Bharat Biotech's Covaxin has proved to be safe, well-tolerated and immunogenic in the paediatric population in Phase-II and -III studies, according to a study published in the peer-reviewed journal The Lancet.
Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required.
The company claimed that Covaxin is one of the first Covid-19 vaccines in the world to generate data in the 2-18 year age group. Data from over 50 million doses given to children in India reveals minimal side effects. This data is now peer-reviewed and published in The Lancet Infectious Diseases.
Bharat Biotech did not report vaccine-related cases of Adverse Events Following Immunisation (AEFIs), such as myocarditis, blood clots, and pericarditis.
"Neutralising antibodies in children were on an average 1.7 times higher than in adults," said Bharat Biotech.
The same dosage of Covaxin can be administered to adults and children for primary immunisation and booster doses.
Bharat Biotech conducted phase 2/3, open-label and multicenter study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group.
The clinical trial conducted in the pediatric population between June 2021 and September 2021 has shown the vaccine to be safe, less reactogenic, and robustly immunogenic. 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.
The study published in The Lancet noted: "From May 27, 2021, to July 10, 2021, we enrolled 526 children sequentially into groups 1 (n=176), 2 (n=175), and 3 (n=175). Vaccination was well tolerated, with no differences in reactogenicity between the three age groups, and no serious adverse events, deaths, or withdrawals due to an adverse event."
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "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."
In the study, no serious adverse event was reported. A total of 374 adverse events were reported, and the majority of adverse events were mild in nature and resolved within one day. Pain at the injection site was the most reported adverse event.