Ocugen Inc said the US regulators have declined to issue an Emergency Use Authorisation (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use in individuals aged two to 18 years.
Ocugen said it intends to continue working with the US Food and Drug Administration (FDA) to evaluate the process for getting an EUA for paediatric use of Covaxin. Ocugen had entered into a deal with vaccine maker Bharat Biotech in late 2020, under which it would develop, supply and commercialise Covaxin for the US market.
Covaxin, which is not cleared for any age group in the US, is one of the two most widely used COVID vaccines in India, and also has an Emergency Use Listing (EUL) from the World Health Organization (WHO).