Medical Product Warning no. 5/2019 (English version)

Counterfeit meningitis vaccines circulate Niger

These medical device warnings apply to the trafficking of confirmed counterfeit Mencevax ACWY in the African WHO region. The original Mencevax ACWY is used to prevent meningitis A, C, W and Y.

On March 15, 2019, the Nigerian Ministry of Public Health issued a call for caution regarding the trafficking of counterfeit Mencevax ACWY vaccines. This WHO Medical Device Alert contains details of those products that have been confirmed to date as fake. Tests show that the supply chain path is those forged
vaccines include other West African countries: as such, greater vigilance is needed in all countries of the region, at all levels of the supply chain.

In Niger, a meningitis A vaccination campaign is being targeted at children 1 to 7 years old.

Table 1: Counterfeit vaccines data for Mencevax ACWY, WHO WHO alert no. 5/2019

The language on the labels of the counterfeit Mencevax ACWY vaccines is shown in English.

Samples are sent for laboratory analysis to determine their content and better risk assessment for public health. This medical product alert no. 5/2019 will subsequently be updated and published on the WHO website after the results of the laboratory are obtained. No serious adverse reactions attributed to these counterfeit vaccines have been reported at this stage of WHO.

The original Mencevax ACWY vaccine is produced by GSK for Pfizer, which has market authorization rights. In relation to the products detailed in Table 1 above, both companies stated that:

• did not produce the above products
• the combination number shown and the expiration date combination do not match the true production data

Page 2 shows photos of counterfeit vaccines subject to this warning, and Page 3 provides health care tips
professionals and patients.

PHOTOS OF FALSIFIED MENCEVAX VACCINES

1. Photos of counterfeit Mencevax ACWY, series number AMEUA108BA
and expiration date 02-2021

2. Photos of counterfeit Mencevax ACWY, serial number AMEUA105BA
and expiration date 07-2021

The WHO requires greater caution in the supply chains of countries likely to be affected by these counterfeit vaccines. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies, and all other suppliers of vaccines and medical devices.

If you own the above series of this vaccine, do not use it. If you have used the above batches of this vaccine or if you suffer an adverse event or unexpected lack of efficacy, seek the advice of a qualified healthcare professional immediately and ensure that they report the incident to your local Ministry of Health / National Medicines Regulatory Authorities / National Pharmacovigilance Center.

All vaccines and medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.

The National Health Authorities ask you to notify WHO immediately if these counterfeit vaccines are detected in their country. If you have any information on the production, distribution or supply of these products, please contact [email protected]

WHO Global Surveillance and Surveillance System
for substandard and counterfeit medical products

For more information, visit: http://www.who.int/medicines/regulation/ssffc/en/

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