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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Globally Resilient Supply Chains
for Seasonal and Pandemic
Influenza Vaccines

Ravi Anupindi, Prashant Yadav, Kenisha M. P. Jefferson, and
Elizabeth Ashby, Editors

Committee on Addressing Issues of Vaccine Distribution and Supply
Chains to Advance Pandemic and Seasonal Influenza Preparedness and
Response

Board on Global Health

Health and Medicine Division

A Consensus Study Report of

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THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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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: 978-0-309-08915-9
International Standard Book Number-10: 0-309-08915-8
Digital Object Identifier: https://doi.org/10.17226/26285
Library of Congress Catalog Number: 2021951358

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Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Globally resilient supply chains for seasonal and pandemic influenza vaccines. Washington, DC: The National Academies Press. https://doi.org/10.17226/26285.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×

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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.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×

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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 typically 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 opinions 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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COMMITTEE ON ADDRESSING ISSUES OF VACCINE DISTRIBUTION AND SUPPLY CHAINS TO ADVANCE PANDEMIC AND SEASONAL INFLUENZA PREPAREDNESS AND RESPONSE

RAVI ANUPINDI (Chair), Colonel William G. and Ann C. Svetlich Professor of Operations Research and Management, University of Michigan

PRASHANT YADAV (Vice Chair), Senior Fellow, Center for Global Development; Affiliate Professor, INSEAD, France; Lecturer, Harvard Medical School

MAHSHID ABIR, Senior Policy Researcher, RAND Corporation; Associate Professor, University of Michigan Medical School

RICK A. BRIGHT, Senior Vice President, Pandemic Prevention and Response, The Rockefeller Foundation

WILLIAM G. BUREL, President and Chief Executive Officer, Hamilton Grace, LLC

MATTHEW DOWNHAM, Sustainable Manufacturing Lead, Coalition for Epidemic Preparedness Innovations

NAGWA HASANIN, Senior Health Advisor, UNICEF

NOREEN A. HYNES, Associate Professor, Johns Hopkins University Schools of Medicine and Public Health

DAVID C. KASLOW, Chief Scientific Officer, PATH

PINAR KESKINOCAK, William W. George Chair and Professor and Director, Center for Health and Humanitarian Systems, Georgia Institute of Technology

SAAD B. OMER, Director, Yale Institute for Global Health

JENNIFER PANCORBO, Director of Industry Programs and Research, Biomanufacturing Training and Education Center, North Carolina State University

Study Staff

KENISHA M. P. JEFFERSON, Study Director

ELIZABETH ASHBY, Research Associate

EMILIE RYAN-CASTILLO, Senior Program Assistant

CLAIRE BIFFL, Senior Program Assistant

PATRICIA A. CUFF, Senior Program Officer

JULIE A. PAVLIN, Senior Director, Board on Global Health

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Consultants

JOSEPH ALPER, Science Writer (until July 2021)

KEVIN FAHEY, Science Writer (from August 2021)

EUGENIA GROHMAN, Editor (from July 2021)

MELISSA MAITIN-SHEPARD, Science Writer (from July 2021)

JANAMARIE PERROUD, Technical Writer

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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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 ANDY STERGACHIS,

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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University of Washington, and BOBBIE BERKOWITZ, Columbia 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×

National Academy of Medicine

Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response Series

This study, Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines, provides recommendations on how to bolster vaccine distribution and enhance global vaccine development and manufacturing infrastructure for pandemic and seasonal influenza events, using lessons learned from 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, public health interventions and countermeasures, and global coordination, partnerships, and financing could be best utilized to improve the development and distribution of 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Acknowledgments

This report is a product of the cooperation and contributions of many people, all of whom helped address a very broad statement of task in an extremely short timeframe. The committee is especially grateful to all the external experts who provided invaluable input at committee meetings. Their names and affiliations can be found in the committee meeting agendas in Appendix C. This report would not be possible without the sponsorship of the U.S. Department of Health and Human Services’ Office of Global Affairs and the support from the National Academy of Medicine’s International Committee, which was integral in conceptualizing the study’s statement of task.

The committee also thanks Leslie Sim and Taryn Young for their flexibility and coordination during the review process as well as Lauren Shern for providing guidance throughout the course of the project. A special thank you to Victor Stewart and Ron Brown for quickly processing contracts and agreements throughout the life cycle of the study.

Our acknowledgments also extend to the directors of the partner influenza studies, Ellen Schenk, Hoda Soltani, and Janelle Winters, for their unwavering support and advice during the study process.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Preface

The global COVID-19 pandemic has exposed serious weaknesses in the supply chain for vaccines and medical products. Many of these challenges have been managed with reactive responses by U.S. government agencies and global actors. However, these responses cannot hide the shortcomings in the current structures for managing vaccine supply chains before and during a pandemic. The supply chain challenges, which have unfolded throughout the COVID-19 pandemic, have exposed major weaknesses in the mechanisms of global coordination.

While the world is still struggling to manage the challenges in the global COVID-19 vaccine supply chain, everyone needs to prepare for a more robust vaccine supply chain to deal with future pandemics. Global health experts have long warned of the risks of influenza variants with potential to cause a pandemic. This committee was tasked with examining the supply chain and distribution challenges related to vaccines and vaccinations during the COVID-19 response (as well as past responses to SARS, H1N1, and Ebola), identify deficiencies in the global supply chain for pandemic and seasonal influenza, and develop recommendations for action by U.S. government agencies and global actors.

Vaccine manufacturing and distribution is a complex task. It requires hundreds of components, globally distributed high-quality biologic manufacturing capacity, a competent supply chain workforce, data and information tools, and financial resources for fast distribution and equitable deployment of vaccines. At a country level, getting vaccines into the arms of people also requires country preparedness and robust planning and the capability to adopt, distribute, deliver, and administer vaccines to appropri-

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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ate cohorts of people at scale. Vaccine characteristics and country access to a portfolio of vaccines also influence vaccine uptake and impact the efficiency of vaccine distribution and delivery.

In a global end-to-end supply chain, actions for different parts of this supply chain are made by different agencies and actors—from private firms to national governments, regional structures, global and UN agencies, and nongovernmental organizations. COVID-19 has also illustrated the devastating impact of a pandemic on the global economy and livelihoods, which necessitates considering roles for a broader set of actors. Health care and non–health care domains can engage in the vaccine supply chain to ensure a safer world through a whole-of-society approach.

The committee’s report takes stock of past actions and reports on seasonal and pandemic influenza vaccine manufacturing and distribution, looks at experiences and structures that have evolved for COVID-19 vaccines, and identifies deficiencies in the global supply chains for seasonal and pandemic influenza vaccines and also covers country preparedness and planning capabilities that need to be urgently addressed. The report points out technical areas and structural weaknesses that need to be strengthened and lays out mechanisms to strengthen coordination and information exchange systems in the global supply chain to ensure rapid and agile decision making to meet global vaccination needs equitably.

We hope that this report will provide clear guidance on the actions required by different stakeholders, both U.S. agencies and global actors, to build a robust and resilient global end-to-end supply chain for seasonal and pandemic influenza vaccines. Pursuing the recommendations in this report will not always be easy: the split of mandate, resourcing, and decision-making processes between national, regional, and global levels creates the need for embedding collaborative and coordinate efforts in existing agencies and structures. Everyone recognizes that for vaccine supply chains to work well during a pandemic, there is need for strong collaboration and coordination between a range of national, regional, and global actors in the supply chain, both public and private actors. If there is one key message that every reader should take away from this report, it is that this committee firmly believes that for the global vaccine supply chain to work well during a pandemic, many of the activities and coordination structures in the supply chain should be designed, created, and resourced during non-pandemic periods and not during a pandemic.

We thank first the members of committee, who committed their time and scientific expertise during an extremely busy period with their multiple roles. Ours was a very interdisciplinary committee, with experts of varied backgrounds in many different aspects of vaccine development, manufacturing, distribution, and policy. The committee members exhibited immense

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
×

patience and respect when discussing items, which for some were relatively straightforward and simple, and for others were new and complex.

Thanks also to National Academies of Sciences, Engineering, and Medicine staff, who helped us stay organized and focused and helped put our thoughts into writing. They worked tirelessly through our sessions, took notes, and iterated with many draft versions of this report. We also thank Janamarie Perroud for providing an overview of previous work on this subject, which was an important foundation for framing this study (see Appendix A). We are also grateful to the many experts who committed their time to present to the committee during public sessions.

Ravi Anupindi, Chair
Prashant Yadav, Vice Chair
Committee on Addressing Issues of Vaccine Distribution and
Supply Chains to Advance Pandemic and Seasonal Influenza
Preparedness and Response

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Acronyms and Abbreviations

ACT-A Access to COVID-19 Tools Accelerator
ALAN American Logistics Aid Network
ASPR Assistant Secretary for Preparedness and Response
BARDA Biomedical Advanced Research and Development Authority
CBER Center for Biological Evaluation and Research
CDC Centers for Disease Control and Prevention
CEPI Coalition for Epidemic Preparedness Innovations
COVAX COVID-19 Vaccines Global Access
CVIC COVID-19 Vaccine Introduction and deployment Costing tool
CVV candidate vaccine viruses
DCVMN Developing Countries Vaccine Manufacturers Network
DPA Defense Production Act
EMA European Medicines Agency
EPI Expanded Program on Immunization
EUA Emergency Use Authorization
FDA U.S. Food and Drug Administration
Page xxii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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GAO U.S. Government Accounting Office
GAP Global Action Plan for Influenza Vaccines
GAVI Global Alliance for Vaccines and Immunization
GISRS Global Influenza Surveillance and Response System
GPMB Global Preparedness Monitoring Board
GVAP Global Vaccine Action Plan
H1N1 Influenza A virus subtype H1N1, aka swine flu
H5N1 Influenza A virus subtype H5N1, aka avian flu
HHS U.S. Department of Health and Human Services
IA2030 Immunization Agenda 2030
IFPMA International Federation of Pharmaceutical Manufacturers & Associations
IIV inactivated influenza virus
IMF International Monetary Fund
IPPPR Independent Panel for Pandemic Preparedness and Response
LAIV live attenuated influenza virus
LMIC low- and middle-income country
LMIS logistic management information system
LSHTM London School of Hygiene & Tropical Medicine
MDCK Madin-Darby Canine Kidney
MERS Middle East Respiratory Syndrome
mRNA messenger RNA
NIH National Institutes of Health
NIS-Flu National Immunization Survey-Flu
NITAG National Immunization Technical Advisory Group
NVAC National Vaccine Advisory Committee
OGA Office of Global Affairs
OWS Operation Warp Speed
PAHO Pan American Health Organization
PEPFAR U.S. President’s Emergency Plan for AIDS Relief
PIP Pandemic Influenza Preparedness framework
PIVI Partnership for Influenza Vaccine Introduction
Page xxiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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TPP Target Product Profiles
TRIPS Trade-Related Aspects of Intellectual Property Rights
UNICEF United Nations Children’s Fund
USAID U.S. Agency for International Development
USTR U.S. Trade Representative
VIPS Vaccine Innovation Prioritization Strategy
VLP virus-like particle
WEF World Economic Forum
WHO World Health Organization
WTO World Trade Organization
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2022. Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/26285.
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Influenza viruses, both seasonal and pandemic, have the potential to disrupt the health and well-being of populations around the world. The global response to the COVID-19 pandemic and prior public health emergencies of international concern illustrate the importance of global preparedness and coordination among governments, academia, scientists, policy makers, nongovernmental organizations, the private sector, and the public to address the threat of pandemic influenza. These health emergencies have revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration.

Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines outlines key findings and recommendations to bolster vaccine distribution, manufacturing, and supply chains for future seasonal and pandemic influenza events. This report addresses the challenges of manufacturing and distributing vaccines for both seasonal and pandemic influenza, highlighting the critical components of vaccine manufacturing and distribution and offering recommendations that would address gaps in the current global vaccine infrastructure.

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