In a Boost to Indigenous Vaccine Plan, Bharat Biotech's Covaxin Gets Clearance for Phase III Trial

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Covaxin, an indigenously developed vaccine candidate by Bharat Biotech, has got clearance for phase three trial in India. A top source said that the trials will start in the first week of November.

The source further said that 18-19 sites have been selected for the trial and over 22,000 volunteers have been selected. Bharat Biotech, in its report last month, had said that an animal study has shown its vaccine candidate has helped develop a strong immune response to the highly infectious coronavirus.

Covaxin is the first indigenous vaccine developed by India against Covid-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. Its trial for phase one and two was already underway after receiving the approval from Drugs Controller General of India (DCGI).

The DCGI had permitted two vaccines — one developed by the Bharat Biotech International Limited in collaboration with the ICMR and another one by Zydas Cadila Healthcare Ltd to go in for phase I and II human clinical trials.

In the past years, India has emerged as a significant vaccine manufacturing hub and Indian manufacturers account for 60 per cent of vaccine supplies made to UNICEF.