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Medical device warning no. 5/2020
A counterfeit quadrivalent flu vaccine identified in the WHO region of America
Warning Summary
This WHO medicinal product warning applies to three different batches of confirmed counterfeit Fluzone® tetravalent influenza vaccines identified in Mexico and reported to the WHO on 16 October 2020.
Fluzone® Quadrivalent is a tetravalent inactivated vaccine for immunization against influenza A (H1N1 and H3N2) viruses and subtypes B.
It is confirmed that the products subject to this warning are counterfeit because they intentionally / falsely represent an incorrect identity, composition or source:
- The real manufacturer of Fluzone® Quadrivalent – Sanofi Pasteur – has confirmed that they have not manufactured or distributed the products that are the subject of this WHO Medical Device Warning no. 6/2020,
- And the variable data (batch number and expiration dates) of these products do not correspond to their original production records.
The original Fluzone® Quadrivalent has not yet been legitimately distributed in Mexico by Sanofi Pasteur and is not expected to hit the market before November 2020.
This counterfeit product has been identified at the patient level.
September 21, 2020 Prominent Strategic Advisory Group of WHO Immunization Experts (SAGE)[1] that health professionals and older adults are considered the highest priority risk groups for receiving influenza vaccines during the COVID-19 pandemic. It is therefore crucial to identify all counterfeit influenza vaccines in circulation as soon as possible.
Table 1: Products subject to WHO Medical Device Warning no. 6/2020
Advice to regulators and the public
The WHO is calling for greater vigilance within supply chains in countries and regions likely to be affected by these counterfeit products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.
All medical devices must be obtained from authorized / licensed and reliable suppliers. The authenticity and physical condition of the product should be carefully checked. In case of doubt, seek advice from a healthcare professional.
If you own the above counterfeit products, do not use them.
If you have used these counterfeit products or have suffered an adverse reaction / event if you have used them, it is advisable to seek medical help immediately from a qualified healthcare professional and to report the incident to the national regulatory authorities / National Pharmacovigilance Center.
National regulatory / health authorities are advised to notify the WHO immediately if these counterfeit products are identified in their country. If you have any information regarding the production, distribution or supply of these products, please contact [email protected]
Table 2: Photographs of products subject to the WHO warning on medical devices no. 6/2020
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Thanks WHO For Help!
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