Bharat Biotech International Limited (BBIL), on Friday, announced that BBV152 (Covaxin) has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study. The findings of the study were published in The Lancet Infectious Diseases on Thursday. The study revealed that the vaccine was well tolerated in children aged 2-18 years and it induced higher neutralising antibody responses than those observed in adults in whom its efficacy has been demonstrated.
Bharat Biotech 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. According to reports, the clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenicity, and robust immunogenicity.
Moreover, 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 6-18 years.
“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,” Dr Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement issued on Friday.
Meanwhile, no serious adverse event was reported in the study. During the study, a total of 374 adverse events were reported, however, majority of them were mild in nature and resolved within a day. It is noteworthy that 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. According to experts, whole-virion inactivated vaccines have proven to be safe, and tolerable with a safety record of several decades.
Moreover, several paediatric vaccines manufactured using this feature are utilised in routine immunization for primary immunization and booster doses. According to reports, several flu vaccines also utilize this manufacturing platform technology, which is safe and effective for repeated annual immunization doses and boosters.
At present, Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required. Moreover, it has established Covaxin manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021.