The World Health Organization (WHO) announced the suspension of delivery of Covaxin made by Bharat Biotech through UN procurement agencies in a statement published on April 2 and advised nations that received the vaccine to take necessary measures. The suspension follows a EUL examination that took place between March 14 and March 22, 2022. ‘This suspension is in reaction to the findings of the WHO post-EUL inspection (14-22 March 2022) and the necessity to modify processes and facilities to address newly revealed GMP inadequacies. There will be a disruption in Covaxin supply owing to the stoppage of export manufacturing,’ the WHO stated in a statement.
‘Bharat has promised to comply by correcting the GMP inadequacies and is drafting a corrective and preventative action plan for submission to the Drugs Controller General of India (DCGI) and WHO,’ the WHO noted. In the meanwhile, and as a precautionary step, Bharat has stated its intention to halt the export of Covaxin. The risk assessment to date shows no change in the risk-benefit ratio. The evidence that was available to WHO demonstrates that the vaccination is efficacious and there are no safety concerns.
Bharat Biotech, an Indian vaccine manufacturer, issued a statement on April 1 announcing the ‘temporary slowing down of Covaxin production for facility optimization’ across its manufacturing facilities, having completed its supply obligations to procurement agencies and anticipating a decrease in demand. The business stated that they will focus on pending facility maintenance, process and facility optimization efforts in the future time.
‘These renovations were overdue since all existing facilities were repurposed for the manufacture of Covaxin, with continuous production over the previous year, to meet the public health emergency of Covid-19. During the Covid-19 outbreak, certain extremely complex equipment needed to improve process stringency was unavailable. It must be emphasized that the quality of Covaxin was never jeopardized at any time,’ the statement read.
In a statement, the organization stated that they had agreed with the WHO team on the ‘scope of the planned improvement actions” and that they will be carried out as quickly as possible’. The company was also relieved to learn from WHO that the necessary optimization work does not suggest a change in the risk-benefit ratio (for Covaxin) and that the data provided to WHO indicates that the vaccine is efficacious and that no safety concerns exist. According to the WHO, ‘the vaccine is now on the WHO Emergency Use Listing (EUL).’
The business stated that the immunization certificates provided to the millions of people who got Covaxin remained legitimate since there was no influence on the vaccine’s efficacy and safety. ‘This WHO risk assessment is based on the delivery of hundreds of millions of doses of Covaxin internationally, during which the product has exhibited a good safety and effectiveness profile in rigorous and thorough post-marketing surveillance efforts,’ Bharat Biotech noted.
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