Indigenously develop Covaxin has been to be safe, well tolerate and immunogenic in children in a PhaseII/III study, with neutralising antibodies find to be on an average 1.7 times higher than in adults.
The results of the paediatric trials, which have uploade on preprint server medRxiv, show seroconversion at 95-98% in children of all the age groups four weeks after the second dose, indicating superior antibody responses in children as compare to adults and also displayed Th1 bias, as per Bharat Biotech.
No serious adverse events or cases of myocarditis or blood clots were report in the trials with pain at the injection site being the most commonly report adverse event, said the research paper, adding that 374 volunteers report either mild or moderate severity symptoms with 78.6% getting resolved within one day.
The open-label, multi-centre paediatric trials were carry out on 525 volunteers aged 2-18 years between June-September 2021 in three cohorts, 176 volunteers aged 12-18 years, 6-12 years (175) and 2-6 years (175).
This makes Covaxin the first vaccine in the world to have studied and generate data on kids as young as 2 years old.
Bharat Biotech chairman & managing director Dr Krishna Ella said the clinical trial data from the paediatric population is very encouraging.
“Safety of the vaccine is critical for children and 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.”
Bharat Biotech had submit the data to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and recently receive emergency use authorisation for use in children aged 12-18 years from the drug regulator.
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