FDA Issues New Warning: Covid Vaccines May Pose Heart Risks, Labels to Include Myocarditis Alert
- byPranay Jain
- 22 May, 2025

As Covid-19 cases begin to rise again in several parts of the world, concerns regarding vaccine side effects have re-emerged. In a significant move, the U.S. Food and Drug Administration (FDA) has now directed major pharmaceutical companies like Pfizer and Moderna to include a mandatory warning on their Covid-19 vaccine labels, highlighting the risk of heart-related issues such as myocarditis and pericarditis.
This update aims to ensure that individuals are fully informed about potential side effects before receiving the vaccine, especially as health authorities continue to promote booster doses in vulnerable populations.
What Are Myocarditis and Pericarditis?
- Myocarditis is an inflammation of the heart muscle, while pericarditis refers to inflammation of the outer lining of the heart.
- These conditions can cause symptoms ranging from chest pain and fatigue to shortness of breath and, in severe cases, heart attack or heart failure.
- Though such cases are rare, they have been observed particularly in young males after mRNA vaccinations, prompting further investigation by health authorities.
FDA's Stand: Transparency for Public Awareness
The FDA’s directive comes in response to growing concerns and reported incidents of post-vaccine cardiac complications. According to the FDA, this labeling change is part of a transparency effort to inform the public about all possible risks — however rare they may be — so individuals can make well-informed decisions in consultation with their healthcare providers.
This development does not imply that the vaccines are unsafe, but rather emphasizes the importance of full disclosure, especially for people with pre-existing heart conditions or weakened immunity.
Past Claims and WHO’s Response
While concerns over heart-related side effects have surfaced in the past, they were largely dismissed by health bodies like the World Health Organization (WHO) and Indian Council of Medical Research (ICMR), citing lack of conclusive evidence. However, the FDA’s recent step indicates a more cautious approach toward vaccine safety, particularly in light of new reports and studies suggesting a possible link between mRNA vaccines and rare cardiac side effects.
Rise in Covid Cases: Should You Be Worried?
Covid-19 is once again gaining traction in countries like Singapore and India, with the emergence of a new JN.1 sub-variant. At present, this variant does not appear to be more dangerous or highly transmissible than earlier strains, but experts are urging vulnerable groups to remain cautious.
People with existing health conditions such as:
- Heart disease
- Kidney infections
- Cancer
- Or compromised immunity
...should continue to follow precautionary measures, including wearing masks in crowded places, maintaining hygiene, and avoiding unnecessary travel.
Should You Still Take the Vaccine?
Yes — but with awareness. Experts continue to stress that the benefits of Covid vaccination far outweigh the risks. The warning is a preventive step meant to guide individuals, not discourage them from getting vaccinated. If you or someone in your family has a history of heart conditions, it is best to consult a doctor before proceeding with the vaccine or booster dose.