The subject expert committee (SEC), an independent panel of experts set up by the Drug Controller General of India, has granted Bharat Biotech's COVAXIN Emergency Use Approval (EUA), according to a report by CNBC-TV18.
This candidate does not need to be administered in clinical trial mode as its Phase 3 trial interim data have been accepted, the business channel reported.
Sources say SEC clears @BharatBiotech's Covaxin for EUA; doesn’t need to be administered in a “'clinical trial mode' & accepts Covaxin’s Phase-3 trial interim dataAlert: Bharat Biotech claims Covaxin has 81% efficacy pic.twitter.com/elMGFcYmHD
— CNBC-TV18 (@CNBCTV18Live) March 10, 2021
Bharat Biotech said on March 3 that its Covaxin vaccine was 81 percent effective in preventing COVID-19 after the third round of clinical trials.
It demonstrated 81 percent interim efficacy in preventing COVID-19 in those without prior infection after the second dose, the company said in a statement.
Covaxin was given restricted emergency use approval in clinical trial mode by the Drug Controller General of India (DCGI), without phase-3 efficacy data. The approval was based on safety and immunogenicity data of phase-1 and phase-2 trials, and of the hypothesis that the vaccine works on mutant strains, including the UK variant.
However, when the nationwide vaccination drive started on January 16, many beneficiaries refused to take the dose citing a lack of efficacy data.