Expert Panel Clears Covaxin After Promoting 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 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 underlying previous guidance of around 60 per cent.

The drug regulator in January had allowed Covaxin as well as the vaccine made by AstraZeneca’s local partner, the Serum Institute of India Ltd.

But the lack of final trial data had inhibited the use of Covaxin, which made up for only about 11 per cent of the more than 1 crore vaccines administered till last week.

Bharat Biotech said the efficacy data was based on tests on 25,800 subjects, the largest ever conducted in India. The Phase 3 study enrolled participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities, it added.

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