Bharat Biotech International Limited (BBIL) on Friday, June 17, announced that its COVID-19 vaccine Covaxin has proven to be “safe, well-tolerated and highly immunogenic” in paediatric subjects in phase II/III study. A press release from the vaccine maker said the study has been accepted and published in the Lancet. Bharat Biotech had 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 2-18 years 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 company said. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received a nod for emergency use in children aged 6-18 years.
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."
The company said that 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," he further 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 release said.