Bharat Biotech International Limited (BBIL) announced on Friday 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 has been accepted and published in Lancet Infectious Diseases, a peer-reviewed, high-impact factor journal. Bharat Biotech has conducted a 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 year age group.
Clinical trial
The clinical trial conducted in the paediatric population between June and September 2021 has shown safety, less reactogenicity, 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 6–18 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,” Krishna Ella, Chairman and Managing Director, Bharat Biotech, said in a release.
“We have now achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children, for primary immunisation and booster doses, making Covaxin a universal vaccine,” Ella added.
It has proven to be a highly safe vaccine based on data from more than five crore doses administered to children in India. Vaccines are a great preventive tool, he said.
Adverse events
In the study, no serious adverse events were reported. A total of 374 adverse events were reported, and the majority of these adverse events were mild in nature and resolved within a 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 a 12 month shelf life and a multi-dose vial policy.
Hyderabad-based Bharat Biotech has a stockpile of more than five crore doses of Covaxin ready to be distributed as required. Bharat Biotech has established Covaxin manufacturing to reach an annualised capacity of 100 crore doses by the end of 2021.