SEC meets again to determine the full market nod of Covaxin and Covishield

January 15, 2022:

The Subject Expert Committee (SEC), an organization under the Directorate General of Drug Control (DCGI) in India, was submitted by the Bharat Biotech and Serum Institute of India for full market approval of their respective Covid vaccines (Covaxin and Covishield). We will meet again to review the application. The SEC met on Friday, but people who knew it couldn’t finish the review of the “huge amount of data” told ET.

“The data is huge, needs review, and takes a lot of time. The SEC will meet within a few days to complete the review,” he said.

On Thursday, Bharat Biotech sought regular market approval from drug regulators for its unique Covid-19 vaccine, Covaxin, which is currently licensed for emergency use in the country.

“The review is ongoing and will continue. It can’t be done in a day,” he said on condition of anonymity.

Experts will meet again soon. “We will meet as soon as possible-in the next 1-2 days,” he added.

The market approval label for a vaccine means that it can be approved for use without reservation or conditions. Previously, the Serum Institute of India had submitted a similar application to Covishield.

In response to the application, DCGI was asking for more information, but sources said it was submitted last week.

Covishield and Covaxin are the leading Covid-19 vaccines used in government vaccination drives. About 88% of the eligible population receives the Covishield. Covaxin accounts for 12% of all Covid-19 vaccines administered in India since January 2021. So far, this is the only jab given to adolescents aged 15-18 years when vaccination began on January 3. ETHealthWorld