Center Gives Nod To Phase II/III Trials Of Covaxin For 2-18 Year-olds

New Delhi: The Central Government has given its permission to Bharat Biotech for Phase II/III clinical trials of Covaxin on two to eighteen year olds. This comes after the Subject Expert Committee on Covid-19 gave its go ahead for the trials.

The clinical trials will be carried out on 525 subjects at various location including AIIMS, New Delhi and Patna and Meditrina Institute of Medical Sciences, Nagpur.

The Expert Committee of the Central Drugs Standard Control Organization had yesterday deliberated upon Bharat Biotech’s application that sought permission for carrying out phase II/III clinical trials of Covaxin in children aged between two to 18 years old.

The permission has been granted to the company subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III trials.