The EuFMD has completed the first stage of establishing a scheme for the prequalification of vaccines against foot-and-mouth disease to improve vaccine security. The term ‘vaccine security’ refers to the coordinated programme of activities that are needed in advance of an outbreak to make sure that vaccines of appropriate quality and characteristics are available whenever they are needed and in sufficient quantity to meet demand. Vaccine security is a particular problem for FMD due to the epizootic nature of the disease, the highly variable nature of FMD virus and the difficulty in creating or sustaining an economic market for the vaccine.  

The use of vaccines of defined and consistent quality is essential for successful eradication campaigns. Access to reliable, independent evidence of the quality of FMD vaccines is difficult to obtain, particularly for vaccines manufactured in countries with poorly developed regulatory systems. For vaccines used in humans, the World Health Organisation operates as system of prequalification to independently evaluate and publish information on vaccines to assure that they comply with minimum international standards. For FMD vaccines, the EuFMD has adopted a broadly similar approach for evaluating compliance of these vaccines with the minimum standards published in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (WOAH standards). Significant differences exist between the human and veterinary domains in the way that vaccines are manufactured, regulated and used and this is the first time that an independent system for prequalification has been developed for a veterinary vaccine. The EuFMD is therefore following a stepwise approach to prequalification.  

The first step has been to demonstrate that it is possible to set up a system of prequalification for a veterinary vaccine as this has never been attempted before.  The EuFMD established the infrastructure necessary to receive and evaluate applications by putting in place an administrative secretariat and convening a scientific expert committee (the Standing Committee on Prequalification of Vaccines - SCPQv). Administrative and technical guidelines were prepared and adopted by the SCPQv following public consultation with the objective that the system is open, transparent and does not discriminate between manufacturers on the basis of size, geographical location or affiliation with any industry association. The EuFMD then issued a call for expression of interest to manufacturers of FMD vaccines to submit applications for prequalification on a voluntary basis. Applications were evaluated for evidence of compliance with WOAH standards, and vaccines found to comply have been included on the list of prequalified vaccines together with a public summary report that describes the key characteristics of the vaccines and the way in which compliance has been demonstrated.

The list of prequalified FMD vaccines can be viewed together with more detailed information on the way in which the prequalification system has been set up and is being progressively developed. The EuFMD would welcome feedback from stakeholders, particularly those that procure or use FMD vaccines, on how useful they find this listing and any suggestions as to how it might be improved.

FAO, WOAH, national regulatory authorities for medicines and for animal health, reference laboratories, manufacturers and purchasers of vaccines, and non-governmental organizations are consulted, aiming to define how best prequalification can complement existing mechanisms for assuring the quality of vaccines by providing a transparent, independent and public source of information on the quality of FAST vaccines.