WHO suspends UN supply of Bharat Biotech’s Covaxin citing ‘deficiencies’

The World Health Organization on Saturday suspended supply of Bharat Biotech‘s Covid vaccine, Covaxin, through UN procurement agencies and recommended to countries that received the vaccine to take actions as appropriate. WHO didn’t specify what actions the countries need to take. “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.

WHO said there will be interruption of supply of Covaxin due to suspension of production for export. “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. In the interim and as a precautionary measure, Bharat Biotech has indicated its commitment to suspend production of Covaxin for export. WHO also said the risk assessment does not indicate change in risk-benefit ratio.

“The data indicate the vaccine is effective and no safety concern exists,” WHO said. On April 1, Bharat Biotech in a statement said it was fully committed to implementing facility improvements and upgrades to ensure that the production of Covaxin meets the global regulatory requirements.

“For millions who have received Covaxin, the vaccine certificates issued stand valid as there is no impact on efficacy and safety of the vaccine,” the vaccine maker said. Bharat Biotech added that it is temporarily slowing down Covaxin production for facility optimisation, as company will focus on pending facility maintenance, process and facility optimisation activities.

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