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Hyderabad-based Bharat Biotech gets DCGI nod for phase-3 trials of Covaxin

A statement from Bharat Biotech said that the DCGI approval was given for Phase 3 clinical trials in 26,000 participants across 25 centres in the country.

Bharat Biotech says its ICMR-backed vaccine set for June 2021 launchCovaxin - the country's first indigenous vaccine is an inactivated one created from the strain of the infectious SARS-CoV-2 virus.
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After the successful completion of the interim analysis from the Phase 1 and 2 clinical trials of COVAXIN, Bharat Biotech has received the DCGI approval for Phase 3 clinical trials.

A statement from Bharat Biotech Friday said that the DCGI approval was given for Phase 3 clinical trials in 26,000 participants across 25 centres in the country.

Covaxin—the country’s first indigenous vaccine— is an inactivated one created from the strain of the infectious SARS-CoV-2 virus. Inactivated vaccines use the killed version of the germ that causes a disease. It helps the immune system mount an antibody response towards the virus. The vaccine was developed along with ICMR- National Institute of Virology

The Hyderabad-based vaccine maker had applied to the DCGI on October 2 seeking permission to conduct Phase 3 clinical trials for its Covid-19 vaccine candidate.

Apart from Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.

Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in the country.

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