Bharat biotech study demonstrates COVAXIN as safe for Children

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Bharat Biotech International Limited, on Thursday, announced that its whole-virion inactivated COVID-19 vaccine candidate, COVAXIN has been demonstrated to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study conducted by the company.

The study report was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021. And in the latest development, the pharma firm has received, an emergency use, nod for children aged 12-18 from DCGI.

“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. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically.” 

Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech

To assess the safety of COVAXIN’s reactogenicity and immunogenicity in healthy children and adolescents aged 2 to 18, Bharat Biotech conducted phase II/III, open-label, and multicenter investigations. 

The pediatric clinical trials between June 2021 and September 2021 have demonstrated a high level of safety, reactogenicity, and immunogenicity.

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