The U.S. Food and Drug Administration (FDA) has finalized new heart risk warnings for COVID-19 vaccines, specifically targeting Pfizer’s Comirnaty and Moderna’s Spikevax. This update, announced on June 26, 2025, expands and clarifies existing cautions about rare heart complications—myocarditis and pericarditis—primarily among young men. The latest labeling now includes detailed information about incidence rates and highlights the importance of monitoring for heart symptoms following vaccination.
The move follows months of review and public health discussions, with the FDA formally requesting both companies to update their warnings in April. The revised labels reflect new data from commercial health insurance claims, emphasizing that while these heart conditions remain rare, they are most frequently reported in males aged 12 to 24. For the general population aged 6 months to 64 years, the risk is approximately 8 cases per million doses. Among males aged 12–24, however, the rate rises to about 27 cases per million doses.
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What the New COVID Vaccines Heart Risk Warning Means
The updated heart risk warning for COVID-19 vaccines focuses on myocarditis and pericarditis, both forms of heart inflammation. Myocarditis affects the heart muscle, while pericarditis involves the outer lining of the heart. Most cases are mild, with symptoms like chest pain, shortness of breath, or a rapid heartbeat appearing within a week after vaccination. The FDA now requires that this information be clearly communicated to both healthcare providers and vaccine recipients.
Parents, caregivers, and young adults should be aware of these symptoms and seek medical attention if they arise. The FDA’s updated guidance also notes that most people who develop these conditions recover quickly, often without long-term complications. Cardiac MRI studies have shown improvement over time in the majority of affected individuals, though ongoing research is examining whether there are any lasting effects.
This latest warning is not entirely new—both Pfizer and Moderna have included information about heart inflammation risks in their labeling since 2021. However, the FDA’s new requirements provide more specific details about the risk groups and incidence rates, ensuring greater transparency for patients and providers.
Who Is Most Affected by COVID Vaccines Heart Risk?
Young males—especially those between 12 and 24 years old—face the highest risk of myocarditis and pericarditis after receiving mRNA COVID-19 vaccines. The updated labeling now specifies that for every million doses given to males in this age group, there are about 27 cases of heart inflammation. For the broader population (6 months to 64 years), the rate is about 8 cases per million doses.
The previous label highlighted risk primarily in 12- to 17-year-olds, but the new data has prompted the FDA to expand the age range for the warning. While these numbers remain low compared to the risks associated with COVID-19 infection itself, the FDA’s decision underscores the importance of informed consent and careful monitoring, especially for parents and young adults.
Here’s a quick summary of the latest key points:
- Heart risk warning expanded for Pfizer and Moderna COVID-19 vaccines
- Myocarditis and pericarditis are rare but most common in males aged 12–24
- Incidence is about 8 cases per million doses for ages 6 months–64 years
- Among males 12–24, incidence rises to about 27 cases per million doses
- Most cases are mild and resolve quickly, but medical attention is important if symptoms develop
How the FDA’s New Warning Compares to Earlier Guidance
The FDA’s latest heart risk warning for COVID-19 vaccines reflects a more detailed and transparent approach than previous guidance. Earlier warnings focused mainly on adolescents, but the new data has broadened the scope to include young adult males up to age 24. The FDA’s decision was driven by analyses of real-world health insurance claims, which provide a more comprehensive view of vaccine safety.
Some experts have pointed out that the new warning appears to conflict with certain findings from other U.S. government agencies. For example, the Centers for Disease Control and Prevention (CDC) previously stated that there was no increased risk of myocarditis detected in government databases for COVID-19 shots from 2022 onward. However, both agencies agree that cases are generally mild and resolve quickly, and that the risk from COVID-19 infection itself is much greater than the risk from vaccination.
The FDA’s updated labeling is part of an ongoing effort to ensure that patients and healthcare providers have the most current and accurate information about vaccine safety. The agency is also requiring both manufacturers to include the new safety information in their fact sheets for healthcare providers and recipients.
What You Should Do Next
If you or a loved one has recently received an mRNA COVID-19 vaccine, be aware of the symptoms of myocarditis and pericarditis: chest pain, shortness of breath, or a fluttering or pounding heart. If you experience any of these symptoms, seek medical attention promptly. Most cases are mild and resolve with rest and monitoring, but early detection is key.
The FDA’s expanded heart risk warning for COVID-19 vaccines is a reminder of the importance of vaccine safety monitoring and transparency. While the risk of heart inflammation remains rare, staying informed and vigilant can help ensure the best possible outcomes for everyone.
Are you up to date with the latest vaccine safety information? Talk to your healthcare provider about your risk and any concerns you may have.