FDA declines pediatric EUA for Ocugen’s COVID vaccine Covaxin, Health Information, ET HealthWorld


Ocugen Inc mentioned on Friday U.S. regulators have declined to factor an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine evolved via its Indian spouse Bharat Biotech, for use in folks elderly 2 to 18 years.

Stocks of Ocugen slumped 30% premarket at the information.

Ocugen mentioned it intends to proceed operating with the U.S. Meals and Drug Management to judge the method for getting an EUA for pediatric use of Covaxin.

Ocugen had entered right into a handle vaccine maker Bharat Biotech in overdue 2020, beneath which it will increase, provide, and commercialize Covaxin for the U.S. marketplace. (https://reut.rs/35nVA1P)

Covaxin, which isn’t cleared for any age workforce in the US, is without doubt one of the two most generally used COVID vaccines in India and in addition has an emergency use record from the Global Health Group.

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