Bharat Biotech's Covaxin has proven to be safe, well-tolerated and highly immunogenic in children and adolescents aged 2-18 years, according to a recent peer review. A study published in The Lancet Infectious Diseases medical journal on Thursday shows that the vaccine “induced higher neutralising antibody responses than those observed in adults”.
Bharat Biotech conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity.
The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and received a nod for emergency use in children aged 6-18 years.
Speaking to reporters, Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "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, for primary immunisation and booster doses, making Covaxin a universal vaccine."
He further added, "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 and the power of vaccines can only be harnessed if used "prophylactically."
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 and resolved within one day. Pain at the injection site was the most commonly reported adverse event, the release said.
