FDA Puts a Snag in Malvern-Based Ocugen’s COVID-19 Vaccine Plans

By

Dr. Shankar Musunuri, CEO, Ocugen
Image via Ocugen.
Ocugen CEO Dr. Shankar Musunuri.

Malvern-based Ocugen has encountered a significant obstacle in its plans to bring the COVID-19 vaccine developed in India to the U.S., writes John George for the Philadelphia Business Journal.

Following an FDA recommendation, the biopharmaceutical company decided to work toward a biologics license application for Covaxin, as the vaccine is known.

Ocugen previously planned to pursue an emergency use authorization for the vaccine. That route would create a faster path to market for it. The company formed a partnership with India’s Bharat Biotech, the vaccine’s developer, in December to bring the vaccine to the U.S.

Ocugen’s stock dropped close to 30 percent following the announcement.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a (biologics license application) path,” said Dr. Shankar Musunuri, the co-founder and CEO of Ocugen. “While this will extend our timelines, we are committed to bringing Covaxin to the United States.”

The FDA reviews of biologics license applications typically take around 10 months. The administration has also asked for additional information and data on the vaccine.

Read more about Ocugen in the Philadelphia Business Journal.

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