Bharat Biotech's COVID-19 vaccine 'Covaxin' into phase-3 trials
The company is also working on another vaccine for COVID-19 in the form of nasal drops which could be ready by next year, Chairman and Managing Director Krishna Ella said.
COVID-19 vaccine - Covaxin - being developed by Bharat Biotech, is now undergoing phase-3 trials, Chairman and Managing Director of the company Krishna Ella said on Monday.
Speaking at a virtual programme organised by the Indian School of Business, Ella said the company is also working on another vaccine for COVID-19 which would be in the form of nasal drops and can be ready by next year.
"We partnered with ICMR (Indian Council of Medical Research) for a COVID-19 vaccine, as we speak it will be entering the phase-3 trials," he said.
Bharat Biotech is the only vaccine company in the world which has BSL3 production facility (Biosafety-level 3), he said.
Last month, the vaccine-maker said it had successfully completed interim analysis of phase-1 and phase-2 trials of the vaccine and is initiating phase-3 trials on 26,000 participants.
Covaxin is being developed by Bharat Biotech, in collaboration with the ICMR - National Institute of Virology (NIV).
The Hyderabad-based vaccine-maker had, on October 2, sought the Drug Controller General of India's (DCGI) permission to conduct phase-3 randomised double-blind placebo-controlled multi-centre trial of its COVID-19 vaccine, sources said.
"We are working on another vaccine through nasal drops. My feeling is by next year it will reach the population," Ella said.
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Bharat Biotech in September said it had entered into a licensing agreement with Washington University School of Medicine in St Louis for a novel 'chimp-adenovirus' (chimpanzee adenovirus), a single-dose intranasal vaccine for COVID-19.
Meanwhile a press release from Bharat Biotech said the phase-3 trials of Covaxin would involve 26,000 volunteers across 25 centres in India and it is being conducted in partnership with ICMR.
It is the largest clinical trial conducted for a COVID-19 vaccine in India.
This is India's first phase-3 efficacy study for a COVID-19 vaccine, and the largest phase-3 efficacy trial ever conducted in the country.
Participating volunteers, who undergo vaccination in the phase-2 trials, would be monitored over the next year to detect occurrence of COVID-19.
The trial volunteers would receive two intramuscular injections approximately 28 days apart, it said.