Bharat Biotech said its Covid-19 vaccine was found safe for children and adolescents in the age group of 2-18 years during clinical trials.
No adverse event was reported, other than pain at the injection site, the company said in a statement. "No cases of myocarditis or blood clots were reported, as expected with inactivated vaccines."
The indigenous vaccine manufacturer conducted a phase II/III, open-label, multi-centre study to evaluate safety, reactogenicity and immunogenicity of Covaxin in volunteers belonging to the 2-18 age group.
Covaxin, a "Whole-Virion inactivated SARS-CoV-2" vaccine, has proven to be safe, well-tolerated and immunogenic in paediatric subjects, the company said. The jab neutralised antibodies in children 1.7 times higher than adults on average, it said.
“Covaxin's clinical trial data from the paediatric population is very encouraging,” Dr Krishna Ella, chairman and managing director of Bharat Biotech, said in the statement. We're glad Covaxin now has proven data for safety and immunogenicity in children, he said.
Earlier this month, Covaxin was approved by the Indian government to immunise children aged between 15 and 18 years against the pandemic.
The vaccine's unique formulation, the company said, allows administration of the same dosage to adults and children.
Essential Business Intelligence, Continuous LIVE TV, Sharp Market Insights, Practical Personal Finance Advice and Latest Stories — On NDTV Profit.
