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FDA Lifts Clinical Hold On Ocugen's COVID-19 Vaccine Trial

The U.S. Food and Drug Administration lifted the clinical hold on Ocugen Inc.'s (OCGN) phase 2/3 clinical trial, OCU-002, for COVAXIN (BBV152), the company said in a statement on Monday.

The company said it could proceed with its clinical trials for COVAXIN, whole virus inactivated COVID-19 vaccine candidate. It will now work with study sites to fully resume this clinical development program immediately.

COVAXIN is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

COVAXIN is listed by the World Health Organization (WHO) as authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN. The trade name, COVAXIN, has not been evaluated by the FDA.

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