Bharat Biotech plans to launch the indigenously developed Covid-19 vaccine by June 2021. The pharma company was given nod to continue with phase III clinical trials on October 22. Covaxin is being developed in association with the Indian Medical Research Council.(ICMR)
The firm will test over 20,000 volunteers spread across 12-14 states in the country. Sai Prasad, executive director, Bharat Biotech International Ltd, told The Indian Express that if all procedures are approved, the vaccine's efficacy should be known by June next year. "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," Prasad said.
In addition to Bharat Biotech, Serum Institute of India, who is developing a coronavirus vaccine called Covishield, is already in the midst of recruiting and vaccinating volunteers for its third phase of trials.
Prasad also said that there are talks of government approving the vaccine before the trials are completed for emergency use. "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,” Prasad said, adding that the company is "not pushing for such 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 added.
The company had said on October 23 that the Phase I and Phase II vaccine trials were completed and had reached out to the drug controller for continuing with Phase III trials. It received the go-ahead to conduct trials on as many as 26,000 individuals spread across 25 centres in the country.