Bharat Biotech's US partner for its Covid-19 vaccine has said that it has submitted an application to the Food and Drug Administration for Emergency Use Authorisation (EUA) of Covaxin for children in the age group of 2-18 years.
The approval request is based on results from a study of 526 kids between ages 2 and 18 who received two doses of Covaxin 28 days apart.
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The findings were compared with those from a group of 25,800 adults in India and it suggested similar protection in children to that demonstrated in adults, the company said.
In the clinical trial with 526 children, there were no serious adverse events or hospitalisations but the study's sample size may not have been large enough to detect rare side effects.
Covaxin was recently awarded Emergency Use Listing by the World Health Organisation.