FDA slaps hold on Ocugen COVID vax trial

Nov. 29, 2021

Ocugen revealed on Friday that the U.S. FDA had issued a clinical hold on the company's investigational new drug application to initiate a phase 3 trial for its COVID-19 vaccine candidate. 

The Malvern, Pennsylvania-based drugmaker is co-developing BBV152, known as Covaxin outside the U.S., with India's Bharat Biotech.

With more than 100 million doses having been administered to adults outside the U.S., Covaxin is authorized under emergency use in 17 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.

Ocugen said it expects to receive formal written communication with the additional information from the FDA, and plans to work with the agency to resolve its questions as promptly as possible.