Bharat Biotech’s Covid-19 vaccine ‘Covaxin’ into phase-3 trials

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

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.

A man rides his motorcycle past a parked bus of Indian biotechnology company Bharat Biotech outside its office in Hyderabad. (REUTERS)

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 by BharatBiotech, 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.

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-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.