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.
Currently organizations purchase FMD vaccines through specific procurement procedures as and when the need arises and are obliged to evaluate the quality of vaccines as part of the procedure, often under emergency situations. 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 prequalification 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 has been established and run by the EuFMD to assure the quality of vaccines against FMD on behalf of Member Nations and any other users of FMD vaccines that wish to make use of its output. In future, the intention is that the scope and scale of the PQv system will be expanded to include vaccines against other FAST diseases and a funding and operational model will be developed to ensure the long term sustainability of the system.
The PQv proposal was developed by EuFMD with the World Organisation for Animal Health and the World Health Organisation as observers organizations. The procedure takes into account the 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, the 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.