Expert panel recommends Covaxin Phase II & III trials on 2-18 age group

Updated - December 06, 2021 at 07:20 AM.

A child wears a face mask and shield as a preventive measure against the spread of the coronavirus, COVID-19, at the Paul Valery French School in Yumbo, Valle del Cauca department, Colombia, on January 29, 2021. - Some children started attending classes in Colombia complying with a biosecurity protocol, wearing face masks and maintaining social distance some days a week. (Photo by Luis ROBAYO / AFP)

The Subject Expert Committee (SEC) of the Central Drug Standards Control Organisation (CDSCO) is understood to have recommended Phase II and III clinical trials of Covaxin on children aged between 2 and 18 years.

Hyderabad-based maker of the vaccine, Bharat Biotech, had submitted a proposal in this regard and was asked to submit a revised clinical trial protocol.

clinical trials of Covaxin on children aged between 2 and 18 years

The company was also asked to submit the interim safety data of Phase II clinical trials along with the DSMB (Data and Safety Monitoring Board) recommendations to the CDSCO before proceeding to Phase III of the study, according to sources

Published on May 13, 2021 05:53