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Monday, 28 September 2015 00:00

Falsified Meningitis Vaccines in circulation

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The attention of the agency has been drawn to the circulation of falsified versions of Meningitis Vaccines in Niger. This information was revealed on the 22nd of May, 2015 by the World Health Organization (WHO) following a report submitted to the Surveillance and Monitoring System for substandard and falsified medical products by the focal point within the Niger Regulatory Authority.

The affected products are Mencevax ACW, ACWY and diluents for Mencevax. Mencevax ACWY is a lyophilized preparation of purified polysaccharides from Neisseria meningitides (meningococcus) of serogroups A, C, W-135 and Y. It is indicated for active immunization of adults and children over two years against meningococcal meningitis (a serious disease in which there is inflammation of the meninges, caused by viral or bacterial infection, and marked by intense headache and fever, sensitivity to light, and muscular rigidity) caused by serogroup A, serogroup C, serogroup W-135 and serogroup Y meningococci.

Details of falsified batches of vaccines are as follows:

PRODUCT

BATCH NUMBER

MANUFACTURING DATE

EXPIRY DATE

Mencevax ACW

AMENA020AA

12-2014

11-2017

Mencevax ACWY

AMEHA020AA

12-2013

11-2016

Diluent

A003B128AA

12-2013

11-2019

Genuine Mencevax is manufactured by Glaxo SmithKline (GSK). This alert is issued on the basis of inconsistencies in the packaging material and confirmation from GSK that the batch number, manufacturing dates, and expiry dates are inconsistent with the genuine product. The falsified products contain 50 doses per vial of Mencevax ACW, ACWY and 50 doses of Mencevax for diluent.

Consequent to the seriousness of the current outbreak of meningitis in West Africa, demand for meningitis vaccines are on the increase.

NAFDAC advices that vaccines should be obtained from authentic and reliable sources. Increased vigilance is hereby encouraged within the supply chain to avoid infiltration by the falsified products.

NAFDAC is committed to ensuring that vaccines distributed for use in Nigeria are of good quality and safe. We encourage you to forward to the National Pharmacovigilance Centre, NAFDAC, any information concerning these batches or reported adverse reactions relating to medicines used in your facilities or by your patients via e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.  or This email address is being protected from spambots. You need JavaScript enabled to view it.

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