A study conducted by the Indian Council of Medical Research (ICMR) has observed that COVID-19 vaccination did not increase the risk of unexplained sudden death among young adults in India, the government informed Parliament on Friday.
In a written reply to a question in the Lok Sabha, Health Minister Mansukh Mandaviya said post hospitalisation due to COVID-19, the family history of sudden death and certain lifestyle behaviours increased the likelihood of unexplained sudden deaths.
The minister was responding to a question on whether there has been any reported instance of a linkage between Covid vaccination and incidents of heart attacks in the country.
Sudden deaths have been reported in some people after they contracted Covid, but sufficient evidence is not available to confirm the cause of such deaths, Mandaviya said.
To ascertain the facts regarding the apprehension of a rising number of cardiac arrest cases after Covid, the ICMR's National Institute of Epidemiology (NIE) conducted a study titled 'Factors associated with unexplained sudden deaths among adults aged 18-45 years in India -- A multicentric matched case-control study' at 47 tertiary-care hospitals located across 19 states and Union territories from May to August.
A multi-centric matched case-control study was conducted. The cases that were studied were apparently of healthy individuals aged 18-45 years without any known co-morbidity, who suddenly died of unexplained causes between October 1, 2021 and March 31, 2023, Mandaviya elaborated.
Four controls were included per case matched for age, gender and neighbourhood. Information was collected regarding data on Covid vaccination, infection, post-Covid conditions, family history of sudden death, smoking, recreational drug use, alcohol frequency, binge drinking and vigorous-intensity physical activity two days before death.
A total of 729 cases and 2,916 controls were included in the analysis.
"It was observed that the receipt of at least one dose of a COVID-19 vaccine lowered the odds for unexplained sudden death, whereas past COVID-19 hospitalisation, family history of sudden death, binge drinking 48 hours before death/interview, use of recreational drug/substance and performing vigorous-intensity physical activity 48 hours before death/interview were positively associated," the minister said.
Two doses of a vaccine lowered the odds of unexplained sudden death, whereas a single dose did not, he added.
"Hence, the study observed that COVID-19 vaccination did not increase the risk of unexplained sudden death among young adults in India. Past COVID-19 hospitalisation, family history of sudden death and certain lifestyle behaviours increased the likelihood of unexplained sudden death," Mandaviya said.
There is a nationwide adverse event following immunisation (AEFI) surveillance system under the health ministry that continuously monitors reports of vaccine-related AEFIs through the CoWIN app.
These are investigated in a time-bound manner at the district level and then AEFI causality is done at the state and national levels, and analysed by the National AEFI Committee on a regular and time-bound basis. Prima facie, no direct signal has emerged till date linking heart attack to Covid vaccines, the minister said.
"The ICMR is not currently conducting any studies for assessing the potential risks associated with the administration of COVID-19 vaccines in children," he added.
However, a phase 2/3 open-label, non-randomised, multi-centre study on the immunogenicity and safety of the BBV152 vaccine conduced in six hospitals on healthy children (male or female) aged 2-18 years observed that the vaccine was well tolerated with no serious adverse events, deaths or withdrawals.
Another prospective observational study on side-effects of the Corbevax vaccine in children aged 12 14 years demonstrated that it is a safe vaccine with a few mild side-effects, Mandaviya said.
