COVAXIN® Phase II/III study analysis for pediatric use

COVAXIN® for Children: Study demonstrates robust safety and immunogenicity in 2-18 Volunteers.

• COVAXIN^Ò is the one of the first COVID-19 vaccines in the world to generate data in 2-18 year age group.
• 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.

Mumbai, December 31, 2021: Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that BBV152 (COVAXIN^Ò), 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.”