Coronavirus vaccine update: ICMR-backed Covaxin to be ready by June 2021, says Bharat Biotech

Officials of Bharat Biotech have revealed that its coronavirus vaccine candidate Covaxin is expected to be ready by June 2021. Earlier on Thursday, the Drug Controller General of India (DGCI) allowed Bharat Biotech International Limited to conduct the Phase III trials of its Covid-19 vaccine candidate Covaxin.

Covaxin expected to be ready by June 2021

According to a report in the Indian Express, a top company official informed that Covaxin should be ready by June 2021-- unless the government advances its launch through emergency use authorisation.

"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, told The Indian Express.

Developed by Bharat Biotech along with the Indian Council of Medical Research and National Institute of Virology, Covaxin is India's first indigenous vaccine candidate against the Covid-19.

'Government may consider emergency use approval'

The official further said, "We are committed to doing all our phase-1, phase-2 and phase-3 clinical trials in its entirety, but I think the government may also be considering emergency use approval".

According to Indian Express, Prasad said that however, the firm is not pushing for such an approval.

“Our intent is to develop everything to its logical conclusion in terms of empirical evidence and data, and efficacy data and safety data. But there are discussions, I guess, within the government about that (emergency use approval),” he told Indian Express.

Bharat Biotech to conduct trials on 26,000 people in 25 centres

Bharat Biotech will be conducting Phase 3 trials for its Covid-19 vaccine candidate, COVAXIN, in 25 centres across India and a total of 26,000 people will be participating in the Phase 3 trials.

“There will be quite a few new sites and there will also be quite a few new states, because the site selection for phase-3 is completely different from a phase-1 or a phase-2. We are looking at, obviously, the capabilities and expertise of the site, but also at what’s happening in terms of Covid-19 disease in those respective areasit’s a multifaceted approach to select a site,” Prasad told Indian Express.

Zydus Cadila, which is close to completing phase-2 trials of ZyCov-D, Russia’s Gamaleya Research Institute, which will soon begin phase 2/3 trials of Sputnik V in collaboration with Dr Reddy’s and Serum Institute of India's Covishield are other coronavirus vaccine candidates in the fray.

(With inputs from Indian Express)