Bharat Biotech’s COVAXIN gets DCGI approval for Phase I & II Human Clinical Trials

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COVAXIN has been successfully developed by Bharat Biotech, a vaccine for COVID-19 by collaborating with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). 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, India.

The permission was granted by the Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare for initiating Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials will likely to start in India in July 2020.

Dr Krishna Ella, Chairman and Managing Director 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 have enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.” Suchitra Ella, Joint Managing Director said.

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