In the wake of Karnataka Chief Minister Siddaramaiah linking heart-related deaths in Hassan district to Covid vaccine, the Union Health Ministry on Wednesday said extensive studies by ICMR and AIIMS have conclusively established no linkages between coronavirus vaccines and sudden deaths.
Siddaramaiah had on Tuesday said "hasty approval and distribution" of the Covid vaccine to the public could also be a reason for these deaths.
He urged everyone to visit the nearest health centre immediately for a check-up if they have symptoms such as chest pain or difficulty breathing, and not to ignore these signs.
The ministry said the matter of sudden unexplained deaths has been investigated through several agencies in the country and these studies have conclusively established that there is no direct link between COVID-19 vaccination and reports of sudden deaths.
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, it said.
Sudden cardiac deaths can result from a wide range of factors, including genetics, lifestyle, pre-existing conditions, and post-Covid complications, the ministry said in a statement.
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.
The first study conducted by ICMR's National Institute of Epidemiology (NIE) was titled "Factors associated with unexplained sudden deaths among adults aged 18-45 years in India - a multi-centric matched case control study." This study was carried out from May to August 2023 across 47 tertiary care hospitals in 19 states and Union territories, the statement said.
It looked at individuals who appeared to be healthy but died suddenly between October 2021 and March 2023.
The findings have conclusively showed that COVID-19 vaccination does not increase the risk of unexplained sudden deaths in young adults.
The second study titled "Establishing the cause in sudden unexplained deaths in young" is currently being conducted by the All India Institute of Medical Sciences (AIIMS), New Delhi with funding and in collaboration with ICMR.
This is a prospective study aimed at determining the 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.
Importantly, no major changes in the pattern of causes have been observed when compared with previous years. In majority of the unexplained death cases, genetic mutations have been identified as a possible cause of these deaths. The final results will be shared once the study is complete.
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.
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.
