Bharat Biotech's partner Ocugen for paediatric use of Covaxin

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.

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.

"Filing for Emergency Use Authorization in the U.S. for paediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic, Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said.