Hyderabad based vaccine manufacturer Bharat Biotech on Thursday announced that Covaxin (BBV152) has been found to be "safe, well-tolerated, and immunogenic" in the age group of 2-18 years in phase II/III study, said a company's statement.
Bharat Biotech 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, added the statement.
The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received an emergency use nod for children aged 12-18 from the Drugs Controller General of India (DCGI), 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 one day, stated the statement.
Pain at the injection site was the most commonly reported adverse event, as per the statement. Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "Covaxin's clinical trial data from the paediatric population is very encouraging. The 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," he added.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner, the statement said.
( With inputs from ANI )
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