Serum Institute’s COVID-19 vaccine triggers ‘behavioural change’ in participant; drug regulator silent

A source close to the family, according to a report in Times of India, stated that though they had demanded for Rs 5 crore as compensation, their focus was not on receiving the money. They wanted the institute to warn other participants of the adverse event, in addition to knowing why the trials had not been halted like in the United Kingdom. The family questioned if the life of an Indian was less valuable than that of a UK national.

The Indian Council of Medical Research, which is a co-sponsor of the trial along with SII, through Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division, stated that according to protocol, the principal investigator at the trial site has to investigate the issue first. This would be followed by an enquiry by the Institutional Ethics Committee at the trial site. ICMR stated that they had informed the drug controller general of India (DCGI), which heads CDSCO, about the adverse event.

Earlier, ‘Covaxin’, a potential COVID-19 vaccine being developed by Bharat Biotech, currently under Phase 3 trials, reported a serious adverse event during Phase I clinical trials in August. At that time too the trials were not halted. It came to light two months after the issue and then the company had released a statement, which said the adverse event during Phase I clinical trials in August 2020 was reported to the CDSCO-DCGI, within 24 hours of its occurrence and confirmation.

Covaxin is being developed byBharatBiotech, in collaboration with the ICMR – National Institute of Virology (NIV).

In this case, it was a 35-year-old participant with no co-morbidities at a trial site in western India. The participant was hospitalised with viral pneumonitis a couple of days after being administered the vaccine.