Bharat Biotech International Ltd on Friday said its COVID-19 vaccine Covaxin has proven to be safe, well-tolerated and highly immunogenic in children and adolescents of 2-18 years age group in phase II/III study.
The company conducted phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years of age group between June 2021 to September 2021, Bharat Biotech International Ltd (BBIL) said in a statement. "The study has been accepted and published in Lancet Infectious diseases, peer-reviewed high impact factor journal," the company said.
The clinical trial conducted in the pediatric population 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, it added. "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. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India," Bharat Biotech Chairman and MD Krishna Ella said. Bharat Biotech said 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 one day. Pain at the injection site was the most commonly reported adverse event.
The company claimed that it has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required.