India's first Covid-19 vaccine set for human trials
The country's first indigenous Covid-19 vaccine COVAXIN, developed by city-based Bharat Biotech in collaboration with ICMR and NIV
Hyderabad: The country's first indigenous Covid-19 vaccine COVAXIN, developed by city-based Bharat Biotech in collaboration with ICMR and NIV, has got the nod for human clinical trials from the Drug Controller General of India, the company said.
The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month.
The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley here, a release said.
The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India in July 2020, the release said.
Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform, he said.”
Besides Bharat Biotech, at least five other Indian companies are working on a vaccine for the deadly coronavirus while similar efforts are underway in different countries.