WHO halts supply of Covaxin by United Nations agencies citing manufacturing defects

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The World Health Organization announced on Saturday that it had suspended supplies of the coronavirus vaccine Covaxin by United Nations procurement agencies.

The global health agency said it made the decision to allow vaccine maker Bharat Biotech to address deficiencies in manufacturing processes found during an inspection. However, the vaccine is safe and effective and there is no “change in the benefit-risk balance”.

“[Bharat Biotech] has committed to compliance by turning to 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 the WHO,” the World Health Organization said. “In the meantime and as a precautionary measure [Bharat Biotech] has committed to suspend production of Covaxin for export.”

The World Health Organization recommended that countries that received shipments of Covaxin “take appropriate action,” but did not specify what those actions were.

On April 1st Bharat Biotech said it is temporarily slowing production of Covaxin and will focus on upcoming maintenance and optimization activities at its facilities. It made the decision after fulfilling its supply obligations to procurement bodies.

“As all existing continuous production Covaxin manufacturing facilities were repurposed over the past year to address the Covid-19 public health emergency, these upgrades were due,” the company said. “Certain sophisticated equipment required to improve process stringency was unavailable during the Covid-19 pandemic.”

However, Bharat Biotech said the quality of the vaccine has not been compromised at any point. It added that vaccination certificates issued to people who received doses of Covaxin are still valid.

Covaxin has been used in India since the vaccination campaign began on January 16 last year. The vaccine received emergency use authorization from the World Health Organization on November 3.

It had taken more than three months for Covaxin to receive WHO approval. Prime Minister Narendra Modi pushed for approval of the vaccine at the G20 summit in November.

Results of the Phase 3 study, published by Bharat Biotech in November, showed that the vaccine’s two-dose regimen had an overall efficacy of 77.8% in symptomatic Covid-19 patients.

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