CDSCO expert panel recommends Covaxin be moved out of 'clinical trial mode'

NEW DELHI: An expert panel of India's central drugs authority on Wednesday recommended granting emergency use authorisation to Bharat Biotech's indigenously developed Covaxin while removing the condition for the vaccine to be administered in 'clinical trial mode', official sources said.

The recommendations have been sent to the Drugs Controller General of India (DCGI) for consideration. If the vaccine is taken off clinical trial mode then the beneficiaries will no longer have to sign a consent form for taking the jab.

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) went through the interim data of Covaxin's phase-3 clinical trial which showed that the vaccine has an efficacy of 80.6 per cent. Following this, the recommendations were made.