Hyderabad-based biotechnology conglomerate Bharat Biotech has submitted phase-3 clinical trial data of its COVID19 vaccine Covaxin to the Drugs Controller General of India (DCGI). 'The required data has reportedly been submitted, and the meeting of the expert panel is likely to take place today,' said an official in the government aware of the development.  The company also has a pre-submission meeting scheduled with representatives of WHO  on Wednesday, June 23, for emergency use listing of Covaxin, their vaccine against Coronavirus disease (Covid-19).

The first interim analysis result that was put out in March was based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus 7 cases observed in the BBV152 (Covaxin) group, resulting in a point estimate of vaccine efficacy of 80.6%. The second interim analysis came out in April based on accruing more than 87 symptomatic cases of Covid-19, and also showed that the efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalisations.

The Phase 3 study enrolled 25,800 participants in 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post-second dose. Covaxin was developed with seed strains received from the National Institute of Virology under the Indian Council of Medical Research.

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