An expert panel has recommended Bharat Biotechs COVID-19 vaccine –Covaxin - for phase II/III clinical trials on individuals aged 2 to 18 years, reported official sources.

The trial is set to be conducted among 525 subjects at several sites, including AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) contemplated Bharat Biotechs application to seek approval for phase II/III clinical trials to determine the safety, reactogenicity and immunogenicity of Covaxin in children aged 2 to 18 years. Following consideration, the committee recommended the proposed trials in that age group, with the condition that the company must submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO prior to starting the phase III of the study… (ET Healthworld – PTI, May 12, 2021)