Bharat Biotech International, developer and manufacturer of Covaxin– the only vaccine that is recommended for inoculation in the young aged between 15 and 18 in the ongoing India vaccination drive, said its whole-virion inactivated COVID-19 vaccine candidate has been proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. The company, which conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of COVAXIN in healthy children and adolescents in the 2-18 age group, said the clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from DCGI recently.

In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 percent getting resolved within 1 day. Pain at the injection site was the most commonly reported adverse event, the company said in a statement.