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MINIMIZING IMPACT Minimizing the Impact of Pandemic GLOBAL INFLUENZA PROGRAMME BACKGROUND DOCUMENT STREAM WHO PUBLIC HEALTH RESEARCH a s d AGENDA FOR d v a e 3 n INFLUENZA e c n e h s lt c a ie e nc c h e li to a pub ddress unmet MINIMIZING IMPACT Minimizing the impact of pandemic, 2017 UPDATE zoonotic, and seasonal epidemic influenza WHO/WHE/IHM/GIP/2017.6 © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/ licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. WHO public health research agenda for influenza: 2017 update. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/ about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. 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 WHO 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. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO 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 WHO be liable for damages arising from its use. MINIMIZING IMPACT Minimizing the impact of pandemic, zoonotic, and seasonal epidemic influenza WHO Public Health Research Agenda for Influenza 2017 Update Contents Abbreviations 3.0 INTRODUCTION 1 Substream 3.1 DETERMINING DISEASE BURDEN AND SOCIAL IMPACT 2 RESEARCH RECOMMENDATION 3.1.1, 3.1.2 AND 3.1.4 Summary of key accomplishments 3.1.1, 3.1.2 and 3.1.4 Knowledge gaps 3.1.1, 3.1.2 and 3.1.4 RESEARCH RECOMMENDATION 3.1.3 Summary of key accomplishments 3.1.3 Unmet public health needs 3.1.3 Knowledge gaps 3.1.3 RESEARCH RECOMMENDATION 3.1.5 Summary of key accomplishments 3.1.5 Unmet public health needs 3.1.5 Knowledge gaps 3.1.5 RESEARCH RECOMMENDATION 3.1.6 Summary of key accomplishments 3.1.6 Unmet public health needs 3.1.6 Knowledge gaps 3.1.6 Key research questions 3.1 Substream 3.2 IMPROVE IMMUNOGENICITY, AVAILABILITY AND DELIVERY OF INFLUENZA VACCINE 7 RESEARCH RECOMMENDATION 3.2.1 Summary of key accomplishments 3.2.1 Unmet public health needs 3.2.1 Knowledge gaps 3.2.1 RESEARCH RECOMMENDATION 3.2.2 Summary of key accomplishments 3.2.2 Unmet public health needs 3.2.2 Knowledge gaps 3.2.2 RESEARCH RECOMMENDATION 3.2.3 Summary of key accomplishments 3.2.3 Unmet public health needs 3.2.3 knowledge gaps 3.2.3 RESEARCH RECOMMENDATION 3.2.4 Summary of key accomplishments 3.2.4 Unmet public health needs 3.2.4 Knowledge gaps 3.2.4 RESEARCH RECOMMENDATION 3.2.5 Summary of key accomplishments 3.2.5 Unmet public health needs 3.2.5 Knowledge gaps 3.2.5 RESEARCH RECOMMENDATION 3.2.6 Summary of key accomplishments 3.2.6 Unmet public health needs 3.2.6 Knowledge gaps 3.2.6 RESEARCH RECOMMENDATION 3.2.7 Summary of key accomplishments 3.2.7 Unmet public health needs 3.2.7 Knowledge gaps 3.2.7 RESEARCH RECOMMENDATION 3.2.8 Summary of key accomplishments 3.2.8 Unmet public health needs 3.2.8 Knowledge gaps 3.2.8 RESEARCH RECOMMENDATION 3.2.9 Summary of key accomplishments Unmet public health needs 3.2.9 Knowledge gaps 3.2.9 Key research questions 3.2 Substream 3.3 PUBLIC HEALTH POLICIES TO REDUCE THE IMPACT OF DISEASE 19 RESEARCH RECOMMENDATION 3.3.1 Summary of key accomplishments 3.3.1 Unmet public health needs 3.3.1 Knowledge gaps 3.3.1 RESEARCH RECOMMENDATION 3.3.2 Summary of key accomplishments 3.3.2 Unmet public health needs 3.3.2 Knowledge gaps 3.3.2 RESEARCH RECOMMENDATION 3.3.3 Summary of key accomplishments 3.3.3 Unmet public health needs 3.3.3 Knowledge gaps 3.3.3 REFERENCES 22 Abbrevations ADCC Antibody Dependent Cellular Cytotoxicity AESI Adverse Events of Special Interest BARDA Biomedical Advanced Research and Development Authority CDC Centers for Disease Control and Prevention CHMP Committee for Medicinal Products for Human Use CMI Cell-mediated Immunity CVV candidate vaccines virus EMA’s European Medical Agency’s EU European Union FACS Fluorescent Activated Cell Sorting GACVS Global Advisory Committee on Vaccine Safety GAP WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply GIVE Global Influenza Vaccine Effectiveness HA Haemagglutinin HI Haemagglutination inhibition HLA Human Leukocyte Antigen HPLC High-performance Liquid Chromatography HPV Human Papillomavirus ICTRP International Clinical Trials Registry Platform IFPMA International Federation of Pharmaceutical Manufacturers & Associations ILI Influenza-like Illness IVS ITF Influenza Vaccine Supply International Task Force KAP Knowledge, Attitude and Practices LAIVs Live Attenuated Influenza Vaccines LMICs Low and Middle Income Countries MDCK Madin Darby Canine Kidney NA Neuraminidase NAI Neuraminidase Inhibitor NGS Next-generation Sequencing NI neuraminidase inhibiting NIH National Institutes of Health RG Reverse Genetics BACKGROUND SAES Serious Adverse Events DOCUMENT SAGE Strategic Advisory Group of Experts (WHO) Minimizing the impact of pandemic,zoonotic, and seasonal epidemic influenza SDS-PAGE Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis STREAM SPR Surface Plasmon Resonance SRD Single Radial Immunodiffusion SRH single radial haemolysis 3 TB Tuberculosis TIP Tailoring Immunization Programmes VE Vaccine Effectiveness VLP Virus-like Particle WHO World Health Organization STREAM 3.0 Introduction 3 Immunization against influenza is an essential public health intervention to control both seasonal epidemics and pandemic influenza. The WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP) – in 2006 with GAP-I (World Health Organization, 2006) and in 2011 with GAP-II (World Health Organization, 2011) – articulated a multifaceted strategy to increase vaccine production and use. The WHO Public Health Research Agenda for Influenza in 2009 outlined research recommendations for minimizing the impact of pandemic, zoonotic and seasonal epidemic influenza (Stream 3) and identified three major topics: • Substream 3.1 Determining disease burden and social impact; • Substream 3.2 Improve immunogenicity, availability and delivery of influenza vaccines; and • Substream 3.3 Public health policies to reduce the impact of disease by immunization. With the global pandemic of A(H1N1)pdm09 influenza virus in 2009 and subsequent extensive research reports published relating to the pandemic, a review of the research recommendations in the 2009 WHO Public Health Research Agenda for Influenza was deemed necessary. In 2013, WHO published a progress review and report (World Health Organization, 2013a). Much progress has been made since the last update of 2009, especially with respect to publications, workshops, international collaborations and the generation of various websites on specific topics from some stakeholders. However, there have been many parallel activities, and although these often represent excellent approaches, they urgently need to be aligned and harmonized, then accepted by global regulatory authorities. For Substream 3.1, major achievements have included the establishment and provision of WHO documents, especially the WHO manual for estimating disease burden (World Health Organization, 2015a), and standardized protocols for surveillance of influenza (World Health Organization, 2012). For Substream 3.2, a range of resources
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