Medical Product Alert N°4/2019: Falsified oral cholera vaccines

This Medical Product Alert relates to the circulation of confirmed falsified DUKORAL in the WHO region of South East Asia. Genuine Dukoral is a WHO pre-qualified oral cholera vaccine.

WHO was recently informed by the manufacturer Valneva that 8000 falsified packs of the oral cholera vaccine Dukoral were distributed in Bangladesh. WHO country office and health authorities in Bangladesh have quarantined the falsified vaccines identified to date.

The packaging of this falsified Dukoral displays text in English and French language.

Samples are being sent for laboratory analysis to determine their contents and better assess the risk to public health. This medical product alert n°4/2019 will subsequently be updated and posted on the WHO website once laboratory results are known. No serious adverse reactions attributed to these falsified vaccines have been reported to WHO at this stage.

The manufacturer of genuine Dukoral is Valneva Sweden AB, formerly named Crucell Sweden AB.

The above product claims to be manufactured by Valneva Canada Inc. However, the manufacturer Valneva Sweden AB has stated that:

• the displayed batch number does not correspond to genuine manufacturing records of either Valneva Canada Inc, or Crucell; and
• the combination of the manufacturers Valneva Canada Inc and Crucell should not exist on any packaging in any market.

The next page shows photographs of the falsified Dukoral subject of this alert and provides advice for healthcare professionals and patients.

WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified vaccines. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of vaccines or medical products.

If you are in possession of the above products, please do not use. If you have taken this falsified product, or if you suffer an adverse event or an unexpected lack of efficacy, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre.

All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

National health authorities are asked to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact: rapidalert@who.int