Ocugen Fails to Get EUA for COVID-19 Vaccine in Children
The FDA has denied Ocugen’s Emergency Use Authorization (EUA) request for use of its COVID-19 vaccine in children aged two to 18 years.
The Malvern, Pa., drugmaker did not disclose why the FDA rejected the EUA application for Covaxin but said it would continue working with the agency “to evaluate the regulatory pathway” for pediatric use of the vaccine.
At present, Covaxin isn’t approved for any segment of the U.S. population. However, the World Health Organization has authorized it as a two-dose regimen for adults 18 years and older.
Ocugen is the U.S. marketing partner of India’s Bharat Biotech, which developed the shot from an inactivated form of the SARS-CoV-2 virus.