FDA declines pediatric EUA to Covaxin
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New Delhi: Ocugen Inc (OCGN.O) said on Friday U.S. regulators have declined to issue an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use in individuals aged 2 to 18 years.
Shares of Ocugen slumped 30% premarket on the news.
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Ocugen said it intends to continue working with the U.S. Food and Drug Administration to evaluate the process for getting an EUA for pediatric use of Covaxin.
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