E-Paper
Covaxin shows robust safety, immunogenicity in children aged 2-18 years: Lancet
The company conducted phase 2/3, open-label, and multi-centre study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years age group
Covaxin, the Hyderabad-based Bharat Biotech’s anti-Covid vaccine, is safe and generates greater immune response in children than adults, according to data from a paediatric study done in children within the age group of 2-18 years published in The Lancet.
“…its whole-virion inactivated Covid-19 vaccine candidate, 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, peer reviewed high impact factor journal,” said Bharat Biotech in a statement.
Covaxin is one of the two anti-Covid vaccines that has largely been used to vaccinate people under the national Covid-19 immunisation programme. It was the first vaccine allowed for use in adolescents (15 years and above).
The company conducted phase 2/3, open-label, and multi-centre study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years age group.
The clinical trial conducted in the paediatric population between June 2021 and September 2021 has shown safety, it is less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021, and received a nod for emergency use in children aged 6-18 years.
“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 highly 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 Krishna Ella, chairman and managing director of Bharat Biotech.
Moreover, no serious adverse effects following immunisation were reported in the study. According to the company, 374 adverse events were reported, and the majority of those were mild in nature and resolved within one day. Pain at the injection site was the most commonly reported adverse event.
The vaccine is formulated uniquely in such a way that the same dosage can be administered to adults and children alike for primary and booster doses. It is a ready-to-use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy.
According to Bharat Biotech, the company has a stockpile of more than 50 million doses of the vaccine that is ready to be distributed as required. “Bharat Biotech has established Covaxin manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021.”
