Countering the Pandemic Threat
Through Global Coordination
on Vaccines
The Influenza Imperative
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
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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
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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.
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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)
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
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 manuscript remain confidential to protect the integrity of the deliberative process.
We thank the following individuals for their review of this report:
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,
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 Coordination 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 Initiative, 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 unprecedented 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.
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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.
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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 underprotected. We urgently need to strengthen our collective defenses against pandemic 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
capabilities, such as disease surveillance, pathogen sharing, vaccine platform technologies, and vaccine deployment systems. The G7 and G20 debates 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 preparedness approach.
The fourth and final theme revolves around equity. Unless equity is embedded into the mechanisms for influenza PPR, frictions about inequitable 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 decades. 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
1 INTRODUCTION: THE IMPERATIVE FOR GLOBAL INVESTMENT IN INFLUENZA VACCINES
What If 2020 Had Been the “Year of Influenza” Instead?
A Disruptive Moment to Reconsider Influenza in the Wider Pandemic Preparedness Landscape
Charge to the Committee on Global Coordination, Partnerships, and Financing
2 THE EXISTING GLOBAL GOVERNANCE LANDSCAPE FOR INFLUENZA VACCINES
World Health Organization and the Influenza “Regime Complex”
Governance Gaps Exposed in the 2009 H1N1 “Swine Flu” Pandemic
Expanding and Enhancing Influenza Surveillance Since 2009
A Snapshot of Current Influenza Vaccine Governance Structures and Frameworks
The Global Influenza Strategy and the Governance Path Forward
3 PATHOGEN SHARING FOR INFLUENZA VACCINE PRODUCTION
The Essential Need for Pathogen Sharing
The Critical Importance of Access and Benefit Sharing
Existing International Instruments for ABS
Barriers and Gaps That Affect ABS for Influenza
4 TECHNOLOGY AND MANUFACTURING PARTNERSHIPS
Platform Technologies in the COVID-19 Era
New Industry Partnerships During COVID-19
The Current State of Influenza Vaccine Manufacturing and the Limitations of Egg-Based Vaccines
New Technologies for Influenza on the Horizon
Accelerating the Development of Platform Technologies for Influenza
Geographically Distributed and Regional Manufacturing Models (“Hubs”)
Capabilities Required for the Transition to Platform Technologies
5 INFLUENZA VACCINE ACCESS AND FINANCING
The COVAX Facility and Its Shortfalls
Approaching Equity in Vaccine Access for Influenza
Lessons from the COVID-19 Vaccine Experience
How Has Pandemic Financing Changed During COVID-19?: Funding for COVID-19 Preparedness and Response
Financing PPR: Economic Principles
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Boxes, Figures, and Tables
BOXES
2-1 Vaccine Governance Gaps in the 2009 H1N1 (Avian Influenza) Pandemic
2-2 Major Influenza Policy and Governance Structures
3-1 Existing Instruments for Influenza Access and Benefit Sharing
5-1 Overview of COVID-19 Vaccines Global Access (COVAX)
FIGURES
1-1 Doses distributed per 1,000 population by WHO region
1-2 Chapter focuses and areas for recommendations
4-1 Global landscape of some of the COVID-19 vaccine production locations in March 2021
4-2 Broad visual depiction of the global influenza vaccine development platform landscape
5-2 Global development assistance for health (2019 dollars)
5-3 COVID-19 vaccine supply agreements (doses) by recipient country/group
5-4 Reported COVID-19 vaccine price per dose
TABLES
1-1 Snapshot of Estimated Economic Costs of Pandemics
4-1 Approved Vaccines, Manufacturers, and Platforms
4-2 Influenza Vaccine Platforms by Clinical Trial Phase
5-1 Types of Financing Modalities Used for Pandemics
5-2 Proposed Quantities of Funding Needed for Pandemic Preparedness
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 |
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 |
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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