`Covaxin' safe for children: Hyderabad-based Bharat Biotech

Hyderabad: Bharat Biotech International Limited (BBIL), on Thursday said Covaxin has been found to be safe, well-tolerated, and immunogenic in pediatric subjects in phase II/III study.

In a statement, Hyderabad vaccine maker said it had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group. Covaxin is a whole-virion inactivated COVID-19 vaccine candidate.

The clinical trials conducted in the pediatric population between June 2021 to September 2021, have shown robust safety, reactogenicity, and immunogenicity, it said the data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received emergency use nod for children aged 12-18 from DCGI, recently.

In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 percent getting resolved within 1 day. Pain at the injection site was the most commonly reported adverse event, the vaccine maker said.

Bharat Biotech Chairman and Managing Director Dr. Krishna Ella, said, "Covaxin clinical trial data from the pediatric 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. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically."

India's indigenous Covaxin is one of the first COVID-19 vaccines in the world to generate data in the 2-18 year age group.