Bharat Biotech International Limited (BBIL), a global developer of vaccines for infectious diseases, today announced that BBV152 (COVAXINÒ), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects of age 2-18 years in phase II/III study. The study has been accepted and published in Lancet Infectious diseases, a peer reviewed high impact factor journal.   

Bharat Biotech had conducted phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity, and immunogenicity COVAXINÒ in healthy children and adolescents in 2-18 years of age group. The clinical trial conducted in the pediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received a nod for emergency use in children aged 6-18years, the company informed in a statement.

Dr 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 immunization 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. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically.”

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 1 day. Pain at the injection site was the most commonly reported adverse event.

"COVAXINÒ, is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses. COVAXIN is a ready to use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy," the company stated in a press statement.

Whole virion inactivated vaccines have proven to be safe, tolerable with a safety track record of several decades. Several paediatric vaccines manufactured using this platform technology are utilized in routine immunization for primary immunization and booster doses. Several flu vaccines also utilize this manufacturing platform technology, which is safe and effective for repeated annual immunization doses and boosters.