USFDA declines EUA nod to Covaxin

New Delhi: The United States Food and Drug Administration (UFDA) has declined to issue an emergency use authorization (EUA) to Ocugen Inc for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use in individuals aged 2 to 18 years.

The company had entered into a deal with vaccine maker Bharat Biotech in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market.

Despite being one of the two most widely used COVID vaccines in India and also receiving emergency use listing from the World Health Organization, Covaxin, has not been cleared for any age group in the United States.

Ocugen said it intends to continue working with the USFDA to evaluate the process for getting an EUA for pediatric use of Covaxin.