bharat biotech: WHO suspends Covaxin supply for UN procurement citing GMP deficiencies at Bharat Biotech facilities | India News
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HYDERABAD: A day after Bharat Biotech said it is temporarily slowing down the production of its Covid-19 vaccine Covaxin, the World Health Organization (WHO) on Saturday said it was confirming the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies citing good manufacturing practices (GMP) deficiencies.
WHO also said it was recommending to countries that received the vaccine to take actions as appropriate.
However, the global health body, which had granted emergency use listing (EUL) to Covaxin on November 3, 2021, did not give any details about what GMP deficiencies it had found at Bharat Biotech’s facilities that were churning out Covaxin doses.
All WHO said was that the suspension comes in response to the outcomes of its post EUL inspection that was conducted between March 14-22, 2022, and the need for Bharat Biotech to conduct process and facility upgrades to address the recently identified GMP deficiencies.
According to WHO, there will be interruption of supply of Covaxin due to the suspension of production for export. “Bharat 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,” WHO said in the statement.
However, WHO clarified that 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.
The WHO suspension comes barely a day after Bharat Biotech put out a statement on Friday night that it was slowing Covaxin production as it had completed its supply obligations and also as it was foreseeing a decrease in demand.
“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 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,” Bharat Biotech had said.
So far, over 30.81 crore doses of Covaxin have been administered in India to those aged 15 years and above under the government’s Covid-19 vaccination drive.
The Hyderabad-based vaccine maker had also said it was working on further improvements and upgrades to ensure that Covaxin production continued to meet the ever-increasing global regulatory requirements.
“Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives. For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” Bharat Biotech had said.
WHO also said it was recommending to countries that received the vaccine to take actions as appropriate.
However, the global health body, which had granted emergency use listing (EUL) to Covaxin on November 3, 2021, did not give any details about what GMP deficiencies it had found at Bharat Biotech’s facilities that were churning out Covaxin doses.
All WHO said was that the suspension comes in response to the outcomes of its post EUL inspection that was conducted between March 14-22, 2022, and the need for Bharat Biotech to conduct process and facility upgrades to address the recently identified GMP deficiencies.
According to WHO, there will be interruption of supply of Covaxin due to the suspension of production for export. “Bharat 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,” WHO said in the statement.
However, WHO clarified that 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.
The WHO suspension comes barely a day after Bharat Biotech put out a statement on Friday night that it was slowing Covaxin production as it had completed its supply obligations and also as it was foreseeing a decrease in demand.
“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 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,” Bharat Biotech had said.
So far, over 30.81 crore doses of Covaxin have been administered in India to those aged 15 years and above under the government’s Covid-19 vaccination drive.
The Hyderabad-based vaccine maker had also said it was working on further improvements and upgrades to ensure that Covaxin production continued to meet the ever-increasing global regulatory requirements.
“Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives. For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” Bharat Biotech had said.
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