Ocugen Inc., Bharat Biotech’s partner for USA and Canada for COVID-19 vaccine Covaxin on Friday said it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the jab for paediatric use.
Representative image.
Hyderabad:
The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India, Ocugen said in a regulatory filing. Some research suggests that people are seeking more choices when selecting a vaccine, especially for their children.
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