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The crucial phase 3 trial data of Bharat Biotech’s Covaxin, detailing the efficacy of the indigenous COVID-19 vaccine produced by ICMR and Bharat Biotech, will be published in the next 7-8 days, according to officials.
The announcement came on the day the US FDA recommended that Covaxin makers apply for full authorisation instead of seeking Emergency Use Authorisation (EUA), thereby delaying a rollout of the vaccine in that country.
According to Dr VK Paul, Niti Aayog member (Health), the US ruling will have no regulatory implications in India. WHO regulatory approvals are expected by July-September 2021, according to the company. Currently, Covaxin accounts for almost 12% of all vaccines administered in India. Based on phase 1 and phase 2 clinical trials with around 680 people, the CDSCO had approved clearance for emergency use of Covaxin.
“Covaxin third-phase data and follow-up studies should be available in the next few days,” Dr.V K Paul said during the press conference on Friday. According to India Today, Bharat Biotech, the manufacturer of Covaxin, has hinted that they will apply for full licensure of Covaxin when all the data is available to them.
It is to be noted that Bharat Biotech has conducted the country’s first and largest phase 3 clinical trial, with 25,800 participants, to determine the efficacy of the vaccine. The interim analysis of phase 3 trials showed the efficacy of 78 per cent.