SEC recommends authorisation to Covaxin without 'clinical trial mode'

The Subject expert committee (SEC) of Drugs Controller General of India (DCGI) on Wednesday recommended removing the "clinical trial mode" condition related to Bharat Biotech's Covaxin.

This entails that the beneficiaries will not be required to sign a consent form to take the indigenous COVID-19 vaccine if the SEC recommendation is accepted by the country's top drugs regulator.

Sources said SEC recommended a nod for Emergency Use Authorisation for Covaxin with the vaccine no longer needed to be administered in clinical trial mode.

They said the decision was taken after going through interim phase three trial data of the vaccine which has been developed by Bharat Biotech in collaboration with ICMR.

The company had earlier this month announced Phase 3 results of Covaxin, stating that the vaccine demonstrates interim clinical efficacy of 81 per cent.

Covaxin had also got emergency licensure in January but the authorisation was in clinical trial mode which made it mandatory for every beneficiary to sign an informed consent while getting the vaccine.

Covaxin is a two-dose vaccine administered to an individual in a gap of 28 days.

Lancet, a top medical journal, which published phase 2 results of Covaxin, has said it was "safe, immunogenic with no serious side effects".

( With inputs from ANI )