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The World Health Organization has suspended its supply of Covaxin. Citing deficiencies, it has called for the up-gradation of Bharat Biotech’s facility. It has also asked countries that have received the vaccine to take appropriate actions without specifying these actions. 

WHO has clarified that the vaccine is effective and has no safety issues. However, the suspension of Covaxin comes from the WHO post-emergency use listing (EUL) inspection, carried out from March 14 to 22.   

The World Health Organization has said, “Bharat Biotech has committed to addressing the GMP deficiencies. Furthermore, the company is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and the World Health Organization (WHO).”

A day before, Bharat Biotech said that it was slowing production as it had fulfilled supply obligations and anticipated a fall in demand. Having delivered more than 30.81 crore doses of Covaxin, Bharat Biotech said it is working on facility upgrades to meet ever-increasing global regulatory requirements. 

As for the facility revamp, the Vaccine maker said, “All the existing facilities were repurposed for the manufacture of Covaxin. And, continuous production during the past year to meet the public health emergency of Covid-19 kept these upgrades were overdue. During the pandemic, some highly sophisticated equipment required to enhance the process stringency were unavailable. However, the quality of Covaxin was never compromised at any point in time.”

Further, assuring those who received Covaxin, Bharat Biotech said, “Patient safety remains the primary consideration for any new vaccine. Hence, there can be no compromises in meeting operational excellence objectives. For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on the efficacy and safety of the vaccine.”

Reference: TOI