Malvern-based Ocugen submitted an investigational new drug application with the FDA. It seeks approval to start a Phase-3 clinical trial that would evaluate the effectiveness of its COVID-19 vaccine, Covaxin, writes John George for The Philadelphia Business Journal.

The vaccine is already approved in India.

The biopharmaceutical company formed a partnership with India-based Bharat Biotech, Covaxin developer, in February to bring the vaccine to the U.S.

“We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public,” said Dr. Shankar Musunuri, CEO and co-founder of Ocugen.

He said that the company is hoping this study conducted under the investigational new drug application “will help demonstrate that the data from India will be applicable to the U.S. population.”

According to Ocugen, Covaxin is a highly purified and inactivated vaccine, which is produced using the same vero cell manufacturing platform that has been used for decades in the production of polio vaccines.

Read more about Ocugen in The Philadelphia Business Journal.