The World Health Organization (WHO) said on Saturday, it had suspended supply of Bharat Biotech’s Covaxin through UN procurement agencies and was recommending to countries that received the vaccine to take actions as appropriate.
“This suspension is in response to the outcomes of WHO post emergency use listing (EUL) inspection (14 – 22 March 2022) and the need to conduct process and facility upgrade to address recently identified good manufacturing practices (GMP) deficiencies,” the WHO note said.
However, it added, the risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicates the vaccine is effective and no safety concern exists.
Supplies of Covaxin will be interrupted due to suspension of production for export, WHO said. “Bharat (Biotech) 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, Bharat (Biotech) has indicated its commitment to suspend its production of Covaxin for export, ”it said.
April 02, 2022