The World Health Organization has halted the distribution of the COVID-19 vaccine Covaxin, manufactured by India’s Bharat Biotech, through United Nations agencies to allow the producer to update facilities and rectify problems discovered during an inspection.
The WHO asked countries that have received the vaccine to take appropriate actions, according to the statement, but did not specify what the appropriate actions would be.
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 the Covaxin supply. It said the suspension is in response to the outcomes of the 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.
A request for comment submitted outside of business hours was not immediately responded to by Bharat Biotech.
The suspension comes just a day after Bharat Biotech said that it was halting Covaxin manufacturing because it had fulfilled its supply obligations and expected a drop in demand.
“These changes were due since all existing facilities were repurposed for the manufacture of Covaxin, with continuous production for the past year to satisfy the public health emergency of Covid-19.” During the epidemic, certain extremely complex equipment that was essential to improve process stringency was unavailable. “It is important to note that the quality of Covaxin has never been affected,” Bharat Biotech stated.
In India, around 30.81 crore doses of Covaxin have been given to people aged 15 and up as part of the government’s Covid-19 immunization campaign.
The vaccine company from Hyderabad had also stated that it was working on more changes and updates to ensure that Covaxin production met the ever-increasing global regulatory criteria.
“There can be no compromises in reaching operational excellence standards because patient safety is the paramount issue for every new vaccine.” “The vaccine certificates issued to the millions who have received Covaxin remain valid because there is no influence on the vaccine’s efficacy and safety,” Bharat Biotech had stated.
The WHO said that the company has “committed to complying 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”.