The U.S. Food and Drug Administration (USFDA) has put on hold the phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin in the U.S.
Bharat Biotech’s partner in the U.S. Ocugen in a release said it was informed by the USFDA that its phase 2/3 immuno-bridging and broadening study for Covaxin (BBV152), OCU-002, had been placed on clinical hold.
The company said it was a result of its decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements of the World Health Organization following inspection of Bharat Biotech manufacturing facility. “We will work with the FDA to address any questions,” Ocugen said.
