Ocugen Plans To Submit EUA Application For COVAXIN To FDA In June

(RTTNews) - Ocugen Inc. (OCGN) confirmed that it plans to submit its Emergency Use Authorization (EUA) application for COVID-19 Vaccine Candidate, COVAXIN, to the U.S. Food & Drug Administration in June.

Ocugen said it does not believe that the FDA's recently revised guidance regarding EUAs raises any concerns about its ability to submit the EUA for COVAXIN as planned.

Ocugen believes that the FDA's new guidance confirms that the company continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application discussions with the FDA.

COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology.

COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech's Phase 3 clinical trial.