EBOLA STRATEGY Global Ebola Vaccine Implementation Team (GEVIT) Practical guidance on the use of Ebola vaccine in an outbreak response Draft Guidance, May 2016 Draft - Not for Implementation This guidance is being distributed for comment purposes only. © World Health Organization 2016. All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Draft-Not for Implementation Contents Contents ......................................................................................................................................... 2 Abbreviations and acronyms ........................................................................................................... 4 Acknowledgements ......................................................................................................................... 6 Introduction ..................................................................................................................................... 8 Purpose of this guide ................................................................................................................... 8 Background ................................................................................................................................. 9 Causative agent ...................................................................................................................................... 10 Clinical signs and symptoms ................................................................................................................... 10 Transmission ........................................................................................................................................... 10 Diagnosis ................................................................................................................................................ 11 Laboratory diagnosis ............................................................................................................................... 11 Ebola vaccine .......................................................................................................................................... 11 Ebola vaccine characteristics .................................................................................................................. 13 Ebola virus disease (EVD) vaccine target product profile ...................................................................... 13 Ebola vaccination phases ............................................................................................................. 14 1. Pre-epidemic preparedness: minimum requirements ............................................................. 16 1.1 What is required at global/regional level before a possible outbreak ............................................... 16 1.2 What is required at country level before a possible outbreak ........................................................... 18 2. Alert: action required when there are suspected cases of EVD ............................................. 23 3. Outbreak response ................................................................................................................ 25 3.1 Case confirmation: immediate action before vaccination ................................................................. 25 3.2 Vaccination response ........................................................................................................................ 28 4. Evaluation ............................................................................................................................. 30 4.1 Assessment of vaccine delivery ........................................................................................................ 30 4.2 Vaccine effectiveness studies ........................................................................................................... 30 Appendices ................................................................................................................................... 31 Appendix A - Ebola vaccines synthesis and documentation ...................................................... 32 Appendix B - Ebola vaccines summary table ............................................................................. 33 Appendix C - Overview of proposed roles and responsibilities of constituencies involved in Ebola vaccine outbreak activities ......................................................................................................... 34 Appendix D - Proposed composition and subgroups of Ebola Vaccine Programme Committee 38 Appendix E - Community engagement ...................................................................................... 41 Appendix F - Community capacity checklist ............................................................................... 43 Appendix G - Outline for communications strategy document for Ebola vaccine use ................. 46 Appendix H - Selection of a vaccination strategy ....................................................................... 49 Appendix I - Composition and training of vaccination teams ...................................................... 54 EBOLA STRATEGY: Global Ebola Vaccine Implementation Team (GEVIT) Practical Guidance 2 on the Use of Ebola Vaccine in an outbreak response Draft-Not for Implementation Appendix J - Minimum infrastructure of the cold chain and logistics country hub ....................... 56 Appendix K - Checklist for vaccination teams and vaccination strategies forecasting tool ......... 61 Appendix L - ICG application template ...................................................................................... 63 Appendix M - Changes to Ebola surveillance systems to incorporate use of vaccines in outbreak response ................................................................................................................................... 64 Appendix N - Monitoring plan during vaccine delivery................................................................ 69 Appendix O - Assessment plan after vaccine delivery ............................................................... 74 Appendix P - Standard practical steps ....................................................................................... 79 Appendix Q - Macro planning template ...................................................................................... 80 Appendix R - Potential study designs for field studies of Ebola vaccine effectiveness ............... 81 EBOLA STRATEGY: Global Ebola Vaccine Implementation Team (GEVIT) Practical Guidance 3 on the Use of Ebola Vaccine in an outbreak response Draft-Not for Implementation Abbreviations and acronyms AD auto disable (syringes) AEFI adverse event following immunization AR attack rate C4D communication for development specialist CCL cold chain and logistics CDC Centers for Disease Control and Prevention (US) EBOV-GP Ebola virus glycoprotein EHF Ebola haemorrhagic fever ELISA enzyme-linked immunosorbent assay EVD Ebola virus disease EVA Ebola outbreak response vaccination activities FLWs front-line workers GACVS WHO Global Advisory Committee on Vaccine Safety Gavi Gavi, the Vaccine Alliance GEVIT Global Ebola Vaccine Implementation Team GOARN Global Outbreak Alert and Response Network HBR home-based record HCW health-care workers ICC Inter-agency Coordination Committee ICG International Coordinating Group ICG EBOV ICG for the provision of Ebola vaccine IDSR Integrated Disease Surveillance and Response IEC information, education and communication (materials) IFRC International Federation of the Red Cross and Red Crescent Societies Ig immunoglobulin IPC infection prevention and control KAP knowledge, attitudes and practices (surveys) NGO non-governmental organization NIP National Immunization Programme NITAG National Immunization Technical Advisory Group NRA National Regulatory Authorities NVT national vaccination team OR odds ratio PCR polymerase chain reaction PCM phase change materials PHD long-range passive container high-density PHEIC Public Health Emergency of International Concern PPE personal protective equipment R&D research and development RNA ribonucleic acid RR risk ratio RRT rapid response team RT-PCR reverse transcriptase-polymerase chain reaction EBOLA STRATEGY: Global Ebola Vaccine Implementation Team (GEVIT) Practical Guidance 4 on the Use of Ebola Vaccine in an outbreak response Draft-Not for Implementation SAGE Strategic Advisory Group of Experts on Immunization (WHO) SG Steering Group (GEVIT) SOPs standard operating procedures SMS short message service (texts) TPP target product profile ToRs terms of reference UNICEF United Nations Children’s Fund USAID United States Agency