The World Health Organization (WHO) has acknowledged that it has halted the distribution of Covaxin, a vaccine manufactured by Hyderabad-based Bharat Biotech, through UN procurement agencies, and has advised nations that have received the COVID-19 vaccine to take necessary measures.
WHO announced the suspension on April 2 in response to the findings of its post-EUL (emergency use authorization) inspection, which took place between March 14 and 22, and the need to update processes and facilities to address previously revealed GMP (good manufacturing practise) issues.
There will be interruption of supply of Covaxin due to suspension of production for export, WHO said. The risk assessment to date does not indicate 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.