The WHO said in a statement late on on Saturday that the Covaxin suspension was in response to the outcomes of its post EUL (emergency use authorization) inspection, held between March 14-22, and the need to conduct process and facility upgrades to address recently identified GMP (good manufacturing practice) deficiencies.
“The World Health Organization (WHO) is today confirming the suspension of supply of Covaxin produced by Bharat (Biotech) through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate,” the global health agency said.
Bharat Biotech on Sunday said it had nothing else to add to an earlier statement where it said it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.
“During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical,” it had said in a statement on April 1.
Hyderabad-based vaccine manufacturer Bharat Biotech then announced the temporary slowing down of its Covid vaccine Covaxin’s production across its manufacturing facilities.
“Bharat Biotech announces the temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand,” it said.
The company will focus on pending facility maintenance, process and facility optimization activities for the coming period, it said.
Source: IANS
