USFDA removes clinical hold on Covaxin trial: Ocugen
COVAXIN is listed by the World Health Organization (WHO) as authorized for emergency use.
Malvern: Bharat Biotech US-based partner Ocugen, Inc. has announced that the U.S. Food and Drug Administration (USFDA) has lifted the clinical hold on the company's Phase 2/3 clinical trial, OCU-002, for COVAXIN (BBV152).
"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."
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. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
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.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines.
