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.

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