Phase-3 efficacy data of Covaxin in two weeks, says Bharat Biotech


Covaxin is India's indigenous Covid-19 vaccine by Hyderabad-based Bharat Biotech. (Image Source: Bharat Biotech)

Chairman and Managing Director of Bharat Biotech Krishna Ella also said that the company is interested to be a part of the COVAX initiative. 

Chairman and Managing Director of Bharat Biotech Krishna Ella said that the company would come out with the phase 3 efficacy data for its Covid-19 vaccine Covaxin in two weeks. Ella who was speaking at a webinar – BioAsia 2021 also said if the company had combined phase 2 and 3 studies then the efficacy data would have been available sooner.

Covaxin was given emergency use approval under clinical trial mode by the Indian drug regulator without phase-3 efficacy data. It was approved based on safety and immunogenicity data of phase-1 and phase-2 trials.

Ella said: “Unfortunately we have missed the efficacy time points, have done the phase 2 and phase 3 combined, we would have captured the efficacy faster.” He said: “Anyways we should be coming out in two weeks with efficacy data.”

Ella also expressed interest to join the COVAX initiative. “The moment we come out with Phase-3 data if everything is alright, then I think we really want to be part of COVAX,” he said. COVAX is an initiative focused on equitable access to Covid-19 vaccines across the world. It is co-led by the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI).

Ella stated that Bharat Biotech is trying to increase its Covaxin production capacity to 40 million doses per month with the commission of a third manufacturing site by end of this week. He added that the company is also focusing on launching the phase-1 clinical trial of its nasal Covid-19 vaccine by the end of this week.

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