New Delhi: Hyderabad-based vaccine manufacturer Bharat Biotech on Friday announced that its whole-virion inactivated Covid vaccine Covaxin has proven to be safe, well-tolerated and highly immunogenic in paediatric subjects in phase II/III study.
“The study has been accepted and published in Lancet Infectious diseases, peer reviewed high impact factor journal,” said Bharat Biotech in a statement.
The vaccine manufacturer had conducted the phase II/III open-label and multicentre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in 2-18 years of age group. “The clinical trial conducted in the paediatric population between June 2021 and September 2021 has shown safety, less reactogenic, and robust immunogenicity,” Bharat Biotech 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.
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”. He 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.
As per the vaccine manufacturer, no serious adverse event was reported in the study. “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,” Bharat Biotech said in the statement.