Clinical trials were conducted in children between June-September 2021, Bharat Biotech said (File)
Bharat Biotech today announced that Covaxin, its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III trials.
Bharat Biotech had conducted phase II/III, open-label, and multicentre studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age groups, a press release from the vaccine maker said.
"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.
The clinical trials conducted in the paediatric population between June-September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and the emergency use approval for children aged 12-18 from DCGI came recently.
In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms, with 78.6 per cent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event, the release said.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing ( enzyme-linked immunoassay). Of these, 525 eligible participants were enrolled. Based on their age, participants were distinguished into three groups in an age de-escalatory manner.