On Saturday, 2 April, the World Health Organization (WHO) said it has suspended supply of India-made COVID-19 vaccine Covaxin through United Nations agencies.
The WHO says this is because Bharat Biotech needs to conduct process and facility upgrades to address manufacturing process deficiencies recently identified in an inspection held between 14 and 22 March, PTI reported.
The organisation also asked countries that have received the vaccine to take appropriate actions, however, it is unclear what these would be.
The WHO clarified that, according to the data it has available, the vaccine is effective and no safety concerns have been identified.
'Bharat Biotech Announces Temporary Slowdown'
On Friday, 1 April, Bharat Biotech announced a temporary slowing down of production of Covaxin, saying that it had completed its supply obligations to procurement agencies and "forseeing a decrease in demand".
It said it will focus on pending facility maintenance, process and facility optimisation activities that were postponed due to all facilities being repurposed for Covaxin manufacturing.
WHO told the company that the necessary optimisation work does not indicate a change in the risk-benefit ratio for Covaxin.
"It has to be stressed that the quality of Covaxin was never compromised at any point in time," said Bharat Biotech in a statement.
During the WHO inspection, Bharat Biotech agreed with the organisation on the scope of the planned improvement activities and said that they will be executed as soon as possible.
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," said the organisation.
(With inputs from Reuters and PTI)
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