Bharat Biotech announced today a Study in which COVAXIN for 2-18 years Children demonstrated Robust Safety and Immunogenicity. BBV152 (COVAXIN), is a whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study.
COVAXIN for 2-18 years Children : Highlights of the study
- Phase II/III, Open-Label, Multi-centre Study was conducted to evaluate the Safety, Reactogenicity, and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®️) in healthy children and adolescents in the 2-18 age group.
- Whole-Virion inactivated SARS-CoV-2 Vaccine (BBV152) has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Neutralizing antibodies in children on an average 1.7 times higher than in adults.
- No serious adverse event was reported. Pain at the injection site was the most commonly reported adverse event. No cases of myocarditis or blood clots were reported, as expected with inactivated vaccines.
COVAXIN is one of the first COVID-19 vaccines in the world to generate data in 2-18 year age group.
Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity COVAXIN®️ in healthy children and adolescents in the 2-18 age group. 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% getting resolved within 1 day. Pain at the injection site was the most commonly reported adverse event.
About COVAXIN®️ Phase II/III study analysis for paediatric use
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 of age 12-18 years (n=175), group II consisted of children of age 6-12 years (n=175), and group III consisted of children of age 2-6 years (n=175).
Seroconversion was documented at 95-98%, 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 was reported. Studies are underway to evaluate T cell responses against the Omicron variant. Since COVAXIN, is an inactivated vaccine corroborative results are expected.
COVAXIN is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN is a ready to use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy.
Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (BBV152) in children from 2 to 18 years of age: an open-label, age-de-escalation phase 2/3 study . Here is the study study link