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 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.