Falsified versions of a meningitis vaccine that contravenes the trademarks of Brazilian drugmaker Bio-Manguinhos/Fiocruz have been found in Niger, says the World Health Organization.
The drugmaker informed the WHO on May 31 that the fake Polysaccharide Meningococcal ACWY Vaccine – marked with the batch number 089UMH002 Z, expiry date 092017 and date of manufacture 092014 – were definitely falsified. The vaccines are packaged in vials of 10 doses apiece.
Bio-Manguinhos said it does not sell a MenACWY vaccine and – based on an examination of photographs of the product – it can confirm that the packaging has been falsified. So far the product has not been subjected to laboratory analysis so it is too early to say whether it contains any vaccine antigens or indeed any harmful substances.
"No adverse events following immunisation attributed to this falsified vaccine are known to have been reported at this stage, said the WHO in a statement.
Men ACWY vaccines are on the WHO's essential medicines list, and Niger is one of the countries that had benefited from routine Men A vaccinations under the GAVI project, resulting in a reduction in cases of the serious infection from more than 800 in 2008 to zero in 2014. There was a major outbreak of Men C in 2015, however, with around 9000 cases identified.
Aside from their potential to cause harm, falsified vaccines are likely to lack efficacy and could undermine the progress being made in combatting meningitis in the so-called 'meningitis belt' of 26 sub-Saharan African nations, stretching from Senegal in the west to Ethiopia in the east.
"If you are in possession of this vaccine, please do not use, contact a healthcare professional as soon as possible for advice and report the incident to your local Ministry of Public Health / National Medicines Regulatory Authorities/ National Pharmacovigilance Centre," said the WHO.
"Please seek immediate advice from a qualified healthcare professional if you have been immunised with this falsified vaccine, or if you suffer an adverse event following its immunisation, and report the incident as indicated above," it continues. "Members of the public who are aware of falsified medical products sold by various retailers should report to their national health authorities."
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