“The company was informed by the USFDA that the agency placed its phase 2/3 immuno-bridging and broadening study for Covaxin (BBV152), OCU-002, on clinical hold,” Ocugen said in a statement.
“This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,” the statement added.
Ocugen said it will work with the FDA to address any questions.
Bharat Biotech has earlier said it is addressing the GMP (good manufacturing practice) deficiencies and is developing a corrective and preventive action plan, for submission to the DCGI and WHO. In the interim and as a precautionary measure, the vaccine maker said it has indicated its commitment to suspend production of Covaxin for export.
WHO also said the risk assessment does not indicate change in risk-benefit ratio.