Panel Recommends Nod To Serum Institute For Covid Jab Trials On Children

The Serum Institute trials would cover 920 children, 460 each in the age groups of 12-17 and 2-11 across 10 sites.

An expert panel of the Central Drugs Standard Control Organisation today recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions, official sources said. The trials would cover 920 children, 460 each in the age groups of 12-17 and 2-11 across 10 sites. "The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated on the revised study protocol application given by SII on Tuesday and recommended granting permission to the firm for conducting phase 2/3 trial of Covovax on children aged 2 to 17 years," a source said. The Pune-based pharmaceutical company had submitted a revised protocol for inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer-blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab.