Centre approves human trials for India's Covid-19 vaccine from July

After successfully testing animals, Union Ministry of Health & Family Welfare has now approved clinical human trials for India's first COVID-19 vaccine- Covaxin. Covaxin has been approved for Phase I & II Human Clinical Trials which will begin from July. The vaccine is being developed by Bharat Biotech in Hyderabad 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 the pharmaceutical company. 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 in Hyderabad. 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. 

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'Collaboration with ICMR and NIV was instrumental'

Announcing the milestone, Dr. Krishna Ella, chairman and managing director of Bharat Biotech, said, “The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

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Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

Suchitra Ella, joint managing director of the company, 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 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.”

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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. Overall, the pharmaceutical has a track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and WHO pre-qualification.

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