Bharat Biotech International Limited (BBIL) announced that its Covid-19 vaccine Covaxin has proved to be safe, well-tolerated and highly immunogenic in children aged 2 to 18 years in phase II/III study.
A press release from the vaccine maker said the study has been accepted and published in Lancet Infectious diseases, peer reviewed high impact factor journal.
Bharat Biotech said that the neutralizing antibodies in children were on an average 1.7 times higher than in adults and that data from over 50 million doses administered to children in India revealed that side effects were minimal.
Bharat Biotech had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in 2-18 years age group.
A total of 374 "adverse events" or side-effects were reported. Majority of these were mild and resolved within a day. Pain at the injection spot was the most common adverse event.
The clinical trial conducted in the paediatric 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 6-18 years.
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 immunisation and booster doses, making Covaxin a universal vaccine."