Bharat Biotech International Ltd said on Friday that its COVID19 vaccine Covaxin has proven safe, well-tolerated, and highly immunogenic in children and adolescents aged 2 to 18 years in phase II/III study. Bharat Biotech International Ltd (BBIL) said in a statement that the company conducted a phase II/III, open-label, multicenter study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents aged 2 to 18 years between June 2021 and September 2021.
The data was submitted to the Central Drugs Standard Control Organization (CDSCO) in October 2021, and it was approved for emergency use in children aged 6 to 18. Bharat Biotech’s Chairman and Managing Director, Dr. Krishna Ella, stated, “The safety of the vaccine is critical for children, and we are pleased to report that Covaxin now has data demonstrating its safety and immunogenicity in children. We have now completed the development of a safe and effective COVID-19 vaccine for adults and children, for both primary immunization and booster doses, making Covaxin a universal vaccine.”
Based on data from more than 50 million doses administered to children in India, it has proven to be a highly safe vaccine. Vaccines are an excellent preventive tool, but their full potential can only be realized when used “prophylactically,” he added.
There were no serious adverse events reported in the study. A total of 374 adverse events were reported, with the majority of them being minor and resolved within a day. According to the release, the most commonly reported adverse event was pain at the injection site.
