Hyderabad: In a statement issued on Thursday, Bharat Biotech International Limited (BBIL), the leading vaccine developer in the country, said that phase II/III clinical trials have proved Covaxin is safe for children and adolescents in the 2-18 age group.
In the study, no serious adverse event was reported. As many as 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within a day. Pain at the injection site was the most commonly reported adverse event.
No cases of myocarditis or blood clots were also reported, as expected with inactivated vaccines, according to Bharat Biotech.
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Dr. Krishna Ella, chairman and managing director of Bharat Biotech, said, “COVAXIN®’s clinical trial data from the paediatric population is very encouraging. 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.”
Bharat Biotech also claimed in the statement that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike. "Covaxin is a ready to use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy," it said.
With this breakthrough development, Covaxin becomes one of the first Covid-19 vaccines in the world to generate data in 2-18 year age group. It can also neutralise antibodies in children on an average 1.7 times higher than in adults, according to the vaccine developer.
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