FDA Remove Clinical Hold On Phase 2 And 3 Trials Of COVAXIN In US


On Monday, 23rd May 2022, Ocugen, biotechnology company announced that, Food and Drug Administration (FDA) of the United States has now lifted the clinical hold on the Phase 2 and Phase 3 trials of the company for the COVAXIN corona virus vaccine in the United States.

Dr. Shankar Musunuri, co-founder and chief executive officer and chairman of Ocugen Inc., said, they are extremely pleased that, they can proceed with their clinical trials for the COVAXIN, which is the whole virus inactivated corona virus vaccine candidate and this need for delivering an additional and differentiated vaccine option and they believe that, this still remains a priority. He has also thanked the clinical trial partners and collaborators of the staff for the company’s ongoing support.

He added that, Ocugen is also going to be working with the study sites for completely resuming this clinical development program immediately. He said that, COVAXIN has been an investigational covid-19 vaccine candidate product in the United States and it had been developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

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The COVAXIN covid-19 vaccine has been a highly purified and inactivated vaccine that is now manufactured by using a Vero cell producing platform and Dr. Shankar Musunuri also said, with over 350 million doses of vaccine being administered to the adults outside the United States, COVAXIN is currently approved the adult people in India and is also authorized for the emergency use in 25 countries.