The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, the company said in a statement.
The Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India next month.
"We are proud to announce Covaxin, India's first indigenous vaccine against Covid-19. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.