News Desk: Hyderabad based vaccine major Bharat Biotech on Monday announced that its COVAXIN with become India’s first COVID-19 vaccine to be approved by the Drug Controller General of India (DCGI). COVAXIN will become the first vaccine that has got the approval of the drug controller for phase I and phase II human clinical trials.
The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2 were approved after the pre-clinical studies demonstrated safety and immune response. The trials would start across the country from next month.
The company said in a release said that the collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) was instrumental in the development of the vaccine.
It is said that the indigenous and inactivated vaccine has been developed at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley.
The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to initiate Phase I Phase II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. The human clinical trials are scheduled to start across India in July 2020.
“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 Chairman and Managing Director of the company Dr. Krishna Ella said.
“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,” he said.
Expedited through the national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.
Results from these studies have been promising and show extensive safety and effective immune responses, the release added.
Besides Bharat Biotech, at least five other Indian companies are working on a vaccine for the deadly coronavirus while similar efforts are underway in different countries.
The COVAXIN trials are designed to test whether the vaccine is safe or not, rather than whether it is effective or not.
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