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
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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