New Delhi, June 17
Bharat Biotech International Ltd on Friday said its COVID-19 vaccine Covaxin has been proven to be safe, well-tolerated and highly immunogenic in children and adolescents aged 2-18 years in a phase II/III study.
Bharat Biotech International Limited conducted a Phase II/III, open-label and multicentre study to evaluate the safety, responsiveness and immunogenicity of Covaxin in healthy children and adolescents aged 2-18 years, between June 2021 and September 2021. (BBIL) said in a statement.
“The study has been accepted and published in The Lancet Infectious Disease, the peer-reviewed High Impact Factor journal,” the company said.
Clinical trials conducted in the pediatric population have shown safety, low reactivity, and strong immunogenicity. The data were submitted to the Central Drugs Standard Control Organization (CDSCO) in October 2021, and were obtained for emergency use in children aged 6–18 years.
“The safety of the vaccine for children is important and we are pleased to report that Covaxin now has proven data for safety and immunity in children.
“We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for primary immunization and booster doses for adults and children, making Covaxin a universal vaccine. Krishna Ella, President and MD, Bharat Biotech, said, “It has proven to be a highly safe vaccine based on data from over 50 million doses administered to children in India.
Bharat Biotech said in the study, no serious adverse events have been reported. A total of 374 adverse events were reported, and most 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 over 50 million doses of Covaxin ready to be distributed as needed.