Hyderabad: Bharat Biotech, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children under 18 years of age, has submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for Emergency Use Authorisation for the jab, company sources said on Wednesday.
“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.