Ocugen Inc, Bharat Biotech's partner for the US and Canada for Covid-19 vaccine Covaxin, has submitted a request to the US 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.
"Filing for Emergency Use Authorization in the US 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, CEO and co-founder of Ocugen said on Friday.
Munsuniri said if cleared, Covaxin will offer another option to the parents who want to get their young ones inoculated against the disease which has killed more than five million people across the globe. The US has been among the worst-affected countries and one of the top contributors in the daily infection tally.
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.
"Filing for Emergency Use Authorization in the US 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, CEO and co-founder of Ocugen said on Friday.
Munsuniri said if cleared, Covaxin will offer another option to the parents who want to get their young ones inoculated against the disease which has killed more than five million people across the globe. The US has been among the worst-affected countries and one of the top contributors in the daily infection tally.
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