In a statement issued, World Health Organisation said that it is suspending the supply of Bharat Biotech’s Covaxin through UN agencies. This is being done due to manufacturing deficiencies reported during an inspection.
“This suspension is in response to the outcomes of WHO post-EUL (emergency use listing) inspection (March 14-22) and the need to conduct process and facility upgrade to address identified GMP deficiencies,” WHO said in a statement.
Bharat Biotech said in a statement that the company “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. For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities.”
“Bharat (Biotech) has committed to comply by addressing the GMP (good manufacturing practice) deficiencies and is developing a corrective and preventive action plan, for submission to the DCGI and WHO,” the agency said.
WHO has informed the Suspension does not indicate that Covaxin is not safe. Covaxin is safe.
“The 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.