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Public Alert No. 0008/2019 – Alert on Falsified Mencevax Meningitis Vaccines Circulating in Niger Republic

 

April 15, 2019,

The National Agency for Food and Drug Administration and Control (NAFDAC) alerts the public, especially the health care providers on the circulation of falsified MencevaxTM ACWY vaccines in Niger Republic. The Health Authorities of Niger Republic issued an alert on the falsified vaccines discovered during routine inspections of the pharmacies in Niamey, Niger Republic on 14th March, 2019.

On 15 March 2019, the Ministry of Public Health in Niger issued a call for vigilance regarding the circulation of falsified Mencevax ACWY vaccines.

Inquiries indicate that the supply chain route of these falsified vaccines includes other countries in West Africa. As such, increased vigilance is requested in all countries of the region, at all levels of the supply chain.

The details of the falsified Mencevax ACWY vaccines are:

Product Name Mencevax ACWY Mencevax ACWY
Batch Number AMEUA108BA AMEUA105BA
Expiry Date 02-2021 07-2021
Manufacturing date 03-2018 03-2016
Stated manufacturer Glaxo Smitne Biologicals s.a. Rixensart-Beigium Glaxo Smith Biologicals s.a. Rixensart-Belgium

Genuine Mencevax ACWY vaccine is used to prevent meningitis types A, C, W and Y. Genuine Mencevax ACWY vaccine is manufactured by Glaxo SmithKline Beecham (GSK). GSK stated that:

▪   They did not manufacture the falsified vaccines,

▪  The batch number and expiry date combinations displayed on the falsified

vaccines do not correspond to genuine manufacturing records.

The genuine Mencevax ACWY vaccine was registered by NAFDAC in favour of Glaxo SmithKline Beecham (GSK). Pfizer acquired the vaccines from GSK in 2015.

Pfizer Specialties Limited, 7th Floor , Heritage Place, 21 Lugard Avenue, Ikoyi Lagos discontinued commercialization of Mencevax Vaccines in Nigeria in June 2018. As a result of the discontinuation of commercialization of the vaccines, Pfizer specialties Limited no longer import the vaccines into Nigeria.

NAFDAC implores all importers, wholesalers and retailers not to illegally import, distribute and sell falsified Mencevax ACWY vaccines.

Surveillance has been strengthened by NAFDAC at all ports of entry to prevent importation of the falsified vaccines from Niger Republic. The agency has also heightened surveillance on hospitals, clinics, health centres, pharmacies and distributors to prevent distribution, sales and use of the falsified vaccines.

Health care providers and other members of the public are advised to be vigilant and contact the nearest NAFDAC office with any information on the falsified vaccines.

Anybody in possession of the falsified vaccine should submit it to the nearest NAFDAC office.

Consumers are advised to report adverse events related to the use of vaccines to the nearest NAFDAC office, NAFDAC PRASCOR ( 20543 TOLL FREE for all Network ) or via pharmacovigilance@nafdac.gov.ng.

NAFDAC.……………Safeguarding the health of the nation!!!