The FDA Is Finally Adding Heart Risk Info to COVID Vaccines.
The U.S. Food and Drug Administration (FDA) has issued an updated warning for Pfizer and Moderna’s COVID-19 mRNA vaccines, including new safety data regarding myocarditis and pericarditis. The June 25 safety communication highlights that males aged 12–24 remain at the highest risk, with at least 27 known cases per million doses during the 2023–2024 vaccination period.
MRI scans from a government-funded study revealed that heart abnormalities often persist for months in vaccine-associated myocarditis patients. The FDA admitted that the long-term consequences of these injuries remain “not known.” The updated warning language was required to be added to the Prescribing Information and Fact Sheets for both Comirnaty (Pfizer) and Spikevax (Moderna), including their Emergency Use Authorization (EUA) versions for children.
The safety communication reads:
“Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.”
The FDA’s revised labeling reflects findings from a U.S. study co-authored by its staff, which tracked approximately 300 myocarditis cases linked to mRNA vaccines. The study found that nearly half of these cases involved moderate to severe injury, with some showing worsening conditions over time.
The FDA has mandated both Pfizer and Moderna to conduct further studies on the long-term heart outcomes of myocarditis cases associated with their vaccines. These investigations are ongoing. Researchers theorize that the condition may result from vaccine-activated immune mechanisms targeting heart muscle cells, potentially linked to spike proteins or other vaccine components.
