Covaxin: Phase II-III trials show vaccine is safe, highly immunogenic in children above 2 years

Hyderabad: Bharat Biotech International Limited (BBIL) said Covaxin has proven to be safe, well-tolerated, and highly immunogenic in pediatric subjects in phase II/III study,

The study has been accepted and published in Lancet Infectious Diseases, a peer-reviewed high-impact factor journal, added the statement.

Bharat Biotech conducted phase II/III, open-label, and multicentre studies to evaluate the safety, reactogenicity, and immunogenicity of COVAXIN in healthy children and adolescents in the 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) in October 2021 and received a nod for emergency use in children aged 6-18years.

 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, and 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 and resolved within 1 day. Pain at the injection site was the most commonly reported adverse event.

COVAXIN is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses, making it truly a universal vaccine. 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 whole virion inactivated vaccines have proven to be safe, and tolerable with a safety track record of several decades. Several pediatric 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.

Bharat Biotech has a stockpile of more than 50 million doses of COVAXIN ready to be distributed as required. Bharat Biotech has established COVAXIN manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021