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

Vaccine Prequalification

Call for Expressions of Interest for FMD vaccine prequalification applications

EuFMD is implementing a prequalification scheme for FMD vaccines (PQv) and is now seeking formal expressions of interest (EOI) from manufacturers who may be interested in submitting an application for their product in 2023.  

The closing date for submitting an EOI has now closed and EuFMD cannot accept any new EOIs at Stage 1. EuFMD will publish a further announcement for new EOI should there be capacity to manage additional applications. Manufacturers who did not submit an EOI by the closing date can still indicate their interest in the PQv scheme by sending their details to the PQv secretariat at [email protected].

Further information on the PQv scheme, including the PQv policy document, can be found here. Implementation will follow a phased approach and arrangements are being finalized to receive applications for evaluation during 2023 as part of Stage 1 (Proof of Concept).

Applications may need to be prioritized depending on the level of interest and EuFMD will inform applicants if their application can be considered as part of Stage 1 by January 31, 2023.  Pre-submission meetings will be held with applicants to address any questions and provide support in assembling and submitting the PQv application.

The technical requirements for PQv applications are detailed in the Technical Guidance for the Prequalification of FMD Vaccines and Content of the Prequalification Evidence File

The administrative steps and timelines for prequalification can be found in the Administrative Procedure for the Prequalification of FMD Vaccines.

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 WOAH. 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 World Organisation for Animal Health (WOAH) and the World Health Organisation (WHO) 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 WOAH 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.