WHO suspends supply of Covaxin under Covax facility
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WHO suspends supply of Covaxin under Covax facility

WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility

  • By IPP Bureau | April 03, 2022

The World Health Organization (WHO) has suspended the supply of Bharat Biotech’s anti-Covid vaccine, Covaxin, under the Covax facility, the UN health body announced.

“The World Health Organization (WHO) is today confirming the suspension of supply of Covaxin produced by Bharat Biotech through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate,” said WHO in a statement.

This suspension is in response to the outcomes of WHO post-emergency use listing inspection conducted between March 14 – 22, and the need to conduct process and facility upgrades to address recently identified good manufacturing practice (GMP) deficiencies.

As a result, there will be an interruption of the supply of Covaxin due to the suspension of production for export.

The production of Covaxin will be "temporarily slowed down", the Bharat Biotech said in a late-night statement on Friday as the vaccine maker further insisted it has "completed its supply obligations to procurement agencies," and it foresees a "decrease in demand".

The statement added, “For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities. 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."

It further pointed out that Covaxin, India's homegrown vaccine against Covid, is currently under the WHO's Emergency Use Listing or EUL.

"The company was also pleased to learn from the WHO, that the necessary optimisation 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'," the statement read.

The vaccine manufaturer is "working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements," it said. "More than 1 million doses of Covaxin were introduced under clinical trial mode, where safety of subjects was actively documented. Finally, Covaxin was extensively evaluated in around 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications," Bhrat Biotech added.

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