Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.
Bharat Biotech on February 22 said that it will be coming up with Phase-3 efficacy data of its COVID-19 vaccine Covaxin in next two weeks.
The Covaxin was given restricted emergency use approval under clinical trial mode by India drug regulator Drug Controller General of India (DCGI) without phase-3 efficacy data. The approval was based on safety and immunogencity data of Phase-1 and Phase-2 trials, and of the hypothesis that the vaccine works on the mutant strains including UK variant.
"Unfortunately we have missed the efficacy time points, have done the Phase 2 and Phase 3 combined, we would have captured the efficacy faster," said Krishna Ella, Chairman and Managing Director of Bharat Biotech, speaking at BioAsia 2021.
"Anyways we should be coming out in two week with efficacy data," Ella added.
Ella said the company is in the process of ramping up Covaxin production capacity to 40 million doses per month, with the commissioning of third manufacuting site by end of this week.
The company has already commissioned two manufacturing facilities.
Ella said his company is keen to be part of COVAX.
"The moment we come out with Phase-3 data if everything is alright, then I think we really want to be part of COVAX," Ella said.
COVAX is co-led by Gavi, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI). The agency was formed to guarantee fair and equitable access to the vaccine for every country in the world. COVAX currently includes more than 190 participating economies.
Nasal vaccine clinical trial
Ella said the Bharat Biotech is also planning to launch the phase-1 clinical trial of its nasal COVID-19 vaccine by end of this week.
Ella said that Bharat Biotech can produce an updated version of Covaxin which is capable of neutralising South African strain in 15 days.
"If the ICMR has got a South African strain, if they give it, I can plug in immediately in the manufacturing. I can make a product quickly. We're not going to change the manufacturing process," Ella added.
Covaxin has found to be effective against the UK variant.
Ella said Covaxin will be good for vaccinating children, as it is based on inactivated platform which is used for making polio vaccines used in infant and child polio immunisation.