A potential COVID-19 vaccine, the first to be developed in India, has been given DCGI (Drug Controller General of India) approval for Phase I and II human clinical trials that are scheduled to start across the country in July.
Developed by Hyderabad-based Bharat Biotech, in association with ICMR (Indian Council for Medical Research), COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus, that has shown promise in preclinical studies, demonstrating extensive safety and effective immune responses.
Human clinical trials are scheduled to start across the country in July for the vaccine, which was developed and manufactured in Bharat Biotech’s facility at Genome Valley in Hyderabad, India.
“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,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, announcing the vaccine development milestone.
The company accelerated its objective in completing the comprehensive preclinical studies. Results from these studies have been promising, showing extensive safety and effective immune responses.
“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 the future pandemics,” said Mrs Suchitra Ella, Joint Managing Director.
Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.