FDA declines issue of EUA for COVAXIN pediatric vaccine

USA-based Ocugen’s (Nasdaq: OCGN) shares were down 31% to $2.27, in premarket trading on Friday, as the company announced that the US Food and Drug Administration (FDA), at this time, has declined to issue an emergency use authorization (EUA) for COVAXIN (BBV152) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals two to 18 years of age.

Ocugen says it intends to continue working with the FDA to evaluate the regulatory pathway for the pediatric use of COVAXIN.

The company is co-developing the Indian drugmaker Bharat Biotech originated COVAXIN vaccine candidate for COVID-19 in the USA and Canadian markets.