Hyderabad company develops India’s first DCGI-approved vaccine candidate, gets nod for human trials

NEW DELHI: Hyderabad vaccine major Bharat Biotech on Monday announced that its COVAXIN has become the country’s first Covid vaccine candidate approved by the Drug Controller General of India (DCGI) and the first vaccine that has got approval of the drug controller for phase 1 and II human clinical trials. The company has been working on the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune for some time, as reported by TOI earlier.
The DCGI gave the permission to the company to initiate phase I & II human clinical trials after it submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across the country in July, a company’s statement said.
Bharat Biotech developed COVAXIN at the company’s bio-safety level-3 containment facility in Hyderabad’s Genome Valley after taking strain of SARS-CoV-2, isolated at the NIV, Pune.
Announcing the breakthrough, Bharat Biotech CMD Krishna Ella 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 Central Drugs Standard Control Organisation (CDSCO) has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
“COVAXIN was evaluated in animals as per schedule Y guidelines of India and World Health Organisation. It was reported to be safe and immunogenic in all animals. We have now moved forward towards clinical development of this vaccine,” Krishna Ella told TOI.
Besides the speedy progress on the indigenous vaccine, Bharat Biotech is simultaneously working on nasal vaccine CoroFlu against Covid-19 in collaboration with American researchers of University of Wisconsin, Madison, and is also leading a CSIR-sanctioned project to develop human monoclonal antibodies as therapy for Covid infection.
“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,” company’s Joint MD Suchitra Ella said.
Bharat Biotech has established an excellent track record of innovation with over 140 global patents and a wide product portfolio of over 16 vaccines.