'No impact on efficacy, safety': Bharat Biotech on Covaxin supply suspension by WHO
The UN health agency, on Saturday, stopped the supply of Covaxin under the Covax facility, citing deficiencies in manufacturing practices.
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FollowBharat Biotech on Sunday released a statement over the suspension of its COVID-19 vaccine supplies by the World Health Organization (WHO) via UN procurement agencies. The company stated in its report that there is no impact on the efficacy and safety of the COVID-19 vaccine Covaxin.Â
As per the statement, the millions who received Covaxin, the vaccine certificates issued still stand valid as there's no impact on the efficacy and safety of the vaccine.Â
The UN health agency, on Saturday, stopped the supply of Covaxin under the Covax facility, citing deficiencies in manufacturing practices.
The suspension was announced following the WHO post-emergency use listing inspection that took place between March 14 and 22. The inspection stressed the need for process and facility improvements to address recently discovered good manufacturing practice (GMP) deficiencies.
Bharat Biotech has announced reducing Covaxin production to accommodate pending facility maintenance, process, and facility optimization activities.
It added that these upgrades were overdue because all existing facilities had been 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 pandemic, specific highly sophisticated equipment needed to improve process stringency was unavailable. It is important to highlight that the quality of Covaxin has never been questioned.
As a result, there will be a disruption in Covaxin supplies. The company urged that it is diligently working to further improvements and upgrades to ensure that the production of Covaxin continues to meet the ever-increasing global regulatory requirements. It also added that patient safety is a primary consideration for any new vaccine; there can be no compromises in meeting operational excellence objectives.Â
The WHO also stated that the risk assessment shows no change in the risk-benefit ratio, with no issues regarding vaccine safety and efficacy.
The statement read that the data available to WHO indicate the vaccine is effective and no safety concern exists. Countries should refer to the respective sage recommendation to continue vaccination with alternative sources of COVID19 vaccines.Â
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