Bharat Biotech's COVID-19 vaccine 'Covaxin' into phase-3 trials

Hyderabad, Nov 16: 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-I and -II trials of the vaccine and is initiating Phase-III trials in 26,000 participants.

Covaxin is being developed byBharatBiotech, in collaboration with the ICMR - National Institute of Virology (NIV).

The city-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 multicentre 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.

BharatBiotech 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-III 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 Indias first phase-3 efficacy study for a COVID-19 vaccine, and the largest phase-III efficacy trial ever conducted in the country. Participating volunteers, who undergo vaccination in the phase-II 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.