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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2021. Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response: Lessons from COVID-19. Washington, DC: The National Academies Press. doi: 10.17226/26282.
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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.

Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response Lessons from COVID-19 Enriqueta Bond, Kanta Subbarao, and Hoda Soltani, Editors Committee on Vaccine Research and Development Recommendations for Advancing Pandemic and Seasonal Influenza Preparedness and Response Board on Global Health Health and Medicine Division A Consensus Study Report of and NATIONAL ACADEMY OF MEDICINE PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW, Washington, DC 20001 This activity was supported by a contract between the National Academy of Sci- ences and the Office of Global Affairs with the U.S. Department of Health and Hu- man 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-XXXXX-X International Standard Book Number-10:  0-309-XXXXX-X Digital Object Identifier:  https://doi.org/10.17226/26282 Library of Congress Catalog Number: XXXXXXXXXX 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 2021 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. 2021. Vaccine research and development to advance pandemic and seasonal influ- enza preparedness and response: Lessons from COVID-19. Washington, DC: The National Academies Press. https://doi.org/10.17226/26282. PREPUBLICATION COPY—Uncorrected Proofs

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. PREPUBLICATION COPY—Uncorrected Proofs

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. PREPUBLICATION COPY—Uncorrected Proofs

COMMITTEE ON VACCINE RESEARCH AND DEVELOPMENT RECOMMENDATIONS FOR ADVANCING PANDEMIC AND SEASONAL INFLUENZA PREPAREDNESS AND RESPONSE1 ENRIQUETA C. BOND (Co-Chair), Founding Partner, QE Philanthropic Advisors KANTA SUBBARAO (Co-Chair), Director, Collaborating Centre for Reference and Research on Influenza, World Health Organization MARIA ELENA BOTTAZZI, Associate Dean, National School of Tropical Medicine; Professor of Pediatrics and Co-Director, Texas Children’s Center for Vaccine Development, Baylor College of Medicine; Co-Chair, Vaccines and Therapeutics Taskforce, Lancet Commission on COVID-19 REBECCA J. COX, Professor of Medical Virology and Head of the Influenza Centre, University of Bergen and Haukeland University Hospital ANNETTE FOX, Senior Research Scientist, Collaborating Centre for Reference and Research on Influenza, World Health Organization FLORIAN KRAMMER, Professor of Microbiology, Department of Microbiology, Icahn School of Medicine at Mount Sinai GRACE M. LEE, Professor of Pediatrics, Stanford University School of Medicine JOHN C. MARTIN (until March 30, 2021, deceased), former Chief Executive Officer and Executive Chairman, Gilead Sciences JOSHUA M. SHARFSTEIN, Professor of the Practice in Health Policy and Management, Johns Hopkins Bloomberg School of Public Health MILAGRITOS D. TAPIA, Professor, Pediatrics, University of Maryland School of Medicine Study Staff HODA SOLTANI, Study Director EMILIE RYAN-CASTILLO, Senior Program Assistant ELIZABETH ASHBY, Research Associate HANNAH K. COLLINS, Research Associate PATRICIA A. CUFF, Senior Program Officer JULIE A. PAVLIN, Senior Director, Board on Global Health Consultant MAARTJE WOUTERS, Science Writer 1  See Appendix B, Disclosure of Unavoidable Conflict of Interest. v PREPUBLICATION COPY—Uncorrected Proofs

In Memoriam John C. Martin, Ph.D., M.B.A. 1951–2021 vi PREPUBLICATION COPY—Uncorrected Proofs

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: RAFI AHMED, Emory University RUSSEL BASSER, Seqirus NORMAN BAYLOR, Biologics Consulting PHIL DORMITZER, Pfizer Vaccine MICHAEL OSTERHOLM, University of Minnesota PETER PALESE, Mount Sinai KATHERINE POEHLING, Wake Forest School of Medicine TED ROSS, University of Georgia Although the reviewers listed above provided many constructive com- ments 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 ANN M. ARVIN, Stan- ford University School of Medicine, and ALASTAIR J. WOOD, Vanderbilt University. They were responsible for making certain that an independent vii PREPUBLICATION COPY—Uncorrected Proofs

viii REVIEWERS 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 au- thoring committee and the National Academies. PREPUBLICATION COPY—Uncorrected Proofs

National Academy of Medicine Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response Series This study, Vaccine Research and Development to Advance Pan- demic and Seasonal Influenza Preparedness and Response: Lessons from COVID-19, provides recommendations on how to leverage the knowledge gained from the COVID-19 pandemic to optimize research and development for future pandemic and seasonal influenza vaccines. 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 in- form and advance future pandemic and seasonal influenza vaccine prepared- ness and response efforts. The three companion studies to this study examine how the lessons learned from COVID-19 around vaccine distribution and supply chain contingencies, public health interventions and countermeasures, and global coordination, partnerships, and financing could be best utilized to improve the development and distribution of future pandemic and seasonal influenza vaccines. Together, the four studies present a path toward better prepared- ness 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 in- ternational 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 PREPUBLICATION COPY—Uncorrected Proofs

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Acknowledgments The committee has been honored and privileged to be able to contribute to this important effort and wishes to acknowledge the valuable contribu- tions and assistance of many individuals who shared their expertise. The Statement of Task was developed by an international committee of experts assembled by the National Academy of Medicine. Many thanks to many area experts who volunteered their time to present to the committee and provided invaluable insights to inform the recommendations in this report. In this vein, we extend our thanks to Ben Cowling (University of Hong Kong); Phil Dormitzer (Pfizer); Barney Graham (NIH); Robert Johnston (BARDA); Rita Helfand (WHO); David Kaslow (PATH); Jerome Kim (International Vaccine Institute); Nicole Lurie (CEPI); Peter Marks (FDA); Kathleen Neuzil (University of Maryland – Center for Vaccine Development); Julie Ostrowsky (CIDRAP); Rino Rappuoli (GlaxoSmithKlein); Nadine Rouphael (Emory Vaccine Center); and Melanie Saville (CEPI). Finally, we thank the outstand- ing support and work of the National Academies of Sciences, Engineering, and Medicine project staff for overseeing the assembly of our committee and the details of this report. We deeply appreciate the work of Hoda Soltani, Study Director; Emilie Ryan-Castillo, Senior Program Assistant; Elizabeth Ashby, Research Associate; Hannah Collins, Research Associate; Patricia Cuff, Senior Program Officer; and Julie Pavlin, Senior Director, Board on Global Health. This project would not be possible without the support of the Office of Global Affairs at the U.S. Department of Health and Human Services. xi PREPUBLICATION COPY—Uncorrected Proofs

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Preface The National Academy of Medicine (NAM) has established an inter- national committee in coordination with the U.S. Department of Health and Human Services’ Office of Global Affairs (OGA) to inform and fa- cilitate efforts to advance global influenza pandemic preparedness. This international committee will provide OGA with an iterative, interactive multidisciplinary process for assessing the global effect that capabilities, technologies, processes, and policies developed for COVID-19 pandemic could have on pandemic and seasonal influenza global preparedness and response, especially regarding vaccine development. As part of the NAM initiative, the National Academies of Sciences, Engineering, and Medicine are carrying out four concurrent consensus studies. As one of the four work streams of this effort, our committee examined the technological and scien- tific advances achieved during the global response to COVID-19 and other outbreaks to distill lessons learned for vaccine research, development, and manufacturing, including the use of platform technologies to recommend strategies to harness the science, technology, policy, and practice required to improve global influenza pandemic preparedness and response. In the 1980s as the United States mounted a response to address the harsh realities of the HIV/AIDS pandemic, Nobel laureate Joshua Lederberg warned that the public and political leadership of the United States needed to seriously address emerging infectious diseases and their potential for devastating epidemics. In 1992 the Institute of Medicine (IOM) published the landmark report Emerging Infections: Microbial Threats to Health in the United States, which pointed to major challenges for the public health and medical care communities in detecting and managing infectious disease xiii PREPUBLICATION COPY—Uncorrected Proofs

xiv PREFACE outbreaks and monitoring the prevalence of endemic diseases. A decade later Microbial Threats to Health: Emergence, Detection, and Response, underscored the revolution in globalization of all spheres including po- litical, economic, cultural, technological, and informational—a new global environment where infectious agents could migrate with the international- ization of goods and people. The severe acute respiratory syndrome (SARS), the Middle East respira- tory syndrome, and Ebola serve as classic examples for how diseases can emerge and reemerge with unexpected fluctuations in different parts of the world. Fortunately, each was controlled before it grew into a pandemic. Then SARS coronavirus 2 (SARS-CoV-2) emerged, causing the COVID-19 pandemic, with dramatic loss of human life and devastating social and economic disruption worldwide. In October 2020, Cutler and Summers estimated the costs of COVID-19 in the United States at $16 trillion. As of August 2021, the Johns Hopkins University map notes that globally there have been nearly 190 million cases, more than 4 million recorded deaths, though some estimate total deaths may be as high as 16 million, and nearly 3.6 billion courses of vaccine administered. While an unprecedented num- ber of vaccines has been developed, much more needs to be done to reach the nearly 8 billion human beings on Earth. The pandemic continues as variants have emerged. Most experts believe that an influenza pandemic is inevitable given (1) the circulation of different influenza A subtypes in animals, (2) current global circulation of two A subtypes in humans, and (3) the ability of the viruses to mutate and reassort. In the early 20 century, the Spanish influenza caused an estimated 50 million deaths worldwide. Additional influenza pandemics in 1957, 1968, and 2009 claimed lower numbers of lives but still had an enormous impact on global human health and the economy. For this reason, for several years, governments, philanthropy, and global organizations have focused much attention to influenza pandemic prepared- ness planning. These efforts certainly facilitated the scientific and public health response to COVID-19, but they fell short, as we have seen with the inequities and the inability to vaccinate all. In the process of responding to COVID-19, lessons learned can be deployed to help the world respond better to the next influenza pandemic. The main lesson has been that, given the astonishing and devastating costs to human life and the global economy, many more resources need to be sustainably invested in continued research, platform development for new influenza vaccines, and the regional capacity to research, manufac- ture, and distribute vaccines. Unprecedented cooperation and coordina- tion among the different academic, government, industry, philanthropic, and global organizations has facilitated COVID-19 vaccine development providing models for the future, but more needs to be done to ensure that PREPUBLICATION COPY—Uncorrected Proofs

PREFACE xv low- and middle-income countries also benefit and that we do not lose mo- mentum in preparing ourselves for a future influenza pandemic. Enriqueta Bond, Co-Chair Kanta Subbarao, Co-Chair Committee on Vaccine Research and Development for Advancing Pandemic and Seasonal Influenza Preparedness and Response PREPUBLICATION COPY—Uncorrected Proofs

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Contents ACRONYMS AND ABBREVIATIONS  xxi SUMMARY  1 1 INTRODUCTION  11 Study Approach and Scope, 13 Background, 14 Organization of the Report, 28 References, 28 2 BASIC AND TRANSLATIONAL SCIENCE  37 The Development of COVID-19 Vaccines, 38 Current Influenza Vaccines, 41 Basic and Translational Science: Applying Lessons from the Development of COVID-19 Vaccines to Vaccines for Influenza, 47 Recommendations, 53 References, 54 3 CLINICAL SCIENCE  63 Clinical Science and the Development of COVID-19 Vaccines, 64 Clinical Science: Applying Lessons from the Development of COVID-19 Vaccines to Vaccines for Influenza, 69 Recommendations, 74 References, 75 xvii PREPUBLICATION COPY—Uncorrected Proofs

xviii CONTENTS 4 MANUFACTURING SCIENCE  81 Manufacturing Science and the Development of COVID-19 Vaccines, 82 Manufacturing Science: Applying Lessons from the Production of COVID-19 Vaccines to Vaccines for Influenza, 84 Recommendations, 101 References, 101 5 REGULATORY SCIENCE  107 Regulatory Science and the Development of COVID-19 Vaccines, 108 Regulatory Science: Applying Lessons from the Development of COVID-19 Vaccines to Vaccines for Influenza, 112 Recommendations, 116 References, 116 6 A BLUEPRINT FOR ACTION  119 Priority Needs for Advancing the Development of Vaccines for Seasonal and Pandemic Influenza, 120 Recommendations, 125 References, 130 APPENDIXES A COMMITTEE BIOGRAPHIES  131 B DISCLOSURE OF UNAVOIDABLE CONFLICT OF INTEREST  137 C STAFF AND CONSULTANT BIOGRAPHIES  139 D PUBLIC MEETING AGENDAS  143 PREPUBLICATION COPY—Uncorrected Proofs

Boxes and Figures BOXES 1-1 Statement of Task, 12 2-1 Basic and Translational Science: Lessons Learned from the COVID-19 Pandemic, 37 3-1 Clinical Science: Lessons Learned from the COVID-19 Pandemic, 63 4-1 Manufacturing Science: Lessons Learned from the COVID-19 Pandemic, 82 4-2 Transformations in Vaccine Research, Development, and Production That Accelerated Manufacturing Timelines for COVID-19 Vaccines, 86 4-3 Gaps and Challenges for the Use of mRNA-based Vaccines as a Tool for Influenza Preparedness, 89 4-4 Essential Responsibilities and Functions of Manufacturers, 93 4-5 Attributes of Effective Manufacturing Technology Transfer During Pandemics, 93 5-1 Regulatory Science: Lessons Learned from the COVID-19 Pandemic, 107 xix PREPUBLICATION COPY—Uncorrected Proofs

xx BOXES AND FIGURES FIGURES 1-1 Mapping the major elements of the committee’s Statement of Task to the chapters of this report, 15 1-2 A history of global pandemics, 17 1-3 The COVID-19 vaccine development timeline, 28 2-1 Coalition for Epidemic Preparedness Innovations–supported COVID-19 vaccines in development, 41 4-1 Estimated potential annual pandemic production capacity over time (since 2006), 87 4-2 Countries reporting adult immunization programs by vaccine type and WHO region, 94 4-3 Countries reporting adult immunization programs by vaccine type and income level, 94 4-4 Countries with influenza vaccine production capacity in 2019, 96 6-1 The future of pandemic vaccine development, 125 6-2 A blueprint for action, 126 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations Ad26 adenovirus serotype 26 ADCC antibody-dependent cellular cytotoxicity APC antigen-presenting cell BARDA Biomedical Advanced Research Development Authority CDC U.S. Centers for Disease Control and Prevention CEIRS Centers of Excellence for Influenza Research and Surveillance CEPI Coalition for Epidemic Preparedness Innovations CIDRAP Center for Infectious Disease Research and Policy CMA commercial marketing authorization CMC chemistry, manufacturing, and control CMO contract manufacturing organization COBRA computational optimized broadly reactive antigens CONSISE Consortium for the Standardization of Influenza Seroepidemiology COVID-19 coronavirus disease 2019 CTL cytolytic T lymphocyte CVD Centre pour le Developpement des Vaccins DC dendritic cell DNA deoxyribonucleic acid ECDC European Centre for Disease Prevention and Control xxi PREPUBLICATION COPY—Uncorrected Proofs

xxii ACRONYMS AND ABBREVIATIONS EMA European Medicines Agency EU European Union EUA Emergency Use Authorization FDA U.S. Food and Drug Administration FLUCOP Standardization and Development of Assays for Assessment of Influenza Vaccine Correlates of Protection GACVS Global Advisory Committee on Vaccine Safety GAO U.S. Government Accountability Office GAP Global Action Plan GISAID Global Initiative on Sharing All Influenza Data GISRS Global Influenza Surveillance and Response System GPMB Global Preparedness Monitoring Board GVAP Global Vaccine Action Plan HA hemagglutinin HHS U.S. Department of Health and Human Services HI hemagglutinin inhibition assay HIC high-income country ICMRA International Coalition of Medicines Regulatory Authorities IHR International Health Regulations IND investigational new drug IP intellectual property LAIV live attenuated influenza vaccine LMIC low- and middle-income country mAb monoclonal antibody MDCK Madin-Darby canine kidney MERS Middle East respiratory syndrome MHC major histocompatibility complex MNC multinational corporation NA neuraminidase NAM National Academy of Medicine NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NK natural killer NP nucleoprotein PREPUBLICATION COPY—Uncorrected Proofs

ACRONYMS AND ABBREVIATIONS xxiii OUCRU Oxford University Clinical Research Unit OWS Operation Warp Speed PRR pattern recognition receptor QIV quadrivalent inactivated vaccine R&D research and development RIV recombinant influenza vaccine RNA ribonucleic acid SARS severe acute respiratory syndrome SARS-CoV-2 severe acute respiratory syndrome coronavirus 2 SF Spodoptera frugiperda SPEAC Safety Platform for Emergency vACcines TIPRA Tool for Influenza Pandemic Risk Assessment TIV trivalent inactivated vaccine TLR toll-like receptor TTS thrombosis with thrombocytopenia syndrome UIV universal influenza vaccine VAERS Vaccine Adverse Event Reporting System VE vaccine effectiveness VSD Vaccine Safety Data Link WHO World Health Organization WHOCCRRI WHO Collaborating Centre for Reference and Research on Influenza WIV whole inactivated virus YODA Yale Open Data Access PREPUBLICATION COPY—Uncorrected Proofs

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The global response to COVID-19 has demonstrated the importance of vigilance and preparedness for infectious diseases, particularly influenza. There is a need for more effective influenza vaccines and modern manufacturing technologies that are adaptable and scalable to meet demand during a pandemic. The rapid development of COVID-19 vaccines has demonstrated what is possible with extensive data sharing, researchers who have the necessary resources and novel technologies to conduct and apply their research, rolling review by regulators, and public-private partnerships. As demonstrated throughout the response to COVID-19, the process of research and development of novel vaccines can be significantly optimized when stakeholders are provided with the resources and technologies needed to support their response.

Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response focuses on how to leverage the knowledge gained from the COVID-19 pandemic to optimize vaccine research and development (R&D) to support the prevention and control of seasonal and pandemic influenza. The committee's findings address four dimensions of vaccine R&D: (1) basic and translational science, (2) clinical science, (3) manufacturing science, and (4) regulatory science.

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