Covaxin more effective for kids and adolescents than adults, Bharat Biotech publishes trial data

​(File image: Vial of Covaxin)

Covaxin, the COVID-19 vaccine by Bharat Biotech, has been found to be safe, well-tolerated in children and adolescents aged 2–17 years, and induced higher neutralizing antibody responses than those observed in adults, a study published in the scientific journal Lancet Infectious Diseases has said.

The Hyderabad-based vaccine maker had conducted phase 2, 3, open-label, and multi-center study between June and September last year to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in 2-17 years of age group.

The clinical trial conducted in the pediatric population between June 2021 and September 2021 has shown safety, less reactogenic, and robust immunogenicity, the company said.

The data - based on trials in 576 kids and adolescents - was submitted to the Central Drugs Standard Control Organisation in October 2021, and received a nod for emergency use in Indian population aged 6-18 years.

However, as of now, the vaccine is being used to inoculated adolescents aged 15-17 years under the National COVID-19 immunisation programme while another vaccine Corbevax by Biological E has been permitted for use in kids aged 12-14 years.

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No COVID-19 vaccine is being offered to kids aged under 12 yet despite regulatory approvals.

No serious adverse events during the trials on kids

Commenting on the findings of the study, Krishna Ella, chairman and managing director, Bharat Biotech, said that the safety of the vaccine is critical for children and added that Covaxin has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India.

The study said that during the trials on kids, no serious adverse event was reported even though a total of 374 adverse events were reported. The majority of adverse events, however, were mild in nature and resolved within one day.

Pain at the injection site was the most commonly reported adverse event.

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The company said that it has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required and added that it has established vaccine manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021.