Hyderabad: Bharat Biotech has developed Covaxin, India’s first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).
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 pre-clinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
Announcing the milestone, Dr Krishna Ella, chairman and managing director, Bharat Biotech, said, “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.”
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.
Speaking about Bharat Biotech’s prowess, Suchitra Ella, joint managing director, Bharat Biotech said, “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 facility 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.”
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