FDA Denies Pediatric EUA To Ocugen For Bharat Biotech's COVID-19 Vaccine Covaxin

• The FDA has declined to issue an Emergency Use Authorization (EUA) for Covaxin for active immunization to prevent COVID-19 in individuals 2 to 18 years of age.
• Ocugen Inc (NASDAQ:OCGN) is working with the vaccine's developer, Bharat Biotech of India, to bring Covaxin to the U.S.
• Related: FDA Lifts Clinical Hold On Ocugen's COVID-19 Vaccine Study In US. 
• Specific details to refuse the EUA were not disclosed.
• Ocugen intends to continue working with FDA to evaluate the regulatory pathway for the pediatric use of Covaxin.
• Price Action: OCGN shares are down 23.10% at $2.53 during the premarket session on the last check Friday.