Bharat Biotech yesterday announced that Covaxin has proven to be safe, well-tolerated and immunogenic in paediatric subjects in phase-II/III study.
In a statement, the company said that Bharat Biotech had conducted phase-II/III, open-label and multi-centre studies to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the two-to-18 age group. The clinical trials conducted in the paediatric population between June 2021 and 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 an emergency use nod for children aged 12-18 from DCGI, recently, the statement further informed.
In the study, no serious adverse event was reported; 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event, according to the statement.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner. Group-I consisted of children aged 12-18 years (n=175), group-II consisted of children aged six-to-12 years (n=175), and group-III consisted of children aged two-to-six years (n=175). Seroconversion was documented at 95-98 per cent, in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias. In earlier Covaxin studies in adults, cross-reactive memory T cells against all variants of concern were reported. Studies are underway to evaluate T cell responses against the Omicron variant. Since Covaxin is an inactivated vaccine, corroborative results are expected, the statement mentioned.