The DCGI (Drug Controler General India) approved human clinical trials that are set to start in July pan India

Guwahati: India’s first indigenous vaccine against COVID-19, COVAXIN, which is reportedly developed by Hyderabad’s Bharat Biotech in collaboration with ICMR (Indian Council of Medical Research) and NIV (National Institute of Virology) can now start its Phase I and Phase II of human trials.

The DCGI (Drug Controler General India)-approved human clinical trials are set to start in July pan India. In NIV Pune, the SARS-CoV-2 strain was isolated and then transferred to Bharat Biotech. The firm, in a release on Monday, stated that the inactivated, indigenous vaccine was manufactured and developed in Bharat Biotech’s BSL-3 (Bio-Safety-Level 3) High Containment facility in Genome Valley, Hyderabad.

After the company submitted results that were generated from pre-clinical trials, demonstrating safety and immune response, the Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of health & family welfare granted permission to initiate Phase 1 & 2 human clinical trials.

Similar efforts of making a vaccine are already underway in various countries across the globe. India itself has at least five other companies working on the same goal of a vaccine against the novel coronavirus.

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Dr Krishna Ella, chairman and managing director of the company, said in the release that they are proud to announce India’s first vaccine against the virus and that the collaboration with NIV and ICMR was instrumental for the vaccine development.

“Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” added Ella.

Facilitated through national regulatory protocols, the organization said it quickened its target in finishing the thorough pre-clinical studies, and added results from these investigations have been promising and show effective immune responses and extensive safety.

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The company’s track record in developing Vero cell culture platform technologies has been proven in several vaccines. This includes rabies, polio, Chikungunya, Zika, Japanese Encephalitis, and rotavirus.

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