India’s 1st COVID-19 Vaccine – COVAXIN™, Developed by Bharat Biotech gets DCGI approval for Phase I & II Human Clinical Trials: Bharat Biotech get the approval from DCGI Drug Controller Of India to start phase I & II for clinical trials of its vaccine named “COVAXIN” in country.
The Vaccine has been produced by Bharat Biotech in collaboration with Indian Council Of Medical Research (ICMR) and National Institute Of Virology by using inactive versions of vaccine.
The Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response, said Bharat Biotech in its press release.
Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said: “We are proud to announce COVAXIN™, India’s 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.”