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lancet: Covaxin safe for kids aged 2-18, found as effective as in adults: Lancet

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Bharat Biotech’s locally developed Covid-19 vaccine, Covaxin, has proven to be safe, well-tolerated and highly immunogenic in children aged 2-18 years in phase 2/3 trials, according to the results of the study published in the Lancet medical journal. The clinical trials were conducted between June 2021 and September 2021 and showed “safety, less reactogenic, and robust immunogenicity”, it said.

The report said neutralising antibody responses were at least similar to those observed in adults in whom the vaccine had been proven to be efficacious against symptomatic and asymptomatic Covid-19.

The data were submitted to India’s Central Drugs Standard Control Organisation in October 2021 and the vaccine has received its approval for emergency use in children aged 6-18 years.

“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,” Bharat Biotech chairman Krishna Ella said in a statement.

“We have now achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children, for primary immunisation and booster doses, making Covaxin a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India,” Ella said.

No serious adverse events were reported during the study, according to the Lancet report.

A total of 374 adverse events were reported, and a majority of these were mild in nature and resolved within a day. Pain at the injection site was the most commonly reported adverse event, it said.

The study had enrolled 526 children in three groups. The sample size is considered relatively small for more detailed analysis.

“Vaccination was well tolerated, with no differences in reactogenicity between the three age groups, and no serious adverse events, deaths, or withdrawals due to an adverse event,” the report said.

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