Adverse events in volunteers have no link to clinical trials, says DCGI
The country’s top drug regulator on Friday gave clean chit to Serum Institute of India(SII) and Bharat Biotech, which are facing allegations of serious adverse events (SAE) in the clinical trials.
Drug Controller General of India (DCGI) VG Somani hinted that the trials are progressing as the SAEs reported have no causal link to the trials of these vaccines. He was replying to queries of reporters at a webinar.
“It has been found that things are going on as per processes,” Somani told the media, referring to the two incidents of SAEs.
Compensation is given when the causality of serious adverse event is found to be related to the trial, he said.
An SAE is any untoward medical occurrence during the trial that may result in the volunteer getting hospitalised, suffers disability, or death. But the causality on whether the SAE is related to the clinical trial has to be established by an expert committee of DCGI for the compensation.
Somani also said that compensation of Rs 12 crore has been awarded for injuries, deaths caused during clinical trials in last 3 years.
The SII has brushed aside allegations of SAE by the Chennai volunteers claiming that its Covishield vaccine is safe and immunogenic and did not cause the neurological serious adverse effect in the 40-year-old participant.