Bharat Biotech gets nod for phase 2/3 clinical trials of Covaxin on 2 to 18-year-olds

The Subject Expert Committee (SEC) under India’s drug regulator has given its nod to Bharat Biotech for conducting phase 2 and 3 clinical trials of its Covid-19 vaccine Covaxin on children aged between 2 to 18-year-old, a senior official told ET.

The trial is expected to be conducted on 525 subjects at various sites, including AIIMS-Delhi, AIIMS-Patna.

On Tuesday, the Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct the clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs among children.


"After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group 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 part of the study," an official said.