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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
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Ranking
Vaccines

A Prioritization Framework

Phase I: Demonstration of Concept and a Software Blueprint

Committee on Identifying and Prioritizing
New Preventive Vaccines for Development

Board on Population Health and Public Health Practice
Board on Global Health

Guruprasad Madhavan, Kinpritma Sangha, Charles Phelps,
Dennis Fryback, Tracy Lieu, Rose Marie Martinez, and
Lonnie King, Editors

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Contract No. HHSP23337024T, TO #45 between the National Academy of Sciences and the National Vaccine Program Office of the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-25525-7

International Standard Book Number-10: 0-309-25525-2

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2012 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2012. Ranking vaccines: A prioritization framework: Phase I: Demonstration of concept and a software blueprint. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITITE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

Committee on Identifying and Prioritizing
New Preventive Vaccines for Development

LONNIE KING (Chair), Dean, College of Veterinary Medicine, and Executive Dean, Health Sciences College, Ohio State University

PAUL CITRON, Retired Vice President, Technology Policy and Academic Relations, Medtronic, Inc.

RITA COLWELL, Chair, Canon U.S. Life Sciences, Inc.; Distinguished Professor, University of Maryland, College Park and Johns Hopkins University Bloomberg School of Public Health; and Former Director, National Science Foundation

KATHRYN EDWARDS, Sarah H. Sell Professor of Pediatrics, Vanderbilt University School of Medicine

JOSHUA EPSTEIN, Professor of Emergency Medicine, Johns Hopkins University, and External Professor, Santa Fe Institute

DENNIS FRYBACK, Professor Emeritus of Population Health Sciences and Industrial Engineering, University of Wisconsin-Madison

PATRICIA GARCIA, Dean and Professor, School of Public Health, Cayetano Heredia University, Peru

DEMISSIE HABTE, President, Ethiopian Academy of Sciences, Ethiopia

VICTORIA HALE, Founder and Chief Executive Officer, Medicines 360

TRACY LIEU, Professor, Department of Population Medicine, Harvard Medical School

WILLIAM PAUL, NIH Distinguished Investigator and Chief, Laboratory of Immunology, National Institute of Allergy and Infectious Diseases, National Institutes of Health

CHARLES PHELPS, University Professor and Provost Emeritus, University of Rochester

RINO RAPPUOLI, Global Head, Vaccines Research, Novartis Vaccines, Italy

ARTHUR REINGOLD, Edward Penhoet Distinguished Professor of Global Health and Infectious Diseases, University of California, Berkeley

VINOD SAHNEY, Senior Fellow, Institute for Health Care Improvement

ROBERT STEINGLASS, Immunization Team Leader, Maternal and Child Health Integrated Program, John Snow, Inc.

Staff

GURUPRASAD MADHAVAN, Study Director

KINPRITMA SANGHA, Research Associate

MALCOLM BILES, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

HOPE HARE, Administrative Assistant

DORIS ROMERO, Financial Associate

ROSE MARIE MARTINEZ, Senior Director, Board on Population Health and Public Health Practice

PATRICK KELLEY, Senior Director, Board on Global Health

KATHLEEN STRATTON, Scholar (until September 2011)

AMY PRYZBOCKI, Financial Associate (until December 2011)

SAMANTHA ARNETT, Christine Mirzayan Science and Technology Policy Fellow (Winter 2011)

Consultants, Modeling and Software Development

SCOTT LEVIN, Assistant Professor of Emergency Medicine, Johns Hopkins University

MATTHEW TOERPER, Senior Software Engineer, Johns Hopkins University

PANAYIOTIS KARABETIS, Partner and Lead Information Designer, VIM Interactive

MICHAEL KAPETANOVIC, Partner and Project Manager, Reef Light Interactive

Consultants, Concept Evaluation

JON ANDRUS, Deputy Director, Pan American Health Organization

CLAIRE BROOME, Adjunct Professor, Department of Global Health, Rollins School of Public Health, Emory University

JOACHIM HOMBACH, Acting Head, Initiative for Vaccine Research, World Health Organization

PHILIP HOSBACH, Vice President of Immunization Policy and Government Relations, Sanofi Pasteur

ROBERT LAWRENCE, Center for a Livable Future Professor, and Professor of Environmental Health Sciences, Health Policy, and International Health, John Hopkins Bloomberg School of Public Health

ADEL MAHMOUD, Professor, Woodrow Wilson School of Public and International Affairs and Department of Molecular Biology, Princeton University; Former President, Merck Vaccines

GREGORY POLAND, Mary Lowell Leary Professor of Medicine and Director, Mayo Vaccine Research Group, Mayo Clinic

JAIME SEPULVEDA, Executive Director, Global Health Sciences, University of California, San Francisco

EDWARD SHORTLIFFE, President and Chief Executive Officer, American Medical Informatics Association; Adjunct Professor, Department of Biomedical Informatics, Columbia University

ALASTAIR WOOD, Partner, Symphony Capital, LLC

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for 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 wish to thank the following individuals for their review of this report:

Yves Bergevin, United Nations Population Fund

John Boslego, PATH

Margaret Brandeau, Stanford University

Michael Drummond, University of York, United Kingdom

Maria Freire, The Albert and Mary Lasker Foundation

Maryellen Giger, The University of Chicago

Robert Greenes, Arizona State University

Prasad Kulkarni, Serum Institute of India, Ltd.

Shabir Madhi, University of Witwatersrand, South Africa

Charles Manski, Northwestern University

Osman Mansoor, United Nations Children’s Fund

Regina Rabinovich, Bill & Melinda Gates Foundation

John Robbins, National Institutes of Health

Thomas Saaty, University of Pittsburgh

Jeanne Stephenne, GlaxoSmithKline Biologicals, Belgium

Detlof von Winterfeldt, University of Southern California

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the con-

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

clusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Stephen Fienberg, Carnegie Mellon University, and Alfred Berg, University of Washington School of Medicine. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

Foreword

Ranking Vaccines: A Prioritization Framework previews a product that is unique in the annals of the Institute of Medicine: an early-stage decision-support software for prioritizing new vaccines.

Decision makers in the area of vaccine development—including developers, investors, practitioners, and policy makers—are constantly challenged by rapidly changing demographics, epidemiology, economics, technologies, and health systems. Thus, a comprehensive yet adaptable framework is needed to assist decision making. The Strategic Multi-Attribute Ranking Tool for Vaccines, or SMART Vaccines, described in this report, provides one such framework.

SMART Vaccines was conceived with the appreciation that changing circumstances, technological developments, and resource availability influence priorities for new vaccines. This tool should make it possible for decision makers in a variety of circumstances to weigh competing values, test assumptions, and explore alternative scenarios to help guide the priority-setting process. Like all decision tools, SMART Vaccines is an aid for decision making, not a substitute for sound judgment.

Beyond its potential applications in independent and collaborative decision making, SMART Vaccines can facilitate focused and informed discussion among various stakeholders. In this role, it can provide a common platform for diverse constituents to arrive at mutually agreeable priorities and help foster collaborations among them. In addition, SMART Vaccines is being designed so that it can be adapted and configured to help set priorities related to health interventions other than vaccines.

We intend the initial prototype to serve as a springboard to further development. With iterative enhancements, SMART Vaccines should become a dynamic, living guide that can be applied both domestically and internationally and reapplied according to changing health needs, scientific knowledge, and financial constraints.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

I congratulate the members and staff of the Committee on Identifying and Prioritizing New Preventive Vaccines for Development for leading this exciting initiative and bringing the project to this promising stage of development.

Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

Preface

Vaccines have profoundly improved the practice and the quality of public health. New opportunities for developing or improving vaccines are promising, even exciting, in this “decade of vaccines.”

However, designing a national and global vaccine development strategy is a Herculean task. Such an effort would involve a concrete, crosscutting understanding of the health, demographic, economic, business, scientific, technological, policy, social, and operational dimensions of vaccines.

The first step toward tackling this complex mission will be to prioritize which vaccines most need to be developed for both domestic and international use. This is a basic task but not an easy one, as the resulting decisions may have significant health, economic, and global consequences. Unfortunately, no universally accepted method or model exists to help guide these important decisions.

To make progress in this area, the Institute of Medicine, at the request of the National Vaccine Program Office of the U.S. Department of Health and Human Services, created a 16-member Committee on Identifying and Prioritizing New Preventive Vaccines for Development. A central commitment of the committee was to ensure that stakeholders were significantly involved in informing the work and the deliberations of the committee.

As part of fulfilling its charge, the committee developed and tested a model designed to assist in the prioritization of new vaccines. The committee also prototyped the beta version of a software named Strategic Multi-Attribute Ranking Tool for Vaccines, or SMART Vaccines. This is a unique product within the National Academies and is expected to be an evolving tool.

In this report we describe the committee’s thought process and modeling strategy, and introduce the software blueprint of SMART Vaccines Beta through illustrative screenshots. Since this is a work in progress and subject to additional improvements, we have chosen not to release SMART

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
×

Vaccines Beta along with this report. Further work in the next phase of this study is expected to result in SMART Vaccines 1.0, which would be made available for public use.

Through this effort we hope to inspire a community of users who will improve, enhance, and potentially manage the capabilities of this product in an open-source environment and who will generate the required data for operating a multi-stakeholder vaccine prioritization software.

On behalf of the committee, I would like to thank a number of individuals and organizations who gave their time, advice, and expertise to our work.

The committee is indebted to the Institute of Medicine study staff, whose diligence, creativity, and excellent organizational skills were critical to our success. The committee gratefully acknowledges the outstanding work of Guru Madhavan, the study director; the invaluable contributions of Kinpritma Sangha, our research associate; and the able administrative assistance from Malcolm Biles.

We recognize Rose Marie Martinez, director of the Board on Population Health and Public Health Practice; Patrick Kelley, director of the Board on Global Health; and Kathleen Stratton, who skillfully led previous Institute of Medicine studies on vaccines, for their thoughtful insights. We deeply appreciate the wise counsel of Clyde Behney, deputy executive officer of the Institute of Medicine, and Marc Gold, associate general counsel of the National Academy of Sciences, as well as the assistance of other staff members throughout this project.

The committee is very appreciative of our modeling consultants, Scott Levin and Matthew Toerper from the Johns Hopkins University, and our software developers, Pete Karabetis of VIM Interactive and Michael Kapetanovic of Reef Light Interactive. The committee also thanks Robert Pool, Laura DeStefano, and Hannan Braun for their terrific editorial assistance and Samantha Arnett, the National Academies’ Christine Mirzayan Science and Technology Policy Fellow, for her research assistance.

Our special thanks go to Jon Andrus, Claire Broome, Joachim Hombach, Philip Hosbach, Robert Lawrence, Adel Mahmoud, Gregory Poland, Jaime Sepulveda, Edward Shortliffe, and Alastair Wood whose thoughtful comments and critical feedback during our concept evaluation sessions have helped us improve SMART Vaccines Beta.

Finally, we would like to thank the National Vaccine Program Office of the Department of Health and Human Services for its sponsorship, support, and encouragement.

Lonnie King, Chair
July 2012

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
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Disclaimer

This report presents SMART Vaccines, a prioritization model and blueprint of associated software in development. This work is being developed by the Institute of Medicine Committee on Identifying and Prioritizing New Preventive Vaccines for Development with the assistance of consultants from Johns Hopkins University and VIM Interactive. This report does not intend to actually provide a ranking of vaccine priorities. It describes the committee’s modeling strategy and assumptions in order to demonstrate a proof of concept.

This consensus study is being conducted in two phases. The Phase I statement of task asked for a model to be developed that prioritizes the development of new preventive vaccines, tested with two or three vaccine candidates. In Phase II the committee will obtain feedback from the stakeholders on the Phase I model and use it to enhance SMART Vaccines in addition to adding three test vaccine candidates. Thus this report describes a product that is purposefully midstream in development.

The committee has chosen to employ a modeling approach based on multi-attribute utility theory, supported by a computational engine and a user-friendly interface. SMART Vaccines Beta processes available or expert-informed data for three conditions (influenza, tuberculosis, and group B streptococcus) in two nations (the United States and South Africa). Thus the examples that appear in this report are limited to comparing hypothetical vaccines only.

SMART Vaccines is intended to serve only as a decision-support tool for vaccine prioritization and not to be used as a decision maker. Final decisions should not be made based on the scores provided by SMART Vaccines. The Institute of Medicine does not warrant the completeness of the model, the accuracy of the software in development, or the reliability of any data presented in this report.

July 2012

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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ranking Vaccines: A Prioritization Framework: Phase I: Demonstration of Concept and a Software Blueprint. Washington, DC: The National Academies Press. doi: 10.17226/13382.
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As a number of diseases emerge or reemerge thus stimulating new vaccine development opportunities to help prevent those diseases, it can be especially difficult for decision makers to know where to invest their limited resources. Therefore, it is increasingly important for decision makers to have the tools that can assist and inform their vaccine prioritization efforts.

In this first phase report, the IOM offers a framework and proof of concept to account for various factors influencing vaccine prioritization-demographic, economic, health, scientific, business, programmatic, social, policy factors and public concerns. Ranking Vaccines: A Prioritization Framework describes a decision-support model and the blueprint of a software-called Strategic Multi-Attribute Ranking Tool for Vaccines or SMART Vaccines. SMART Vaccines should be of help to decision makers. SMART Vaccines Beta is not available for public use, but SMART Vaccines 1.0 is expected to be released at the end of the second phase of this study, when it will be fully operational and capable of guiding discussions about prioritizing the development and introduction of new vaccines.

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