India’s first COVID-19 vaccine ‘COVAXIN’ gets DCGI approval for clinical trials – Times Now

Hyderabad: COVAXIN, India’s first vaccine candidate against the novel coronavirus, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), has received approval from the Drug Controller General of India (DGCI) to conduct Phase I and 2 human trials. According to the vaccine maker, human clinical trials of the experimental COVID-19 are scheduled to start across the country in July 2020.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured by Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India, the firm said in a release on Monday.

The Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare, granted permission to initiate Phase I and II human trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

“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.