The Lokmanya Tilak Municipal General Hospital, popularly known as the Sion hospital in Mumbai is waiting for the final approval from its ethics committee to start the clinical trial of the first indigenous vaccine for the coronavirus, Covaxin.
In the last week of October, the Indian Council of Medical Research (ICMR) had selected the Sion hospital for the trial of the third phase of Covaxin which is being manufactured by Hyderabad-based firm Bharat Biotech. A proposal for the same was then placed before the hospital’s ethics committee in the first week of November for the final approval.
As per reports, at least 1,000 volunteers between ages 18 and 60 are to be part of the trial, of which 20 per cent will constitute those with comorbidities whereas 5 per cent of the participants will be the health workers. According to the rules put forward by ICMR, the hospital will follow-up with the volunteers for 12 months over their health.
The phase-3 clinical trials of Covaxin are touted to have 26,000 participants across 22 sites in the country. Covaxin, the largest clinical trial that is being conducted for the coronavirus in India, has been registered with the clinical trials registry of India and approved by the Drugs Controller General of India (DCGI).
Earlier on June 29, the Hyderabad-based firm had announced that the Drug Controller General of India (DGI) gave the green light for phase-1 and phase-2 human clinical trials of the indigenously developed drug. The company had submitted results generated from pre-clinical (animal) studies to get approval to conduct human clinical trials. These trials are meant to demonstrate safety and immune responses.
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