Ocugen on Friday said that the US Food and Drug Administration (FDA) has 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 2 to 18 years.
“The US FDA, at this time, has declined to issue an EUA for Covaxin for active immunisation to prevent Covid-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age,” the company said in a statement on Friday.
Ocugen intends to continue working with FDA to evaluate the regulatory pathway for the pediatric use of Covaxin, it added in the statement.
Ocugen is a clinical stage biopharmaceutical company which is co-developing Bharat Biotech’s Covaxin vaccine candidate for Covid-19 in the US and Canadian markets.