India's first Covid-19 vaccine gets DCGI nod for human trials

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India's 'first' indigenous Covid-19 vaccine COVAXIN, developed by vaccine maker Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), has got the nod for human clinical trials from the Drug Controller General of India, the company said.

The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month.

The collaboration with ICMR and the NIV was instrumental in the development of the vaccine, the company said in a release.

The vaccine Covaxin has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley in Hyderabad, the release said.

The Drug Controller General of India granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.

Human clinical trials are scheduled to start across India in July 2020, the release said.

Chairman and Managing Director of the company Dr. Krishna Ella said, “We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. "


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