The Phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin in the United States have been halted by the United States Food and Drug Administration (USFDA).
Ocugen, Bharat Biotech’s US partner, stated in a statement that the USFDA had placed its phase 2/3 immuno-bridging and widening research for Covaxin (BBV152), OCU-002, on clinical hold.
It was the outcome of the business’s decision to voluntarily implement a temporary delay in dosing OCU-002 participants while it examines remarks made by the World Health Organization following an examination of the Bharat Biotech production site, according to the company. “Any questions will be addressed in collaboration with the FDA,” Ocugen stated.
COVAXIN shipment stopped by UN
The WHO said earlier this month that Covaxin shipments through UN procurement agencies will be suspended, and that nations that uses the vaccine should take appropriate steps. The suspension came after a WHO inspection from March 14–22 and a recommendation to Bharat Biotech to “perform process and facility upgrades to address recently found weaknesses in good manufacturing procedures [GMP],” according to the WHO.
The data provided to the WHO indicates that the vaccination is efficacious and that there are no safety issues, according to the world health organization.
Action strategy for prevention
Bharat Biotech has committed to correcting the GMP violations and is working on a corrective and preventive action plan to submit to the Drugs Controller General of India and the World Health Organization. In the meanwhile, the business has announced that it will stop producing Covaxin for export as a precautionary step. As a result, the WHO predicts that supply will be disrupted for the foreseeable future.
Bharat Biotech said it is “diligently striving to further modifications and upgrades to guarantee the vaccine production continues to satisfy ever-increasing worldwide regulatory requirements” while temporarily delaying vaccine output throughout its manufacturing facilities. During a recent WHO post-EUL inspection, the company agreed with the WHO team on the extent of the planned improvement actions and stated that they will be carried out as soon as possible.”