By IT Correspondent
Pune, June 30:
In a significant development on the COVID-19 vaccine front, Indian pharma major “Bharat Biotech” on Monday announced development of COVAXIN™, India’s first vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Now human clinical trials will be conducted in phase I and phase II from next month. The Hyderabad based company has a track record in developing vero cell culture platform technologies and has proven record in inventing several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.
The SARS-CoV-2 strain was isolated in NIV, Pune and was 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.
The company declared that the Drug Controller General of India – CDSCO, Union Ministry of Health & Family Welfare have granted permission to initiate Phase I & II Human clinical trials after the it 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 has 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 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” Bharat Biotech Joint Managing Director Suchitra Ella said.
