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Phase-1 clinical trials for Covaxin begin, 375 volunteers enrolled


By: Express News Service | Pune |

Published: July 17, 2020 10:52:41 pm


The vaccine has been developed by Hyderabad-based pharmaceutical company Bharat Biotech in collaboration with the National Institute of Virology and Indian Council of Medical Research.

Phase-1 clinical trials for India’s first indigenous Covid-19 vaccine, Covaxin, started across the country on July 15. While 375 volunteers will be enrolled in Phase 1 of the human clinical trial, plans are underway to enroll a total of 1,125 for both phases.

The vaccine has been developed by Hyderabad-based pharmaceutical company Bharat Biotech in collaboration with the National Institute of Virology and Indian Council of Medical Research.

A statement from Bharat Biotech on Friday stated that this is a randomised, double blind placebo-controlled clinical trial with 375 volunteers. “Eventually, we plan to enroll 1,125 for both phase I and II. The human clinical trials commenced at AIIMS, Patna,” added the statement.

Bharat Biotech got the country’s drug regulator’s approval to start clinical trials of its anti-corona vaccine recently. Another firm, Zydus Cadila, has also received approval from authorities to start human trials for its anti-Covid-19 vaccine.

Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune and ICMR has selected 12 sites to conduct the clinical trials.

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