SII has conducted all necessary casualty assessment and said that the review does not require any changes in the trial proceedings.
Trashing reports of ‘severe adverse effects’ of coronavirus vaccine Covidshield, the Serum Institute of India (SII) has said that there's no change in the timeline of production and trials of the vaccine.
SII has conducted all necessary casualty assessment and said that the review does not require any changes in the trial proceedings.
This comes a day after the Centre backed the vaccine in wake of the allegations by a Chennai based volunteer who claimed that he suffered from serious side effects including a virtual neurological breakdown and impairment of cognitive functions.
“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 stressed that SII has taken several measures to keep a tab on any adverse reactions during such trials, as per a report in The Indian Express. What tops the list is a “prior informed consent form” which a volunteer must sign before participating in the trials.
“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.”
Last week, a 40-year-old business consultant, who was a volunteer for the Covidshield vaccine that is under development at SII, sought Rs 5 crore compensation for the neurological complications he developed after being administered the test dose.
SII, in return, sought damages worth Rs 100 crore for 'malicious allegations'.
Saying that it was sympathetic with the candidate's medical condition, the SII in its statement said, "The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent."
"In-spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company," it further said.
The SII asserted that it would take all steps to defend itself from all such malicious claims.
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