Priorities for the National Vaccine Plan (2010) / Chapter Skim
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Appendix D: Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office
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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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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APPENDIX D al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html 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 Copyright © National Academy of Sciences. All rights reserved.
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2008. Initial guidance for an update of the national vaccine plan: A letter report to the national vaccine program office.
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APPENDIX D al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html Copyright © National Academy of Sciences. All rights reserved.
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PRIORITIES FOR THE NATIONAL VACCINE PLAN al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html 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.
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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 v Copyright © National Academy of Sciences. All rights reserved.
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al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html Copyright © National Academy of Sciences. All rights reserved.
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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
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al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html Copyright © National Academy of Sciences. All rights reserved.
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APPENDIX D al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html 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 ix Copyright © National Academy of Sciences. All rights reserved.
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al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html Copyright © National Academy of Sciences. All rights reserved.
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The language of the 1994 plan provides the following description of NVPO's role: 1 The 1994 National Vaccine Plan is available at http://www.hhs.gov/nvpo/vacc_plan/. 2 The committee's other tasks include holding five workshops with national expert stakeholders in medicine, public health, industry, and vaccinology to review publicly available, draft planning documents from the Department of Health and Human Services, and then preparing a report with conclusions and recommendations about priority actions within the major components of the draft update to the new National Vaccine Plan.
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The release of the 1994 National Vaccine Plan coincided with other federal action to expand immunization coverage among children and adults. Such actions included increased federal appropriations for state immunization efforts and passage of the Vaccines for Children (VFC)
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In the second section of this letter report, the committee uses what it learned from reviewing the 1994 plan and the process of preparing it to distill key elements. Based on these elements, the committee offers guidance to NVPO and its partners on developing the update to the national vaccine plan.
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Research on vaccine safety has increased and regulatory attention to safety has intensified. Milestones include the withdrawal in 1999 of the first licensed rotavirus vaccine after cases of intussusception were reported to VAERS and subsequent research by CDC showed that this type of bowel obstruction occurred with significantly increased frequency after rotavirus vaccine administration, and the replacement of older pertussis and polio vaccines with safer products (see below)
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Also, vaccines with improved safety profiles received regulatory approval. For example, the introduction of a new acellular pertussis vaccine led to a reduction in reports of adverse events compared with the older, whole-cell vaccine (Braun et al., 2000)
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is a collaborative effort between CDC's Immunization Safety Office and several large managed care organizations to monitor immunization safety and address the "gaps in scientific knowledge about rare and serious side effects following immunization." Unlike VAERS, VSD permits systematic case finding and analysis of control data to assess potential adverse events, testing hypotheses concerning relationships between receipt of specific vaccines and the occurrence of specific adverse events. The VSD project, which has expanded from 4 to 8 participating managed care organization sites, not only conducts traditional epidemiologic studies on vaccine safety, but also has developed the capacity to conduct near real-time surveillance for adverse events after vaccination using Rapid Cycle Analysis methods.
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Seven of the 14 anticipated outcomes in the 1994 plan are associated with this goal and include extending age-appropriate immunization with recommended vaccines to at least 90 percent of infants and children (the only measurable outcome or objective provided in the plan) , and eliminating childhood diseases (e.g., diphtheria, Haemophilus influenzae Type b)
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. GUIDANCE FOR DEVELOPING A NEW NATIONAL VACCINE PLAN The committee learned from presentations at its March 2008 meeting and from conversations with individuals knowledgeable about the development of the 1994 National Vaccine Plan that its development served as (1)
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1. A Plan of National Scope A National Vaccine Plan provides a mechanism for defining national, state, and local vaccine and immunization priorities and potentially for coordinating the activities of multiple federal agencies with the private sector to achieve them.
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The relationship between NVPO and NVAC in the development of the National Vaccine Plan in 1994 and the current update is important to understand. The 1994 plan stated that "[v]
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The update to the National Vaccine Plan should contain appropriate evaluative mechanisms, objective measures, and milestones, if the plan is to fulfill its potential as a blueprint for action on national priorities in vaccine development and immunization. Recommendation 1: The committee recommends that NVPO and its partners include for each strategic initiative listed under the four plan goals the following details: The primary responsible party (government agency or other stakeholder)
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An exception appears to be the federally-sponsored Task Force on Safer Childhood Vaccines, which issued a report in 1998 and noted that its recommendations were consistent with the goals of the National Vaccine Plan (NIAID, 1998)
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. These topics include enhancing vaccine research and development, developing specific vaccines, adult immunization, adolescent immunization, childhood vaccination, financial barriers, vaccine supply, vaccine safety, vaccine injury/compensation, communication and education, surveillance, preparedness, and global health.
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In light of the nation's complex approach to health care financing, which rests on a patchwork of public and private health insurance arrangements, supplemented by various federal and state direct public investments in the purchase, distribution, and administration of vaccines, the updated National Vaccine Plan needs to consider the issue of financing in a more substantive manner than the 1994 plan. This consideration may take into account that because vaccines are administered by health professionals in various practice settings, addressing the issue of financing requires more than deciding whether a particular type of vaccine will be covered, but also how administration costs will be financed and the manner in which coverage will be effectuated and payment made and even what types of professionals are authorized to administer vaccines.
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VFC also provides vaccines to underinsured children (i.e., those enrolled in health insurance plans that do not cover the cost of all recommended vaccines) , but only if they are served at Federally Qualified Health Centers or Rural Health Centers, which are not readily accessible to all children.
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The committee believes strategic initiatives to consider the factors that contribute to vaccine shortages and possible solutions can be pursued as part of the update to the National Vaccine Plan. Recommendation 6: The committee recommends that NVPO and its partners consider ways the update to the National Vaccine Plan could spur research for creative solutions to vaccine supply problems.
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. CONCLUDING REMARKS This letter report contains the committee's initial guidance to the National Vaccine Program Office and its partners as they draft the update to the National Vaccine Plan.
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al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html Copyright © National Academy of Sciences. All rights reserved.
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Telling the public about MMR vaccine safety. Journal of Medical Ethics 29:22-26.
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2008. Draft priorities of the national vaccine plan.
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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.
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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. 22 Copyright © National Academy of Sciences.
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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?
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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 Biologics 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 Copyright © National Academy of Sciences.
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0 APPENDIX D al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html APPENDIX C 25 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 Copyright © National Academy of Sciences.
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Achieve better use of improved vaccines safety and effectiveness of public and members of the existing vaccines to vaccines and health professions on the prevent disease, disability, immunizations benefits and risks of and death immunizations OBJECTIVES 1.1 Develop new and 2.1 Enhance the ability to 3.1 Increase public 4.1 Ensure an adequate improved vaccines for evaluate the safety and demand for immunization, supply of vaccines priority diseases effectiveness of vaccines especially among populations at risk of underimmunization 1.2 Ensure the Nation's 2.2 Improve the 3.2 Improve the 4.2 Increase immunization capability to detect and surveillance and evaluation immunization practices of coverage levels for infants respond effectively to new of adverse events all health care providers and children and emerging diseases in following vaccination the United States and abroad 1.3 Enhance the process 2.3 Ensure the optimal use 3.3. Increase the 4.3 Maintain of translating technologic of vaccines awareness of the benefits immunization coverage innovations into new of immunization among levels for school-aged vaccines special target audiences children (third-party payers, employers, legislators, community leaders, hospital administrators, etc.)
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APPENDIX D al Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office ://www.nap.edu/catalog/12257.html APPENDIX D 27 1.4 Ensure the Nation's 2.4 Continue to ensure 3.4 Develop more 4.4 Increase immunization capability to evaluate new fair and efficient effective methods of coverage levels among vaccines, and to conduct compensation to communicating the older adolescents, adults, prompt reviews of new individuals injured by benefits and risks of and the elderly and improved candidate vaccines immunization to health vaccines care providers, patients, and parents/guardians 1.5 Promote the 2.5 Promote and support 3.5 Continue to evaluate 4.5 Improve the improvement of existing the efforts of the World the benefits and impact of surveillance of vaccine vaccines and development Health Organization to immunization through the preventable diseases to of new vaccines ad develop and harmonize use of cost-effectiveness assess the impact of vaccine-related international standards and studies immunization programs technologies for other improve regulatory diseases of importance in capabilities in countries developing countries involved in vaccine production 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 Copyright © National Academy of Sciences.
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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.
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