44TH GENERAL SESSION OF THE EUFMD COMMISSION
ONLINE 21-22-23 APRIL 2021
Assuring the quality of vaccines through a Pre-Qualification system1 Presented by David Mackay, EuFMD (Appendix 11) Key Messages 1. The EuFMD is committed to improving vaccine security by making sure that vaccines of appropriate, high quality are available when needed. 2. The pre-qualification vaccine system (PQv) is a procedure for independent peer review of information on vaccines against FAST diseases, to confirm compliance with the minimum internationally accepted standards for vaccines, as defined in the World Organisation for Animal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (OIE Terrestrial Manual). 3. The procedure is separate to, but dependent on, registration procedures by national competent authorities. Only products that have been approved by at least one national competent authority will be eligible for PQv and authorities play an essential role in monitoring of products on their markets. 4. PQv will form part of a wider framework for vaccine security by promoting the uptake of ‘quality assured’ vaccines (Assured Emergency Supply Options -AESOP). 5. The PQ procedure benefits manufacturers, purchasers and users of vaccines against FAST diseases as independent PQv reduces the time and amount of work required by procurement managers by removing the need to evaluate ‘quality’ as part of the procurement process. Summary The EuFMD is committed to improving vaccine security by making sure that vaccines of appropriate, high quality are available when needed. Establishing a Pre-Qualification vaccine (PQv) procedure aims to ensure that vaccines supplied to EUFMD meet minimal internationally accepted criteria for quality, safety and efficacy, and are produced and controlled consistently in manufacturing facilities that operate according to the principles of good manufacturing practice. The system includes a procedure for independent peer review against the standards for vaccines that are defined in the World Organisation for Animal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (OIE Terrestrial Manual), and contributes one important element of a future system for Assured Emergency Supply OPtion (AESOP) of FMD vaccines. It further provides vaccine security by promoting predictability for suppliers and assisting vaccine production planning, reducing the timescale required for procurement and the risks for countries to procure vaccines of inadequate quality as it confirms the quality of vaccines in advance of need. It separates assessment of quality from the tendering procedure. PQv is separate from, but relies upon, national and regional registration procedures. Only vaccines that have been approved by at least one national competent authority will be eligible for PQv, and national authorities play a key role in continued monitoring of vaccines on their markets. The PQv procedure requires applicants to supply evidence of the ’quality’ of a vaccine in terms of: pharmaceutical quality including evidence for consistency of production; safety with respect to target animals, users, consumers of products from vaccinated animals, and the environment; efficacy in terms of evidence to support the claims made for the product on the label; and, standards of manufacture (compliance with the principles of Good Manufacturing Practice). These aspects will be considered in the independent peer review performed by recognized experts and against internationally accepted standards. Vaccines that are approved will be published in a list of PQ vaccines, thus readily available to contingency planners and risk managers.
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Based on the same principles as the existing system for human vaccines operated by WHO.
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