Hyderabad, April 26 (UNI) Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, on Tuesday announced that BBV152 (COVAXIN), its whole-virion inactivated Covid-19 vaccine candidate, has received emergency use approval in children in the age group of 6-12 years.
Bharat Biotech had conducted phase II and III, open-label and multicenter studies to evaluate the safety, reactogenicity and immunogenicity COVAXIN in healthy children and adolescents in the age group of 2-18 years.
The clinical trials conducted in the paediatric population between June to September last year, have shown robust safety, reactogenicity, and immunogenicity, Hyderabad-based Bharat Biotech said in a statement here.
The data readouts were submitted to the Central Drugs Standard Control Organisation (CDSCO) during October last year and received emergency use nod for children aged between 12-18 from DCGI during December 2021.
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 per cent, 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 neutralisation studies against Delta and Omicron variants have been published, along with impact of cell mediated immune responses.
Since COVAXIN is an inactivated vaccine, corroborative results are expected in children similar to that of adults.
Booster dose of COVAXIN in adults generated robust neutralising antibody responses against both Omicron (B.1.529) and Delta (B.1.617.2) using a live virus neutralisation assay.
Hundred per cent of test serum samples showed neutralisation of Delta variant and more than 90 per cent of serum samples showed neutralisation of 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. 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 multi-dose vial policy. The same vaccine can also be used for two dose primary immunisation and for booster dose vaccinations, making it truly an universal vaccine
Fresh stocks of COVAXIN are available and ready for supplies. Bharat Biotech has readily available more than 50 million doses of COVAXIN in vials, and more than 200 million doses as drug substance. Additional production capacity is also available to meet product demand.
