Updated: October 23, 2020 7:49:23 pm
Covaxin: the country’s first indigenous vaccine is an inactivated one created from the infectious virus strain SARS-CoV-2.
After successfully completing the interim analysis of the COVAXIN phase 1 and 2 clinical trials, Bharat Biotech has received approval from DCGI for phase 3 clinical trials.
A statement from Bharat Biotech on Friday said DCGI approval was granted for Phase 3 clinical trials in 26,000 participants at 25 centers across the country.
Covaxin, the country’s first indigenous vaccine, is an inactivated vaccine created from the infectious virus strain SARS-CoV-2. Inactivated vaccines use the dead version of the germ that causes disease. Helps the immune system mount an antibody response against the virus. The vaccine was developed together with ICMR- National Institute of Virology
Hyderabad-based vaccine manufacturer had requested the DCGI on October 2 asking for permission to conduct phase 3 clinical trials for their Covid-19 vaccine candidate.
In addition to Bharat Biotech, a candidate vaccine developed by Zydus Cadila Ltd is also in Phase 2 human clinical trials.
Pune-based Serum Institute of India, which has partnered with AstraZeneca to make the Oxford Covid-19 candidate vaccine, is also conducting Phase 2 and 3 human clinical trials in the country.
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