WHO suspends Covaxin supply through United Nations agencies citing manufacturing deficiencies
There is no change in the efficacy of the coronavirus vaccine, the health body said.
The World Health Organization on Saturday said that it has suspended the supply of coronavirus vaccine Covaxin through United Nations procurement agencies.
The global health body said that it took the decision in order to allow the vaccine manufacturer, Bharat Biotech, to address shortcomings in manufacturing practices that were found during an inspection. It, however, said that the vaccine is safe and effective, and there is no “change in the risk-benefit ratio”.
“[Bharat Biotech] has committed to comply by addressing the GMP [good manufacturing practices] deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India DCGI and WHO,” the World Health Organization said. “In the interim and as a precautionary measure, [Bharat Biotech] has indicated its commitment to suspend its production of Covaxin for export.”
The World Health Organisation recommended that countries that have received supplies of Covaxin to “take actions as appropriate”, but did not specify what these actions were.
On April 1, Bharat Biotech said that it was temporarily slowing down the production of Covaxin, and will focus on pending maintenance and optimisation activities at its facilities. It said that it took the decision after having completed its supply obligations to procurement agencies.
“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,” the company said. “Certain highly sophisticated equipment which were required to enhance the process stringency were unavailable during the Covid-19 pandemic.”
Bharat Biotech, however, said that the quality of the vaccine was not compromised at any point of time. It added that vaccine certificates issued to people who received Covaxin doses remain valid.
Covaxin has been used in India since the immunisation drive started on January 16 last year. The vaccine received the World Health Organization’s emergency use approval on November 3.
It had taken more than three months for Covaxin to get the WHO’s clearance. Prime Minister Narendra Modi had pushed for the vaccine’s approval at the G20 summit held in November.
Phase 3 trial results published by Bharat Biotech in November showed that the two-dose regimen of the vaccine had an overall efficacy of 77.8% in symptomatic Covid-19 patients.