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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Peter Sands and Janelle Winters, Editors Committee on Global Coordination, Partnerships, and Financing Recommendations for Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response Board on Global Health Health and Medicine Division A Consensus Study Report of and NATIONAL ACADEMY OF MEDICINE

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW, Washington, DC 20001 This activity was supported by a contract between the National Academy of Sciences and the Office of Global Affairs with the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13:  978-0-309-08870-1 International Standard Book Number-10:  0-309-08870-4 Digital Object Identifier:  https://doi.org/10.17226/26284 Library of Congress Catalog Number: 2021951345 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2022 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Countering the pandemic threat through global coordination on vaccines: The influenza imperative. Washington, DC: The National Academies Press. https:// doi.org/10.17226/26284.

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Consensus Study Reports published  by the National Academies of Sciences, Engineering, and Medicine  document the evidence-based consensus  on the study’s statement of task by an authoring committee of experts. Reports typi- cally include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process, and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opin- ions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

COMMITTEE ON GLOBAL COORDINATION, PARTNERSHIPS, AND FINANCING RECOMMENDATIONS FOR ADVANCING PANDEMIC AND SEASONAL INFLUENZA VACCINE PREPAREDNESS AND RESPONSE PETER SANDS (Chair), Executive Director, The Global Fund to Fight AIDS, Tuberculosis and Malaria DEVI SRIDHAR (Vice Chair), Professor and Chair of Global Public Health, Usher Institute, University of Edinburgh SALAH T. AL AWAIDY, Communicable Disease Advisor, Ministry of Health, Oman WILLIAM AMPOFO, Associate Professor, Virology Department, Noguchi Memorial Institute for Medical Research, University of Ghana PHYLLIS ARTHUR, Vice President, Infectious Diseases and Emerging Science Policy, Biotechnology Innovation Organization CHRISTOPHER T. BAUCH, Professor of Applied Mathematics, University of Waterloo GIAN LUCA BURCI, Professor of International Law, Graduate Institute of International and Development Studies KEIJI FUKUDA, Director and Clinical Professor, School of Public Health, LKS Faculty of Medicine, The University of Hong Kong BRUCE G. GELLIN, Chief, Global Public Health Strategy, The Rockefeller Foundation AMANDA L. GLASSMAN, Executive Vice President and Senior Fellow, Center for Global Development RICHARD J. HATCHETT, Chief Executive Officer, Coalition for Epidemic Preparedness Innovations JOHN NKENGASONG, Director, Africa Centres for Disease Control and Prevention CHARLES “OK” PANNENBORG, Chief Health Scientist and Director, World Bank (Retired) ALEXANDRA L. PHELAN, Assistant Professor, Center for Global Health Science and Security, Georgetown University Medical Center, Adjunct Professor, Georgetown University Law Center CHRISTOPHER SNYDER, Joel and Susan Hyatt Professor of Economics, Department of Economics, Dartmouth College CHARLOTTE WELLER, Head of Prevention, Wellcome Trust Study Staff JANELLE WINTERS, Study Director CLAIRE MOERDER, Research Associate (until June 2021) v

ERIKA JAUREGUI, Research Associate (from June to August 2021) INEZ ADAMS, Research Associate (from June to August 2021) TOCHI OGBU-MBADIUGHA, Senior Program Assistant (from April 2021) EMILIE RYAN-CASTILLO, Senior Program Assistant PATRICIA A. CUFF, Senior Program Officer, Board on Global Health JULIE A. PAVLIN, Senior Director, Board on Global Health FRANCES SHARPLES, Science Writer ROGER YAT-NORK CHUNG, National Academy of Medicine International Health Policy Fellow Consultant ANNA NICHOLSON, Science Writer vi

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manu- script remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: SUSAN ATHEY, Stanford Institute for Economic Policy Research CARLOS CORREA, South Centre MARK DYBUL, Georgetown University Medical Center DAVID FIDLER, Council on Foreign Relations KEITH KLUGMAN, Bill & Melinda Gates Foundation ANUP MALANI, University of Chicago Law School DEEPALI PATEL, Gavi, the Vaccine Alliance SAI D. PRASAD, Bharat Biotech International Ltd. NITEEN WAIRAGKAR, Vaccines for All Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report, nor did they see the final draft before its release. The review of this report was overseen by GAIL CASSELL, vii

viii REVIEWERS Harvard University, and HELEN MILNER, Princeton University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

National Academy of Medicine Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response Series This study, Countering the Pandemic Threat Through Global Coordi- nation on Vaccines: The Influenza Imperative, provides recommendations on how to identify and overcome barriers to effective global coordination and sustainable financing for pandemic and seasonal influenza vaccines and vaccinations, drawing on successes and challenges from the global response to COVID-19. It is one of four studies conducted under the Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response Ini- tiative, which explores how the scientific and technological breakthroughs throughout the COVID-19 pandemic could inform and advance future pandemic and seasonal influenza vaccine preparedness and response efforts. The three companion studies to this study examine how the lessons learned from COVID-19 around vaccine research and development, vaccine distribution and supply chain, and public health interventions and countermeasures could be best utilized to improve the development and distribution of future pandemic and seasonal influenza vaccines. Together, the four consensus studies present a path toward better preparedness in addressing pandemic and seasonal influenza. Launched by the National Academy of Medicine with support from the Office of Global Affairs, U.S. Department of Health and Human Services, the Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response Initiative acknowledges that influenza is here to stay. The unprec- edented scope of this initiative allowed for international experts to look at this issue from multiple angles and provide recommendations that set out a pathway to more effective influenza vaccines worldwide. Driven by international cooperation, this independent initiative provides a platform to highlight why we need to act as a global community to better prepare for pandemic and seasonal influenza. ix

Acknowledgments This study is timely, in terms of considering how to harness lessons and best prepare for a major future pandemic threat during a debilitating current pandemic. This timeliness created an intense study schedule for the committee members and staff. First and foremost, we would like to thank the members of the pandemic preparedness and response (PPR) community who took the time to speak to us, on top of incredibly busy schedules. Appendix B lists the names and affiliations of all speakers. This study would not have been possible without their intellectual contributions and candid perspectives on what has worked (and not worked) in pandemic preparedness for COVID-19, influenza, and other threats. We would also like to thank our sponsor, the Office of Global Affairs in the U.S. Department of Health and Human Services. We appreciate your dedication to advancing the pandemic influenza preparedness agenda. We are further indebted to members of the influenza PPR international committee, under the umbrella of the National Academy of Medicine, who guided the development of the four consensus studies. Finally, we thank members of the Health and Medicine Division, particularly Lauren Shern for providing study guidance and Leslie Sim and Taryn Young for coordinating the review process. Last, but certainly not least, we are grateful for the support of members of the “flu team” at the Board on Global Health, especially Kenisha Jefferson, Ellen Schenk, and Hoda Soltani. xi

Preface COVID-19 has taught the world a harsh lesson on the perils of being unprepared for a pandemic. More than 18 months since the World Health Organization (WHO) declared a public health emergency of international concern, governments across the world are still struggling to contain new waves of infection and death. The human and economic costs of this crisis are staggering, and it is far from over. This reality underscores this report’s title, Countering the Pandemic Threat Through Global Coordination on Vaccines: The Influenza Imperative. COVID-19 has been terrible, but an influenza pandemic comparable to that of 1918–1919 could be even worse. The world cannot afford to be as unprepared for an influenza pandemic as we turned out to be for COVID-19. So, while the immediate priority must be to defeat COVID-19, we must also move decisively to strengthen our ability to protect people from future threats, pandemic influenza above all. The seven recommendations in this report aim to provide this agenda for action. Underpinning the recommendations are four crosscutting themes. The first is simply the inadequacy of our current defenses: we have too many gaps, and too much is dependent on underfunded, often informal arrangements. Against the scale of the threat, we are woefully underpro- tected. We urgently need to strengthen our collective defenses against pan- demic influenza and must do so in a way that is sustainable. The second theme is the need to integrate the solutions for pandemic influenza into whatever broader solution global policy makers devise for pandemic preparedness and response (PPR) through the G7 or G20. It no longer makes sense to have purely influenza-specific mechanisms for critical xiii

xiv PREFACE capabilities, such as disease surveillance, pathogen sharing, vaccine plat- form technologies, and vaccine deployment systems. The G7 and G20 de- bates around determining this broader set of solutions have been unfolding in parallel with the committee’s deliberations, posing a challenge in framing our recommendations: we want our proposals for pandemic influenza to fit the broader overarching solution for pandemic preparedness, without yet knowing precisely what this will look like. The third theme is in slight tension with the second. We must integrate influenza PPR with the broader pandemic preparedness agenda, but we must avoid inadvertently weakening the existing influenza mechanisms. For all their limitations, current arrangements for global coordination, partnerships, and financing for pandemic influenza are typically much more established than the equivalents for other pathogens of pandemic potential. Moreover, influenza’s unique characteristics, such as its seasonality, create distinct challenges and opportunities that must be factored into the pre- paredness approach. The fourth and final theme revolves around equity. Unless equity is embedded into the mechanisms for influenza PPR, frictions about inequi- table access will corrode the collaboration and partnerships that are so vital to protecting us all. Moral, epidemiological, and practical perspectives all point to the need for an equitable approach to PPR. The world might be lucky and not face an influenza pandemic for de- cades. But we might also be unlucky and find ourselves confronted by such a threat even before we surmount COVID-19. We cannot rely on luck. Too much is at stake. More effective global coordination, deeper partnerships, and scaled-up and sustained financing are essential to deliver reinforced protection against pandemic influenza. This committee, combining in its membership an extraordinary range of experience and expertise, aided by the superb staff of the National Academies, and informed by exceptional speakers bringing a wide spectrum of perspectives, has sought to explore these issues and lay out a set of actionable recommendations to address this imperative and make us all safer from the threat of pandemic influenza. Peter Sands, Chair Committee on Global Coordination, Partnerships, and Financing Recommendations for Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response

Contents ACRONYMS AND ABBREVIATIONS  xxi SUMMARY  1 1 INTRODUCTION: THE IMPERATIVE FOR GLOBAL INVESTMENT IN INFLUENZA VACCINES  21 What If 2020 Had Been the “Year of Influenza” Instead?, 23 A Disruptive Moment to Reconsider Influenza in the Wider Pandemic Preparedness Landscape, 28 Charge to the Committee on Global Coordination, Partnerships, and Financing, 31 Structure of the Report, 33 References, 35 2 THE EXISTING GLOBAL GOVERNANCE LANDSCAPE FOR INFLUENZA VACCINES  39 World Health Organization and the Influenza “Regime Complex,” 39 Governance Gaps Exposed in the 2009 H1N1 “Swine Flu” Pandemic, 40 Expanding and Enhancing Influenza Surveillance Since 2009, 44 A Snapshot of Current Influenza Vaccine Governance Structures and Frameworks, 47 The Global Influenza Strategy and the Governance Path Forward, 52 xv

xvi CONTENTS Key Findings and Conclusions, 55 References, 56 3 PATHOGEN SHARING FOR INFLUENZA VACCINE PRODUCTION  59 The Essential Need for Pathogen Sharing, 59 The Critical Importance of Access and Benefit Sharing, 61 Equity and Human Rights, 62 Existing International Instruments for ABS, 63 Barriers and Gaps That Affect ABS for Influenza, 68 How Has the “COVID-19 Lens” Changed the Way Governments, Organizations, and Institutions Look at ABS Instruments?, 71 Key Findings and Conclusions, 74 References, 75 4 TECHNOLOGY AND MANUFACTURING PARTNERSHIPS 79 Platform Technologies in the COVID-19 Era, 79 New Industry Partnerships During COVID-19, 83 The Current State of Influenza Vaccine Manufacturing and the Limitations of Egg-Based Vaccines, 83 New Technologies for Influenza on the Horizon, 85 Accelerating the Development of Platform Technologies for Influenza, 87 Geographically Distributed and Regional Manufacturing Models (“Hubs”), 91 Capabilities Required for the Transition to Platform Technologies, 93 Barriers and Pathways to Success for Effective Global Partnerships to Support Next-Generation Influenza Vaccines, 94 Key Findings and Conclusions, 108 References, 110 5 INFLUENZA VACCINE ACCESS AND FINANCING  115 The COVAX Facility and Its Shortfalls, 115 Approaching Equity in Vaccine Access for Influenza, 119 Lessons from the COVID-19 Vaccine Experience, 120 How Has Pandemic Financing Changed During COVID-19?: Funding for COVID-19 Preparedness and Response, 121 Financing PPR: Economic Principles, 127 IPPPR’s Argument About PPR Financing, 130 Scale of Investment Needed to Improve Global PPR, 130

CONTENTS xvii Strategies to Drive Investment in Influenza Preparedness and Response: Engaging High- and Middle-Income Countries, 133 Key Considerations in Determining Scale and Incentives for Financing PPR, 134 Key Findings and Conclusions, 149 References, 151 6 RECOMMENDATIONS AND THE PATH FORWARD 155 Situating Influenza in the Broader Pandemic Preparedness and Response Context, 155 Conclusions and Recommendations, 159 The Path Forward, 183 References, 188 APPENDIXES A COMMITTEE AND STAFF BIOGRAPHIES  191 B COMMITTEE MEETING AGENDAS  203

Boxes, Figures, and Tables BOXES 2-1 Vaccine Governance Gaps in the 2009 H1N1 (Avian Influenza) Pandemic, 42 2-2 Major Influenza Policy and Governance Structures, 48 3-1 Existing Instruments for Influenza Access and Benefit Sharing, 64 4-1 Lessons Learned from the Global Action Plan for Influenza Vaccines (GAP) Influenza Manufacturing Capacity-Building Partnerships, 98 5-1 Overview of COVID-19 Vaccines Global Access (COVAX), 117 FIGURES 1-1 Doses distributed per 1,000 population by WHO region, 26 1-2 Chapter focuses and areas for recommendations, 34 2-1 GISRS+ capacity building, 46 4-1 Global landscape of some of the COVID-19 vaccine production locations in March 2021, 80 4-2 Broad visual depiction of the global influenza vaccine development platform landscape, 86 xix

xx BOXES, FIGURES, AND TABLES 4-3 Expected change in cost centers and other non-cost variables when comparing a centralized model with a decentralized system, each producing the same total product volume, 102 5-1 Global share of individuals who have received at least one dose of COVID-19 vaccine (as of June 15, 2021), 118 5-2 Global development assistance for health (2019 dollars), 121 5-3 COVID-19 vaccine supply agreements (doses) by recipient country/group, 145 5-4 Reported COVID-19 vaccine price per dose, 145 TABLES 1-1 Snapshot of Estimated Economic Costs of Pandemics, 25 4-1 Approved Vaccines, Manufacturers, and Platforms, 81 4-2 Influenza Vaccine Platforms by Clinical Trial Phase, 86 5-1 Types of Financing Modalities Used for Pandemics, 122 5-2 Proposed Quantities of Funding Needed for Pandemic Preparedness, 131

Acronyms and Abbreviations ABS access and benefit sharing Africa CDC Africa Centres for Disease Control and Prevention AMC advance market commitment AU African Union BARDA Biomedical Advanced Research and Development Authority BMGF Bill & Melinda Gates Foundation CBD Convention on Biological Diversity CC WHO Collaborating Center CDC U.S. Centers for Disease Control and Prevention CEPI Coalition for Epidemic Preparedness Innovations CIDRAP Center for Infectious Disease Research and Policy COVAX COVID-19 Vaccines Global Access CRS U.S. Congressional Research Service CVV candidate vaccine virus DARPA Defense Advanced Research Project Agency EU European Union FAO Food and Agriculture Organization of the United Nations xxi

xxii ACRONYMS AND ABBREVIATIONS FCTC Framework Convention on Tobacco Control GAO U.S. Government Accountability Office GAP WHO Global Vaccine Action Plan GIP Global Influenza Program GISN Global Influenza Surveillance Network GISRS Global Influenza Surveillance and Response System GLEWS Global Early Warning System for Major Animal Diseases GloPID-R Global Research Collaboration for Infectious Disease Preparedness GPMB Global Preparedness Monitoring Board HERA Health Emergency Preparedness and Response Authority Incubator HIC high-income country HLIP G20 High-Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response IFC International Finance Corporation IFPMA International Federation of Pharmaceutical Manufacturers & Associations IHR International Health Regulations IIV inactivated influenza vaccines IMF International Monetary Fund IP intellectual property IPPPR Independent Panel for Pandemic Preparedness and Response IVPP influenza viruses with pandemic potential LAIV live attenuated influenza vaccine LMIC low- and middle-income country MERS Middle East respiratory syndrome MIT Massachusetts Institute of Technology mRNA messenger RNA NGO nongovernmental organization NIAID National Institute of Allergy and Infectious Diseases NIC WHO National Influenza Centre

ACRONYMS AND ABBREVIATIONS xxiii OECD Organisation for Economic Co-operation and Development OFFLU OIE/FAO Joint Network of Expertise on Animal Influenza OIE World Organisation for Animal Health OWS Operation Warp Speed PHEIC Public Health Emergency of International Concern PIP Pandemic Influenza Preparedness Framework PPP G7/UK International Pandemic Preparedness Partnership PPR pandemic preparedness and response R&D research and development REDISSE World Bank Regional Disease Surveillance Systems Enhancement Project in West Africa SARS severe acute respiratory syndrome SMTA-2 standard material transfer agreement 2 TAG technical advisory group TWN Third World Network UNICEF United Nations Children’s Fund WHA World Health Assembly WHO World Health Organization WTO World Trade Organization

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The COVID-19 pandemic has laid bare the fragility of the global system of preparedness and response to pandemics and the fragmentation of our research and development ecosystem. The pandemic has provided a disruptive moment to advance new norms and frameworks for influenza. It also has demonstrated how innovative global public-private partnerships and coordination mechanisms can lead to rapid successes in viral vaccine research, manufacturing, and risk pooling.

Countering the Pandemic Threat Through Global Coordination on Vaccines identifies ways to strengthen pandemic and seasonal influenza global coordination, partnerships, and financing. This report presents seven overarching recommendations for how the urgent influenza threat should be conceptualized and prioritized within the global pandemic preparedness and response agenda in the future.

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