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Priorities for the National Vaccine Plan (2010)
Board on Population Health and Public Health Practice (BPH)

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. "Appendix A: Draft Strategic National Vaccine Plan." Priorities for the National Vaccine Plan. Washington, DC: The National Academies Press, 2010.

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Priorities for the National Vaccine Plan

Appendix A
Draft Strategic National Vaccine Plan

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153

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Priorities for the National Vaccine Plan Appendix A Draft Strategic National Vaccine Plan

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Priorities for the National Vaccine Plan Draft Strategic National Vaccine Plan November 26, 2008

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Priorities for the National Vaccine Plan Draft Strategic National Vaccine Plan Table of Contents Page      Preface: Letter from the Assistant Secretary for Health   4      Acronyms and Abbreviations   5      Executive Summary   8      Introduction   15      Purpose, Perspective, and Scope   17      Approach to Developing the Plan   18      Framework   20      National Vaccine Plan Structure   21      Monitoring and Evaluation   22      Goal 1:  Develop new and improved vaccines   25      Goal 2:  Enhance the safety of vaccines and vaccination practices   32      Goal 3:  Support informed vaccine decision-making by the public, providers, and policy-makers   39      Goal 4:  Ensure a stable supply of recommended vaccines, and achieve better use of existing vaccines to prevent disease, disability, and death in the United States.   47      Goal 5:  Increase global prevention of death and disease through safe and effective vaccination   56      Appendix 1:  Anticipated outcomes from the 1994 National Vaccine Plan and the extent to which each has been achieved at the time the draft strategic National Vaccine Plan was drafted in 2008   63      Appendix 2:  IOM committee recommendations from the June 11,2008 letter report “Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office” and National Vaccine Program Office responses   67

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Priorities for the National Vaccine Plan      Appendix 3:  Key Stakeholders in the United States National Vaccine System   70      Appendix 4:  Roles and Responsibilities of Department of Health and Human Services Agencies and Offices, and other federal Departments in the draft strategic National Vaccine Plan   73      Appendix 5:  HHS Agency and Other Federal Department Strategic Plans relevant to the draft strategic National Vaccine Plan   84

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Priorities for the National Vaccine Plan Preface: Letter from the Assistant Secretary for Health Given the importance of vaccines and immunizations in the prevention of an expanding number of infectious diseases, it is important that we – as a Department and as a Nation --clearly articulate our vision for the vaccine and immunization enterprise. In my role as the Assistant Secretary for Health and the Director of the National Vaccine Program, I have directed and monitored the efforts to update the 1994 National Vaccine Plan The accompanying draft strategic National Vaccine Plan reflects current priorities and potential future directions for the next decade. This draft Plan offers a clear signal about our goals for vaccines and immunizations to our domestic and international partners in the United States vaccine and immunization enterprise and abroad, both public and private in the United States and abroad. It is a strong beginning, but requires extensive consultation with and input from many partners, including the public. This input will also enable us to develop an implementation plan with discrete activities and measurable milestones. With release of this draft Plan, consultations with stakeholders will begin, led by the National Vaccine Program Office and the National Vaccine Advisory Committee. We all look forward to the final products of these efforts in late 2009. This draft strategic National Vaccine Plan responds to the mandate of Congress contained in P.L. 99-660, in which the vision of the National Vaccine Program was first outlined. The first National Vaccine Plan had fourteen expected outcomes, most of which have been achieved at least in part. However, the world of vaccines has changed dramatically since 1994, with more diseases for which vaccines could be available, multiple new research tools, many available new vaccines, heightened interest in vaccine safety, new communications tools, and many more people for whom vaccines are routinely recommended. This draft Plan describes proposed strategies for ways in which the United States can promote immunization to protect the health of all people. Subsequent work with our many partners will enhance and improve this draft, so the final plan can implement strategies to assure all people can benefit from the prevention of infectious diseases. Joxel Garcia, M.D., M.B.A. Assistant Secretary for Health And Director, National Vaccine Program

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Priorities for the National Vaccine Plan Acronyms and Abbreviations AAFP American Academy of Family Physicians AAP American Academy of Pediatrics ACIP Advisory Committee on Immunization Practices AEFI adverse events following immunization ASPA Assistant Secretary for Public Affairs (Department of Health and Human Services) ASPR Assistant Secretary for Preparedness and Response (Department of Health and Human Services) BARDA Biomedical Advanced Research and Development Authority BLA Biologics License Application CDC Centers for Disease Control and Prevention CBER Center for Biologics Evaluation and Research CMS Centers for Medicare and Medicaid Services DARPA Defense Advanced Research Projects Agency DoD Department of Defense DHS Department of Homeland Security DoJ Department of Justice DTP diphtheria, tetanus toxoids, and pertussis vaccine DTaP diphtheria, tetanus toxoids, and acellular pertussis vaccine DTRA Defense Threat Reduction Agency DVIC Division of Vaccine Injury Compensation FDA Food and Drug Administration FY fiscal year GAVI Global Alliance for Vaccines and Immunization, now formally known as the GAVI Alliance GMP Good Manufacturing Practices HBV Hepatitis B virus HEDIS Healthcare Effectiveness Data and Information Set HHS U.S. Department of Health and Human Services Hib Haemophilus influenzae type b HIV human immunodeficiency virus HP2010 Healthy People 2010 HRSA Health Resources and Services Administration IDSA Infectious Diseases Society of America IHS Indian Health Service IOM Institute of Medicine IPV inactivated polio vaccine

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Priorities for the National Vaccine Plan MCOs managed care organizations MMR measles, mumps, and rubella virus vaccine (combined) NCIRD National Center for Immunization and Respiratory Diseases NCPDCID National Center for Preparedness, Detection, and Control of Infectious Diseases NGO Non-governmental organization NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NVAC National Vaccine Advisory Committee NVP National Vaccine Program NVPO National Vaccine Program Office OD Office of the Director OMHHD Office of Minority Health and Health Disparities OPDIV Operating Division of the Department of Health and Human Services (e.g., CDC) OPV oral polio vaccine PHEMCE Public Health Emergency Medical Countermeasures Enterprise PHS Public Health Service P.L. public law STAFFDIV Staff Division of the Department of Health and Human Services (e.g., Office of Public Health and Science, of which NVPO is included) TB tuberculosis Td tetanus and diphtheria toxoids (adult formulation) Tdap tetanus and diphtheria toxoids, and acellular pertussis vaccine (adult formulation) UNICEF United Nations International Children’s Emergency Fund (now United Nation’s Children’s Fund) USAID U.S. Agency for International Development USAMRIID U.S. Army Medical Research Institute of Infectious Diseases VA Department of Veterans Affairs VAERS Vaccine Adverse Event Reporting System VFC Vaccines for Children program VHA Veterans Health Administration VICP National Vaccine Injury Compensation Program VPD vaccine-preventable disease VRC Vaccine Research Center VSD Vaccine Safety Datalink project

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Priorities for the National Vaccine Plan WHO World Health Organization

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Priorities for the National Vaccine Plan Executive Summary The National Vaccine Program was established in 1986 to achieve optimal prevention of infectious diseases through immunization and optimal prevention of adverse reactions to vaccines. The purpose of the National Vaccine Plan is to promote achievement of the National Vaccine Program mission by providing strategic direction and promoting coordinated action by vaccine and immunization enterprise stakeholders. Federal involvement in civilian and military vaccination programs is longstanding, including in research and development, regulation, vaccine delivery and the evaluation of the impacts of immunizations. This draft strategic National Vaccine Plan builds on the many achievements of the vaccine and immunization enterprise prior to and since the establishment of the National Vaccine Program in 1986 and the completion of the first National Vaccine Plan in 1994. New vaccine preventable disease targets have been identified and new vaccines have been developed and licensed; many of these new vaccines are now recommended for children, adolescents and adults. These new vaccines have expanded the number of infections that can be prevented, and more effectively and safely prevent some diseases for which earlier generation vaccines already existed. In addition, federal immunization financing programs have reduced or eliminated many financial barriers to immunizations, particularly for children. The number of infections that are preventable by vaccination has decreased significantly while vaccination coverage in the United States has increased, and coverage for many vaccines has reached record levels. More robust systems have been developed to identify adverse events following immunization and to assess potential associations of those events with vaccination. Globally, the United States has worked with multilateral and bilateral partners and non-governmental organizations in contributing to improvements in child health status and the prevention of hundreds of thousands of child deaths each year through improved vaccine coverage and introduction of new vaccines. Of the fourteen anticipated outcomes included in the 1994 National Vaccine Plan, most were substantially or fully realized (see Appendix 1). Despite these successes, however, many of the challenges that stimulated establishment of the National Vaccine Program and the development of the 1994 National Vaccine Plan remain relevant today. Vaccine shortages have frequently been experienced for many routinely recommended vaccines. Despite improved vaccination coverage among children, the occurrence of several recent vaccine preventable disease outbreaks serves as a reminder that these diseases still occur. Among older adults both vaccination coverage and the effectiveness of some routinely recommended vaccines remain sub-optimal. As the number of vaccines has increased and vaccine preventable diseases have declined, vaccine safety concerns are expressed more prominently today and may be more widely shared. Enhancing the current vaccine safety system is important to keep pace with several factors influencing it: an increasing number of vaccines and vaccine combinations, expanding target populations, and a better understanding of human biology, especially the human immune system. As the cost of vaccination has increased, financial barriers to vaccination have emerged for health departments, healthcare providers, and the public. Significant scientific challenges remain in the development of

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Priorities for the National Vaccine Plan safe and effective vaccines against existing global health threats, such as HIV, TB and malaria. Vaccines that have been developed and are in use in industrialized countries have the potential to make major contributions to health in developing countries, but are being underused. Additionally, emerging and pandemic infections and bioterrorist threats pose new challenges for vaccine development and regulation, manufacturing, vaccine delivery and access in the US and abroad. In the context of the many challenges and opportunities that exist, updating the 1994 National Vaccine Plan is an opportunity to provide a strategic focus for the nation’s efforts to improve disease prevention and enhance vaccine safety. This draft strategic National Vaccine Plan is primarily the result of deliberation, analysis, and input from multiple Federal agencies under the coordination of the National Vaccine Program Office (NVPO). A committee empanelled by the National Academy of Sciences’ Institute of Medicine (IOM) reviewed the 1994 National Vaccine Plan and provided guidance on the development of the updated Plan (see Appendix 2). Because successfully preventing infectious diseases and enhancing vaccine safety are outcomes of a complex process, identifying objectives and strategies that lead to and sustain these outcomes is facilitated by understanding the many interconnected determinants of these outcomes. A framework that identifies components of the vaccine and immunization enterprise and illustrates their interrelationships is shown in Figure 1. While a simplification of a complex system, this framework provides an overview of key processes from beginning to end (critical components are shown as rectangular boxes and intermediate and long term outcomes as rounded boxes). The intermediate and long term inputs and outcomes of the vaccine and immunization enterprise include the Recognition of public health priorities, Vaccination (adult, adolescent and childhood), High vaccination rates, Population health protection against infectious disease in the U.S. and globally, and Reduced morbidity and mortality from infectious diseases in the U.S. and globally. The critical components of the vaccine and immunization enterprise that contribute to achieving the desired outcomes include Translational research for diffusion of innovation, Disease surveillance, Vaccine research, Vaccine development, Vaccine licensure, Vaccine manufacture, Vaccine sales/purchase, Vaccine distribution, Communications and education strategies, Attitudes about vaccination, Develop vaccine recommendations, Access/payment for vaccination reimbursement, Adverse event monitoring, Vaccine effectiveness, and Vaccine coverage surveillance. Figure 1. Overview of the vaccine and immunization enterprise

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Priorities for the National Vaccine Plan The goals, objectives, and strategies included in this plan were drafted by Federal departments and agencies for which vaccines and immunization are a significant part of their mission and provide a comprehensive approach to reach these outcomes through coordinated efforts of Federal, State, local, multinational and non-governmental stakeholders. Recognizing that success is facilitated by careful planning that includes defining specific activities, milestones and measurable outcomes, an implementation plan will be developed based on this draft plan. With a ten-year horizon, the framework balances a strategic vision, which requires development and implementation of new initiatives, with the recognition that changing circumstances and new opportunities and challenges will occur over the next decade. The ten-year horizon also allows incorporation of the HealthyPeople 2020 objectives once those are established. Annual monitoring of progress and a mid-course review will promote both accountability and flexibility. The Plan is built around the achievement of five broad goals: Goal 1: Develop new and improved vaccines Goal 2: Enhance the safety of vaccines and vaccination practices Goal 3: Support informed vaccine decision-making by the public, providers, and policy-makers

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Priorities for the National Vaccine Plan Office of the Assistant Secretary for Public Affairs Coordinates public information and communications, including all aspects of vaccination, vaccine supply, vaccine preventable diseases and vaccine safety issues Office of Intergovernmental Affairs Advises and coordinates outreach and communications to state, local and tribal officials and national intergovernmental organizations Office of the Surgeon General Oversees the operations of the 6,200 active duty officers of the Commissioned Corps of the U.S. Public Health Service Deploys commissioned officers to meet urgent public health needs and provide public health and medical services in response to natural and man-made disasters. Provides trusted and credible health and medical information to the public, improving health and reducing the risk of illness and injury Assigns officers to HHS and non-HHS Federal agencies to provide clinical, technical, regulatory, disease surveillance, program management and research services. Coordinates nearly 800 local units of the Civilian Volunteer Medical Reserve Corps, representing over 170,000 health volunteers. Coordinates the USPHS Inactive Reserve Corps comprising over 1,000 health professionals in 11 professional categories who are Federalized to respond to disasters or urgent public health need. Office of the General Counsel Advises on legal issues and authorities related to key vaccination activities Office of Global Health Affairs Coordinates interactions with health authorities in other governments and international organizations in

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Priorities for the National Vaccine Plan   coordination with the Department of State Office of the National Coordinator for Health Information Technology   Coordinates the Department of Health and Human Services’ (HHS) health information technology policies and programs internally and with other relevant executive branch agencies Develops, maintains, and directs the implementation of HHS’ strategic plan to guide the nationwide implementation of interoperable health information technology in both the public and private health care sectors, to the extent permitted by law, including immunization information systems Provides comments and advice at the request of OMB regarding specific Federal health information technology programs. National Vaccine Program Office (NVPO)   Coordinates communication between vaccine manufacturers and HHS agencies Coordinates National Vaccine Plan development and periodic review Coordinates vaccine safety planning and public engagement Coordinates and provides direction on vaccine research and development Coordinates vaccine supply activities Coordinates governmental and non-governmental vaccine activities Agency for Healthcare Research and Quality   Communicates with and supports federal, state, and local public health partners on vaccination and healthcare delivery plans Centers for Disease Control and Prevention (CDC)   Conducts and supports clinical and laboratory vaccine-preventable disease and microorganism surveillance, as well for diseases and microorganisms that may become vaccine preventable Coordinates vaccine-preventable disease response

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Priorities for the National Vaccine Plan   activities with state, local and tribal public health agencies Investigates epidemiology, environmental contributions to, and clinical characteristics, of vaccine-preventable disease Leads in federal vaccination program implementation and supports state and health care provider immunization through vaccine purchase, distribution, guidance, evaluation, and quality control Distributes public sector vaccines Co-leads with FDA in monitoring and investigating vaccine adverse events Assesses vaccine effectiveness in population-based studies Makes recommendations on diagnosis, management, and prevention of vaccine-preventable disease illness Conducts and supports basic and applied research on vaccine-preventable diseases Leads federal activities for surveillance, detection, and response to pandemic influenza Provides training and reagents for diagnosis of vaccine-preventable diseases Conducts and supports research and development of diagnostic test and immunologic assays for vaccine-preventable diseases Conducts human health risk assessment of new and emerging vaccine-preventable diseases in the US and globally Conducts laboratory and animal studies of emerging vaccine-preventable diseases to identify markers for virulence and transmission among humans Communicates with state and local health departments and other public health partners Communicates information on vaccine-preventable disease health impacts and vaccination in collaboration with ASPA and other partners Maintains close communication with vaccine manufacturers Provides reference strains for influenza vaccine manufacturing Works with WHO and other international organizations to promote global health through vaccination Provides scientific leadership and support to global laboratory networks for vaccine preventable diseases, technical support to eradication and elimination

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Priorities for the National Vaccine Plan   efforts and accelerating use of new and underutilized vaccines Centers for Medicare and Medicaid (CMS) Provides streamlined payment mechanisms and works with prescription drug plans, Medicare managed care plans, and Medicare providers, as necessary, to ensure ready access to vaccines for Medicare’s population Communicates specific vaccine-preventable disease guidance to the nation’s hospitals, home health agencies, skilled nursing facilities and other health care providers, suppliers and practitioners that participate in Medicare and Medicaid Communicates vaccine-preventable disease related information through existing outreach networks to Medicare and Medicaid beneficiary populations Supports tracking and surveillance of Medicare and Medicaid patients, including high-risk and vulnerable patients, who have received vaccines, including review of Medicare and Medicaid claims and quality data Food and Drug Administration (FDA) Performs research to 1) facilitate vaccine development and evaluation, including through innovation in regulatory pathways, and 2) enhance manufacturing and product quality (including assays, biomarkers and models for product safety, quality and efficacy, and methods for statistical and epidemiological analysis) Regulates vaccines’ manufacturing processes and promotes enhancement of manufacturing quality and problem prevention Prepares reference strains, assays, standards, and reagents appropriate for vaccine manufacturing Evaluates and licenses vaccines Monitors vaccine quality, releases vaccine lots for distribution, performs testing of vaccine quality and potency Facilitates the development, evaluation and clearance or approval of diagnostic tests and devices Reviews vaccine supply issues Evaluates and issues Emergency Use Authorizations when appropriate With CDC, monitors vaccine adverse events Maintains close communication with vaccine manufacturers

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Priorities for the National Vaccine Plan   Makes necessary changes in prescribing and patient information, including dosing, target populations, and other direction for use, for vaccines based on research and adverse events Monitors to protect against the distribution of counterfeit vaccines Designated as a WHO Collaborating Center for Biological Standardization, which encompasses responsibilities of setting and providing standards needed to assure products are high quality, safe, and available, and supporting efforts to harmonize product development and regulation. National Institutes of Health (NIH) Studies the evolution and emergence of microorganisms, including the identification of factors that affect their host-range and virulence Determines the molecular basis of virulence in humans and animals Supports laboratory-based surveillance studies of the distribution of microorganisms that are, or may be, vaccine-preventable Develops sensitive, specific, and rapid diagnostic tests for vaccine-preventable diseases Develops and clinically evaluates novel vaccines and vaccination strategies (e.g., adjuvants, delivery systems) Evaluates the immune response to infection and vaccination Supports basic research, with the goal of identifying new therapeutic targets Evaluates the molecular and/or environmental factors that influence the transmission of viruses, bacteria and other organisms, including drug-resistant strains Maintains close communication with vaccine manufacturers Prepares reference strains appropriate for vaccine manufacturing Health Resources and Services Administration (HRSA) Provides national leadership, program resources and services needed to improve access to culturally, competent (including linguistic and health literate), quality health care. As the Nation’s access agency, focuses on uninsured, underserved, and special needs populations in its

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Priorities for the National Vaccine Plan   goals and program activities (including vaccine preventable diseases and vaccine administration). Communicates with and provides technical assistance and training to support vaccine-preventable disease control activities of state primary care associations, health centers, and other community-based providers Operates the National Vaccine Injury Compensation Program to ensure an adequate supply of vaccines, stabilize vaccine costs, establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines to receive compensation. Indian Health Service Communicates with and supports state, local, and tribal vaccination and vaccine-preventable disease response activities at HHS, tribal, and urban Indian sites serving American Indian and Alaska Native populations Substance Abuse & Mental Health Services Administration Brings effective alcohol and drug treatment to every community.   Provides national leadership to expand the availability of effective treatment and recovery services for alcohol and drug problems; to improve access, reduce barriers and promote high-quality effective treatment and medical care services (including vaccination services) for people with alcohol and drug problems, abuse, or addiction as well as for their families and communities. Department of Agriculture Manages Women, Infant, and Children’s program for supplemental nutrition that also provides vaccination services.   Performs research on animal vaccines to prevent disease Department of Defense   Assistant Secretary of Serves as the principal civilian advisor to the Deputy

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Priorities for the National Vaccine Plan Defense for Health Affairs Secretary of Defense for health service support for pandemic influenza preparedness and response Responsible for overall leadership of the Military Health System Serves as the principal advisor to the Secretary of Defense for all Department of Defense (DoD) health policies and programs Oversees all DoD health resources Defense Advanced Research Projects Agency Maintains the technological superiority of the U.S. military and prevent technological surprise from harming our national security. Funds researchers in industry, universities, government laboratories and elsewhere to conduct high-risk, high-reward research and development projects that will benefit U.S. national security. Develops technologies to accelerate the development and production of vaccines and other medical therapeutics from 12 years to only 12 weeks Defense Threat Reduction Agency Provides capabilities to reduce, eliminate, and counter the threat of weapons of mass destruction (chemical, biological, radiological, nuclear and high explosives), and mitigate its effects. Analyzes weapons of mass destruction threats, develops requirements forecasts and integrates the results into DTRA’s future resource planning Develops, provides, and maintains security, counterintelligence, and force protection products and services in support of the agency’s global missions. The Military Vaccine (Milvax) Agency Synchronize information among the Military Services and DoD staff elements Deliver education for healthcare workers and the public (e.g., Immunization University, www.vaccines.mil (877) GET-VACC, Vaccines@amedd.army.mil Promote quality in immunization understanding and delivery Coordinate and assess U.S. military immunization programs worldwide

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Priorities for the National Vaccine Plan   Assist senior DoD leaders with policy development, especially related to biodefense and pandemic issues Safeguard shipping and handling of temperature-sensitive medical products Enhance scientific understanding of the benefits and risks of vaccines Foster mutually beneficial relationships between DoD, other government agencies, and professional associations related to immunizations Integrate electronic immunization tracking efforts of DoD and the Services   Conducts basic and applied research on biological threats resulting in medical solutions to protect the warfighter. Plays a key role as the only laboratory in the Department of Defense (DoD) equipped to safely study highly hazardous infectious agents requiring maximum containment at biosafety level (BSL)-4. United States Army Medical Institute for Infectious Diseases   Ensures that research is conducted in a safe and secure environment. Delivers competitive products to the advanced developer on schedule with the best value and quality.   Participates in the Global Alliance for Vaccines and Immunization and introduces new and under-utilized vaccines into developing countries. Provides technical and commodity assistance to more than 100 countries in support of routine child immunization programs, working closely with host-country Ministry’s of Health, Non-governmental Organizations, International Organizations such as WHO and UNICEF, foundations and other international partners Maintains a vaccine development program targeting malaria and HIV/AIDS in developing countries in coordination with DoD, HHS, and non-federal partners. Provides technical assistance and funding for the Global Polio Eradication Initiative Supports global goals to eliminate and control other United States Agency for International Development

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Priorities for the National Vaccine Plan   vaccine preventable diseases such as measles and neonatal tetanus. Raises awareness and helps generate greater resources, from both the public and private sectors, to help countries improve and sustain their capacity to deliver lifesaving vaccines and address diseases of international and domestic public health importance   Mounts a system-wide annual seasonal influenza campaign for VHA patients and health care providers Actively monitors, on a national basis, receipt of influenza and pneumococcal vaccine among at risk VHA patients Monitors adverse events to vaccinations as part of a national pharmacovigilance program Supports health services research in the area of improving vaccine delivery within VHA healthcare settings Educates, communicates with, and provides technical assistance to VHA providers to support vaccine-preventable disease control activities in all VA health care facilities Participates in clinical trials to determine efficacy of new/improved vaccines Monitors national influenza vaccination rates of employees working in VHA health care facilities Developing an occupational health record system for employees to track vaccination status Contributes support and provides expertise to national bodies focused on vaccine and immunization programs. Department of Veterans Affairs (VA)

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Priorities for the National Vaccine Plan Appendix 5: HHS Agency and Other Federal Department Strategic Plans relevant to the draft strategic National Vaccine Plan HHS: U.S. Department of Health and Human Services Strategic Plan - FY 2007-2012   http://aspe.hhs.gov/hhsplan/2007/ ASPR: HHS PHEMCE Strategy and HHS PHEMCE Implementation Plan   http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html   Draft BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement   http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/bardaplan.html CDC: National Immunization Program Strategic Plan 2000-2005 http://vyww.cdc.gov/ncird/downloads/strategic-plan.rtf   Immunization Information Systems Strategic Plan 2002-2007 http://www.cdc.gov/vaccines/programs/iis/activities/strategic-plan.htm   CDC Global Immunization Strategic Framework 2006-2010 http://www.cdc.gov/vaccines/programs/global/downloads/gisf-2006-2010.pdf FDA: FDA Strategic Action Plan, Fall, 2007 http://www.fda.gov/ope/stratplan07/stratplan07.htm ODPHP:   HealthyPeople 2010 http://www.healthypeople.gov/Publications/     HealthyPeople 2020 http://www.healthypeople.gov/hp2020/ HRSA: HRSA Strategic Plan FY 2005-2010 http://www.hrsa.gov/about/strategicplan.htm NIH: NIAID Strategic Plan for Biodefense Research, 2007 http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/about/strategicplan.htm   NIAID: Planning for the 21st Century http://www3.niaid.nih.gov/about/overview/planningPriorities/strategicplan/ Department of Agriculture

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Priorities for the National Vaccine Plan   USDA Strategic Plan 2005-2010 http://www.ocfo.usda.gov/usdasp/sp2005/sp2005.pdf DoD: U.S. Department of Defense Military Health System Strategic Plan http://www.health.mil/StrategicPlan/Default.aspx DARPA Defense Advanced Research Projects Agency Strategic Plan 2007 http://www.darpa.mil/body/pdf/DARPA2007StrategicPlanfinalMarchl4.pdf DoJ U.S. Department of Justice Strategic Plan 2007-2012 http://www.usdoj.gov/jmd/mps/strategic2007-2012/12/ VA: VA Strategic Plan (2006-2011) http://wwwl.va.gov/op3/docs/VA2011Plan.pdf USAID:   Strategic Plan: Fiscal Years 2007-2012 http://www.usaid.gov/policy/coordination/stratplan_fy07-12.html