Bharat Biotech’s Covaxin recommended for trial on under 18 age groups

The Hyderabad-based Bharat Biotech’s COVID-19 Vaccine, Covaxin was recommended an expert panel for phase II/III clinical trial on the children between 2 to 18 age groups on Tuesday, said an official source.

As per sources, the trial will take place in 525 subjects at various sites including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Science, Nagpur.

The proposal of vaccination for children was earlier deliberated in the Subject Expert Committee (SEC) meeting on February 24 and the firm was asked to submit a revised clinical trial protocol.

The Central Drug Standard Control Organisation (CDSCO) on Tuesday deliberated upon Biotech’s application seeking permission to conduct phase II/III clinical trial of the whole virion inactivated COVID vaccine in the age groups below 18 subject to the condition that the firm should submit the interim safety data of Phase II clinical trials along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study, the source said.