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Bharat Biotech’s indigenous COVID-19 vaccine ‘COVAXIN’ gets approval for phase I & II human clinical trials

Pharma major Bharat Biotech has announced the development of India’s 1st vaccine candidate for COVID-19, named COVAXIN, in collaboration 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. 

Bharat Biotech declared that the Drug Controller General of India – CDSCO and Ministry of Health and Family Welfare have granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.

Announcing the vaccine development, Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech 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.”

Expedited through national regulatory protocols, 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.

“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,” said Suchitra Ella, joint managing director, Bharat Biotech.

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.