The Centre on Tuesday (December 1) backed Pune-based Serum Institute of India’s coronavirus vaccine Covishield after a Chennai-based volunteer claimed that he had faced “severe adverse effects” following 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 senior government official asserted that the alleged adverse event will not affect the timeline of the vaccine and added that several measures were taken by SII to keep a tab on any adverse reactions during such trials, according to The Indian Express. 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. Whenever there is an adverse event, the ethics committee takes note of it and gives its findings…to the regulator within 30 days.”
On Sunday (November 29), the SII had rejected the claims by a trial participant who alleged serious side-effects of ‘Covishield’ coronavirus vaccine.
“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.