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