Covaxin safe, immunogenic in children aged 2-18 years: Lancet

HYDERABAD:

Bharat Biotech

International Limited (

BBIL

)’s whole-virion inactivated Covid-19 vaccine candidate

Covaxin

has proven to be safe, well-tolerated, and highly immunogenic in children aged 2-18 years in a phase II/III study, the results of which have been published in the prestigious, peer-reviewed

Lancet

Infectious diseases, peer reviewed high impact factor journal.

Bharat Biotech said 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.

In the study, no serious adverse event was reported and pain at the injection site was the most commonly reported adverse event. Of the total 374 adverse events reported, the majority were mild in nature and resolved within one day, the study said.

Data on pharmacovigilance and AEFI after introduction in several countries are very positive, it said, adding that vaccine related cases of AEFI’s such as myocarditis, blood clots, pericarditis, were not reported in the vaccine in the paediatric population, BBIL said.

With this study, the safety of Covaxin in both adults and children is now well established and 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, the company said.

The phase II/III, open-label, and multicentre study was conducted between June 2021 to September 2021 to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in 2-18 years of age group.

Bharat Biotech said the study has not only shown the vaccine’s safety, less reactogenicity and robust immunogenicity, Covaxin has also proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India.

The data was submitted to the

Central Drugs Standard Control Organisation

(CDSCO) during October 2021, after which BBIL received a nod for emergency use in children aged 6-18years.

Bharat Biotech chairman and managing director

Dr Krishna Ella

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 immunization and booster doses, making Covaxin a universal vaccine.”

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