doses. A recent Congressional investigation claimed the Biden administration may have downplayed such risks by suppressing a U.S. Centers for Disease Control and Prevention (CDC) Health Alert Network message.
In addition to the new labeling requirements, the FDA has also said that updated COVID-19 vaccines will no longer be automatically approved without clinical safety trials and may soon stop being routinely recommended for children, teens, and pregnant women. The expanded warnings and regulatory changes come amid growing scrutiny of mRNA vaccine safety and highlight concerns that immune reactions to vaccine components may trigger heart inflammation.
To read how a growing number of people – scientists, doctors, and ordinary observers alike – are raising new concerns about the safety of mRNA vaccines, see this article on our website.
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May 30, 2025Trump’s FDA Drops COVID-19 Vaccine Bombshell as Pfizer and Moderna Admit Heart Damage Risk
News
The United States Food and Drug Administration (FDA) is forcing Pfizer and Moderna to use expanded warning labels about the risks of heart damage tied to COVID-19 vaccines.
[Source: dailymail.co.uk]
[Image source: Adobe Stock]
Comment
The FDA’s announcement follows evidence that mRNA COVID-19 vaccines carry a risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the pericardium, the sac-like membrane surrounding the heart). This is particularly the case in males aged 16 to 25, for whom analysis of insurance data has found that cases of myocarditis occur as frequently as one in 250 doses. A recent Congressional investigation claimed the Biden administration may have downplayed such risks by suppressing a U.S. Centers for Disease Control and Prevention (CDC) Health Alert Network message.
In addition to the new labeling requirements, the FDA has also said that updated COVID-19 vaccines will no longer be automatically approved without clinical safety trials and may soon stop being routinely recommended for children, teens, and pregnant women. The expanded warnings and regulatory changes come amid growing scrutiny of mRNA vaccine safety and highlight concerns that immune reactions to vaccine components may trigger heart inflammation.
To read how a growing number of people – scientists, doctors, and ordinary observers alike – are raising new concerns about the safety of mRNA vaccines, see this article on our website.
Dr. Rath Health Foundation
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