Bharat Biotech, which completed the phase-II/III 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 (EUA) for the jab, company sources said recently.
“Covaxin clinical trial data of two-to-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-I, II and III clinical trials in adults,” sources told PTI.
Krishna Ella, Chairman and Managing Director, Bharat Biotech, had said on 21st September that the paediatric Covaxin completed phase-II/III 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-II trials of intra-nasal 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.