Bharat Biotech’s Covid-19 vaccine — Covaxin — has reported higher neutralising antibodies in children and on an average, it was 1.7 times higher than in adults. The vaccine was well-tolerated and immunogenic in paediatric subjects in Phase II/III study. The study has been accepted and published in Lancet Infectious Diseases.
Covaxin is one of the first Covid-19 vaccines in the world to generate data in 2–18-year age group. Data from over 50 million doses given to children in India revealed that side effects were minimal.
Dr. Krishna Ella, chairman and managing director, Bharat Biotech, said, the safety of the vaccine was critical for children and Covaxin now had 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,” Ella said.
Bharat Biotech said the safety of Covaxin in both adults and children is now well established. Data on pharmacovigilance and adverse event after immunization (AEFI) after introduction in several countries was positive. Vaccine-related cases of AEFI’s such as myocarditis, blood clots, pericarditis, were not reported.
The data has now been peer-reviewed in the Lancet Infectious Diseases.
Bharat Biotech had conducted phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity, and immunogenicity in the pediatric population between June 2021 and September 2021. It has shown safety, less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation during October 2021, and the vaccine received a nod for emergency use in children aged 6-18 years.
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 annualised capacity of one billion doses.