Alert 001/2024

FMD vaccine bottles with WOAH emblem circulating in Africa, Middle East, and Asia & the Pacific Region

Alert Summary

This Veterinary Product Alert relates to a confirmed case of misuse of WOAH’s emblem on labels of Foot and Mouth Disease (FMD) vaccine bottles circulating in at least one WOAH Member from the African Region. There are not evidences suggesting that physicochemical properties of these vaccines were compromised. However, the case was assigned as substandard due to the failure on the information authorised to be included on the labelling.

An investigation conducted by WOAH reflected that vaccines with WOAH’s former and new emblem are advertised online, affecting Members from Africa, Middle East and Aisa and the Pacific Regions. The use of WOAH emblem in vaccines is not allowed. WOAH urges not to authorise any vaccine containing WOAH’s emblem for importation and exportation, and to recall any affected vaccines from the market.

Description

This incident was formally reported to WOAH’s pilot Veterinary Surveillance and Monitoring System for Substandard and Falsified Veterinary Products (VSAFE). Bottles of FMD vaccine containing WOAH emblem on the label were found at distribution level in a Member from African Region in November 2023. The product details are presented below: 

The genuine manufacturer for the product has been contacted and they confirmed that they DID make the product. The manufacturer also contacted the MAH advising to stop using WOAH’s emblem on labels, and to recall all vaccines affected in the affected Member. Neither adverse reactions nor lack of expected efficacy due to the use to these veterinary products were reported.

Following an internal investigation, it was noted that vaccines and websites advertising the sales of vaccines containing WOAH’s emblem in their labels, as well as in their promotional brochures were available in Africa, Middle East, and Asia and the Pacific regions. The use of WOAH emblem on the labels of vaccine bottles and on promotional brochures, even by a recognised Reference Centre, is not allowed.

WOAH continues monitoring this situation very seriously as the effect of the use of these vaccines in animal health management programmes, and animal safety is unknown. Furthermore, both genuine manufacturers’ and WOAH’s institutional reputations are at risk.

Advice to regulatory authorities and the public

In light of the above, WOAH urges for the cooperation from National Competent Authorities and Members to not authorise any vaccine containing WOAH’s emblem for importation and exportation, and to recall any vaccine with WOAH’s emblem from the market.

WOAH requests increased vigilance within the supply chains of Members likely to be affected by the presence of vaccines containing WOAH’s former or new emblem. Increased vigilance should include veterinary clinics, pharmacies, wholesalers, distributors, and any other suppliers of veterinary products.

If you note any websites advertising the sales of vaccines containing WOAH’s emblem, please do not purchase and notify to your National Regulatory Authority for Veterinary Products.

If you are in possession of vaccines with WOAH’s emblem on the label, please do not use.

If you have used any vaccine with WOAH’s emblem in the label and you are aware of an adverse event in a human, animal or to the environment associated with the use of these products, please seek immediate advice from a qualified veterinary professional, and ensure they report the incident to your National Regulatory Authority for Veterinary Products or Pharmacovigilance Centre.

National Competent Authorities are asked to immediately notify WOAH if these products are discovered in their country. If you have any information, please contact [email protected].