The European Commission for the Control of Foot-and-Mouth Disease (EuFMD)

Vaccine Pre-Qualification

Background and rationale

The EuFMD aims to counter the threat of Foot-and-Mouth and Similar Transboundary Animal Diseases (FAST) and works with Member Nations and neighbouring countries on their preparedness to put in place sustainable control programmes, and to support and promote the progressive control of FMD in all regions under the Global FMD Control Strategy of FAO and OIE. Vaccine security in terms of assuring the supply of high quality vaccines forms an important part of this programme.

To date, EuFMD has obtained vaccines through specific procurement procedures run by FAO as and when the need arises. Having in place a system to assure the quality of vaccines in advance of need would improve vaccine security. The 44th General Session of the EuFMD, in April 2021, endorsed the establishment of a pre-qualification system for vaccines (PQv) against FAST diseases in line with the proposal on this topic prepared by EuFMD through consultation with affected stakeholders. In the first instance, the PQv procedure will be established and run by the EuFMD to assure the quality of vaccines against FMD on behalf of Member Nations. In future, on the basis of a suitable mandate, the scope and scale of the PQv system could be expanded to include vaccines against other FAST diseases and for other animal disease control programmes operated by FAO.

The PQv proposal was developed in close cooperation with the International Organisation for Animal Health (OIE) and the World Health Organisation as partner organizations. The procedure takes into account experience gained by WHO in developing their ‘Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies’  and aims to be consistent with, and complementary to, the OIE Vaccine Bank. 

In developing this procedure, EuFMD recognized that there are substantial differences between the human and veterinary domains in terms of the resources and approach that are applied in licensing and making vaccines available at national and international level. Consequently, whilst the same fundamental approach is taken in terms of evaluating the evidence of vaccine quality, the procedures, standards and outcome have been designed with the specific needs of the veterinary sector in mind.

This webpage will be updated as the project to implement PQv progresses. Guidance documents on the administrative procedures and technical requirements for PQv will be published here. All documents will be subject to a wide ranging and transparent consultation procedure to ensure scientific rigor and stakeholder engagement. Guidance Documents will be published following final adoption by the Standing Committee on Pre-Qualification of Vaccines which is currently being established to provide governance and oversight of the procedure.