FDA Rejects Covaxin EUA Request for Children

The US Food and Drug Authority (FDA) declined the filed request of Ougen corporation's Covaxin for emergency use for children aged between two and 18 years, Reuters reported on Friday.

Developed by Bharat Biotech, the Indian partner of Ougen corporation, the vaccine approved good protection in the various phases of clinical trials with 77.8% against COVID-19 symptoms, 93.4% against severe COVID-19 symptoms.

The corporation announced the news of the rejection of the FDA in an official statement, saying: "Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19."

It added: "Today announced that the U.S. Food and Drug Administration (FDA), at this time, has declined to issue an EUA for COVAXIN™ for active immunization to prevent COVID-19 caused by SARS-CoV-2 in inpiduals 2 to 18 years of age. Ocugen intends to continue working with FDA to evaluate the regulatory pathway for the pediatric use of COVAXIN."