Lancet: Covaxin is safe, immunogenic in kids aged 2-18 yrs
- Bharat Biotech had conducted phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in 2-18 years of age group
New Delhi: A study published in the Lancet has reported that Bharat Biotech’s Covaxin, a covid-19 vaccine, has demonstrated robust safety and immunogenicity in children aged 2-18 years. With this, researchers at Bharat Biotech claimed that Covaxin has become the world’s first covid-19 jab for 2-18-year-olds.
Bharat Biotech had conducted phase II and III, open-label and multicentre studies to evaluate the safety, reactogenicity, and immunogenicity of the vaccine in healthy children and adolescents in the 2-18 years age group.
“The clinical trial conducted in 526 paediatric populations between June 2021 to September 2021 has shown safety, less reactogenicity, and robust immunogenicity. Neutralizing antibodies in children are on an average 1.7 times higher than in adults,” the company said.
The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and the company received a nod for emergency use of the vaccine in children aged 6-18 years. At present, Covaxin is being administered to 15-18 year-olds under the national covid-19 vaccination programme.
Another vaccine, Corbevax, manufactured by Biological E, is being administered to 12-14-years-olds.
“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 immunization 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, Bharat Biotech.
No serious adverse event was reported during the study. A total of 374 adverse events were reported, which were mostly mild in nature and were resolved in a day. Pain at the injection site was the most commonly reported adverse event.
The data has been peer reviewed and published in the Lancet Infectious Diseases, a high impact factor journal.
Bharat Biotech has more than 50 million doses of Covaxin ready to be distributed, it said.
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First Published:17 Jun 2022, 10:46 PM IST
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