Ocugen Inc stated on Friday US regulators have declined to subject an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian companion Bharat Biotech, to be used in people aged 2 to 18 years.
Shares of Ocugen slumped 30% premarket on the information.
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Ocugen stated it intends to proceed working with the US Food and Drug Administration to judge the method for getting an EUA for pediatric use of Covaxin. Ocugen had entered right into a take care of vaccine maker Bharat Biotech in late 2020, underneath which it could develop, provide , and commercialize Covaxin for the US market.
Covaxin, which isn’t cleared for any age group within the United States, is among the two most generally used COVID vaccines in India and likewise has an emergency use itemizing from the World Health Organization.
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With inputs from TheIndianEXPRESS
