USFDA lifts clinical hold on Covaxin new drug application: Ocugen
Malvern: Ocugen, Inc. has recently announced that the U.S. Food and Drug Administration (USFDA) has lifted its clinical hold on the Company's Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN outside the United States.
COVAXIN is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
"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, Chairman of the Board, Chief Executive Officer, and Co-Founder 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."
With more than 200 million doses having been administered to adults outside the U.S., COVAXIN is currently authorized under emergency use in 20 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN to its list of vaccines 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.
Read also: USFDA issues clinical hold on Covaxin new drug application: Ocugen
