With the Sion Hospital in Mumbai gearing up to conduct the third phase of clinical trials for Covaxin, the indigenous vaccine being developed for the coronavirus by Bharat Biotech, at least 300 people have registered to take part in the test.
According to sources, the hospital has received the required approval from the Ethics Committee and the trials are to begin from Tuesday, December 1. As per reports, the phase-3 clinical trials is touted to have 26,000 participants across 22 sites in the country. Moreover, it is to be conducted in partnership with the Indian Council of Medical Research (ICMR). 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.
As this is a phase-3 test, it will have to be done on more than a thousand volunteers. So far, 300 people have been selected who are to be vaccinated. Out of the total volunteers for the test, 20 per cent will be those with high-risk illnesses. This will include people with heart diseases, kidney diseases, liver diseases and other ailments. Moreover, 5 per cent of the participants will be from health workers.
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