DCGI gives approval for human clinical trials of COVAXIN

  • Posted on: 30 June 2020
  • By: PharmaTutor News

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Drug Controller General of India (DCGI) has given approval for human clinical trials of COVAXIN, the first potential COVID-19 Vaccine developed in India. The potential vaccine has been developed by Hyderabad-based Bharat Biotech, in association with Indian Council for Medical Research (ICMR). Human Trials for Phase I and Phase II are scheduled to start across the country from next month.

COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus. It has shown promising results in the pre-clinical studies demonstrating extensive safety and effective immune responses.

Drug manufacturers and research consortiums around the world are working towards development of a vaccine against the novel coronavirus.

"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," said Chairman and Managing Director, Dr. Krishna Ella.

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