In phase II/III trials, Bharat Biotech’s whole-virion inactivated COVID-19 vaccine candidate, Covaxin, was found to be safe, well-tolerated, and immunogenic in paediatric subjects.

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According to a press release from Bharat Biotech, the vaccine producer conducted phase II/III, open-label, and multicentre trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the age range of 2-18.

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

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Between June and September 2021, clinical trials in the paediatric population revealed high levels of safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organization (CDSCO) in October 2021, and DCGI just approved emergency usage for children between the age of 12 to 18.

There were no major adverse events recorded in the research. 374 people had mild or moderate-severity symptoms, with 78.6% of them disappearing within a day. According to the press release, the most usually reported adverse event was pain at the injection site.

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In the study, 976 people were tested for SARS-CoV-2 using RT-PCR and ELISA (enzyme-linked immunoassay). A total of 525 people were enrolled in the study. Participants were divided into three groups based on their age in a decreasing order of age.

Covaxin was approved by the Indian government earlier this month to immunise children between the age of 15 to 18 years against the coronavirus. The vaccine’s unique formulation, according to the manufacturer, allows adults and children to receive the same dose.