The World Health Organization (WHO) has suspended the supply of Bharat Biotech’s anti-Covid vaccine, Covaxin, under the Covax facility, the UN health body announced on Saturday, attributing it to deficiencies in manufacturing practices.
“The World Health Organization (WHO) is today 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,” said WHO in a statement.
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This suspension is in response to the outcomes of WHO post emergency use listing inspection conducted between March 14 – 22, and the need to conduct process and facility upgrade to address recently identified good manufacturing practice (GMP) deficiencies.
As a result, there will be interruption of supply of Covaxin due to suspension of production for export.
The company, however, 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 has indicated its commitment to suspend its production of Covaxin for export,” read the statement.
The UN body, however, clarified there were absolutely no issues with the safety and efficacy of the product.
“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. For continuation of vaccination with alternative sources of Covid 19 vaccines countries should refer to the respective SAGE recommendation,” read the WHO statement.
While the company did not respond to queries on the suspension, in a statement issued on Friday to announce Covaxin for production slow down, it said that it was making appropriate changes in manufacturing processes to match WHO standards.
“…During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical…,” read the Bharat Biotech statement.
“As all existing facilities were repurposed for the manufacture of COVAXIN, with continuous production during the past year, to meet the public health emergency of COVID-19, these upgrades were due. Certain highly sophisticated equipment which were required to enhance the process stringency were unavailable during the COVID-19 pandemic. It has to be stressed that the quality of COVAXIN was never compromised at any point in time.”
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WHO suspends Covaxin supplies under UN procurement - Hindustan Times
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