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COVID-19 vaccine: Assam hospital likely to be selected for Phase-II trials of Covaxin, says Himanta Biswa Sarma

The Drugs Controller General of India granted permission to Bharat Biotech for Phase-I and II human clinical trials after it had submitted results generated from pre- clinical studies, demonstrating safety and immune response.

The Gauhati Medical College and Hospital (GMCH) is likely to be selected as one of the centres for Phase-II trial of ‘Covaxin’, the country’s first indigenous vaccine, Assam Health Minister Himanta Biswa Sarma said on Friday. Hyderabad-based Bharat Biotech has “successfully completed” Phase-I human clinical trials of the vaccine and
Phase-II will start soon, Sarma said at a plasma donation camp organised by the BJP here.

On June 29, Bharat Biotech had announced that it had successfully developed ‘Covaxin’ in collaboration with Indian
Council of Medical Research (ICMR) and National Institute of Virology (NIV). “They (Bharat Biotech) have started the process to have GMCH as one of the centres for Phase-II testing of the vaccine.

“It is almost 99 per cent sure that GMCH will participate (in Phase-II trials),” Sarma said. At present, paper work is going on between Bharat Biotech and Gauhati Medical College and Hospital (GMCH), he added.

The Drugs Controller General of India granted permission to Bharat Biotech for Phase-I and II human clinical trials after it had submitted results generated from pre- clinical studies, demonstrating safety and immune response.

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