The World Health Organization (WHO) has confirmed the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies citing good manufacturing practices (GMP) deficiencies, according to Reuters.
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 World Health Organization (WHO) has confirmed the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies citing good manufacturing practices (GMP) deficiencies, according to Reuters.
This comes a day after Bharat Biotech said it is temporarily slowing down the production of its Covid-19 vaccine Covaxin as demand was dropping along with a fall in infections and wider immunisation coverage in the country.
WHO to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection.
The WHO also asked countries that have received the vaccine to take appropriate actions.
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.
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.
The WHO said that the company 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".
So far, over 30.81 crore doses of Covaxin have been administered in India to those aged 15 years and above.
Bharat Biotech 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.