Safe, no link to sudden deaths: Covishield maker after Siddaramaiah's vaccine remark

Karnataka chief minister Siddaramaiah had said that the recent heart attack deaths in Hassan may be linked to the Covid-19 vaccination drive.

After Karnataka chief minister Siddaramaiah linked the recent heart attack deaths in Hassan district to the Covid-19 vaccines, Covishield's maker, Serum Institute of India, has denied such a connection and said that it is "safe and scientifically validated".

Karnataka CM Siddaramaiah had also said that the Covid-19 vaccines were "hastily" approved. (Bloomberg)

The vaccine maker has backed the statement given by the ministry of health, which cited two large-scale studies by ICMR and AIIMS to affirm that no links have been found between Covid-19 vaccines and sudden deaths.

"In light of recent concerns, we affirm: Two large-scale studies by ICMR and AIIMS, as cited by the Ministry of Health (@MoHFW_INDIA) have found no link between COVID-19 vaccines and sudden deaths. The vaccines are safe and scientifically validated," SII said in a post on its X handle.

Congress leader and Karnataka CM Siddaramaiah had said that the vaccines were "hastily" approved, adding that the recent heart attack deaths in Hassan may be linked to the vaccination drive.

Earlier the central government also issued a release in this regard and said, "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 complications."

The findings of the first study conducted by ICMR's National Institute of Epidemiology (NIE), titled “Factors associated with unexplained sudden deaths among adults aged 18-45 years in India – A multicentric matched case–control study", conclusively revealed that Covid-19 vaccination "does not increase the risk of unexplained sudden deaths in young adults".

Meanwhile, the second study, being carried out by the All India Institute of Medical Sciences (AIIMS), titled “Establishing the cause in sudden unexplained deaths in young," has from its early analysis, indicated that heart attacks, or myocardial infarction (MI), continue to be the leading cause of sudden death in this age group.

"It has also been revealed 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 ministry of health's statement added.

Further, citing scientific experts, the statement termed all reports linking Covid-19 vaccination to sudden deaths as "false" and "misleading", saying that they are not supported by scientific consensus.

What are doctors saying?

Dr Rajiv Narang, Professor & Head, Department of Cardiology, AIIMS, while addressing a press conference, said that knowing the cause behind the sudden spike in young people dying from a heart attack is important. He addressed the growing speculation over the links between these deaths and the Covid-19 vaccine, saying that there was no significant increase in any side effects soon after vaccination.

"What we are talking about is that very small, let's say 0.001 per cent increase if it is there… The study done by ICMR and AIIIMS found that those who got COVID vaccines, they were actually having less risk of sudden cardiac death. Those who got two doses lowered the odds of unexplained sudden death by 50 per cent… This is very clearly showing that COVID vaccine was actually beneficial and not really harmful," he added.

Dr Karan Madan, Associate Professor, Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS Delhi, also backed Dr Narang's statement in saying that the vaccines, which were used on a large number of people, "provided a lot of benefits in preventing excess mortality".

"The benefits provided by the vaccines are immense. A study was done on sudden cardiac deaths to review the vaccines used so far, but no clear association was found with sudden cardiac deaths," Madan said during the press conference.

Siddaramaiah's allegations

Meanwhile, in Hassan, Siddaramaiah ordered a high-level probe into the sudden spike in deaths by cardiac arrest. Within a span of 24 hours, a total of 21 such deaths were reported in the district over the past 40 days.

While announcing the formation of an expert panel led by Dr CN Manjunath on Tuesday, Siddaramaiah also questioned the side effects of Covid-19 vaccine. “Why are young and otherwise healthy individuals dying so suddenly?” he asked in a post on X.

Siddaramaiah cited international studies indicating a potential link between Covid-19 vaccines and rising cardiac arrest incidents, saying that the Centre cannot rule out this possibility. He said that the Union government's "rushed approval and mass rollout” of the vaccines might have contributed to unintended health consequences.

“We have taken the issue seriously and a comprehensive evaluation is underway, including detailed examinations of patients with heart-related ailments,” he said. “There are global reports indicating a possible correlation between the vaccines and cardiac incidents.”

The Karnataka CM said that the expert panel in Hassan will explore medical, environmental, and any other vaccine-related factors that might be contributing to the spike in cardiac deaths.