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.
Earlier this month, the WHO had announced suspension of Covaxin supplies through UN procurement agencies and recommended countries using the vaccine to take action as appropriate. The suspension followed inspection, from March 14–22, and advisory to Bharat Biotech on “the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices [GMP],” the WHO said.
The data, available to the WHO, indicate the vaccine is effective and no safety concerns exist, the global health body said.
Preventive action plan
Bharat Biotech has committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India and the WHO. In the interim and as a precautionary measure, the company has indicated that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future, the WHO said.
While announcing that it temporarily slowing down production of the vaccine across its manufacturing facilities, Bharat Biotech said “it is diligently working to further improvements and upgrades to ensure the vaccine production continues to meet ever increasing global regulatory requirements. During post-EUL inspection by the WHO recently, the company had agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical.”
