Hyderabad: The Drugs Controller General of India (DCGI) on Tuesday granted an emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for the age group of 6-12 years.
The Hyderabad-based Pharma company Bharat Biotech in a statement said that it 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 emergency use nod for children aged 12-18 from DCGI during December 2021,” it said.
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 percent, four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias.
“In earlier Covaxin studies in adults, cross-reactive memory T cells against all variants of concern was reported. Data from neutralization studies against Delta and Omicron variants have been published along with the impact of cell-mediated immune responses. Since Covaxin, is an inactivated vaccine corroborative results are expected in children similar to that of adults,” the statement further reads.
A booster dose of COVAXIN in adults, generated robust neutralizing antibody responses against both Omicron (B.1.529) and Delta (B.1.617.2) using a live virus neutralization assay.
“100 percent of test serum samples showed neutralization of the Delta variant and more than 90 percent of serum samples showed neutralization of the Omicron variant. These data add to the body of evidence that the broad-spectrum mechanism of action of a whole virus inactivated COVID-19 vaccine, like Covaxin (BBV152), is a viable option in this continuously evolving pandemic,” it added.
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 degrees Celsius, with 12 months shelf life and a multi-dose vial policy.
It further said that the same vaccine can also be used for two-dose primary immunization and for booster dose vaccinations, making it truly a universal vaccine.
Bharat Biotech has readily available more than 50 million doses of COVAXIN in vials, and more than 200 million doses as a drug substance. Additional production capacity is also available to meet product demand.