Phase 3 Trial of Covishield approved following complaint of side-effect

GOI stands by  Pune-based Serum Institute of India’s coronavirus vaccine Covishield after a Chennai-based volunteer claiming that he has faced “severe adverse effects” after the trial of Covishield. After initial causality assessment, findings did not necessitate stoppage of the Serum trials,” Health Secretary Rajesh Bhushan said at a press briefing SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials,” he added. The Chennai based volunteer’s alleged side-effect will not affect the timeline of the vaccine adding that several measures were taken by SII to keep a tab on any adverse reactions during such trials.  The first of these was the “prior informed consent form” which must be signed by a volunteer before participation. “Second, these vaccine trials are multi-centric and multi-site; the subjects are given the vaccine under medical care, they are monitored and observed,” Bhushan said. “Every site has an institutional ethics committee, which is independent of the sponsors and government, The Indian Express quoted him as saying. SII said “The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer,” said the Serum Institute of India in a statement. According to a PTI report, the Chennai man has alleged that the candidate COVID-19 vaccine was not safe and claimed that he suffered from serious side effects including a virtual neurological breakdown and impairment of cognitive functions. In a legal notice to the SII and others, he has sought a compensation of Rs 5 crore and also sought cancelling approval for its testing, ‘manufacture and distribution’, failing which legal action would be taken. In a legal notice to the SII and others, he has sought a compensation of Rs 5 crore and also sought cancelling approval for its testing, ‘manufacture and distribution’, failing which legal action would be taken.“