COVAXIN for children: Study demonstrates robust safety & immunogenicity in 2-18 age-group volunteers.

Hyderabad: Bharat Biotech International Limited has announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study.

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.

Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “COVAXIN’s clinical trial data from the pediatric population is very encouraging. Safety of the vaccine is critical for children, and we are glad to share that COVAXIN has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically.”

About COVAXIN Phase II/III study analysis for pediatric 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.