Serum Institute and IVMA Reassert COVID-19 Vaccine Safety

Amid renewed public discussions about vaccine safety, the Serum Institute of India (SII) and Indian Vaccine Manufacturers Association (IVMA) pointedly reiterated that COVID-19 vaccines are safe, efficacious and scientifically verified.

Their reiteration comes on the heels of speculative assertions on social media linking vaccinations to sudden cardiac events and deaths. “Patient safety and product quality are always prioritised during the vaccine development and its manufacture,” said Dr G V J A Harshavardhan, Director General, IVMA.

The SII and IVMA caried claims with evidence substantiated by the Indian Council of Medical Research (ICMR) and AIIMS; there was no direct association established between COVID-19 vaccines and sudden death. The Indian Council of Medical Research (ICMR) study, a multicentric case–control study of sudden deaths across 47 hospitals in 19 states, found no elevated risk of unexplained sudden death in individuals vaccinated with COVID vaccines in the 18–45 age range. The ongoing multi-year study being conducted by researchers at AIIMS and the ICMR correlates sudden death with a history of heart problems, congenital predispositions and lifestyle, not vaccination.

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The Health Ministry has reiterated that every Covid-19 vaccine that was approved under India’s emergency use authorisation underwent clinical trials and had undergone batch wise assessment by the Central Drugs Laboratory for safety, efficacy and immunogenicity.

India's vaccine manufacturers promote collective reliance on science-laden data substantiated with expert reviewed studies, with the aim of reassuring the public of its commitment to public health. With the dynamic nature of the biopharma and vaccine industry, the authors have confidence as they collectively continue to build upon global safety standards, these statements restore trust that their efforts in very important life-saving immunization will not cause sudden death.