Ocugen announced that the U.S. Food and Drug Administration (FDA), at this time, has declined to issue a EUA 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

Earlier last month, Ocugen had announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold on the company’s Investigational New Drug application (IND) to evaluate the Covid-19 vaccine candidate, Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

With more than 200 million doses having been administered to adults outside the U.S., Covaxin is currently authorized under emergency use in 20 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added Covaxin to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using Covaxin.