FDA updates COVID-19 vaccine warnings for risk of heart inflammation
- The FDA requires Pfizer/BioNTech and Moderna COVID-19 vaccines to add expanded warning labels about rare heart inflammation as of April 17, 2025.
- This update is based on data from 2020 to 2022 indicating that vaccination is linked to a measurable rise in myocarditis cases, particularly among males aged 16 to 25.
- The labels extend previous myocarditis warnings to include pericarditis and specifically target males ages 16 to 25, while cases remain rare and acute myocarditis typically resolves quickly.
- Analysis of vaccine safety data indicates approximately 38 instances of myocarditis and pericarditis per million doses in males aged 16 to 25, and about eight cases per million doses across individuals from six months to 64 years old; the CDC describes this review as the most thorough safety evaluation in U.S. History.
- The FDA has tightened approval evidence for updated COVID-19 vaccines expected this fall and limits availability to adults 65+ and at-risk individuals, as officials call for further placebo-controlled trials before broader recommendations.
22 Articles
22 Articles
FDA expands COVID vaccine heart risk warnings - WNKY News 40 Television
(CNN) – The U.S. Food and Drug Administration will now require COVID-19 vaccines from Pfizer and Moderna to come with new warning labels. The shots already come with a warning about heart inflammation called myocarditis. Moderna’s warning indicates it’s a risk for 18- to 24-year-old males, while Pfizer indicates 12- to 17-year-old boys. Moving forward, both shots will increase that range for males 16 to 25 years old. Myocarditis is extremely rar…
FDA Orders COVID-19 Vaccine Makers to Expand Heart Inflammation Warning - News Addicts
The Food and Drug Administration has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21. The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis. Richard Forshee, acting director of […] The post FDA Orders COVID-19 Vaccine Makers to Expand Heart…


FDA Forces Moderna and Pfizer to Admit Covid “Vaccines” Cause Lasting Heart Damage in Young Males
(Natural News)—For years, parents and medical professionals have sounded the alarm about the dangerous link between mRNA COVID-19 vaccines and heart inflammation in young males—only to be dismissed as “anti-vaxxers” or conspiracy theorists. Now, in a stunning reversal, the U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to strengthen their warning labels, finally admitting that these shots can cause long-lasting heart dama…
Coverage Details
Bias Distribution
- 77% of the sources are Center
To view factuality data please Upgrade to Premium
Ownership
To view ownership data please Upgrade to Vantage