NEW DELHI: The World Health Organisation (WHO) has said it has suspended the supply through United Nations agencies of Covid-19 vaccine Covaxin by Bharat Biotech to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection.
The Hyderabad-based pharma company said that there is "no impact on efficacy and safety of the Covid-19 vaccine Covaxin" and added that “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.”
The WHO also asked countries that have received India's indigenous Covid-19 vaccine to take appropriate actions, however, it did not specify what the appropriate actions would be.
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The world health body, which had granted emergency use listing (EUL) to Covaxin on November 3, 2021 did not specify what good manufacturing practices (GMP) deficiencies were found at the Bharat Biotech facilities.
The WHO said the vaccine is effective and no safety concerns exist, but the suspension of production for export will result in the interruption of Covaxin supply.
It said the suspension is in response to the outcomes of WHO post emergency use listing (EUL) inspection conducted from March 14 to 22, and the vaccine maker has indicated its commitment to suspend production of Covaxin for export.
The world health body suspension came after Bharat Biotech on Friday night announced that it was slowing down its Covaxin production as it has completed its supply obligation and also as it was foreseeing a decrease in demand.
Over 30.81 doses of Covaxin have been administered in India to those aged 15 years and above under the Indian government’s Covid-19 vaccination drive.
In a statement, the pharma company said, “It has to be stressed that the quality of COVAXIN was never compromised at any point in time” and added that in the coming period, "it will focus on pending facility maintenance, process and facility optimisation activities."
“Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives,” it said.
“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. The company was also pleased to learn from the WHO, that the necessary optimization work “Does not indicate a change in the risk-benefit ratio (for Covaxin) and the data, available to WHO, indicates the vaccine is effective and no safety concern exists.”
“This risk assessment by the WHO is based on the supply of hundreds of millions of doses of Covaxin globally, during which the product has demonstrated an excellent safety and efficacy profile in detailed and thorough post marketing surveillance activities,” the company said. The Indian government has exported Covaxin and Covishield under its ‘vaccine Maitri’ initiative to over 90 countries.