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
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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.
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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.
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.
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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.
GURUPRASAD MADHAVAN, Study Director
KINPRITMA SANGHA, Research Associate
MALCOLM BILES, Senior Program Assistant
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
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-
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.
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.
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
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
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.