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Covaxin found to be safe, well tolerated and immunogenic in 2 18 age group: Bharat Biotech

Covaxin found to be safe, well-tolerated and immunogenic in 2-18 age group: Bharat Biotech

Covaxin found to be safe, well-tolerated and immunogenic in 2-18 age group: Bharat Biotech
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By CNBCTV18.com Dec 30, 2021 7:02:31 PM IST (Updated)

Covaxin has proven to be safe, well-tolerated and immunogenic in the age group of 2-18 years.

Bharat Biotech on Thursday said that its COVID-19 vaccine, Covaxin has proven to be safe, well-tolerated and immunogenic in the age group of 2-18 years.

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Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group, the vaccine maker said.
Krishna Ella, Chairman and Managing Director, 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."
The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from DCGI recently.
In the study, no serious adverse event was reported. A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6 percent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event, the company release said.
(With inputs from PTI)
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