Officials of Bharat Biotech said today they will come out with the company’s coronavirus vaccine candidate COVAXIN by June 2021. Earlier on 22 October, the Drug Controller General of India (DGCI) had allowed Bharat Biotech International Limited to conduct the Phase III trials of its Covid-19 vaccine candidate COVAXIN.
COVAXIN expected by June 2021
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 III 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 (ICMR) and National Institute of Virology, COVAXIN is India’s first indigenous vaccine candidate against the Covid-19.
Government may consider ’emergency-use’
The official further said, “We are committed to doing all our Phase I, Phase II and Phase III clinical trials in its entirety, but I think the government may also be considering emergency use approval.”
According to The Indian Express, Prasad said that the firm is not pushing for such approval, though. “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 was quoted as saying.
Bharat Biotech to conduct trials on 26,000 people in 25 centres
Bharat Biotech will conduct 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 III 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 III is completely different from a Phase I or a Phase II. 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 areas. It’s a multifaceted approach to select a site,” Prasad said.
Zydus Cadila, which is close to completing Phase II trials of ZyCov-D, Russia’s Gamaleya Research Institute, which will soon begin Phase II/III 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.