New Delhi: Responding to recent remarks by Karnataka Chief Minister Siddaramaiah linking heart-related deaths in Hassan district to COVID-19 vaccination, the Union Health Ministry has reiterated that there is no scientific evidence connecting the vaccines to sudden fatalities.

On Tuesday, Siddaramaiah had suggested that the “hasty approval and distribution” of COVID-19 vaccines could potentially be a cause behind the rise in such deaths. He urged individuals experiencing symptoms like chest pain or breathing difficulties to seek immediate medical attention.

However, the Ministry on Wednesday emphasised that comprehensive studies conducted by the Indian Council of Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS) have found no direct connection between COVID-19 vaccines and sudden deaths.

In a statement, the ministry clarified that multiple investigations by national health agencies — including ICMR and the National Centre for Disease Control (NCDC) — have confirmed that COVID-19 vaccines used in India are both safe and effective, with serious side effects being extremely rare.

According to the ministry, sudden cardiac deaths can result from various causes, such as genetic factors, pre-existing medical conditions, lifestyle habits, and complications following COVID-19 infection.

The ICMR and NCDC have been working together to understand the causes behind sudden unexplained deaths, especially in young adults between the ages of 18 and 45 years. To explore this, two complementary studies were undertaken using different research approaches -- one based on past data and another involving real-time investigation.

ICMR-NIE Study (May–August 2023)
Conducted by the ICMR's National Institute of Epidemiology across 47 tertiary care hospitals in 19 states and Union Territories, this study focused on individuals aged 18–45 who died suddenly between October 2021 and March 2023. This study found that no increased risk of unexplained sudden deaths was associated with COVID-19 vaccination.

Ongoing AIIMS Study
Titled “Establishing the Cause in Sudden Unexplained Deaths in Young,” this prospective study—carried out in collaboration with ICMR—aims to determine common causes of sudden deaths in young adults. Early analysis of data from the study indicates that heart attacks or myocardial infarction (MI) continue to be the leading cause of sudden death in this age group, the statement said. Genetic mutations have also been identified as a factor in many unexplained cases.

Final findings will be released once the study is complete.

COVID vaccine does not increase risk
Together, these two studies offer a more comprehensive understanding of sudden unexplained deaths in young adults in India. It has also been found that COVID-19 vaccination does not appear to increase the risk, whereas, the role of underlying health issues, genetic predisposition and risky lifestyle choices does play a role in unexplained sudden deaths, the statement said.

"Scientific experts have reiterated that statements linking Covid vaccination to sudden deaths are false and misleading, and are not supported by scientific consensus," the statement said.

Speculative claims without conclusive evidence risk undermining public confidence in vaccines, which have played a crucial role in saving millions of lives during the pandemic, it said.

Such unfounded reports and claims could strongly contribute to vaccine hesitancy in the country, thereby adversely impacting public health.

The government remains committed to evidence-based public health research to protect the well-being of its citizens, the statement said.

Karnataka CM's arguments
The Karnataka chief minister had said more than 20 people have died due to heart attacks in the past month alone in just one district of Hassan.

"The government is taking this matter very seriously. To identify the exact cause of these series of deaths and to find solutions, a committee of experts has been formed under the leadership of Dr Ravindranath, Director of Jayadeva Institute of Cardiovascular Sciences and Research, and they have been instructed to submit a study report within 10 days," he said in a post on X.

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