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 on Monday.
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 collaboration with Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) was instrumental in the development of the vaccine, the company
said in a release.
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.
Chairman and Managing Director of the company Dr. Krishna Ella said: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine.
"The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," he said.
Expedited through the 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, the released added.
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.