Covid-19 globally has infected more than 10 million people and has killed half a million. Many Pharmaceutical companies around the globe are working to find a cure for the virus, but have not yet found the cure and are yet to be found.
But on Monday, Hyderabad vaccine Major ‘Bharat Biotech’ announced that India’s first Covid vaccine candidate ‘COVAXIN’ has been approved by the Drug Controller General of India (DCGI) and the first vaccine has got the approval of drug regulator for phase I and II of human clinical trials.
The drug has been developed by the company in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune for sometimes. The indigenous, Inactive vaccine named COVAXIN has been developed and manufactured by Bharat Biotech at the company’s bio-safety level-3 containment facility in Hyderabad’s Genome Valley after National Institute of Virology (NIV), Pune transferred isolated strain of SARS-CoV-2 to the company.
The permission was given by DCGI to the company to start Phase I and II of Human Clinical Trials after the company has submitted the results generated from preclinical studies, demonstrating safety and immune response.
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According to the company, human clinical trials are scheduled to start from July 2020 across the country. And the results are expected to be out by October 2020, following which large clinical trials will be conducted.
Bharat Biotech, Chairman and Managing Director (CMD), Dr. Krishna Ella said announcing the development, “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.”
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. The results reported from these studies have been promising and show extensive safety and effective immune responses and have now moved towards the clinical development of this vaccine.
Besides this, Bharat Biotech is also working on another vaccine candidate, ‘CoroFlu’ against Covid-19, which it is developing in collaboration with American researchers of the University of Wisconsin–Madison and vaccine manufacturer FluGen and is also leading a CSIR- sanctioned project to develop human monoclonal antibodies as therapy for Covid infection.
Bharat Biotech Joint Managing Director, Suchitra said, “Our ongoing research and expertise in forecasting epidemic has enabled us to successfully manufacture a vaccine for the H1N1 pandemic.”
She added, “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.”
Globally, around 150 vaccine candidates are under development currently, of which 17 are undergoing human trials. And at least five other Indian companies are working on a vaccine for the deadly coronavirus,
Source: Times of India, CNBC-TV18, Business world