Published: Published Date – 06:07 PM, Fri – 17 June 22
Hyderabad: Covid vaccine maker Bharat Biotech International Limited (BBIL), announced that its Covaxin (BBV152), has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study. The study has been accepted and published in Lancet Infectious Diseases, a peer reviewed journal. Bharat Biotech had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in 2-18 years of age group.
The clinical trial conducted in the pediatric population between June to September 2021 has shown safety, less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received a nod for emergency use in children aged 6-18years.
“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, for primary immunisation and booster doses, making Covaxin a universal vaccine. It has proven to be a safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically, ” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
In the study, no serious adverse event was reported. A total of 374 adverse events were reported, and a majority of the adverse events were mild in nature and resolved within one day. Pain at the injection site was the most commonly reported adverse event.
Covaxin is formulated such that the same dosage can be administered to adults and children alike, for primary and booster doses, making it truly a universal vaccine. Covaxin is a ready-to-use liquid vaccine with 12 months shelf life and multi-dose vial policy.
Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required, it said in a release.