Vaccine PreQualification

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The EuFMD aims to counter the threat of Foot-and-Mouth and Similar Transboundary Animal Diseases (FAST) and works with member nations on their preparedness, with European neighbours, 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. An assured supply of high quality vaccines forms an important part of this programme.

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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. A Prequalification system would be established and run by the EuFMD to assure the quality of vaccines against FMD on behalf of Member Countries. In future, on the basis of a suitable mandate, the scope and scale of the PQ system could be expanded to include vaccines against other FAST diseases and for other animal disease control programmes operated by FAO.

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The Prequalification described has been developed in close cooperation with the International Organisation for Animal Health (OIE) and the World Health Organisation as partner organisations. 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. 

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In developing this procedure, EuFMD recognised 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.

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Key principles

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• The PQ procedure will be operated by EuFMD using the best available expertise on FAST vaccines to evaluate the suitability of vaccines for pre-qualification.

• Applications for PQ will be submitted by applicants who may be manufacturers themselves,  or who may be other companies or individuals acting on behalf of manufacturers, that undertake to provide the information and data required at the time of submission of an application for PQ and thereafter.

• Evaluation of PQ applications will be carried out by a team of independent experts (the ‘Evaluation Team’) commissioned by EuFMD to prepare a report based on evaluation of the application submitted.

• The operation of the procedure will be overseen by a Standing Committee of experts established by EuFMD for this purpose (the ‘Standing Committee on Pre-Qualification’; SCPQ).

• PQ is not a regulatory procedure. It is a scientific peer review process aiming to provide assurance that a vaccine complies with minimum international standards.

• The PQ procedure will rely on standards and norms that have been defined by international organisations for animal health.  As a minimum, compliance will be assured with the relevant general and specific chapters of the International Organisation for Animal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (‘OIE Terrestrial Manual’).  

• The EuFMD will produce the guidance and documentation necessary for operation of the procedure on the basis of a transparent consultation process with all relevant stakeholders, including manufacturers, in line with standard EuFMD procedures.

• Vaccines for which evidence is supplied of compliance with minimum international standards will be included on a list of PQ vaccines published by EuFMD.

• Evaluation of fitness-for-purpose for use of a vaccine in particular epidemiological situations will not form part of the PQ procedure.  The epidemiological relevance of the vaccine and the ability of the manufacturer to meet specific logistical and capacity requirements should be evaluated as part of a separate tender procedure.

• The process of prequalification will be simplified and shortened for products which have already been approved by a competent authority recognised as functional by EuFMD for the purposes of assuring the quality, safety and efficacy of veterinary medicinal products.  

• There is currently no internationally recognised system for evaluating veterinary medicines competent authorities for functionality and maturity.  In the first instance therefore evaluation of functionality will rely on proxy measures such as membership of VICH, evaluations that have taken place in the context of the voluntary OIE Performance of Veterinary Services (PVS) scheme, the PIC/S scheme for inspection activities, and other objective measures that can be identified (details in Annex 3).

• Where a National Regulatory Authority (NRA) is considered functional, the PQ procedure will rely on this authority to act as the Supervisory Authority in the country in which a product is manufactured (or batch released and/or authorised, as appropriate).  

• In countries with less developed systems for regulation of veterinary vaccines, EuFMD will cooperate closely with NRAs performing the role of Supervisory Authority and will provide support where required.  The extent of cooperation and support will depend of the functionality of the NRA concerned. This approach is consistent with the role of EuFMD in building capacity and capability for control of FAST diseases in Low to Middle Income Countries (LMIC). 

• When fully operational a system of fees and charges may be introduced on the basis of cost recovery to ensure the sustainability of the PQ procedure.

• The EuFMD will ensure that the PQ procedure does not directly or indirectly discriminate between applicants on the basis of geography, affiliation with any industry representative organisation, size of enterprise or ability to pay fees.

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A phased approach will be adopted, focusing initially on establishing a list of PQ vaccines against FMD and progressively expanding to establish lists for other FAST diseases.

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Establishing a PQ procedure aims to:

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• Ensure that vaccines supplied to EuFMD

  • meet minimal internationally accepted criteria for quality, safety and efficacy

  • can be produced and controlled  consistently in manufacturing facilities that operate according to the principles of good manufacturing practice

• Form one element of a future system for assured emergency supply (AESOP) of FMD vaccines, thereby contributing to vaccine security by promoting predictability for suppliers and assisting vaccine production planning

• Reduce the timescale required for procurement and reduce the risks of procuring vaccines of inadequate quality

• Provide a standardised, transparent, rapid & objective evaluation procedure to suppliers of FAST vaccines to EuFMD

• Provide an independent and internationally recognised source of information for risk managers and other potential purchasers on vaccines against FAST diseases that comply with the requirements for PQ.