The country’s ‘first’ indigenous COVID-19 vaccine COVAXIN, developed by the use of city-based Bharat Biotech in collaboration with ICMR and NIV, has got the nod for human medical trials from the Drug Controller General of India, the company mentioned on Monday.
The Phase I and Phase II medical trials of the vaccine for SARS-CoV-2, licensed after pre-clinical analysis demonstrated coverage and immune response, would get began across the country next month.
The collaboration with Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) was once instrumental inside the construction of the vaccine, the company
mentioned in a free up.
The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility positioned inside the Genome Valley proper right here, a free up mentioned.
The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to start out Phase I & II Human medical trials after the company submitted results generated from pre-clinical analysis, demonstrating coverage and immune response. Human medical trials are scheduled to start out during India in July 2020, the release mentioned.
Chairman and Managing Director of the company Dr. Krishna Ella mentioned: We are proud to announce COVAXIN, Indias first indigenous vaccine in opposition to COVID-19. The collaboration with ICMR and NIV was once instrumental inside the construction 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,” he mentioned.
Expedited during the national regulatory protocols, the company accelerated its function in completing the very good pre-clinical analysis.
Results from the ones analysis had been promising and show extensive coverage and environment friendly immune responses, the introduced added.
Besides Bharat Biotech, no less than five other Indian companies are operating on a vaccine for the deadly coronavirus while an an identical efforts are underway in a large number of countries.
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