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Ocugen Announces FDA Removes Clinical Hold on Phase 2/3 Clinical Trial for COVAXIN

Ocugen, Inc., a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Company’s Phase 2/3 clinical trial, OCU-002, for COVAXIN (BBV152).

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“We’re extremely pleased that we can proceed with our clinical trials for COVAXIN™, our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately.”

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COVAXIN (BBVI52) 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 (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 350 million doses having been administered to adults outside the U.S., COVAXIN is currently approved for adults in India and authorized under emergency use in 25 countries. Applications for emergency use authorization are pending in more than 60 other countries. 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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