NEW DELHI: Bharat Biotech International Limited confirms that COVAXIN successfully conducted the stage II/III study on children. The trials have proven to be safe, well tolerated and immunogenic among children. COVAXIN trails show even better response in children aged between 2-18 years than adults.
Bharat Biotech conducted the phase II/III multicenter studies to evaluate the safety,, and immunogenicity of COVAXIN among children and adolescents in the age group of 2-18 years. The data was submitted to the Central Drugs Standard Control Organisation in October 2021 and received emergency use nod for children between 12-18 of age from DCGI, recently.
In the study conducted by Bharat Biotech, no serious or adverse effect was reported. The open-label, multi-centre trials on children were carried out on 525 kids aged between 2-18 years. From June-September 2021 in three cohorts. Based on the age, participants were distinguished into three groups based on age. Group I consisted of children of age 12-18 years (175), group II consisted of children of age 6-12 years (175), and group III consisted of children of age 2-6 years (175).
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “COVAXIN’s clinical trial data from the paediatric 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.”
With this, COVAXIN becomes world’s first to have studied and generated data on kids as young as 2 years of age.
Bharat Biotech has established COVAXIN manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are in progress to companies in India, United States and other countries.