Bharat Biotech announced that Covaxin has received emergency use approval in children 6-12 years of age.

Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data readouts were submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received an emergency use nod for children aged 12-18 from DCGI during December 2021.

Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We have established Covaxin as a universal vaccine for adults and children. 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 achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children.”

Clinical trials in children documented seroconversion at 95-98%, four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias.

Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike. Covaxin is a ready-to-use liquid vaccine, stored at 2-8°C, with 12 months shelf life and a multi-dose vial policy. The same vaccine can also be used for 2 doses of primary immunization and for booster dose vaccinations, making it truly a universal vaccine.