The SARS-CoV-2 strain was isolated at NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech’s BSL-3 high containment facility in Genome Valley, Hyderabad.
The Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare, has granted permission to initiate Phase I and II human trials after Bharat Biotech submitted results generated from pre-clinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India in July 2020.
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. We worked tirelessly to deploy our proprietary technologies towards this platform.”
Expedited through national regulatory protocols , the company accelerated its objective to complete comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “Our ongoing research and expertise in forecasting epidemics enabled us to successfully manufacture a vaccine for the H1N1 pandemic. We are continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India.”
In the past, Bharat Biotech has developed vero cell culture platform technologies, which have been helpful in several vaccines for polio, rabies, rotavirus, Japanese encephalitis, chikungunya, and Zika.
Other Indian firms working on COVID-19 vaccines include Zydus Cadila, Serum Institute of India, and Panacea Biotec.
Meanwhile, India’s coronavirus burden continues to rise. With over 18,000 cases reported on Monday, the number of COVID-19 cases rose to 5,67,423. The Ministry of Home Affairs has releases Unlock 2.0 guidelines, which will be in force till 31 July.