Washington: Ocugen Inc., Bharat Biotech’s partner for USA and Canada for COVID-19 vaccine Covaxin said it has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the jab for paediatric use.
The approval request is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which demonstrated comparable neutralising antibody response as seen in a large adult Phase 3 clinical trial conducted in India.
Covaxin was recently awarded Emergency Use Listing by the World Health Organisation (WHO).
