Covaxin well-tolerated, immunogenic in children: Lancet Journal review

Bharat Biotech’s Covaxin has proven to be safe, well-tolerated, and immunogenic in the paediatric population in phase 2/3 studies, showed a study published in the peer-reviewed journal The Lancet.

Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required.

The company claimed that Covaxin is one of the first Covid19 vaccines in the world to generate data in the 2-18 year age group. Data from over 50 million doses given to children in India reveals that side effects are minimal. This data is now peer-reviewed and published in Lancet Infectious Diseases.

Bharat Biotech said that vaccine-related cases of AEFI’s such as myocarditis, blood clots, and pericarditis were not reported. “Neutralizing antibodies in children on average 1.7 times higher than in adults,” it added.

The same dosage of Covaxin can be administered to adults and children for primary immunisation and booster doses.

Bharat Biotech conducted phase 2/3, open-label, and multicenter study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years of age group. The clinical trial conducted in the paediatric population between June 2021 and September 2021 has shown safety, less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and received a nod for emergency use in children aged 6-18 years.

The study published in The Lancet noted: “From May 27, 2021 to July 10, 2021, we enrolled 526 children sequentially into groups 1 (n=176), 2 (n=175), and 3 (n=175). 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.”

Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “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, for primary immunization 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.”

In the study, no serious adverse event was reported. A total of 374 adverse events were reported, and the majority of adverse events was mild in nature and resolved within one day. Pain at the injection site was the most commonly reported adverse event.

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