Covaxin Could be Ready for June 2021 Rollout, Says Bharat Biotech
An official told The Indian Express that the government may be considering emergency use approval for the vaccine.
Bharat Biotech, the company which is developing one of India’s indigenous vaccine candidates called Covaxin, expects that the shot will be ready by June 2021, according to a report by The Indian Express.
“If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase-3 clinical trial — April, May, June, for example. That is for the full efficacy results,”Sai Prasad, executive director, Bharat Biotech International Ltd said, to The Indian Express.
On Thursday, reports said that the Drugs Controller General of India's (DCGI) subject expert committee has recommended granting permission for phase 3 clinical trials for Covaxin. The panel’s decision came after assessing data from phases 1 and 2, along with the animal challenge study.
Prasad also told the newspaper in his interaction with them that the government may be considering emergency use approval for the vaccine candidate, although the company was not pushing for it. He added that Bharat Biotech was committed to doing the phase-1, phase-2 and phase-3 clinical trials in their entirety.
The firm, which is based out of Hyderabad, reportedly plans to enrol “25,000 to 26,000” participants, targeting setting up around 25 clinical trial sites across 12-13 states.
Bharat Biotech is developing its COVID-19 vaccine candidate in partnership with the Indian Council of Medical Research (ICMR). Apart from Covaxin, the other vaccine candidates undergoing clinical trials in India include the Oxford-AstraZeneca candidate as well as the one by Zydus Cadila Ltd.
(With inputs from The Indian Express.)
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