Bharat Biotech with the help of Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) has developed India’s 1st vaccine for COVID-19 which is named as COVAXIN. To develop this vaccine first SARS-CoV-2 strain was isolated in NIV and then was transferred to Bharat Biotech where it was manufactured by its BSL-3 (Bio-Safety Level 3) High Containment facility. Bharat Biotech has got approval from the Drug Controller General of India – CDSCO and Ministry of Health and Family Welfare for starting Phase I & II Human clinical trials. The company had submitted results based on preclinical studies, demonstrating safety and immune response to get the approval. Human Clinical trials will start from July 2020, across India.
Chairman and MD of Bharat Biotech, Dr Krishna Ella 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.”
The company said it “accelerated its objective in completing the comprehensive pre-clinical studies and added results from these studies have been promising and show extensive safety and effective immune responses”.
Joint MD of Bharat Biotech, Suchitra Ella said, “Our ongoing research and expertise in forecasting epidemics have 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”.