June 10, 2008

Dr. Bruce Gellin, MD, MPH

Director

National Vaccine Program Office

U.S. Department of Health and Human Services

Hubert H. Humphrey Building 200 Independence Avenue, SW Room 715H Washington, DC 20201–0004

Dear Dr. Gellin:

The Committee on Review of Priorities in the National Vaccine Plan is pleased to offer you its letter report, Initial Guidance for an Update to the National Vaccine Plan. The committee has been given a statement of task in two parts (see Appendix B). The second part tasks the committee with reviewing priorities in the update to the National Vaccine Plan, which is currently under development by an interagency group led by the National Vaccine Program Office (NVPO). The first part of the statement of task asks the committee to review the 1994 National Vaccine Plan1 and then provide guidance on the development of the update to the plan.2 This letter report responds to the first part of the statement of task.

As part of its information-gathering activities, the committee held a meeting that included presentations from representatives of NVPO and several Department of Health and Human Services (DHHS) agencies on the development of the 1994 plan, on accomplishments since 1994, and on early thinking about the update to the plan (see Appendix C for the meeting agenda). The committee also reviewed relevant literature, and study staff along with one or two committee members held informal conversations with several individuals familiar with the 1994 plan and its development.

BACKGROUND

NVPO was established by the enactment of Title XXI of the Public Health Service Act (Public Law 99-660), which also called for the preparation of the National Vaccine Plan. 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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June 10, 2008 Dr. Bruce Gellin, MD, MPH Director National Vaccine Program Office U.S. Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue, SW Room 715H Washington, DC 20201–0004 Dear Dr. Gellin: The Committee on Review of Priorities in the National Vaccine Plan is pleased to offer you its letter report, Initial Guidance for an Update to the National Vaccine Plan. The committee has been given a statement of task in two parts (see Appendix B). The second part tasks the committee with reviewing priorities in the update to the National Vaccine Plan, which is currently under development by an interagency group led by the National Vaccine Program Office (NVPO). The first part of the statement of task asks the committee to review the 1994 National Vaccine Plan1 and then provide guidance on the development of the update to the plan.2 This letter report responds to the first part of the statement of task. As part of its information-gathering activities, the committee held a meeting that included presentations from representatives of NVPO and several Department of Health and Human Services (DHHS) agencies on the development of the 1994 plan, on accomplishments since 1994, and on early thinking about the update to the plan (see Appendix C for the meeting agenda). The committee also reviewed relevant literature, and study staff along with one or two committee members held informal conversations with several individuals familiar with the 1994 plan and its development. BACKGROUND NVPO was established by the enactment of Title XXI of the Public Health Service Act (Public Law 99-660), which also called for the preparation of the National Vaccine Plan. 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. 1

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2 INITIAL GUIDANCE [T]he principal coordinating organization for the NVP is the National Vaccine Program Office (NVPO), within the Public Health Service (PHS). The NVPO’s responsibilities include providing overall leadership for the collaborative effort and monitoring the progress being made in achieving the plan’s goals. Within the PHS, the NVPO has the task of reviewing all budget requests associated with vaccine development and immunization programs to ensure that all major priorities are adequately covered and that there is no duplication of effort. (NVPO, 1994) The legislation represented a response to several different developments. These developments included problems of vaccine safety; the reemergence of vaccine- preventable diseases, especially pertussis and measles, in the United States and other developed countries; the persistence of these and other vaccine-preventable diseases in developing countries; and vaccine industry concern regarding financial and liability- related impediments to the development of new vaccines. The legislation also contained provisions aimed at improved monitoring of the safety of recommended vaccines and at reducing industry concern about liability risks. The Vaccine Adverse Events Reporting System (VAERS) and the National Vaccine Injury Compensation Program both became operational in 1988. 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) amendments to Medicaid (Public Law 103-66). VFC, building on the existing entitlement to immunizations for children enrolled in Medicaid, strengthened federal immunization coverage standards while extending the immunization entitlement to uninsured children, children served by American Indian and Alaska Native health programs, and underinsured children served through Federally Qualified Health Centers (FQHCs). In 1990, DHHS released Healthy People 2000, which set forth 19 objectives related to reducing infectious disease and improving immunization coverage among children and adults. Various nonprofit organizations interested in children’s health and welfare also were part of efforts in the early 1990s to improve immunization services. Every Child By Two, for example, sought to draw family and community attention to the need to ensure that young children received vaccines according to the recommended schedule, not simply in response to school entry requirements. The Children’s Vaccine Initiative, begun in 1990 under the auspices of United Nations agencies, focused on delivery of vaccines to children in developing countries.

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LETTER REPORT 3 Features of the 1994 National Vaccine Plan The plan was to “establish priorities in research and the development, testing, licensing, production, 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 functions in consultation and coordination with the [National Vaccine] Program and in conformity with such priorities.” The 1994 plan’s aims included reducing “the incidence of infectious diseases through vaccine development and immunization” and integrating all U.S. efforts on vaccine development and immunization, whether their focus was domestic or global (NVPO, 1994: p. 13). The plan had four goals3: (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 on the benefits and risks of immunizations; and (4) to achieve better use of existing vaccines to prevent disease, disability, and death. The plan also offered 26 objectives along with more than 70 strategies for achieving those objectives. In addition, 14 anticipated outcomes were offered as a basis for judging the success of the plan (see Appendix D). The Committee’s Approach to Reviewing the Plan The committee reviewed the goals, objectives, strategies, and anticipated outcomes presented in the plan. In the interest of time and in recognition of the statement of task and the plan’s acknowledged limitations (notably, the lack of measurable objectives), the committee did not undertake a point-by-point evaluation of what the plan has or has not achieved. Instead, in the first section of this letter report, the committee examines what has changed in the broader social, policy, and economic context of vaccine development and immunization, and highlights several areas where noteworthy progress has been made, particularly by federal agencies. The committee acknowledges that progress in developing and delivering vaccines has benefited from essential contributions by other stakeholders, including researchers, manufacturers, state and local public health agencies, and health care providers. 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. CHANGES SINCE 1994 Important changes in the world, in American society, and in the delivery and financing of health care have occurred or have grown in prominence since 1994. For example, several key changes have been made in how the U.S. health care delivery system is organized. More elderly and underserved populations receive health care, including immunizations, through private health care delivery systems under the auspices of Medicaid and Medicare managed care programs.4 With significant government- 3 NVPO intends to retain these goals to structure the update to the plan. 4 According to CMS, two-thirds of the Medicaid population is enrolled in managed care organizations (more than 90 percent in many states). There are now over 500 separate managed care plans nationally providing health services to more than 40 million enrollees (CMS, 2006).

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4 INITIAL GUIDANCE financed immunization activity now occurring through private entities that have a role in and the ability to influence coverage and financing decisions, there is growing dependence on the private sector to ensure that immunization goals for senior and underserved populations are met. Like other medical products, vaccines have benefits and risks, and in recent decades vaccine safety has emerged as an important topic both for the public health and medical communities and for the public. 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). Multiple factors converged to facilitate the emergence of an increasingly organized and vocal movement that questions the need for vaccines and their safety in general and alleges that specific vaccines, features of vaccines, or the expansion of the pediatric immunization schedule in the past 15 years have caused health problems in some children. These factors include the decline in the incidence of vaccine-preventable diseases in the United States, the greater interest in complementary and alternative medicine, an increase in consumerism, broader public concern about the varied risks inherent in modern life, a growing public mistrust of government agencies, and the proliferation of electronic communication (Clements and Ratzan, 2003; Clements et al., 1999; Colgrove and Bayer, 2005). Major transformation also has occurred in the area of funding for vaccine research, both globally and domestically. In the United States, the federal government has a greater role in funding and guiding the development and evaluation of vaccines, particularly those directed against pandemic influenza and potential agents of bioterrorism. Globally, the Bill & Melinda Gates Foundation and international partnerships such as the GAVI Alliance5 fund new vaccine purchase, support strengthening immunization infrastructure in developing countries, and foster vaccine research and development. PROGRESS SINCE 1994 As noted above, at its March 2008 meeting the committee heard a series of presentations from DHHS agencies, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS) (see Appendix C for the complete agenda). Characteristics of the 1994 plan make it difficult to attribute specific activities to plan objectives, and accordingly, the presentations given to the committee in general did not attempt to link accomplishments to the plan, other than noting their relevance to the pertinent goal in the plan. These presentations described many remarkable achievements, both in process (e.g., enhanced regulatory tools) and substance (e.g., approval of safe and effective new vaccines), of federal agencies working in collaboration with other 5 Global Alliance for Vaccines and Immunization

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LETTER REPORT 5 stakeholders in the U.S. vaccine system. Below, the committee highlights several examples of these achievements, as well as other areas of progress, and also notes the 1994 plan’s anticipated outcomes in areas that coincide with areas of progress (see Appendix D for a complete list of the outcomes). However, the committee does not attempt to assess the extent to which each of the 14 anticipated outcomes was realized,6 or to illustrate achievements related to all of the outcomes under each goal. Also, the committee did not undertake a systematic evaluation of achievements or failures to achieve plan objectives. The focus on progress in the field is intended to provide some context for the current environment for vaccine development and delivery, with the understanding that gaps and challenges remain in this complex domain of science, public health, and health care. Goal 1: Develop new and improved vaccines. Four of the 14 anticipated outcomes in the 1994 plan are associated with this goal and include: improved vaccines, vaccines for diseases without vaccines, and regulatory improvements to facilitate vaccine licensure. Much progress has been made in the area of vaccine development. Since 1994, more than 20 new vaccine products resulting from the collaborative efforts of NIH, academic, and industry researchers were approved by FDA (IOM, 2008). Novel vaccines introduced include vaccines against pediatric pneumococcal disease, meningococcal disease, and human papilloma virus. 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). Similarly, the 1996 recommendation by the Advisory Committee on Immunization Practices (ACIP) to begin replacing oral polio vaccine with inactivated polio vaccine,7 and 2000 ACIP recommendation to replace all OPV with IPV led to the disappearance in the United States of vaccine-associated paralytic poliomyelitis (CDC, 2000; Wattigney et al., 2001). NIH plays a crucial role in conducting and supporting both basic and applied vaccine research. In recent years, the agency has been involved in supporting a number of Investigational New Drug applications for vaccines, playing a role in the licensure of 17 different vaccines between 1994 and 2006, and has collaborated with the World Health Organization and nongovernmental organizations on vaccines of importance to developing countries. Most recently, NIH has been engaged in research related to vaccines for potential agents of bioterrorism and pandemic influenza (e.g., H5N1 inactivated vaccine). 6 This was done to some extent by NVPO’s evaluation of the 1994 (NVPO, 1997). 7 This was done by changing the OPV vaccination schedule to a sequential OPV-IPV schedule, with two doses of IPV administered at ages 2 and 4 months, followed by two doses of OPV at ages 12–18 months and 4–6 years (CDC, 2000).

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6 INITIAL GUIDANCE Goal 2: Ensure the optimal safety and effectiveness of vaccines and immunization. One of the 14 anticipated outcomes in the 1994 plan is associated with this goal; it refers to continuous monitoring of vaccine efficacy and safety. There have been several notable activities in this area. Since 1994, the FDA Center for Biologics Evaluation and Research (CBER), which regulates vaccines, has had an expanding array of regulatory tools and legislative requirements that facilitate the review and approval of safe and efficacious vaccines. For example, CBER has become better equipped to monitor manufacturer commitments to study the safety of vaccines after they are licensed. In the past fourteen years, FDA and CDC have collaborated on surveillance for and evaluation of adverse events through their joint operation of VAERS. VAERS reporting procedures have been improved and simplified and better methods for monitoring and analyzing the data collected have been developed. Efforts have also been made to increase collaboration with CMS, the Department of Defense, and the Department of Veterans Affairs to improve surveillance and reporting of adverse events following immunization in the adult populations these agencies serve. In addition, the Vaccine Safety Datalink (VSD) 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. In 2001, the Clinical Immunization Safety Assessment (CISA) Network was established. CISA is a network of six medical research centers with expertise in immunization safety. CISA sites focus on pathophysiologic mechanisms and identify biologic risks of adverse events following immunization (Iskander, 2007). Examples of CISA studies include research on possible genetic risk factors for post-vaccination Guillain-Barré syndrome and research on vaccine-associated encephalitis. One of the objectives under Goal 2 in the 1994 plan was to “continue to ensure fair and efficient compensation to individuals injured by vaccines,” in reference to the National Vaccine Injury Compensation Program (VICP), which is based at HRSA and has operated since 1988 (see Appendix D for a list of goals and objectives). The VICP is a no-fault mechanism through which compensation can be awarded for claims of vaccine- related injury or death. Since 1994, nine vaccines have been added to the program and the list of compensable injuries has been updated periodically to incorporate new findings on vaccine safety, including those from Institute of Medicine (IOM) reviews and CDC studies.8 8 The IOM reviews were federally funded studies that brought together panels of experts to examine the available scientific evidence on specific vaccine safety concerns. Eight reports of the IOM Immunization

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LETTER REPORT 7 Goal 3: Better educate the public and members of the health professions about the benefits and risks of immunizations. Two of the 14 anticipated outcomes in the 1994 plan are associated with this goal, and they include the establishment of educational communication networks to inform all potential audiences about vaccine risks and benefits, and providing information to the public on the costs and benefits of the plan. There have been several developments in this area. Since 1999, the American Academy of Pediatrics (AAP) has received funding through a cooperative agreement with CDC for its Childhood Immunization Support Program (CISP). CISP has been providing educational resources on immunization and immunization-related issues to health care providers and parents. In 2000, DHHS, CDC, and the American Medical Association co-sponsored the first National Influenza Vaccine Summit, a group that meets annually and has members representing 100 public and private organizations interested in preventing influenza. Major aims of this activity include finding new ways to communicate with and to the public and health care providers. Between 2002 and 2003, NVPO, CDC, IOM, and the Keystone Center9 collaborated on a proposal to stimulate public engagement in vaccine policy development. A National Vaccine Advisory Committee working group discussed the proposal and other models of public engagement during a 2004 workshop (NVAC, 2004). The collaboration among these organizations continued in 2005 in the form of a demonstration, or proof of principle, that vaccine policymaking could be well-informed by a substantive engagement of stakeholders and the public (The Keystone Center, 2005). The demonstration topic was pandemic influenza vaccine prioritization. In 2007, FDA formed a risk communication advisory committee that will advise the agency on communication of risk and benefit information about the products the agency regulates. Goal 4: Achieve better use of existing vaccines to prevent disease, disability, and death. 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) as significant causes of death. Below, the committee highlights examples of progress the use of vaccines. For each birth cohort (the approximately 4 million children born each year), routine childhood immunization has been estimated to prevent approximately 33,500 premature deaths and 14.3 million cases of vaccine-preventable illnesses (Zhou et al., 2005). The introduction of Haemophilus influenzae Type b (Hib) and pertussis vaccines Safety Review Committee were published between 2001 through 2004 and may be viewed at www.nap.edu. 9 The Keystone Center is a nonprofit that facilitates consensus-building for science-based public policy decisions (www.keystone.org).

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8 INITIAL GUIDANCE illustrates the impact of immunization. Hib once affected 1 out of 200 children under age 5 and killed 600 U.S. children each year. One-quarter of children surviving Hib meningitis had neurologic damage. Conjugate Hib vaccine was recommended by ACIP for all infants in 1991. Between 1994 and 1998, fewer than 10 fatal cases of invasive Hib disease were reported (CDC, 2007a), and rates of the disease fell by 99 percent overall (Adams et al., 1993). Before pertussis vaccine became available in the 1940s, the disease caused between 150,000 and 260,000 cases and from 5,000 to a peak of 9,000 deaths annually (CDC, 2006, 2007a). Between 1990 and 1996, there were 57 pertussis deaths, most in infants under 6 months of age (CDC, 2007a). Since 1994, the number of vaccines recommended for children and adolescents has increased from 9 to 16, including vaccines against varicella, pneumococcal disease, influenza, meningococcal disease, hepatitis A, rotavirus, and human papilloma virus (HPV). In 2006, immunization coverage for children aged 19–35 months exceeded 90 percent for several individual vaccines.10 However, 77 percent of children in this age group had received all doses of a series of recommended vaccines11 (CDC, 2007b). 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) a tool to foster interagency dialogue, and (2) a mechanism for cataloguing activities and listing policy and research aspirations and prominent concerns that existed at that time (IOM, 2008; IOM Staff, 2008). However, there is little evidence that the plan served to guide or motivate activity that occurred after its preparation. As a result, it is difficult to attribute to the plan any changes that have occurred since 1994. On the basis of its review of the 1994 plan and information gathered about its development, the committee has indentified several process and content areas that deserve particular attention as the update to the plan is developed. Process Issues The committee identified several limitations of the process of developing the 1994 plan that provide useful lessons in drafting the update to the National Vaccine Plan. These limitations include: the federal, rather than national, scope of the 1994 plan; the absence of a framework for evaluating and updating the plan; and the lack of explicit roles in the plan for stakeholders beyond the federal government (Figure 1 offers an illustration of the immunization system, which, despite being an incomplete representation, depicts the system’s complexity). Also, NVPO and agencies involved in 10 This is one area where a plan objective may be said to have been met and exceeded. As noted elsewhere, given the structure and contents of the 1994 plan, it is generally not possible to attribute specific changes to specific objectives in the plan. 11 This refers to the series of ≥4 doses of diphtheria, tetanus toxoid, and any acellular pertussis vaccine; >3 doses of poliovirus vaccine; >1 dose of measles, mumps, and rubella vaccine; >3 doses of Haemophilus influenzae type b vaccine; >3 doses of hepatitis B vaccine; and >1 dose of varicella vaccine.

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LETTER REPORT 9 Academic MIDRC research NVPO enterprise Microbiology and Infectious State governments (DHHS) Diseases Research Committee state, tribal, and local public health agencies NVAC NIH Vaccine National Vaccine Advisory (DHHS) Industry Committee COPR CDC NIH Director’s Council of ACIP Public Representatives (DHHS) Advisory Committee on Immunization Practices FDA VRBPAC Public (DHHS) Vaccines & Related Biological Products Advisory Committee Primary care delivery system private and public ACCV HRSA Advisory Commission on CMS Childhood Vaccines (DHHS) (DHHS) Payers and Plans Figure 1 This figure is intended to illustrate some aspects of the immunization system’s complexity, not to be a complete description of the system. A number of federal advisory committees exist to provide advice and guidance to agencies in the Department of Health and Human Services (DHHS). Several of these committees are associated with vaccine- or immunization-specific programs. Four such committees, as well as two additional relevant committees are depicted in the figure. Legend: Gray boxes represent federal agencies in the Department of Health and Human Services (DHHS) (other departments, such as the Departments of Defense, Veterans Affairs, and Homeland Security, also play important roles in the immunization system); white boxes represent federal advisory committees associated with DHHS agencies, and gray ovals represent other stakeholders. Acronyms: CDC = Centers for Disease Control and Prevention; CMS = Centers for Medicare & Medicaid Services; FDA = Food and Drug Administration; HRSA = Health Resources and Services Administration; NIH = National Institutes of Health; NVPO = National Vaccine Program Office. Notes about the federal advisory committees above: ACCV includes attorneys for injured children and for industry; NVAC Includes public, industry, state public health, and health care (AHIP) representation; ACIP includes public and state and local public health representation and liaisons to the vaccine industry and professional associations; COPR includes patients, family members of patients, health care and education professionals and members of the general public who advise the Director of the NIH on “matters of public interest, outreach and participation in NIH’s research-related activities”; VRBPAC includes public and nonvoting industry representation. the development of the 1994 plan acknowledged that it did not serve as a central document for strategic planning among federal agencies. To help avoid important limitations of the 1994 plan, the committee urges NVPO to give special attention to the following points as it coordinates the development of update to the plan. 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. NVPO has stated its intention and the commitment of the interagency group involved in drafting the new National Vaccine Plan to prepare a national plan and not merely a federal plan.

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10 INITIAL GUIDANCE Box 1: On the Coordinating Role of NVPO (excerpt from the 1994 plan) Two formal mechanisms exist for coordinating Federal activity. The NVP Interagency Group includes those agencies with major vaccine-related responsibilities specifically mentioned in Public Law. 99-660, and the Interagency Committee on Immunization (ICI) includes all those Federal departments and agencies involved in immunization. . . . Each of these groups meets regularly to supplement day-to-day information exchange, and coordination, cooperation, and planning that is facilitated by the NVPO staff. In addition, the NVPO coordinates special cross- agency initiatives that are undertaken from time to time on specific topics of importance or other identified needs. (Source: NVPO, 1994: p. 49.) The committee is aware that the 1986 legislation for the National Vaccine Plan called for a plan to “describe how each of the various departments and agencies will carry out their functions in consultation and coordination” with NVPO and “in conformity” with priorities in the plan (NVPO, 1994: p. 60); see Box 1 for a description of NVPO’s coordinating role as provided in the 1994 plan. 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]arious entities participate in the process of guiding and coordinating NVP activities. For example, the National Vaccine Advisory Committee (NVAC) (composed of nongovernmental experts in vaccine development and immunization) provides overall advice on vaccine development and immunization, as specified under P.L. 99-660” (NVPO, 1994: p. 49). It is the committee’s understanding that NVAC will play an important role in the development of the update to the plan, by reviewing early drafts and contributing white papers developed by NVAC subcommittees or working groups (e.g., on vaccine finance, on vaccine safety). The statute does not mention the involvement of non-federal stakeholders, including the broad array described above. At the committee’s March 2008 meeting, however, NVPO described the vision of a national plan involving broad stakeholder input. The committee believes this vision is consistent with NVPO’s charge to “achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines” (Public Law 99-660, §2103 [300aa-3]), a charge that can only be met through the efforts of multiple stakeholders, in addition to those of the federal government. To develop a national plan, it will be important to give essential partners beyond federal agencies an early and meaningful role in framing the plan’s scope, goals, and objectives. Essential stakeholders in the U.S. immunization system include not only federal agencies but also the pharmaceutical industry, insurers, purchasers of health care services, health care providers, researchers in areas ranging from the basic sciences through health economics and health services research, state and local public health agencies responsible for vaccine delivery, schools and day care centers, foundations and other not-for-profit organizations, the mass media, and very importantly, a spectrum of the public, reflecting varying perspectives on the value of immunization (some, but not all relevant stakeholders are included in Figure 1). This IOM committee has been asked to engage a broad range of expert stakeholders around each of the four goals in the national vaccine plan at a series of workshops. However, the committee underscores the importance of including the full

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LETTER REPORT 11 array of interested and relevant stakeholders as early as possible in the process of developing the plan. The committee recognizes the role of NVAC, which includes stakeholder representatives, in contributing to and reviewing the draft update to the plan. Other options for involving stakeholders early in the process include obtaining advance input from all relevant federal advisory committees (most of which include consumer, state public health agency, and industry representation), and notifying participants at the IOM committee’s stakeholder meetings that the draft plan is fully open to stakeholder input.12 At the federal level, NVPO has already engaged many agencies within the DHHS, as well as the Department of Defense, the Department of Veterans Affairs, and the State Department (the U.S. Agency for International Development). Additional consideration, could be (if it has not already been) given to involving the Department of Homeland Security, the Department of Agriculture, and perhaps others. Despite its support for efforts to generate a more truly national plan, the committee recognizes that there are formidable barriers to achieving meaningful collaboration in this complex field where public health, medical, ethical, economic, societal, and individual objectives collide. Participation of all potential stakeholders would involve a wide array of potentially conflicting agendas, accountabilities, as well as regulatory, legal, and other limitations. Effective collaboration will be challenging to achieve even among federal agencies such as CDC, NIH, FDA, and HRSA, each of which has its own priorities, resource constraints, and culture. 2. A Plan that Is Used, Evaluated, and Updated Ideally, a national vaccine plan would serve as a critical reference and coordinating mechanism for federal agency strategic planning. It would also enable and sustain greater coordination among all stakeholders with a role in vaccine development, delivery, and policy. Empirical research in management shows that systematic evaluation leads to a higher likelihood of success in implementing strategic plans (Armstrong, 1982; Kaplan and Norton, 1992). The 1994 plan lacked activity milestones and specific role designations for initiatives, and it did not differentiate longer- and shorter-term outcomes to help measure plan success. 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) • Secondary participant(s) (government agency or other stakeholder) • Measurable short, mid, and longer term outcomes to assess success of the • initiative 12 The IOM committee will manage a process to capture and organize stakeholder input throughout the course of the study.

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12 INITIAL GUIDANCE Identification of costs and potential funding sources (e.g., professional • judgment budgets) to support pursuit of the initiative The plan also should include a timetable and process for regular updates that reflect the dynamic nature of the field. 3. Facilitating and Sustaining Stakeholder Participation in Plan Implementation The 1994 plan does not appear to have been coordinated with related efforts that were already under way when it was being developed, such as Healthy People 2000, or to have been a reference point for subsequent efforts, including Healthy People 2010. 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). Obtaining input from a broad range of stakeholders, including the public, as described in (1) above, should be followed by finding ways to encourage and motivate continued involvement of those stakeholders. One way to accomplish this is to link the plan with other national plans, and the committee understands that an effort has begun to consider ways to coordinate with the Healthy People 2020 process. Recommendation 2: The committee recommends that NVPO and its partners identify specific and creative strategies (not limited to funding) that federal agencies and programs could use to motivate stakeholders to implement objectives in the national vaccine plan. Examples include linking various types of grant programs to the plan (e.g., in announcing • vaccine-related research grants, require applicants to explain how the proposed research relates to or advances a goal or objective of the plan); and asking recipients of other types of federal funding, such as vaccine funding for • states, federal health financing programs (Medicare and Medicaid) or health care delivery programs (Federally Qualified Health Centers), to demonstrate that their activities promote plan objectives. 4. Making Explicit What Was Important in Developing the Plan A plan cannot and should not offer to take every possible action to achieve a goal, and it should not be simply a wide-ranging collection of planned activities or a list of desired activities. The committee believes it is important that NVPO and its planning partners explain in the draft update to the plan the process by which priorities and objectives in the plan were selected. Ideally, a plan will aim to address a well-targeted set of major strategic issues, such as considering the relative opportunity cost and cost– benefit of pursuing one type of objective compared to another. A second important aspect of the process would involve identifying cross-cutting issues that require the attention and engagement of multiple federal agencies, as well as multiple stakeholders.

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LETTER REPORT 13 Recommendation 3: The committee recommends that NVPO and its partners explain in the draft update to the National Vaccine Plan13 what was important to include and why, and the process by which items were selected for inclusion or discarded. Content Areas The committee noted some important omissions in the 1994 plan and identified several emerging areas and changes in context that will require attention in a major national document on the future of vaccine development and immunization. NVPO’s initial work on the update to the National Vaccine Plan identified 13 topics of interest (Orenstein, 2008). 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. The committee agrees that many of these topics deserve attention in the updated plan, but is not commenting on all of them here. Specific guidance is, however, offered on two topics that NVPO has already identified: vaccine finance and communication. On the pages that follow, the committee highlights these and four additional topical areas it believes are important to consider in developing the update to the plan. 1. A Flexible Immunization System Capable of Responding to Innovation in the Development and Use of Vaccines In the last several years, the use and purpose of vaccines has broadened to include new populations, new applications (e.g., exploration of therapeutic vaccines), and new technologies (e.g., introduction of new modes of delivery or combination vaccines, research on adjuvants to extend available vaccine doses). The science, technology, and use of vaccines continue to evolve. These changes will require flexibility and adaptability in the existing mechanisms for vaccine delivery, finance, communication about vaccines, and so on. For example, implementation of the ACIP recommendation for universal annual influenza immunization in children exceeds the current capacity of the health care system to administer the vaccine to all relevant populations. Another example is found in the introduction of an HPV vaccine as a means for cervical cancer prevention, which has presented new communication and coverage challenges. Recommendation 4: The committee recommends that NVPO and its partners include in the update to the National Vaccine Plan mechanisms to assess the “horizon” of innovation and new developments in vaccines, and explore strategic objectives or initiatives that enable timely consideration of and decision making to address emerging opportunities and challenges. 13 Refers to the draft (or components thereof) that will be reviewed by the IOM committee and stakeholders.

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14 INITIAL GUIDANCE 2. Vaccine Financing The mechanisms that the nation employs to finance the purchase of vaccines, and their deployment to and administration in clinical settings are central to national planning efforts, particularly for more costly new vaccines. 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. As one example, no mechanism currently exists for ensuring that new adult vaccines recommended by ACIP will be accounted for in existing public funding sources in a timely way to ensure use of these vaccines on the large scale needed to support national disease prevention goals. Another recent example, which points to the importance of a national strategic focus on the intricacies of vaccine financing and how best to structure an effective payment approach, is the case of Medicare beneficiaries’ experience with the varicella- zoster vaccine. Medicare vaccine coverage now spans both Medicare Part B (medical care) and Part D (outpatient prescription drugs), which employ different approaches to coverage and payment. Part B treats payment of covered vaccines as an ancillary clinical service. This means that the treating clinician can accept assignment of the benefit and bill directly for the vaccine and its administration fee. However, Medicare Part B covers only certain specified vaccines (against hepatitis B, influenza, and pneumococcal pneumonia). The Part D prescription drug program remedies this shortcoming by entitling enrolled beneficiaries to coverage of recommended vaccines not covered under Part B (Whitman, 2008). At the same time, however, Part D is not structured to operate as a means of financing provider- administered drugs and biologics; indeed, providers are barred from billing for services. As a result, a Medicare beneficiary enrolled in Part D must go through an unusually complicated series of steps to gain access to vaccine coverage for a new and important vaccine such as the varicella-zoster vaccine. The physician must prescribe varicella- zoster vaccine before the patient’s visit, and the patient then must procure the vaccine and bring it to the physician’s office to be administered. Medicaid also deserves national attention because of its importance in closing the health gap between the richest and poorest Americans. Coverage of immunizations under Medicaid is an option in the case of beneficiaries ages 21 and older. A 2003 study conducted for CDC documented that immunization coverage at ACIP recommended levels is far less than universal for non-institutionalized adults, with only 32 states offering such coverage (Stewart et al., 2003). Adult immunization objectives would be reached more widely if state Medicaid agencies had available to them more active guidance on the value of adult immunization coverage, and tools for coverage and

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LETTER REPORT 15 payment options (including the use of replacement programs for the adult immunization supply). 3. Focus on Disparities in Access to Vaccines Access to immunization is an issue closely linked with vaccine financing. The 1994 plan did not include a focus on disparities—whether socioeconomic or ethnic disparities—in access to vaccines, and the committee believes it is important to consider this area in drafting the update to the plan. Innovations in vaccine research and development have led to the availability of several new vaccines (e.g., HPV vaccine, meningococcal conjugate vaccine, varicella- zoster vaccine). However, the growing number and cost of new vaccines in recent years have resulted in significant financial barriers and subsequently reduced access to newer vaccines now available for both children and adults. Although VFC (Vaccines for Children) has made vaccines available to the uninsured, there are still formidable barriers to access to care (including for Medicaid patients) and to some vaccines for the underinsured. The VFC program has been remarkably successful in ensuring access to new vaccines for children who are uninsured, Medicaid insured, or Alaskan Native or American Indian. 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. If underinsured children are seen in a private provider’s office, they must pay out-of-pocket for the cost of newer, more expensive vaccines or go to public health clinics to receive these vaccines. Of grave concern is the inability of some states to provide these vaccines even in public health clinics due to limitations in federal and state financing (Lee et al., 2007). This greatly limits timely access to new vaccines and perpetuates the personal, societal, and economic costs of these diseases. 4. Communication as a Key Component of Vaccine Policies and Practices A growing proportion of the public (and health care professionals) are uncertain about the benefits and the safety of vaccines and recommended immunization practices (Poland and Jacobson, 2001). Such concerns have resulted in underimmunization, disease outbreaks in the United States, and sustained transmissions of vaccine-preventable disease in other countries. These facts indicate that developing communication strategies to support immunization objectives requires understanding the beliefs and values of intended audiences. To understand all the dimensions of the public’s decision making about vaccines, it is necessary to examine the gaps between what the experts perceive as risks and benefits, and what members of the public perceive to be the risks and benefits of vaccines. This work, informed by research in communication and the social sciences, is needed to (1) develop strategies to mitigate misinformation and to communicate messages relevant to the prevalent concerns, and (2) provide people with the information they need in language they understand to help them make informed decisions.

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16 INITIAL GUIDANCE Recommendation 5: The committee recommends that the update to the National Vaccine Plan include a comprehensive framework for communicating with the public and other key stakeholders such as health care providers about the benefits (both individual and community) and risks of vaccination. Communication strategies that are implemented should be evaluated for their effect on knowledge and behavior. Such a framework could include strategies to communicate at every stage of a vaccine’s lifecycle (i.e., not only at the time of FDA approval and ACIP recommendation), an emphasis on two-way communication with the public and health care providers, and strategies to incorporate the best available scientific evidence (e.g., on human behavior and decision making) and a range of communication approaches (social marketing techniques, use of targeted strategies to provide information to people who search the World Wide Web for immunization or vaccine information, etc.). Other strategies could include training key spokespersons (e.g., top scientists and others who are not communication professionals) on effectively communicating with the media regarding vaccines and immunization. 5. Vaccine Supply Issues as a Barrier to Achieving Optimal Coverage In the year after the 2000 FDA approval of the 7-valent pneumococcal conjugate vaccine, and subsequent ACIP recommendation for universal childhood use of the vaccine, the supplier announced a shortfall in supplies (CDC, 2001). CDC published interim recommendations that called for reserving the vaccine for certain groups of children. This example illustrates one of several possible causes of inadequate vaccine supply, which also may be caused by “companies leaving the vaccine market, manufacturing or production problems, and insufficient stockpiles” (CDC, 2008). New state-of-the-art vaccine production and inventory management techniques have greatly increased the efficiency and profitability of vaccine manufacture in the United States, but they have also exacerbated the nation’s vulnerability to vaccine supply shortages. For example, “just-in-time” business practices (i.e., deliberately reducing inventory levels and delivering products only on an as-needed basis) discourage stockpiling (Wysocki and Lueck, 2006). They may create the incentive to under-produce (which could potentially lead to shortages), and they lead manufacturers to move production facilities to locations outside the country (potentially raising concerns about supply and complicating FDA oversight). In presentations at the committee’s March 2008 meeting, NVPO identified supply issues as a priority area. 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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LETTER REPORT 17 Exploring the costs and benefits of shifting from a just-in-time to a just-in-case approach (Wysocki and Lueck, 2006), and the use of incentives, cost-sharing contracts, accounting rule modifications, and other mechanisms to align societal public health objectives with private manufacturing choices are among many areas that warrant more research and innovation. 6. Changes in the Global Context As noted above, it has become nearly impossible to neatly separate domestic and global vaccine issues because of porous borders and emerging infectious diseases on the one hand, and the global vaccine marketplace on the other hand. The committee believes it is important that drafters of the update to the National Vaccine Plan pay special attention to the evolving global vaccine and immunization issues, in particular to industry views of the global marketplace as a more viable market for their vaccine products than the United States (Milstien et al., 2006). There is current tension between developing products for the U.S. market and focusing on global needs. For example, different serotypes of a disease-causing agent may be prevalent in different geographic areas, and some vaccines are developed to target serotypes found in the United States and exclude those that affect developing countries (Cutts et al., 2005; Klugman et al., 2003; Milstien et al., 2006). 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. Based on the committee’s review of the 1994 plan and the process to develop it, and our knowledge about changes since 1994, we identified four process and six content areas to bring to NVPO’s attention. The committee also made six recommendations. The committee underscores the preliminary nature of the guidance provided in this letter report. The committee’s continuing work, including reviewing the evidence and receiving the input of national stakeholders, will form the basis for more detailed recommendations on priorities in the update to the National Vaccine Plan. The committee thanks you for the opportunity to assist the National Vaccine Program Office as it coordinates the drafting of the update to the National Vaccine Plan. Claire V. Broome, Chair Committee on the Review of Priorities in the National Vaccine Plan

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