Does Ocugen Have a Shot at Winning EUA for Its COVID Vaccine in Kids?
Until late 2020, Ocugen (NASDAQ: OCGN) was an under-the-radar biotech company focusing on developing gene therapies targeting eye disease. Then along came Bharat Biotech. The drugmaker had already won authorization for its COVID-19 vaccine Covaxin in India. Bharat wanted a partner to help get Covaxin into the U.S. market. It picked Ocugen.
Advancing Covaxin in the U.S. proved to be more difficult than either company hoped, though. Ocugen eventually punted on the Emergency Use Authorization (EUA) route and decided to pursue full U.S. approval for the vaccine in immunizing adults.
Last Friday, however, the company announced a plot twist. Ocugen revealed that it had filed for EUA with the U.S. Food and Drug Administration (FDA) for Covaxin in children ages two to 18. But does the company have a realistic shot at winning U.S. EUA for Covaxin in kids?
Source Fool.com
