Hyderabad-based Bharat Biotech International Limited (BBIL) has said that Covid-vaccine Covaxin (BBV152) has proven to be safe, well-tolerated, and highly immunogenic in pediatric subjects in phase II/III study. The study, according to the company, has been accepted and published in Lancet.
The company in its statement issued here said that Bharat Biotech had conducted phase II/III, open-label, and multi-center study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years of age group.
“The clinical trial conducted in the pediatric population between June 2021 and September 2021 has shown safety, less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received a nod for emergency use in children aged 6-18years,’’ said the statement.
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said: “Safety of the vaccine is critical for children 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, for primary immunization and booster doses, making Covaxin a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically.”
He added that in the study, no serious adverse event was reported. A total of 374 adverse events were reported, and the majority of adverse events were mild in nature and resolved within a day. Pain at the injection site was the most commonly reported adverse event.
“Covaxin, is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses, making it truly a universal vaccine. Covaxin is a ready-to-use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy,’’ added the statement. It further added that Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required.