COVER STORY
conditions, genetic factors, or unhealthy lifestyle choices. It is crucial that public perception is based on evidence, not speculation. Vaccines should continue to be viewed as an essential preventive tool, and efforts should focus on improving awareness about heart health and early detection.”
Public health experts and immunologists have backed ICMR’ s findings but acknowledge the need for continuous monitoring and transparency. A vaccine policy specialist, commented:“ It’ s dangerous to politicize vaccines. However, all scientific bodies should strive for clarity and open access to safety data. Rumors fill the vacuum when communication lags.”
However, some independent scientists have complications. called for an openaccess dashboard of all post-vaccine complications, redacted for personal data, to foster public confidence. A few also criticized the initial pace of ICMR’ s response to concerns raised in late 2024, particularly after some media reports linked unexplained cardiac deaths in metros like Mumbai and Delhi to recent vaccinations.
Global context: Not an isolated debate
India isn’ t alone in grappling with vaccine safety concerns. Similar debates have surfaced in countries such as the United
ICMR study dismisses concerns
Studies by the Indian Council of Medical Research( ICMR) and National Centre for Disease Control( NCDC) affirm that COVID-19 vaccines in India are safe and effective, with extremely rare instances of serious side effects. Sudden cardiac deaths can result from a wide range of factors, including genetics, lifestyle, pre-existing conditions, and post-COVID
States, members of the European Union, and Japan— particularly around mRNA vaccines like Pfizer-BioNTech’ s BNT162b2 and Moderna’ s mRNA-1273. These concerns have largely centered on rare cases of myocarditis and pericarditis, predominantly observed in younger males after the second dose.
In the United States, the Centers for Disease Control and Prevention( CDC) and the Food and Drug Administration( FDA) closely monitored these events. According to a 2022 CDC report, the rate of myocarditis was approximately 12.6 cases per million doses among individuals aged 12 – 39. However, the CDC emphasized that“ the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks.”
In Europe, the European Medicines Agency( EMA) acknowledged similar findings but maintained full support for ongoing vaccination campaigns. The EMA’ s Pharmacovigilance Risk Assessment Committee( PRAC) concluded that“ cases of myocarditis and pericarditis following vaccination are very rare, and the overall benefit-risk balance of COVID-19 vaccines remains positive.”
In Japan, where vaccine hesitancy has traditionally been higher, the Ministry of Health, Labour and Welfare( MHLW) transparently reported adverse events and issued safety updates. Even as it listed myocarditis as a possible side effect for mRNA vaccines, the ministry stated that
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BioVoiceNews | July-August 2025