FDA Adds Stronger Warning Label: mRNA COVID Shots Cause Myocarditis & Pericarditis
FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Heart Inflammation Following Injection*
On June 25, 2025, the U.S. FDA announced it has approved required updates to the labeling of Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines to include new safety information about the risk of myocarditis (heart muscle inflammation) and pericarditis (inflammation of the heart lining) following vaccination.
The updated warning highlights that the highest risk remains in males aged 12 to 24, with an estimated 27 cases of myocarditis/pericarditis per million doses within a week of receiving the latest mRNA shot. The FDA also cites data showing that signs of heart injury on cardiac MRI often persist for months in those diagnosed with vaccine-related myocarditis — though the long-term impact of this damage remains unknown.
This latest admission reinforces concerns long raised by independent doctors and researchers: that mRNA COVID-19 shots can cause serious, lasting harm to the heart, particularly in young males.
*As of July 3, 2025, no such warning has been issued by Health Canada. No Canadian regulatory body has required the kind of expanded warnings or cardiac‑MRI data disclosure that the FDA just approved.
Watch the announcement by Dr. Vinay Prasad:
In response to the FDA’s announcement, the McCullough Foundation’s Nicolas Huscher, MPH replied:
The FDA Still Ignores That COVID-19 Vaccine-Induced Myocarditis Can Be FATAL — Refuses to Issue a Class I Recall or Even Add a Black Box Warning
🚨 FDA Still Ignores That COVID-19 Vaccine-Induced Myocarditis Can Be FATAL — Refuses to Issue a Class I Recall or Even Add a Black Box Warning
Our peer-reviewed autopsy study PROVED a causal link between COVID-19 vaccines and death from myocarditis:
Hulscher N, Hodkinson R,… https://t.co/BmKStGpz9g pic.twitter.com/WvSBTuAvbh
— Nicolas Hulscher, MPH (@NicHulscher) July 2, 2025
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