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Priorities for the National Vaccine Plan Appendix D Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office
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Priorities for the National Vaccine Plan Initial Guidance for an Update of the National Vaccine Plan A Letter Report to the National Vaccine Program Office Committee on the Review of Priorities in the National Vaccine Plan Board on Population Health and Public Health Practice INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu
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Priorities for the National Vaccine Plan THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. 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. HHSP23320042509XI, TO #15 between the National Academy of Sciences and 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. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 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). 2008. Initial guidance for an update of the national vaccine plan: A letter report to the national vaccine program office. Washington, DC: The National Academies Press.
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Priorities for the National Vaccine Plan “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.
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Priorities for the National Vaccine Plan 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
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Priorities for the National Vaccine Plan COMMITTEE ON THE REVIEW OF PRIORITIES IN THE NATIONAL VACCINE PLAN CLAIRE V. BROOME (Chair), Adjunct Professor, Division of Global Health, Rollins School of Public Health, Emory University ÈLAINE CHATIGNY, Director General of Communications, Public Health Agency of Canada TIMOTHY J. HOFF, Associate Professor of Health Policy and Management, Department of Health Policy, Management and Behavior, University at Albany, State University of New York GRACE M. LEE, Assistant Professor of Pediatrics, Children’s Hospital, Harvard University School of Medicine RICHARD MANDSAGER, Executive Director, The Children’s Hospital at Providence, Anchorage, Alaska EDGAR K. MARCUSE, Professor of Pediatrics, Children’s Hospital and Regional Medical Center, University of Washington School of Medicine A. DAVID PALTIEL, Professor and Acting Head, Division of Health Policy and Administration, Yale School of Public Health, Yale University ARTHUR REINGOLD, Professor and Head, Division of Epidemiology, School of Public Health, University of California, Berkeley DAVID B. REUBEN, Chief, Geriatric Medicine, and Director, Multicampus Program in Geriatric Medicine and Gerontology, University of California, Los Angeles SARA ROSENBAUM, Hirsh Professor and Chair, Department of Health Policy, The George Washington University School of Public Health and Health Services MILAGRITOS D. TAPIA, Assistant Professor, Pediatric Infectious Diseases, University of Maryland Study Staff ALINA BACIU, Study Director AMY GELLER, Senior Health Policy Associate LOUISE JORDAN, Senior Project Assistant ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice
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Priorities for the National Vaccine Plan 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: Jo Ivey Boufford, New York Academy of Medicine Julie S. Downs, Department of Social and Decision Science, Carnegie Mellon University Barton F. Haynes, Duke Human Vaccine Institute Lisa Jackson, Group Health Center for Health Studies Samuel L. Katz, Department of Pediatrics, Duke University Medical Center Adel A.F. Mahmoud, Woodrow Wilson School and Department of Molecular Biology Princeton University Joshua P. Metlay, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Thomas W. Valente, Department of Preventive Medicine, Keck School of Medicine, University of Southern California Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Floyd E. Bloom, The Scripps Research Institute. Appointed by the National Research Council, he was 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.
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Priorities for the National Vaccine Plan CONTENTS BACKGROUND 1 Features of the 1994 National Vaccine Plan, 3 The Committee’s Approach to Reviewing the Plan, 3 CHANGES SINCE 1994 3 PROGRESS SINCE 1994 4 GUIDANCE FOR DEVELOPING A NEW NATIONAL VACCINE PLAN 8 Process Issues, 8 Content Areas, 13 CONCLUDING REMARKS 17 APPENDIXES A References 19 B Statement of Task 22 C Meeting One Agenda 23 D 1994 National Vaccine Plan Goals, Objectives, and Anticipated Outcomes 26
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Priorities for the National Vaccine Plan Appendix A References Adams, W. G., K. A. Deaver, S. L. Cochi, B. D. Plikaytis, E. R. Zell, C. V. Broome, and J. D. Wenger. 1993. Decline of childhood haemophilus influenzae type b (hib) disease in the hib vaccine era. Journal of the American Medical Association 269(2):221-226. Armstrong, J. 1982. The value of formal planning for strategic decisions: Review of empirical research. Strategic Management Journal 3(3): 197-211. Braun, M. M., G. T. Mootrey, M. E. Salive, R. T. Chen, S. S. Ellenberg, and V. W. Group. 2000. Infant immunization with acellular pertussis vaccines in the United States: Assessment of the first two years’ data from the Vaccine Adverse Event Reporting System (VAERS). Pediatrics 106(4). CDC (Centers for Disease Control and Prevention). 2000 (May 19). Poliomyelitis Prevention in the United States. Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Morality Weekly Report 49(KR05):1-22. CDC. 2001. Vaccines and preventable diseases: Decreased availability of pneumococcal conjugate vaccine (PCV-7). http://www.cdc.gov/vaccines/vacgen/shortages/past/pneumo-2001.htm (accessed June 5, 2008). CDC. 2006 (December 15). Immunization information systems progress—United States, 2005. Morbidity and Morality Weekly Report 55(49): 1327-1329. CDC. 2007a. What would happen if we stopped vaccinations? http://www.cdc.gov/vaccines/vacgen/whatifstop.htm (accessed April 29, 2008). CDC. 2007b (August 31). National, state, and local area vaccination coverage among children aged 19—35 months—United States, 2006. Morbidity and Morality Weekly Report 56(34):880-885. CDC 2008. Current vaccine shortages and delays, http://www.cdc.gov/vaccines/vacgen/shortages/default.htm#why (accessed June 5,2008). Clements, C. J., and S. Ratzan. 2003. Misled and confused? Telling the public about MMR vaccine safety. Journal of Medical Ethics 29:22-26.
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Priorities for the National Vaccine Plan Clements, C., G. Evans, S. Dittman, and A. Reeler. 1999. Vaccine safety concerns everyone. Vaccine October 29(17 Suppl 3):S90-S94. CMS (Centers for Medicare and Medicaid Services). 2006. Medicaid managed care enrollment report. http://www.cms.hhs.gov/MedicaidDataSourcesGenInfo/Downloads/mmcer06.pdf (accessed April 21, 2008). Colgrove, J., and R. Bayer. 2005. Could it happen here? Vaccine risk controversies and the specter of derailment. Health Affairs 24(3):729-739. Cutts, F. T., S. M. A. Zaman, G. Enwere, S. Jaffar, O. S. Levine, J. B. Okoko, C. Oluwalana, A. Vaughan, S. K. Obaro, A. Leach, K. P. McAdam, E. Biney, M. Saaka, U. Onwuchekwa, F. Yallop, N. F. Pierce, B. M. Greenwood, and R. A. Adegbola. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in the Gambia: Randomised, double-blind, placebo-controlled trial. The Lancet 365(9465): 1139-1146. IOM (Institute of Medicine). 2008. Transcript of meeting one of the Committee on the Review of Priorities in the National Vaccine Plan. Washington, DC. IOM Staff. 2008. IOM staff notes: Major themes from conversations with key individuals knowledgeable about the process of preparing the 1994 National Vaccine Plan. Washington, DC. Iskander, J. 2007. Current CDC vaccine safety activities. Presentation at Vaccine Safety Evaluation: Post Marketing Surveillance Conference. Bethesda, MD. Kaplan, R. S., and D. P. Norton. 1992. The balanced scorecard: Measures that drive performance. Harvard Business Review 70(1):71-79. The Keystone Center. 2005. Citizen voices on pandemic flu choices: A report of the public engagement pilot project on pandemic influenza. http://www.keystone.org/spp/documents/FINALREPORT_PEPPPI_DEC_2005.pdf (accessed June 3,2008). Klugman, K. P., S. A. Madhi, R. E. Huebner, R. Kohberger, N. Mbelle, N. Pierce, and the Vaccine Trialists Group. 2003. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. New England Journal of Medicine 349(14):1341-1348. Lee, G. M., J. M. Santoli, and C. Hannan. 2007. Gaps in vaccine financing for underinsured children in the United States. Journal of the American Medical Association 298(6):638-643. Milstien, J. B., M. Kaddar, and M. P. Kieny. 2006. The impact of globalization on vaccine development and availability. Health Affairs 25(4):1061-1069. NIAID (National Institute of Allergy and Infectious Diseases). 1998. Task force on safer childhood vaccines: Final report and recommendations. Bethesda, MD: National Institues of Health. NVAC (National Vaccine Advisory Committee). 2004. Public participation working group meeting on models for enhancing public involvement in vaccine decision-making meeting summary. http://www.hhs.gOv/nvpo/public_participation/NVAC_Public_Participcompleteminutes.html (accessed May 22, 2008). NVPO (National Vaccine Program Office). 1994. Disease prevention through vaccine development and immunization: The U.S. National Vaccine Plan—1994. Washington, DC: Department of Health and Human Services. NVPO. 1997. NVPO Interagency group workshop agenda book. St. Michaels, MD: NVPO. Orenstein, W. A. 2008. Draft priorities of the national vaccine plan. Presentation at Meeting One of the Committee on Review of Priorities in the National Vaccine Plan. Washington, DC.
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Priorities for the National Vaccine Plan Poland, G. A., and R. M. Jacobson. 2001. Unde rstanding those who do not understand: A brief review of the anti-vaccine movement. Vaccine 19:2440-2445. Stewart, A., S. Rosenbaum, M. Cox, and A. Lee. 2003. Medicaid coverage of immunizations for non-institutionalized adults. Washington, DC: The George Washington University. http://www.gwumc.edu/sphhs/departments/healthpolicy/chsrp/downloads/Medicaid_Immunization_Study.pdf (accessed June 5, 2008). Wattigney, W. A., G. T. Mootrey, M. M. Braun, and R. T. Chen. 2001. Surveillance for poliovirus vaccine adverse events, 1991 to 1998: Impact of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine. Pediatrics 107(83). Whitman, B. 2008. Clearing up confusion over Medicare coverage for vaccines. ACP Internist March 2008:8. http://www.acponline.org/clinical_information/journals_publications/acp_internist/mar08/nine.htm (accessed May 15, 2008). Wysocki, B., and S. Lueck. 2006. Margin of safety: Just-in-time inventories make U.S. vulnerable in a pandemic. Wall Street Journal, January 12, 2006. Zhou, F., J. Santoli, M. L. Messonnier, H. R. Yusuf, A. Shefer, S. Y. Chu, L. Rodewald, and R. Harpaz. 2005. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001. Archives of Pediatric & Adolescent Medicine 159(12):1136-1144.
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Priorities for the National Vaccine Plan Appendix B Statement of Task The federal government issued “Disease Prevention through Vaccine Development and Immunization, The US National Vaccine Plan” in 1994. The Institute of Medicine will convene an ad hoc committee to review the 1994 National Vaccine Plan and then provide guidance on the development of the update to the National Vaccine Plan. This will be delineated in a letter report to the National Vaccine Program Office. The paragraph above constitutes the statement of task for the first part of the committee’s work. A short description of the second part of the committee’s work is provided below. The committee will hold five meetings, each of which will involve a significant portion of time in open session with expert stakeholders to explore areas of the developing plan. Verbatim, uncorrected transcripts of the open sessions will be delivered to NVPO within a month after each meeting. Commissioned papers will be presented on less-well explored areas of the Plan. A final consensus report about priorities for the updated National Vaccine Plan will be delivered and publicly released no later than six months after the final meeting.
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Priorities for the National Vaccine Plan Appendix C Meeting One Agenda14 Meeting One, March 3,2008 Committee on Review of Priorities in the National Vaccine Plan AGENDA National Academy of Sciences Building 2101 Constitution Avenue NW, Washington, DC Lecture Room 1:00 - 1:10 pm Welcome and Committee Introductions Claire V. Broome Committee Chair 1:10-1:20 pm Presentation Anand Parekh Acting Deputy Assistant Secretary for Health (Science and Medicine) Office of the Assistant Secretary for Health Department of Health and Human Services 14 A Website (http://www.iom.edu/vaccineplan) and listserv were created to provide information to the public about the committee’s work and to facilitate communication with the committee. Materials from the committee’s March 2008 meeting are available in electronic form on the website. Further, a list of materials reviewed by the committee (in the form in which they were reviewed) including all submissions of information from the public and many items not cited in this report, can be found in the study’s public access file, obtained from the National Academies Public Access Records Office at (202)334-3543 or http://www8.nationalacademies.org/cp/ManageRequest.aspx?key=48905.
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Priorities for the National Vaccine Plan 1:20 – 1:50 pm Charge to the IOM Committee CAPT Raymond A. Strikas Medical Officer U.S. Public Health Service National Vaccine Program Office Department of Health and Human Services 1:50 – 2:05 pm Questions from the Committee 2:05 – 3:05 pm Key Dimensions of the National Vaccine Plan: Since 1994 and Future Melinda Wharton Deputy Director National Center for Immunizations and Respiratory Diseases Centers for Disease Control and Prevention Norman Baylor Director Office of Vaccines Research and Review Center for Biologies Evaluation Food and Drug Administration Carole A. Heilman Director Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of Health 3:05 – 3:20 pm Questions from the Committee 3:20 – 3:30 pm Break 3:30 – 4:10 pm Key Dimensions of the National Vaccine Plan, continued Jeffrey Kelman Chief Medical Officer Center for Beneficiary Choices Centers for Medicare and Medicaid Services Geoffrey Evans Director Division of Vaccine Injury Compensation Healthcare Systems Bureau Health Resources and Services Administration Jerome Donlon Chief Scientist Advisor & Medical Officer, Office of the Assistant Secretary for Public Health Emergency Preparedness Department of Health and Human Services 4:10 – 4:30 pm Questions from the Committee
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Priorities for the National Vaccine Plan 4:30 – 4:45 pm Relationship Between the National Vaccine Plan and Healthy People 2020 RADM Penelope Slade Royall Director Office of Disease Prevention and Health Promotion Office of Public Health and Science, Office of the Secretary Department of Health and Human Service 4:45 – 5:15 pm Status of the New National Vaccine Plan Draft priorities for the National Vaccine Plan Walter Orenstein Professor of Medicine and Pediatrics Emory University School of Medicine Deputy Director, Emory Vaccine Center Consultant to the National Vaccine Plan Results of the first focus groups for public engagement Richard Tardif Oak Ridge Institute for Science and Education (ORISE) Consultant to the National Vaccine Plan Future plans for public engagement Roger Bernier Centers for Disease Control and Prevention 5:15 – 5:30 pm Questions from the Committee 5:30 – 5:45 pm Public Comments 5:45 pm Adjourn
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Priorities for the National Vaccine Plan Appendix D 1994 National Vaccine Plan Goals, Objectives, and Anticipated Outcomes GOALS 1. Develop new and improved vaccines 2. Ensure the optimal safety and effectiveness of vaccines and immunizations 3. Better educate the public and members of the health professions on the benefits and risks of immunizations 4. Achieve better use of existing vaccines to prevent disease, disability, and death OBJECTIVES 1.1 Develop new and improved vaccines for priority diseases 2.1 Enhance the ability to evaluate the safety and effectiveness of vaccines 3.1 Increase public demand for immunization, especially among populations at risk of underimmunization 4.1 Ensure an adequate supply of vaccines 1.2 Ensure the Nation’s capability to detect and respond effectively to new and emerging diseases in the United States and abroad 2.2 Improve the surveillance and evaluation of adverse events following vaccination 3.2 Improve the immunization practices of all health care providers 4.2 Increase immunization coverage levels for infants and children 1.3 Enhance the process of translating technologic innovations into new 2.3 Ensure the optimal use of vaccines 3.3. Increase the awareness of the benefits of immunization among special target audiences (third-party payers, employers, legislators, community leaders, hospital administrators, etc.) 4.3 Maintain immunization coverage levels for school-aged children
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Priorities for the National Vaccine Plan 1.4 Ensure the Nation’s capability to evaluate new vaccines, and to conduct prompt reviews of new and improved candidate 2.4 Continue to ensure fair and efficient compensation to individuals injured by vaccines 3.4 Develop more effective methods of communicating the benefits and risks of immunization to health care providers, patients, and parents/guardians 4.4 Increase immunization coverage levels among older adolescents, adults, and the elderly 1.5 Promote the improvement of existing vaccines and development of new vaccines ad vaccine-related technologies for other diseases of importance in developing countries 2.5 Promote and support the efforts of the World Health Organization to develop and harmonize international standards and improve regulatory capabilities in countries involved in vaccine production 3.5 Continue to evaluate the benefits and impact of immunization through the use of cost-effectiveness studies 4.5 Improve the surveillance of vaccine preventable diseases to assess the impact of immunization programs 4.6 Establish registry and immunization tracking systems 4.7 Enhance immunization coverage to strengthen national defense 4.8 Enhance immunization coverage of international travelers who are of highest risk of acquiring vaccine-preventable diseases 4.9 Eradicate poliomyelitis globally 4.10 Promote better control of neonatal tetanus and measles, worldwide 4.11 Promote the self-sustaining capacity of immunization programs in developing countries ANTICIPATED15 OUTCOMES Provision of adequate resources to make possible the vigorous and comprehensive pursuit of the wide range of activities outlined in the National Vaccine Plan could result in substantial health benefits for the American people by the year 2000. These benefits are expected to be realized as the following outcomes: 15 Also described as “predicted” outcomes in the National Vaccine Plan
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Priorities for the National Vaccine Plan Age-appropriate immunization with all recommended vaccines will be extended to at least 90 percent of infants and children, and access to affordable vaccination services will be made available for every person in the United States. Diphtheria, tetanus, poliomyelitis, measles, rubella, mumps, some forms of hepatitis, pertussis (whooping cough), and bacterial meningitis (from Haemophilus influenzae type b) will be essentially eliminated as significant causes of death, disease, and disability in the United States. Educational communication networks will be in place that will inform all health care providers, communities, and families of the benefits and risks of vaccination. In a global context, polio will be drastically reduced, if not eliminated, and neonatal tetanus and measles will be better controlled. Pneumococcal pneumonia and influenza in American adults over the age of 65 will be significantly reduced. A nationwide system will monitor the vaccines that children receive, and will remind parents when individual infants and children should be vaccinated. A nationwide surveillance system will report and investigate cases of vaccine-preventable diseases. Vaccine safety and efficacy will be continuously monitored, and adverse events following immunization will be reported and carefully analyzed. Improved vaccines will replace some of the vaccines in current use. Some vaccines requiring multiple doses and multiple contacts with the health care system will be replaced by more cost-effective ones that will improve people’s access to immunization. Many new vaccines will be developed, or be much closer to licensure, for diseases for which effective vaccines do not now exist. New mechanisms for the more rapid assessment of vaccines proposed for licensure will be in place. A reliable supply of all recommended vaccines and a capability to respond to emergencies and emergent threats to public health will be achieved and sustained. Information on the cost and benefits of the National Vaccine Plan will be made available on an ongoing basis to the American people.