FDA Lifts Clinical Hold On Ocugen's COVID-19 Vaccine Study In US

The FDA has lifted its clinical hold on Ocugen Inc's OCGN investigational new drug application seeking approval to conduct testing of the COVID-19 vaccine Covaxin in the U.S.

• "We are pleased to be able to move our clinical program for Covaxin forward, which we hope will bring us closer to offering an alternative Covid-19 vaccine," said Dr. Shankar Musunuri, CEO of Ocugen. "We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate."
• Ocugen is working with the vaccine's developer, Bharat Biotech of India, to bring Covaxin to the U.S.
• Related: Ocugen-Bharat Biotech Partnered COVID-19 Booster Covaxin Neutralizes Omicron, Delta Variants.
• More than 200 million doses of the vaccine have been administered to adults outside the U.S. Covaxin is authorized under emergency use in 20 countries, and applications for emergency use authorization are pending in more than 60 other countries.
• The FDA in November put a clinical hold on Ocugen's application and asked the company to address undisclosed deficiencies.
• Price Action: OCGN shares are up 17.30% at $4.06 during the premarket session on the last check Tuesday.