The Hyderabad-based vaccine manufacturer, Bharat Biotech, has been accorded permission by the Drug Controller General of India (DCGI) to initiate Phase I & II human clinical trials for India’s first vaccine candidate against COVID-19.
It was developed and manufactured at the company’s Bio-safety Level-III high containment facility at Genome Valley in the city.
Meanwhile, another big single-day spike of 19,459 COVID-19 cases took India’s tally close to 5.5 lakh on Monday, even as the recovery rate further improved to 58.67 per cent.
India’s COVID-19 case tally rose to 5,48,318, while the death toll climbed to 16,475 with 380 new fatalities, according to the Union Health Ministry data.
This is the sixth consecutive day that coronavirus infections have increased by more than 15,000.
The indigenously developed vaccine has been named Covaxin and is an inactivated vaccine. It has been developed after the National Institute of Virology, Pune isolated a strain of the SARS-CoV-2 and transferred it to the company.
The permission for human clinical trials was granted by DCGI after the company submitted results generated from preclinical studies, demonstrating safety and immune response. The human clinical trials are scheduled to start across India in July 2020.
Dr. Krishna Ella, Chairman and Managing Director, 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.”
According to a media release by the company, it accelerated its objective in completing the comprehensive pre-clinical studies by expediting through the national regulatory protocols. It also said that the 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 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.”
The company has developed vaccines till now for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.