India’s first Covid-19 vaccine Phase-1 clinical trials done on 375 volunteers

Human clinical trials for Covaxin, a vaccine candidate for COVID-19 being developed by Bharat Biotech has been initiated across the country in 375 volunteers, the company sources said on Friday.

"India's first indigenous COVID-19 vaccine Covaxin initiated phase-1 clinical trials across the country on 15th July 2020. This is a randomised, double-blind, placebo-controlled clinical trial in 375 volunteers in India," the sources said.

As far as clinical trials are concerned, "double- blindmeansneither patient nor researcher knows who is getting a placebo and who is getting the



treatment.

The Drugs Controller General of India (DCGI) had permitted two vaccines -- one developed by the Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and another one by ZydusCadila Healthcare Ltd to go in for the first and second phase of human clinical trials.

There are two Indian vaccine candidates that have undergone successful toxicity studies in rats, mice and rabbits and this data was submitted to the DCGI, following which both got clearance to start an early phase human trials earlier this month, ICMR Director General Dr Balram Bhargava had said.