Full market approval for Covaxin, Covishield: Expert panel to meet today – ET HealthWorld

The subject expert committee (SEC), a body under the Drugs Controller General of India (DCGI), will meet today to review applications filed by Bharat Biotech and Serum Institute of India for full market approval of their respective Covid vaccines – Covaxin and Covishield.

“The review will continue in the meeting today and if all goes well both will be granted full market approval,” people in the know told ET.

The SEC had met on Friday but could not finish the review of the ‘huge amount of data’.

On Thursday, Bharat Biotech had sought regular market approval from the drug regulator for its indigenous Covid-19 vaccine Covaxin, which is at present authorised for emergency use in the country.

A market authorisation label for a vaccine means it can be authorised for use without any reservations or conditions.

Earlier, Pune-based Serum Institute of India (SII) had also filed a similar application for Covishield.

In response to the application, the DCGI had sought more information which, according to sources,was submitted last week.

Covishield and Covaxin are the main Covid-19 vaccines used in the government’s vaccination drive. About 88% of the eligible population has received Covishied.

Covaxin accounts for 12 per cent of the total Covid-19 vaccines administered in India since January 2021. It is so far the only jab that is administered to youngsters in the age-group of 15-18 years, for whom vaccination started on January 3.

Both the vaccines were granted Emergency Use Authorisation (EUA) on January 3 last year.

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