New Delhi: The World Health Organisation said on Saturday it has suspended supply through United Nations agencies of COVID-19 vaccine Covaxin, produced by India’s Bharat Biotech, to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection.
The WHO asked countries that have received the vaccine to take appropriate actions, according to the statement, but did not specify what the appropriate actions would be.
According to the WHO, it is “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 WHO said the vaccine is effective and no safety concerns exist, but the suspension of production for export will result in the interruption of Covaxin supply.
It said the suspension is in response to the outcomes of WHO post emergency use listing (EUL) inspection conducted from March 14 to 22, and the vaccine maker has indicated its commitment to suspend production of Covaxin for export.
There will be an interruption of the supply of Covaxin due to the suspension of production for export, WHO said. The risk assessment to date does not indicate a change in the risk-benefit ratio.
The data, available to WHO, indicate the vaccine is effective and no safety concern exists, WHO said. Company officials could not be reached immediately for a response. Bharat Biotech on April 1 announced the temporary slowing down of production of its covid-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand. During the recent WHO inspection, Bharat Biotech agreed with the former’s team on the scope of the planned improvement activities and indicated that they will be executed as soon as possible.
The company has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, the company has indicated its commitment to suspend its production of Covaxin for export, WHO said.
