Pune, June 17:
Covaxin (BBV152) was well tolerated in children aged 2-18 years and induced higher neutralising antibody responses than those observed in adults in whom its efficacy (ie, the prevention or decrease in severity of Covid-19 infection) has been demonstrated. Bharat Biotech International Limited (BBIL), on Friday announced that BBV152 (Covaxin), its whole-virion inactivated Covid-19 vaccine candidate, has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study.
The study was published online in the Lancet Infectious Diseases, a peer-reviewed high-impact journal, on June 16.
Bharat Biotech had conducted phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenicity 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 6-18 years.
Dr Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement issued on Friday: “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.”
No serious adverse event was reported in the study. A total of 374 adverse events were reported, and the majority of them were mild in nature and resolved within a day. Pain at the injection site was the most commonly reported adverse event.
Covaxin is a ready-to-use liquid vaccine, stored at 2-8°C, with a shelf life of 12 months and a multi-dose vial policy.
Whole-virion inactivated vaccines have proven to be safe, tolerable with a safety record of several decades. Several paediatric vaccines manufactured using this platform 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. It has established Covaxin manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021.
