Covid-19 vaccine: Bharat Biotech's Covaxin goes off clinical trial mode

Expert panel recommends emergency use authorisation

Bharat Biotech’s Covaxin on Wednesday got the nod from the subject expert committee (SEC), an independent panel set up by the Drugs Controller General of India (DCGI) to advise it, for a restricted emergency use of the Covid-19 vaccine.

Covaxin was granted restricted use approval in ‘clinical trial mode’ in January by the DCGI. At that time, the phase 3 trial on 25,800 volunteers was underway.

“The decision to allow a restricted emergency use of Covaxin is based on the interim data from phase 3 trials,” said a source. The SEC met on Wednesday to review the application of Bharat Biotech.

The removal