The phase three trial of Bharat Biotech's Covaxin has shown an efficacy of 77.8 per cent in protection against COVID-19, sources said on Tuesday. The trials were conducted on 25,800 individuals across India and the results were approved by the Drugs Controller General of India (DCGI) Subject Expert Committee, they added.
It is expected that Covaxin may receive clearance from the country's drug regulator today itself.
Hyderabad-based Bharat Biotech has been facing tough questions over the delay in announcing its phase 3 trial data of the vaccine.
Phase 3 trial data is crucial for it will clearly state the efficacy of the vaccine developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR).
Meanwhile, in a major boost for Bharat Biotech, the World Health Organisation has accepted its Expression of Interest (EoI) for Covid-19 vaccine Covaxin and scheduled a pre-submission meeting on June 23, a step that will take the vaccine maker closer to a WHO emergency use listing (EUL).
Bharat Biotech had said last month that it expects approval for its vaccine Covaxin from the World Health Organisation for emergency use listing during July-September.