Expert Panel Clears Covaxin After Promising Phase 3 Trial Data. Now, Beneficiaries May Not Have to Sign Consent Form Bharat Biot...

Expert Panel Clears Covaxin After Promising Phase 3 Trial Data. Now, Beneficiaries May Not Have to Sign Consent Form

Bharat Biotech’s Covid-19 vaccine Covaxin can be granted Emergency Use Approval, Drug regulator’s Subject Expert Committee (SEC) recommended on Wednesday.

Covaxin can be taken off clinical trial mode, a subject expert committee that has been monitoring the development has recommended DCGI, which will take a final call on the matter. If Covaxin is not administered under the clinical trial mode, people will not be asked to sign the consent form to take the vaccine. The removal of the clinical trial mode would mean a great deal for Covaxin, which has so far struggled with acceptance beneficiaries and states like Chhattisgarh, Kerala and Punjab.

The recommendation of the SEC was based on the India-made vaccine’s phase 3 trial data.

Earlier, Covaxin had shown 81 per cent efficacy in preventing symptomatic COVID-19 in an interim analysis of the advanced clinical trial, the company had said. Covaxin, which was shunned by some health workers due to lack of final trial data, showed efficacy better than the company’s previous guidance of around 60 per cent.