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Medical device warning no. 2/2021: Counterfeit vaccine COVID-19 BNT162b2
Warning Summary
This WHO medical device warning applies to the counterfeit COVID-19 vaccine identified as “BNT162b2” detected in Mexico in February 2021 and recently confirmed as counterfeit to the WHO. The counterfeit product was delivered and administered to patients outside of approved vaccination programs.
This counterfeit COVID-19 vaccine may still be on the market in the region and may continue to be offered to patients outside approved vaccination programs.
A laboratory analysis of the content of counterfeit products is pending and this alert will be updated as soon as the results are available.
The original COVID-19 BNT162b2 vaccine is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus in persons over 16 years of age. The use of native vaccines against COVID-19 should be in accordance with official guidelines of national regulatory authorities.
Counterfeit COVID-19 vaccines pose a serious risk to global public health and pose an additional burden to vulnerable populations and health systems. It is important to identify them and remove them from traffic.
It is confirmed that the product identified in this warning is counterfeit on the grounds that it intentionally / fraudulently represents the identity, composition or source of:
- The real manufacturer of COVID-19 vaccine BNT162b2 confirmed that it did not produce the product.
- Batch number and expiration dates are fake.
- Glass vials and labels differ from the original vials of COVID-19 BNT162b2 vaccine.
Table 1: Products subject to WHO Medical Device Alert no. 2/2021
Advice to regulators and the public
The WHO is calling for greater vigilance within the supply chains of countries and regions that could 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 suppliers. The authenticity and physical condition of the product should be carefully checked. If in doubt, seek advice from a healthcare professional.
If you own the above products, do not use them.
If you have used these products or have experienced an adverse reaction / event if you have used them, it is advisable to seek medical advice 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 products are detected in their country. If you have any information regarding the production, distribution or supply of these products, please contact WHO World Surveillance and Monitoring System over it [email protected]
Table 2: Photographs of products subject to WHO Medical Device Alert no. 2/2021
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