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Expert Opinion on Vaccine And/Or Diagnostic Banks for Major Animal Diseases

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Expert Opinion on Vaccine And/Or Diagnostic Banks for Major Animal Diseases EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate D — Animal Health and Welfare D1-Animal Health and Standing Committees Brussels, May 2010 SANCO/7070/2010 EXPERT OPINION ON VACCINE AND/OR DIAGNOSTIC BANKS FOR MAJOR ANIMAL DISEASES STRATEGIC PLANNING OPTIONS FOR EMERGENCY SITUATIONS OR MAJOR CRISES This document does not necessarily represent the views of the Commission Services Please note that this document is the outcome of an expert group and has been prepared for information and consultation purposes only. It has not been adopted or in any way approved by the European Commission and should not be regarded as representative of the views of the Commission Services either. The European Commission does not guarantee the accuracy of the information provided, nor does it accept responsibility for any use made thereof. 1. Acknowledgements ............................................................................................................ 5 2. Acronyms and abreviations................................................................................................ 6 3. Key Messages..................................................................................................................... 7 4. Summary ............................................................................................................................ 8 4.1. Background ................................................................................................................ 8 4.2. Scope of this paper ..................................................................................................... 9 4.3. Criteria for vaccine banks .......................................................................................... 9 4.4. Conditions for emergency vaccination..................................................................... 10 4.5. Alternatives to vaccine banks................................................................................... 11 4.6. Recommendations for particular vaccine and diagnostic banks .............................. 11 4.6.1. Foot-and-mouth disease (FMD)....................................................................... 11 4.6.2. Avian Influenza (AI) ........................................................................................ 12 4.6.3. Classical swine fever (CSF) ............................................................................. 13 4.6.4. African horse sickness (AHS) .......................................................................... 13 4.6.5. Blue tongue (BT).............................................................................................. 14 4.6.6. African swine fever (ASF) ............................................................................... 14 4.7. General issues related to the vaccines industry........................................................ 15 4.8. Overview of proposals for vaccine and diagnostic banks ........................................ 16 5. Main Report...................................................................................................................... 17 5.1. Issues and background ............................................................................................. 17 5.2. Scope of policy paper............................................................................................... 19 5.3. Criteria for having vaccine and antigen banks ......................................................... 20 5.4. Conditions for emergency vaccination..................................................................... 20 5.5. Identification of infectious diseases for which vaccine, antigen and diagnostic banks should be available in the EU in case of an emergency ........................................... 21 5.6. Alternatives to Vaccine banks.................................................................................. 21 6. Foot-and-mouth disease (FMD)....................................................................................... 23 6.1. Severity/likelihood ................................................................................................... 23 6.2. FMD vaccines .......................................................................................................... 23 6.3. FMD vaccine banks.................................................................................................. 25 6.4. Diagnostic considerations........................................................................................ 26 6.5. Strategy on how the VB/DB should be used in case of emergency......................... 27 6.6. Legal basis for vaccination/vaccine banks ............................................................... 28 6.7. Recommendations for EU FMD vaccine and diagnostic banks............................... 28 6.8. Key references FMD ................................................................................................ 29 7. Avian Influenza (AI) ........................................................................................................ 30 7.1. Introduction .............................................................................................................. 30 7.2. Vaccination for AI control ....................................................................................... 30 7.3. AI vaccines............................................................................................................... 31 7.4. AI vaccine bank........................................................................................................ 32 7.5. Example of decision making steps for AI emergency vaccination .......................... 34 7.6. Diagnostic considerations........................................................................................ 35 7.7. Size of vaccine bank................................................................................................. 35 7.8. Estimated costs of the vaccine bank......................................................................... 36 7.9. Diagnostic bank........................................................................................................ 36 7.10. Legal basis for vaccination/vaccine banks ........................................................... 37 7.11. Recommendations for AI vaccine and diagnostic banks ..................................... 37 7.12. Key references AI................................................................................................. 38 2 8. Classical swine fever (CSF) ............................................................................................. 39 8.1. Introduction .............................................................................................................. 39 8.2. CSFV Vaccination....................................................................................................39 8.3. CSF vaccines (EFSA, Scientific Report on CSF, 2009) .......................................... 40 8.4. Diagnostics/DIVA.................................................................................................... 40 8.5. Strategic approach.................................................................................................... 41 8.6. Feral pigs/wild boar.................................................................................................. 42 8.7. Domestic pigs........................................................................................................... 42 8.8. Size of CSFV vaccine bank...................................................................................... 42 8.9. CSFV diagnostic bank.............................................................................................. 43 8.10. Legal Basis for vaccination/vaccine banks .......................................................... 43 8.11. Conclusions .......................................................................................................... 44 8.12. Recommendations for CSF vaccine and diagnostic banks................................... 44 9. African horse sickness (AHS) .......................................................................................... 45 9.1. Severity and likelihood............................................................................................. 45 9.2. AHS vaccines........................................................................................................... 46 9.3. Vaccination strategy................................................................................................. 46 9.4. Recommendations for an AHS vaccine and diagnostic bank .................................. 47 9.5. Conclusions and Recommendations......................................................................... 48 9.6. References AHS....................................................................................................... 48 10. Bluetongue (BT)........................................................................................................... 51 10.1. Vaccination for BT control .................................................................................. 53 10.2. BT Control: Legislative Frame work ................................................................... 53 10.3. BT vaccines.......................................................................................................... 54 10.4. Strategic approach for BT vaccine bank .............................................................. 55 10.5. BT vaccine bank conclusions
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