Bharat Biotech on Thursday, 30 December, announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said:
“COVAXIN’s 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.”
Bharat Biotech had conducted the phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity COVAXIN in healthy children and adolescents in the 2-18 age group.
The clinical trials, conducted between June 2021 to September 2021, have shown "robust safety, reactogenicity, and immunogenicity".
The data was then submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use approval for children aged 12-18 from DCGI recently.
Though no serious adverse events were reported, 374 subjects reported either mild or moderate severity symptoms with 78.6 percent getting resolved within a day.
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 from ages 2 to 18.
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