Ocugen Inc. said Friday that the U.S. Food and Drug Administration has declined to issue an Emergency Use Authorization for Covaxin.
The biopharmaceutical company said its Covaxin vaccine's EUA was for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age.
Ocugen said it intends to continue working with the FDA to evaluate the regulatory pathway for the pediatric use of Covaxin.
Ocugen shares were down 30%, to $2.3, in premarket trading.
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