Study concluded Covid vaccine didn't increase unexplained sudden death risk: Nadda to RS

New Delhi, Dec 10: An ICMR study has conclusively documented that Covid vaccination did not increase the risk of unexplained sudden death among young adults in India, instead lowering their odds, Union Health Minister J P Nadda told the Rajya Sabha on Tuesday.

Past COVID-19 hospitalization, family history of sudden death and certain lifestyle behaviours increased the likelihood of unexplained sudden death, he said responding to a question.

He said the Indian Council of Medical Research (ICMR) has informed that the ICMR-National Institute of Epidemiology 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 in 19 states and Union Territories during May-August last year.

The cases were apparently healthy individuals without any known co-morbidity, who suddenly (less than 24 hours of hospitalisation or seen apparently healthy 24 hours before death) died of unexplained causes between October 1, 2021, and March 31, 2023, Nadda said.

Four controls were included per case matched for age, gender and neighbourhood. Information was collected regarding data on COVID-19 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 among the cases / interviewed controls.

A total of 729 sudden death cases and 2,916 controls were included in the analysis.

It was observed that receipt of any dose of COVID-19 vaccine reduced the odds of unexplained sudden death. Receiving two doses of COVID-19 vaccine significantly reduced the odds of unexplained sudden death.

Past Covid 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 increased the odds of sudden death, the Union health minister said.

"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 hospitalization, family history of sudden death and certain lifestyle behaviours increased the likelihood of unexplained sudden death," Nadda said.

He also told the House the Covid-19 Vaccine Administration Cell has informed that a robust adverse event following immunization (AEFI) surveillance system has been in place under the guidance of the national AEFI committee to evaluate each vaccine-related adverse event and fatalities reported.

"The study mentioned has conclusively documented that COVID-19 vaccination did not increase the risk of unexplained sudden death among young adults in India, and it has instead lowered the odds for unexplained sudden death," Nadda said.

The government has implemented several strategies to raise public awareness regarding vaccine side-effects reporting and to ensure timely medical interventions for affected individuals, he informed the Rajya Sabha.

Nadda said guidelines were issued to states and Union Territories to direct district immunization officers to strengthen reporting of AEFIs following COVID-19 vaccination.

For the reporting of COVID-19 vaccine AEFIs, the SAFEVAC (a web-based application for AEFI) has been integrated into Co-WIN for reporting of AEFIs. The Co-WIN SAFEVAC has the provision of reporting AEFIs by the vaccinator, district immunization officer and the beneficiary themselves.

Frequently Asked Questions with details of Adverse effects of COVID-19 vaccines is available on the Health Ministry's website, the minister said.

Besides, information, education and communication material on AEFI have been shared with states for translation into local language and display at the vaccination session sites. Awareness on AEFI-related information and messages were also amplified through social media and the engagement of various immunization partners.

To ensure timely medical interventions for affected individuals, preventive measures have been put in place like compulsory observation of vaccine recipients for 30 minutes at the session site for any adverse events after vaccination, availability of anaphylaxis kit at each vaccination site and immediate referral to AEFI management centre for timely treatment.

The AEFI management of such cases has been provided free of cost treatment in public health facilities, Nadda added.