Introduction

The 2008 draft National Vaccine Plan was prepared by the National Vaccine Program Office (NVPO) in the Department of Health and Human Services (HHS) with input from other departments and agencies (HHS, 2008). The plan consists of 5 goals, 36 objectives, and 156 strategies. The Institute of Medicine (IOM) Committee on Review of Priorities in the National Vaccine Plan was convened to review the plan and to make recommendations regarding priority actions in the major components of the plan (see Charge to the Committee below). For ease of reference, the committee organized its report according to the five goals, which are listed in Table I-1 along with the chapters in which they are discussed. Each chapter contains recommendations and rationale for a set of priority actions.

CHARGE TO THE COMMITTEE

The National Vaccine Plan originates in the 1986 National Childhood Vaccine Injury Act (NCVIA) that also established the National Vaccine Program (and by extension, the National Vaccine Program Office) and the National Vaccine Advisory Committee (NVAC).

The act asked the Secretary of HHS to “establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines”1 (NCVIA) and called on the program director to “prepare and issue a plan for the

1

Public Law 99-660, 42 U.S.C. 300aa-1, § 2101 1986; see Appendix C.



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Introduction The 2008 draft National Vaccine Plan was prepared by the National Vaccine Program Office (NVPO) in the Department of Health and Human Services (HHS) with input from other departments and agencies (HHS, 2008). The plan consists of 5 goals, 36 objectives, and 156 strategies. The Institute of Medicine (IOM) Committee on Review of Priorities in the Na- tional Vaccine Plan was convened to review the plan and to make recom- mendations regarding priority actions in the major components of the plan (see Charge to the Committee below). For ease of reference, the committee organized its report according to the five goals, which are listed in Table I-1 along with the chapters in which they are discussed. Each chapter contains recommendations and rationale for a set of priority actions. CHARGE TO THE COMMITTEE The National Vaccine Plan originates in the 1986 National Childhood Vaccine Injury Act (NCVIA) that also established the National Vaccine Program (and by extension, the National Vaccine Program Office) and the National Vaccine Advisory Committee (NVAC). The act asked the Secretary of HHS to “establish in the Department of Health and Human Services a National Vaccine Program to achieve opti- mal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines”1 (NCVIA) and called on the program director to “prepare and issue a plan for the 1 Public Law 99-660, 42 U.S.C. 300aa-1, § 2101 1986; see Appendix C. 

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN TABLE I-1 National Vaccine Plan Goals Goal Chapter 1 Develop new and improved vaccines 1 2 Enhance the safety of vaccines and vaccination practices 2 3 Support informed vaccine decision making by the public, 3 providers, and policy makers 4 Ensure a stable supply of recommended vaccines, and achieve 4 better use of existing vaccines to prevent disease, disability, and death in the United States 5 Increase global prevention of death and disease through safe and 5 effective vaccination implementation of the responsibilities of the Director” and stated that the plan (which originally was to be updated annually)2 would establish priorities in research and the development, testing, licensing, pro- duction, procurement, distribution, and effective use of vaccines, describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine functions in consultation and coordination with the Program and in conformity with such priorities. (Public Law 99-660, Title XXI, Subtitle 1, Section 2103:3757) The first National Vaccine Plan was issued in 1994. The plan was updated by NVPO in 2008 at the request of the Assistant Secretary for Health, and NVPO subsequently began to gather stakeholder input on the plan. As part of the process, NVPO asked the IOM to convene an ad hoc committee and gave the committee a two-part charge. The committee was asked to first “prepare a letter report on its review of the 1994 plan” and then to “hold workshops with national expert stakeholders in medicine, public health, and vaccinology to review a publicly available, draft update of the Plan” and prepare a “report with conclusions and recommendations about priority actions within the major components of the new draft plan” (see Box I-1). The 1994 National Vaccine Plan had four goals: (1) to develop new and improved vaccines; (2) to ensure the optimal safety and effectiveness of vaccines and immunization; (3) to better educate the public and members of the health professions about the benefits and risks of immunizations; and (4) to achieve better use of existing vaccines to prevent disease, disability, and death (HHS, 1994). The plan also offered 26 objectives and more than 70 strategies for achieving those objectives. In addition, 14 anticipated 2 In 1998 the requirement for annual updates of the National Vaccine Plan was repealed by Public Law 105-362, Title VI, § 601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285.

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 INTRODUCTION Box I-1 The Charge to the Committee The federal government issued “Disease Prevention through Vaccine Devel- opment and Immunization, The US National Vaccine Plan” in 1994. The Institute of Medicine will convene an ad hoc committee to evaluate the 1994 National Vaccine Plan and then review and make recommendations regarding an update of this National Vaccine Plan. The committee will hold workshopsa with national expert stakeholders in medicine, public health, and vaccinology to review a publicly available, draft update of the Plan. The committee will prepare a letter report of the evaluation of the 1994 Plan, and a report with conclusions and recommendations about priority actions within the major components of the draft Plan. a The IOM Committee on Review of Priorities in the National Vaccine Plan conducted its work between March 2008 and November 2009, including five information-gathering meetings with national stakeholders in Washington, DC, Chicago, Seattle, and Irvine. outcomes, only one of which was measurable, were offered as a basis for judging the success of the plan. To address the first part of its charge the committee authored a letter report addressed to HHS (and published in June 2008) briefly reviewing the 1994 plan and providing guidance on developing the new plan. As the committee noted in its letter report (see Appendix D), the 1994 plan contained almost no measurable objectives or indicators, and its content was largely a reflection of then current activities of relevant HHS agencies. Given that “[c]haracteristics of the 1994 plan [made] it difficult to attribute specific activities to plan objectives,” the committee did not attempt to link accomplishments to the plan (IOM, 2008). In the letter report, the commit- tee examined changes in the broader social, policy, and economic context of vaccine development and immunization, and highlighted several areas in which noteworthy progress has been made, particularly by federal agencies. The committee acknowledged that progress in developing and delivering vaccines has benefited from essential contributions by other stakeholders, including researchers, manufacturers, state and local public health agen- cies, and health care providers. Based on this review of the 1994 plan, the committee offered guidance to NVPO and its partners on key process and content areas to be considered in developing the update to the National Vaccine Plan. The complete letter report can be found in Appendix D. This report, Priorities for the National Vaccine Plan, responds to the second part of the committee’s charge, highlighting major themes that emerged from meetings with expert stakeholders and offering a series of

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0 PRIORITIES FOR THE NATIONAL VACCINE PLAN recommendations about priority actions in the major components of the draft National Vaccine Plan. The committee deliberated at length about the relationship between NVPO and the plan and the implications of NVPO’s current limited resources and status for its ability to ensure and support successful implementation of priorities reflected in the plan’s goals, objec- tives, and strategies. NVPO, the entity that was to be the main coordina- tor on vaccine issues according to the vision apparent in the 1986 statute, was formed in 1988, and in less than one decade after the enactment of the NCVIA, NVPO became subject to funding and staffing cuts required by Congress (House of Representatives, 1995).3 Chapter 6 provides an in- depth examination of the plan as a tool of coordination and NVPO as the structural entity charged with coordinating those efforts. METHODS The committee was charged with holding meetings with expert stake- holders to discuss the draft National Vaccine Plan and with developing “recommendations about priority actions within the major components of the draft new plan.” Because of the wide range of subjects addressed and the varied level (for example, big-picture and broad versus low-level and detailed) represented among the objectives and strategies in the National Vaccine Plan (as well as input received from stakeholders and by NVPO and NVAC), the committee judged that it was neither feasible nor appropriate to use a quantitative priority-setting process. The committee held information-gathering meetings on each of the five goal areas in the draft plan and reviewed material from the literature pertinent to each goal. Each meeting involved a wide range of stakeholders, as reflected in the agendas provided in Appendix F. After each meeting, the committee met in closed session and developed a list of themes and issues emerging from stakeholder input and from a review of the literature. Subse- quently, the committee compared each of the five lists of themes and issues to each of the five goals in the plan; identified gaps and areas of overlap; further reviewed the literature pertinent to each set of themes; and applied several criteria to refine the list of themes and issues and to develop the recommendations described in each chapter. The criteria used included feasi- bility (financial and technical), potential impact on morbidity and mortality, and strategic opportunity (likely to require and motivate multi-stakeholder involvement). 3 NVPO’s budget was appropriated $9,631,000 in 1991, dropped annually between 1991 and 1994, and was cut sharply between 1994 and 1995 to approximately $1 million. The total staff began at 23, increased to 33, and dropped to 9 by 1996 (House of Representatives, 1995). It has remained at approximately this level since.

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 INTRODUCTION GENERAL COMMENTS ABOUT THE 2008 DRAFT PLAN The committee believes that the plan would be strengthened by the ad- dition of a clear vision statement about what the plan is or should be. For example, should the plan serve as (a) a gathering of many of the activities agencies are already undertaking, and then highlighting accomplishments at a later date, when some or many of those activities have been completed and objectives achieved; or (b) a short list of specific critical needs and gaps that require coordinated attention by specific agencies, or by vari- ous permutations of agencies and stakeholders; or (c) both a and b; or (d) something else? The committee believes that the plan may serve these or other valuable functions. It is understandable why the plan’s drafters chose to include both activities that are part of existing strategic plans and are certain to be ac- complished in the near future, and activities that are novel, not necessarily represented in any other planning document, and require multi-sectoral coordination and collaboration. The committee suggests that NVPO con- sider distinguishing between objectives or strategies that are likely to be accomplished regardless of their placement in the National Vaccine Plan and those that are unique to the plan and require coordination among agencies and with non-government stakeholders in order to be achieved.4 The committee’s recommendations about “priority areas within major components of the plan” refer to the latter type of objectives and strategies. Additionally, the committee believes that the final (implementation) plan will be strengthened by a clear explanation of how the indicators in each goal relate to the objectives and strategies in that goal. In this report, the committee uses national accine program in lower case to denote the vast and complex network of actors and actions related to vaccines and immunization, and uses National Vaccine Program (per the 1986 act) when referring to the governmental agencies that have responsi- bilities related to vaccines and immunization. Below, the committee high- lights several dimensions of the national vaccine program that provide useful context for the plan. The committee also provides a minimalist illustration of many of the relevant federal agencies and stakeholders. Table I-2 is not comprehensive or complete, but may help to orient some readers to a com- plex network of actors. A more elaborate, but still incomplete illustration including federal advisory committees and depicting some of the relation- ships among various actors was originally provided in the committee’s June 2008 letter report available in Appendix D. 4 W. Orenstein, 2007 NVAC meeting (NVAC, 2007).

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN TABLE I-2 The National Vaccine Program: Government and Stakeholders Stakeholders Federal Government The public: individuals and communities HHS (includes NVPO) CDCa State, territorial, tribal, and local public CMSb health agencies FDAc Industry HRSAd Academic research enterprise NIHe Primary care (part of the health care delivery system) Department of Defense Payers and Plans Vaccine Healthcare Centers Network Community organizations National organizations and professional Department of State societies U.S. Agency for International Foundations Development International and multilateral organizations a Centers for Disease Control and Prevention. b Centers for Medicare & Medicaid Services. c Food and Drug Administration. d Health Resources and Services Administration. e National Institutes of Health. THE PURPOSE OF IMMUNIZATION Vaccines have the capacity to prevent infectious disease in vaccinated individuals and to prevent their spread in populations and vulnerable indi- viduals who cannot be vaccinated because of their age or health. Vaccines also serve a dual purpose: as medical interventions used with individuals (and, like all medical interventions, characterized by risks and benefits), and as public health interventions used in the population at large to prevent infectious disease outbreaks and reduce or eliminate disease, disability, and death. Given the value of vaccination,5 its enormous and continuing impor- tance to public health and the complex issues of national health policy that it raises, the federal government’s involvement is broad and deep, spanning virtually all aspects of the immunization enterprise, across mul- tiple federal agencies and often involving collaboration with stakeholders. Public insurance programs such as Medicare, Medicaid, and the Children’s Health Insurance Program finance the purchase and administration of vac- cines for more than 100 million program beneficiaries. The Vaccines for 5 The terms vaccination and immunization are sometimes used interchangeably. The commit- tee uses vaccination to refer to the delivery of the vaccine to an individual, and immunization services to refer to the range of activities related to vaccination.

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 INTRODUCTION Children (VFC) program, a component of Medicaid, plays a crucial role in ensuring immunization access not only for children enrolled in Medicaid but also for uninsured, underinsured, and medically underserved children. Programs such as the Indian Health Service, federally funded community health centers and services of the Veterans’ Health Administration in the Department of Veterans Affairs ensure access to immunization services for key populations including veterans, the uninsured, and children and adults whose health insurance does not cover vaccinations. The Centers for Disease Control and Prevention (CDC) plays a central role for the nation in measuring population immunization status and promoting access, while the Food and Drug Administration (FDA) and CDC are national stewards of vaccine safety surveillance and monitoring as well as for policies aimed at ensuring a safe and adequate vaccine supply. The U.S. Agency for Inter- national Development (in the State Department) promotes global vaccine access policy to improve the health of nations and directly funds research for diseases that affect developing countries. CDC also provides technical training and support in several areas of global immunization programs, including surveillance. The National Institutes of Health (NIH), the Depart- ment of Defense, and the Biomedical Advanced Research and Development Authority in HHS are instrumental in the development of new vaccine technology for both domestic and global needs. In its policy and planning roles, the federal government leads the nation in the development of poli- cies for ensuring high levels of immunization in the population regardless of health insurance status. With enactment of national health care reform increasingly likely, the federal government would play the central role in translating reforms in coverage, payment, access, quality, and community prevention into improved vaccination outcomes. Four ethical principles or values—beneficence, justice, public safety, and autonomy6—shape the way policy makers, health care providers, and individuals think about vaccines, and they also inform national and state immunization policies. Sometimes, these considerations give rise to conflicts and dilemmas. The imperative of protecting public safety sometimes re- quires government agencies to place limitations on personal autonomy. This is the case with state vaccine requirements for entry to school and child care, but similar examples may be found in the mandatory use of seat belts and child safety seats. The principles of beneficence and distributive justice have made vaccines a high national priority. For example, the federal government funds and administers the VFC program at a current cost of approximately $3 billion, with the aim of ensuring that children can receive vaccination 6 Beneficence (and its corollary, non-maleficence), justice, and autonomy are widely acknowl- edged as fundamental ethical principles that guide the delivery of health care. Public safety or public benefit is a guiding principle in public health practice (Kass, 2001; Public Health Ethics Society, 2002).

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN without financial barriers (Shefer, 2008). These same principles also call for compensation of injuries through the Vaccine Injury Compensation Program (VICP) established in 1987 in accordance with the NCVIA in order to en- sure that those who bear the burden of rare serious adverse events possibly caused by vaccines are compensated. The principles of public safety and beneficence also contribute to the motivation to develop new and improved vaccines to prevent diseases that cause suffering, result in higher rates of disease and death, and affect individuals’ and society’s economic well-being, including days of work missed due to vaccine-preventable disease and health care expenditures to treat serious sequelae of infectious diseases. Risk and Benefit As with all medical products, vaccines have risks and benefits, and gov- ernment regulators in the Center for Biologics Evaluation and Research at FDA evaluate a vaccine’s efficacy and safety before and after its licensure. At the time a company’s Biologic License Application is reviewed by FDA, pertinent data are also presented to FDA’s Vaccines and Related Biologi- cal Products Advisory Committee and to CDC’s Advisory Committee on Immunization Practices (ACIP). Vaccines are licensed only if regulators are satisfied that they are efficacious and safe and have a favorable risk- benefit profile. However, it is important to note that there is no perfectly safe7 or effective vaccine, and a vaccine’s risk-benefit profile evolves over time as a result of growing knowledge about a product and changes in the environment in which a product is used. Four major types of studies in hu- mans are conducted during a vaccine’s lifecycle. Studies are conducted by manufacturers before a vaccine can be considered for licensure, and include the following: Phase I study in a small number of subjects to assess safety; study of safety and immunogenicity in Phase II; and large-scale, generally randomized controlled studies to assess efficacy and safety in Phase III. At the point of licensure, regulators may require additional safety studies after a vaccine is marketed and begins to be used in the general population (Phase IV studies). Also, after licensure, vaccines are released into the market after each batch is tested by FDA. Balancing risks and benefits is complex. In general, studies are designed (i.e., statistically powered) primarily to assess efficacy and thus are only ca- pable of detecting relatively common adverse events (the second generation rotavirus vaccine studies discussed in Chapter 2, which were designed to capture an adverse event previously identified, are an exception). Although 7 The Code of Federal Regulations defines safety as “the relative freedom from harmful ef- fects of the recipient when a product is prudently administered, taking into consideration the characteristics of the product in the relationship to the condition of the recipient at the time” (21 CFR § 600.3).

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 INTRODUCTION safety is equal in importance to efficacy, establishing absolute safety is im- possible. Pre-licensure trials large enough to detect unexpected rare adverse events would be logistically difficult and would substantially delay introduc- tion of a product that has been proven to save lives. Therefore, regulators and other public health agencies must rely on post-marketing vigilance to detect possible uncommon adverse events following immunization. The vaccine safety system, although primarily organized and supported by the federal government, involves many non-government stakeholders that contribute to the system in one or more ways. The system includes vac- cine manufacturers that are required to report within 15 days of detection serious adverse events following immunization, academic research centers and health care organizations that collaborate with government to conduct safety research (including investigation of safety concerns that arise), health care providers, and the public.8 The Immunization Safety Office in CDC is a central component of the system, and in collaboration with FDA and other stakeholders, it supports an array of safety-related activities. The following activities are important to highlight: • The Vaccine Adverse Events Reporting System, a passive surveil- lance system that receives reports of possible adverse events via mail, e-mail, fax, and web-based submission from vaccine manufacturers, health care providers, and the public, may detect “signals” (serious adverse events that might be associated with a preceding immunization) and be used to generate hypotheses; • The Vaccine Safety Datalink project, which is a large linked data- base that integrates data on more than 8 million people enrolled in eight health maintenance organizations and conducts active surveillance and testing of vaccine safety hypotheses; and • The Clinical Immunization Safety Assessment network based in several academic and clinical centers, which is equipped to provide basic sci- ence and clinical investigation of adverse events following immunization. The vaccine safety system has a long and rich history that illustrates both the complexity of vaccine regulation and the capacity of the system to moni- tor safety and respond with speed and competence to evolving concerns. Chapter 2 provides an in-depth discussion of the system and offers a case study of the response to a safety concern that emerged in the wake of FDA li- censure of the first rotavirus vaccine and expanded use in the population. As noted earlier, the VICP provides compensation for conditions that might be adverse effects of vaccines. The compensation program is located 8 A working group of NVAC has also been asked to review and make recommendations about the federal vaccine safety system, and the product of its information-gathering and deliberation is expected to be released in 2010.

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN Box I-2 Pathways to Compensation in the Vaccine Injury Compensation Program The first pathway to vaccine injury compensation is for individuals whose injuries are listed in the vaccine injury table.a The table, established as part of the 1986 legislation, recognized the potential of certain vaccines to produce specific injuries (i.e., there is medical and scientific evidence that the vaccine can cause the listed injury). If a vaccine identified in the table is administered and an injury listed in the table ensues, compensation is awarded. This process was intended to be non-adversarial or no-fault, swift, and simple. Individuals claiming an “on-table” injury need not demonstrate a causal link between the injury and the vaccine—the injury table is evidence that such a link has been established. The second pathway for compensation recognized under the NCVIA is for individuals with an “off-table” injury, that is, an injury that allegedly is the result of a specific vaccine or vaccine ingredient but for which no scientific consensus about causality has been reached due to insufficient or conflicting evidence. The off- table pathway allows individuals who believe they have been injured by a vaccine to argue that the preponderance of evidence in that case is sufficient to warrant compensation even though it may fall short of the scientific standard for establish- ing a causal link between the vaccine administered and the alleged injury. a The table is available on the VICP web site at http://www.hrsa.gov/Vaccinecompensation/ table.htm. in the Health Resources and Services Administration at HHS, and three federal government entities, HHS, the Department of Justice, and the U.S. Court of Federal Claims, play roles in the program (VICP, 2009). The 1986 law (NCVIA) requires that plaintiffs, called petitioners, first bring their case to the program before seeking compensation in civil courts and offers two pathways for awarding compensation (VICP, 2009; see Box I-2). Chapter 2 provides additional discussion of how information from the program can contribute to the safety research agenda, and Chapter 3 examines implica- tions of the program’s legal actions on communication about vaccine risks and benefits. Communication Society has changed, but the ways in which government communicates about vaccines have not kept up with those changes. Over the past three decades, there has been a great increase in the public’s interest, expecta- tions, knowledge (including faster access to information via the Internet),

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 INTRODUCTION and involvement in aspects of health care, including quality and safety, pa- tients’ rights, and research. In the past decade of the 20th century, multiple examples emerged of the “ubiquity of risk in modern industrial society” as a “central concern of U.S. politics, law, and popular culture” (Colgrove and Bayer, 2005). There is also a high level of sometimes confusing, conflicting, and inaccurate mass media and news media contributions to public beliefs about vaccines (this has been heightened during the implementation of the H1N1 monovalent influenza vaccine). In this environment, government agencies can no longer simply impart information as issues arise (i.e., reac- tive communication) or appear silent on questions about safety. The gov- ernment (federal, state, and local public health agencies) needs to engage in dialogue with the public about vaccines and vaccine safety on an ongoing basis and to communicate factual information about vaccines and vaccina- tion in a timely, complete, and clear way. The landscape of immunization has also changed as successful vaccines have resulted in the disappearance or near-disappearance of the diseases that claimed the lives of many children and caused great fear among parents (although some diseases, such as pertussis, remain endemic, and others, such as measles, may be reintroduced into a community). The benefits of immunization appear less clear both as the memory of vaccine-preventable diseases recedes and as the incidence of many diseases decreases to the extent that some have become invisible in the community. Also, the sciences of vaccinology and vaccine safety are not characterized by absolute certainty; there are areas of uncertainty that are complex but require clear and timely communication. The complex work of communicating about risk and ben- efit and about the basis for immunization policy must be approached in a much more strategic, evidence-based, and effective form. The committee discusses communication and informed decision making (Goal 3 of the draft plan) in Chapter 3. Elimination and Control of Vaccine-Preventable Diseases The vaccine and immunization enterprise can be described succinctly as developing effective and safe vaccines, and using those vaccines to prevent disease. Both components involve the roles of and coordination between government and private sector actors. Chapter 1 of this report discusses vaccine research and development and recommends several priority actions in Goal 1 of the National Vaccine Plan. Chapter 4 discusses vaccine supply and use and recommends several priority actions in Goal 4 of the National Vaccine Plan. Vaccine research and development involves government, especially NIH, academic research institutions, and industry (large pharmaceutical companies, biotechnology companies, and venture capitalists). With respect

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 PRIORITIES FOR THE NATIONAL VACCINE PLAN to vaccines for global use, the array of actors is even broader, and includes philanthropies, varied multilateral entities, and formal public-private part- nerships such as product development partnerships. Vaccine research and development has as its end-goal the production of effective and safe vaccines that confer long-term protection on those vaccinated. The path that leads from discovery to licensure and use, however, is lengthy (e.g., 10 years), challenging, and resource-intensive (WHO, 2006). Multiple factors lead to decisions about what is pursued in research and development, including public health need, market prospects and likelihood of a return on invest- ment, and scientific and technological obstacles. Although manufacturers establish their own priority lists, there is no systematic national process for prioritizing candidates. Chapter 1 discusses research and development and the roles of NIH and FDA in greater detail. Use of vaccines involves CDC, state, tribal, territorial, and local public health agencies, and the health care delivery system at all levels (providers, plans, payers). In the United States, the ACIP makes recommendations to CDC on the use of vaccines to prevent disease in all age groups. ACIP rec- ommendations are considered in federal and state policies and funding deci- sions that largely aim to ensure that children receive all ACIP-recommended vaccines regardless of insurance status. Chapter 4 discusses the use of vac- cines, including vaccine supply; use of vaccines for public health emergencies such as the ongoing H1N1 epidemic; public financing of vaccines through the VFC program and Section 317 (state discretionary funding for immu- nization); and immunization as an indicator of health care system quality and performance. In Chapter 5, the committee examines major issues in the global use of vaccines and makes recommendations about priority actions in Goal 5 of the National Vaccine Plan. Global issues include the different burden of disease caused by many pathogens for which there are no effec- tive vaccines, and some considerable limitations in the infrastructure and capacity of low-income countries to manage and use existing vaccines. The reasons for both challenges include lack of financial resources. Novel part- nerships between the public and private sectors have emerged in the past decade to address these challenges. Federal Immunization Laws, Policies, and Programs The Public Health Service Act and amendments to it, such as the NCVIA, form the foundation of federal immunization law and outline the responsibilities of government and to a lesser extent those of individu- als. States make policy to support their role of ensuring immunization of the population (including financing immunization services and requiring vaccination for school entry), but the federal government strongly shapes national direction with regard to immunization. Amendments to Medicaid

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 INTRODUCTION in the 1993 Omnibus Reconciliation Act (Public Law 103-66) included the establishment of the Vaccines for Children Program, an entitlement program that provides free vaccine for children who are Medicaid eligible, uninsured, underinsured for immunization services (i.e., individuals whose insurance policy covers only some or no vaccines), or are American Indian or Alaska Native. Vaccine cost, cost-effectiveness, and financing are among the important and complex considerations that inform policy decisions about the use of vaccines to prevent disease, disability, and death as a component of national and state public health policies. The use of vaccines has implications not only for the health of individuals and communities (i.e., in preventing spread of disease) but it also has multi-faceted implications for the health care delivery system, employers, schools, and parents. Vaccines have long been known to be cost-effective, and older vaccines (introduced before 2000) are also cost-saving. Newer, more expensive vaccines are cost-effective but not cost-saving. A 2008 NVAC report noted that the considerable increase in the cost of providing all ACIP-recommended childhood vaccines (a 336 percent increase in vaccines for males and 476 percent in vaccines for females) “has raised concerns about the ability of the current public and private vaccine delivery systems to maintain access to all vaccines recommended for routine use in children and adolescents without financial barriers” (NVAC, 2008). Medical practices, public health clinics and other settings where vaccination is administered also incur significant and growing non-vaccine costs that include counseling, storage, administration, and staff time. Reimbursement for these costs is frequently inadequate. At the global level vaccine financ- ing issues are different than in the United States (see Chapter 5), but are similarly complex. NVAC, the IOM, and several professional societies such as the American Academy of Pediatrics have examined these interrelated problems of vaccine financing and have proposed solutions (AAP, 2007; IOM, 2000, 2003; NVAC, 2009). REFERENCES AAP Task Force on Immunization. 2007. Discussion Paper: Immunization Financing: Where is the Breaking Point? Available: http://www.aap.org/immunization/pediatricians/pdf/ TaskForceWhitePaper.pdf [accessed July 12, 2009]. Colgrove, J., and R. Bayer. 2005. Could it happen here? Vaccine risk controversies and the specter of derailment. Health Aff 24(3):729-739. HHS (Department of Health and Human Services). 1994.  National Vaccine Plan. Avail- able: http://www.hhs.gov/nvpo/vacc_plan/1994plan/ [accessed January 2008]. HHS. 2008 (November). Draft Strategic National Vaccine Plan. Available: http://www.hhs. gov/nvpo/vacc_plan/2008plan/draftvaccineplan.pdf [accessed December, 2008]. House of Representatives. 1995 (March 8). Hearings before the Committee on Appropriations, 104th Congress, First Session. Subcommittee on the Departments of Labor, Health and Human Serices, Education, and Related Agencies Appropriations for .

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0 PRIORITIES FOR THE NATIONAL VACCINE PLAN IOM (Institute of Medicine). 2000. Calling the Shots: Immunization Finance Policies and Practices. Washington, DC: National Academy Press. IOM. 2003. Financing Vaccines in the st Century: Assuring Access and Aailability. Wash- ington, DC: The National Academies Press. IOM. 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. Kass, N.E. 2001. An ethics framework for public health. AJPH Nov 91(11):1776-1782. NVAC (National Vaccine Advisory Committee). 2007. June -, 00, Meeting Minutes. Available: http://www.hhs.gov/nvpo/nvac/documents/MinutesJun07.doc [accessed July 12, 2009]. NVAC. 2008. A Comprehensie Reiew of Federal Vaccine Safety Programs and Public Health Actiities. Available: http://www.hhs.gov/nvpo/nvac/documents/vaccine-safety-review.pdf [accessed January 2009]. NVAC Vaccine Financing Working Group. 2009. Assuring Vaccination of Children and Adoles- cents without Financial Barriers: Recommendations from the National Vaccine Adisory Committee (NVAC). Washington, DC: Department of Health and Human Services. Public Health Ethics Society. 2002. Principles of the Ethical Practice of Public Health. Available: http://www.apha.org/NR/rdonlyres/1CED3CEA-287E-4185-9CBD-BD405FC60856/0/ ethicsbrochure.pdf [accessed November 2009]. Shefer, A. 2008 (May). The Childhood Immunization Program. Available: http://www.cdc. gov/omhd/CAMICC/LectureSeries2008/PDFs/Shefer.pdf [accessed January 2009]. VICP (Vaccine Injury Compensation Program). 2009. National Vaccine Injury Compensation Program (VICP). Available: http://www.hrsa.gov/Vaccinecompensation/ [accessed August 21, 2009]. WHO (World Health Organization). 2006. Deelopment of New Vaccines. Available: http:// www.who.int/mediacentre/factsheets/fs289/en/index.html [accessed October 8, 2009].