Covaxin trial data in children submitted to CDSCO

"Covaxin clinical trial data of 2-18 years age group has been submitted to CDSCO...This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase 1,2 and 3 clinical trials in adults," sources told PTI.

Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella, had said on September 21 that the Paediatric Covaxin completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on.

As part of the Phase II/III trial, the two-dose Covaxin was administered with 28 days apart.

"We will be submitting the data (to the regulator) by next week," he had said.

He also had said that Phase 2 trials of intranasal vaccine to prevent COVID-19 were going on and expected to be over in October.

If approved, Covaxin will be the first COVID-19 vaccine that can be administered to children in India.

Medical dialogues team had earlier reported that the WHO would take a call on granting Emergency Use Listing (EUL) status for Bharat Biotech's COVID-19 vaccine Covaxin next week.

"WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin," the global health body had tweeted.