Bharat Biotech International Ltd announced on June 17 that its COVID-19 vaccine Covaxin was safe, well-tolerated, and highly immunogenic in children and adolescents aged 2 to 18 years in a 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.
Paediatric clinical trial demonstrated safety
“The study was accepted and published in Lancet Infectious Diseases, a peer-reviewed journal with a high impact factor,” the company said. The paediatric clinical trial demonstrated safety, less reactogenicity, and robust immunogenicity. 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, according to the company.
Achieved goal of developing safe COVID-19 vaccine for adults and children
“We are pleased to report that Covaxin has now demonstrated 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.” Based on data from more than 50 million doses administered to children in India, it has proven to be a highly safe
vaccine,” said Bharat Biotech Chairman and MD Krishna Ella.
According to Bharat Biotech, no serious adverse events were reported in the study. A total of 374 adverse events were reported, with the majority of them being minor and resolved within one day. The most frequently reported adverse event was pain at the injection site. According to the company, it has a stockpile of more than 50 million doses of Covaxin ready to be distributed as needed.
