This Medical Product Alert relates to the confirmed circulation of falsified versions of “AMARIL stabilised vaccine” in South East Asia.
This vaccine is used to immunise against yellow fever and is a WHO prequalified product. Yellow fever vaccine is on the WHO list of Essential Medicines.
On the 9th of February 2016, the Pasteur Institute in Dakar, Senegal, informed WHO that they had identified a falsified version of their “AMARIL stabilised vaccine” circulating in Bangladesh.
Genuine AMARIL vaccines and solvents are manufactured by the Pasteur Institute in Dakar, Senegal.
The Pasteur Institute in Dakar has confirmed there are a number of falsified elements on the packaging, including a falsified expiry date, as well as other inconsistencies that were identified through visual inspection of photographs of the falsified products, as compared to the genuine products. Laboratory analysis is pending.
Details and photographs are available here.
It is necessary to ensure that all vaccines and medical products are obtained from authentic and reliable sources. Their authenticity and origin should be carefully checked and verified with manufacturers before use.
No serious adverse reactions attributed to this falsified vaccine have been reported at this stage. However, if you have been immunized with this falsified product, or if you suffer an adverse event following an immunisation with this falsified product, please seek immediate advice from a qualified healthcare professional and report the incident to your local Ministry of Public Health / National Medicines Regulatory Authorities/ National Pharmacovigilance Centre.
If you are in possession of the same products as above, please do not use, contact a healthcare professional as soon as possible for advice and report the incident as indicated above.
WHO requests increased vigilance for the supply chains of countries likely to be affected by these falsified products. Vigilance should include hospitals, clinics, pharmacies and any other vendors of medical products.
Authorities are asked to immediately notify WHO if this falsified product is discovered. If you have any information on the supply and/or distribution of the falsified product please contact rapidalert@who.int.
Details and photographs are available here.