Effectiveness in achieving the goals of the National Vaccine Plan requires (1) agreement on a shared purpose and vision among all relevant government entities and stakeholders, and (2) coordination of the complex network of actors and activities needed to achieve this goal.
As the committee noted in its June 2008 letter report,1 it is impossible to evaluate the effect of the 1994 plan (HHS, 1994) because it had few measurable objectives and was largely a collection of short-term activities that were part of agency strategic plans and were scheduled to occur regardless of the National Vaccine Plan. Also, by many accounts, the 1994 plan developed by the National Vaccine Program Office (NVPO) with input from other agencies in the Department of Health and Human Services (HHS) was shelved (IOM, 2008). It was neither designed to be nor played the role of a “living” strategic document, and was not updated or evaluated as required by the 1986 law2 that called for a National Vaccine Plan.
The committee’s charge did not explicitly mention the matter of coordination. However, coordination is at the heart of the National Vaccine Plan purpose, which is “to promote achievement of the National Vaccine Program mission by providing strategic direction and promoting coordinated action by vaccine and immunization enterprise stakeholders” (HHS, 2008:8). For this reason the committee found it difficult to separate the goals and the priorities identified for the plan from the question of how coordination on these matters could be accomplished. Additionally, in a letter to the Institute
Full letter report available in Appendix D.
National Childhood Vaccine Injury Act, Public Law 99-660, 42 U.S.C. 300aa-1, § 2101 1986.
of Medicine (IOM) committee (provided in Appendix B) the National Vaccine Advisory Committee (NVAC) urged the IOM committee to comment on NVPO’s coordinating role with regard to the National Vaccine Plan, including interagency and interdepartmental coordination and coordination with external stakeholders.
In this chapter, the committee examines what it considers the inextricable link between NVPO’s effectiveness to coordinate and the plan’s success, and develops the rationale for strengthening NVPO to ensure successful implementation and maintenance of the National Vaccine Plan as a tool for coordination on critical issues in the national vaccine program.3 This chapter also discusses several case studies that illustrate the effects of a lack of coordination: unmet challenges and unmet statutory responsibilities.
COORDINATION: ESSENTIAL TO PLAN SUCCESS
The IOM committee received input from multiple stakeholders on NVPO’s role, authority, and resources and its ability to coordinate on communication and research prioritization (IOM, 2009a,b,c). NVPO’s role and effectiveness also have been reviewed and discussed by Cooper et al. (2008), and were the subject of an evaluation conducted by RAND Corporation. RAND found that NVAC’s role and effectiveness have suffered as a result of the fact that NVPO is underfunded and understaffed (Ringel et al., 2009).
The committee believes that coordination will not occur in areas where it is needed in the absence of a federal entity that can support it, and that the 1986 National Childhood Vaccine Injury Act (NCVIA) defined such an entity and outlined its responsibilities. NVPO was established to comply with the act but has not been given the opportunity to play the crucial role described in the statute (i.e., “coordinate and provide direction” to relevant government agencies in several areas of the National Vaccine Program).4 It was not given the resources described in the act or the authority needed to motivate and facilitate coordination on major challenges facing the U.S. immunization effort in the past two decades.
Public administration literature on interorganizational coordination
offers several concepts that may be useful to understanding the role and potential of NVPO. The National Vaccine Program is an interorganizational network—a set of federal organizations linked by common purpose in relationships that vary in strength and complexity (Provan et al., 2007). The literature describes entities such as NVPO as network administration organizations (Provan et al., 2007) or as coordinating units (Alexander, 1993). These terms refer to entities created expressly to support and facilitate coordination and collaboration among the organizations in a network; these entities generally do not have any “line” functions and are not responsible for implementing any of the tasks they are charged with coordinating (Alexander, 1993). However, entities charged with facilitating interorganizational coordination have the potential to be powerful and effective under certain conditions. Notably, a balance of authority and resources is needed to enable such entities to be effective—“If it has decision-making power but lacks implementation resources, the coordinating unit may suffer a ‘crisis of competence;’ if it controls resources but lacks authority, it may encounter a ‘crisis of legitimacy’” (Alexander, 1993:337). As discussed in this chapter and elsewhere in the report, NVPO has neither sufficient authority to “coordinate and provide direction”5 nor resources to accomplish its statutory responsibilities and optimally support the various roles it plays as a coordinator both within government and with stakeholders.
Interorganizational networks use a variety of formal and informal tools to facilitate coordination, including agreements, contracts, and plans (Alexander, 1993; Graddy, 2008; Provan et al., 2007). The coordinating tool for the National Vaccine Program is the National Vaccine Plan, but as noted in this report, it has been underused.
The need for high-level coordination in important areas of the National Vaccine Program has been noted by a Congressional Research Service report that described the large group of federal agencies with roles in vaccines and immunization but noted that “[t]here is no central federal authority for vaccine policy” (Thaul, 2005),6 and has been noted repeatedly by NVAC (NVAC, 2009; Appendix B). Over the years, there have been efforts at different levels to coordinate the actions of government agencies responsible for vaccine and immunization policies and programs. The large and complex network of government agencies and diverse stakeholders understandably requires a variety of mechanisms, processes, and groups to achieve some shared goals. Examples of prior or existing entities created within the National Vaccine Program include the Interagency Vaccine Group, an ongoing activity, and the Task Force on Safety of Childhood Vaccines, a temporary group that produced an important report on vaccine safety (NIAID, 1998).
Similarly, each government agency undertakes its own internal efforts to coordinate activities and ensure efficient and satisfactory achievement of its own strategic plans, budgetary imperatives, and commitments to constituencies.
It is apparent that the responsibilities of the National Vaccine Program described in the 1986 statute do not refer merely to ad hoc interorganizational committees or other informal and often temporary structures for coordination (called interorganizational groups in the public administration literature [Alexander, 1993]). The law clearly describes a central coordinating unit with its own budget, staff, and scope of work separate from those of federal agencies concerned with vaccines and immunization, and NVPO was clearly established to be that entity. Below, the committee summarizes some of the differences between interorganizational groups (in this case, the Interagency Vaccine Group) that arise within networks such as the National Vaccine Program, and coordinating units, such as NVPO, that are created, resourced, and empowered specifically to facilitate coordination (see Table 6-1).
Why Authority and Resources Are Needed
What then is the nature of structural arrangements that are likely to be associated with inter-organizational effectiveness? First, a clear delineation of roles and responsibilities is critical for effective collective action. Transaction costs decline and uncertainty is reduced when the roles of constituent parties are clearly delineated. In addition, some mechanism must direct resources to collective activities, rather than individual organizational goals. (Graddy, 2008)
NVPO’s authority to facilitate and even compel coordination in areas of great importance to the success of the National Vaccine Program was never clarified, and the office has struggled to reach its full potential. NVPO is located in the Office of Public Health and Science, which is led by the Assistant Secretary for Health. It seems that soon after the act was signed into law by an administration that had “grave reservations” about it (Reagan, 1986), the National Vaccine Plan and the statutory requirement for a process of implementing, assessing effectiveness of, and periodically updating the plan ceased to be a priority for HHS leadership. Over the following two decades, NVPO’s budget to support coordination never reached even the baseline established by the 1986 act (see Introduction for additional information).
In 1986, the Assistant Secretary for Health had line and budgetary authority over the agencies of the Public Health Service (PHS). Following major changes in the composition of the department in the 1980s and 1990s, authority over the PHS agencies was transferred to the Secretary of HHS and the Assistant Secretary for Health was named primary advisor to the Secretary on public health matters (HHS, 2009). Some attribute the
TABLE 6-1 Comparison of Two Types of Coordinating Mechanisms at HHS
a Centers for Disease Control and Prevention.
b National Institutes of Health.
c Food and Drug Administration.
d However, some of the agencies represented have their own federal advisory committee.
challenges faced by NVPO to the shift in the role of the Assistant Secretary for Health, but it is unclear whether that is the case. The committee believes that a structural change is not necessarily an appropriate solution for an operational problem. The Assistant Secretary for Health represents the Secretary. Therefore, a strong secretarial endorsement of NVPO and the National Vaccine Plan, conveyed through the Assistant Secretary as a departmental policy and priority, and a forceful call for the full participation of relevant HHS agencies would be sufficient to clarify NVPO’s authority and the plan’s relevance.
Information gathered for a 2009 review of the effectiveness of NVAC
in fulfilling its role as advisors to the National Vaccine Program and its Director (the Assistant Secretary for Health) included input from former and current members of NVAC, and NVPO’s lack of resources and adequate staffing was a frequent theme of key informant interviews (Ringel et al., 2009). The review also included references to areas where NVPO expertise could be strengthened, such as communication.
Effects of the Gap in Coordination
Evidence of the need for a higher level of coordination and an effective coordinating entity may be found in two areas: (1) unmet challenges and (2) unmet statutory responsibilities described by the 1986 act.
First, the need for alternate production methods for influenza vaccine (such as cell culture) has been recognized for decades, but manufacturers continue to rely on egg-based vaccine production nearly seven decades after development of the first influenza vaccine. Significant progress in the direction of cell-based vaccine was not made until the emergence of the 2009 influenza pandemic and the critical need to increase vaccine production capacity. Although many factors contributed to maintenance of the status quo, one can postulate that a coherent effort led by NVPO could have encouraged targeted research funded by the National Institute of Allergy and Infectious Diseases (NIAID) to undertake the necessary initial studies. Strategic approaches to licensing alternate production methods would need to engage the Food and Drug Administration (FDA), but would also need to consider financial incentives. As an example, companies currently have little or no incentive to invest the very substantial financial and personnel resources needed to apply for licensure of a new production method when the current method is viable.
Pandemic influenza also provides a positive example regarding the utility of NVPO coordination. The emergence of H1N1 has occasioned a newly heightened profile for NVPO that has filled the gap of limited coordination among the various government agencies, including FDA, CMS (Centers for Medicare & Medicaid Services), CDC (Centers for Disease Control and Prevention), and the Department of Defense, responsible for managing some aspect of H1N1 vaccine safety. NVPO convened an interagency working group to ensure coordination and collaboration on safety protocols related to the 2009 H1N1 pandemic influenza vaccine and is providing a crucial convening function and serving as a clearinghouse for all safety information
related to the new vaccine.7 With regard to the H1N1 pandemic influenza vaccine effort, NVPO’s potential as a coordinating entity has blossomed. The Assistant Secretary for Health and the Assistant Secretary for Preparedness and Response have shown support for NVPO in letters to NVAC and comments made at meetings. It is important to ensure that this example of NVPO’s potential does not remain a rare exception and that it is not dependent on the support or goodwill of specific individuals or officials. The full support and imprimatur of the Secretary of HHS is needed to clarify NVPO’s authority.
Second, communication about vaccine safety issues—clarity and transparency about the safety system, including areas of uncertainty—has been a consistent challenge that has not been appropriately met. By calling for a coordinated national strategy for vaccine communication and its well-resourced implementation, the National Vaccine Plan and coordination by NVPO can help guide public health communication about vaccines and immunization toward greater transparency, sophistication, and cohesion. The public engagement efforts conducted by CDC and increasingly, by NVPO, illustrate one positive area of vaccine communication, where efforts are made to bring together the public health and medical communities with groups opposed to vaccines (and others whose concerns about vaccine safety inform their refusal of some or all vaccinations).
Third, in Chapter 1 the committee discussed the need for a periodic, systematic process for prioritizing candidate vaccines and recommended more coordinated research and development of priority vaccines. The committee asserts that enhanced coordination by a stronger and better resourced NVPO may have supported the establishment and maintenance of such a process sooner. Such an action could have led to better alignment of basic research with public health and other needs for specific vaccines. As further discussed in Chapter 1, pharmaceutical research has made advances in identifying compounds that may enhance immune response to a vaccine. These compounds, called adjuvants, may be added to a vaccine or may be administered concurrently with a vaccine, and effects of their use may include needing less antigen in the vaccine and better immune response in the elderly and newborns (Aguilar and Rodríguez, 2007). Due to several regulatory and scientific obstacles, the United States has been slower to evaluate and license vaccines containing adjuvants other than alum. Novel adjuvants may pose novel safety concerns, but they also may hold great promise with their potential to lessen the amount of antigen needed and to strengthen immune reaction and therefore, vaccine effectiveness, in older adults. The committee asserts that enhanced coordination by a stronger and better resourced NVPO might have contributed to more rapid resolution of
scientific and regulatory questions (including concerns about the safety of adjuvants) and integration of adjuvants into U.S. vaccines. As an example, one of NVPO’s responsibilities is a convening role. Through the membership of NVAC, NVPO is uniquely able to engage industry representatives with other stakeholders. NVPO and NVAC have convened meetings and developed proceedings and reports on several matters of relevance to the future of the vaccine industry. These included the 2000 Workshop on Aluminum in Vaccines, which included a call for research on new adjuvants (Eickhoff and Myers, 2002).
Statutory Responsibilities That Have Not Been Met
The 1986 NCVIA charged the National Vaccine Program, and thus NVPO, to provide supplementary funding to government agencies (e.g., CDC, NIH [National Institutes of Health], FDA) to implement the National Vaccine Plan.
The Director of the Program shall make available to Federal agencies involved in the implementation of the plan8 issued under section 2103 funds appropriated under section 2106 to supplement the funds otherwise available to such agencies for activities under the plan. (Public Law 99-660, Title XXI, Subtitle 1, Section 2102:3757)
Section 2106 of the act authorized the appropriation of $20 million dollars in the first year of the program’s existence (projected to be 1987, but NVPO did not come into existence until 1991), with annual increases of $2.5 million. This level of funding was never allocated to NVPO, and as described in the introductory chapter, NVPO’s funding decreased sharply for several years, and then increased to its current, modest level of just under $7 million (House of Representatives, 1995). As a result of its limited funding and staffing, NVPO’s ability to “coordinate and provide direction” in the areas outlined by the act has been hampered, resulting in the missed opportunities described above.
FACTORS CONTRIBUTING TO THE PROBLEM
There are several factors that contribute to the problem of an inadequately supported NVPO, a National Vaccine Plan that was not updated, and a series of major and persistent systemic challenges (including the unmet challenges described above) that have not been addressed sufficiently. Factors include (1) statutory limitations, (2) inadequate funding and staff resources for NVPO, (3) vaguely defined responsibilities for NVPO, and (4) resistance from other agencies and inertia.
First, the 1986 act is limited in two ways. Its existence alone will not ensure that the activities described will be accomplished. Attention and support at the departmental level is necessary. Further the act itself lacks any built-in incentives for the department to support the formal structure for coordination it describes, to attract the relevant agencies to work with NVPO as the coordinator, and to actively participate in developing an actionable and measureable (in terms of outcomes in disease prevention, innovation, and efficiency and effectiveness in the delivery of immunization services) plan, which is needed to ensure the plan’s success.
Second, NVPO’s funding and staff resources are not adequate to support its coordinating role. At the time this report was written, NVPO had a staff of five and a budget of $6.9 million for FY2009. The budget covers the FTEs (full-time employees) and program activities, including the Strategic Issues in Vaccine Research Program (SIVR, known before 2007 as the “unmet needs fund”) that has provided competitive, peer-reviewed grants to HHS agencies and academic researchers. According to NVAC meeting materials from 2005 and 2006 (the most recent information about the program that is publicly available), the research fund supported projects totaling approximately $4-5 million dollars (NVAC, 2006; Schwartz, 2005, 2006). The minutes from a 2007 NVAC meeting include the following description of 2007 funding disbursed by the program:
A total of 31 projects were funded from a pool of over $4 million, with an average award of $129,000. Of these projects, 19 were continuation projects in one of the previous year’s priority topic areas, and 12 projects are new proposals in one of the 5 priority areas for 2007 established with NVAC input: Vaccine safety, adolescent vaccination, vaccine economics and financing, public engagement, and improved diagnostic tests for vaccine-preventable diseases (VPDs). Notably, nine of the new projects included interagency collaborations, a real success of the program. (NVAC, 2007)
The SIVR program is a unique mechanism for dispersing funding to conduct research that may not be supported by other federal agencies to advance vaccine research. (This is consistent with provisions in the 1986 act that called for specific funds to “supplement the funds otherwise available to such agencies for activities under the plan” [Public Law 99-660, 42 U.S.C. 300aa-6].) It is also noteworthy that collaborative interagency projects funded by the program constitute a concrete and potentially fruitful way to facilitate collaboration on critical issues.
Third, NVPO’s role is vaguely defined. On NVPO’s website, its role is described as “coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. The NVPO provides leadership and coordination among Federal agencies, as they work together to carry out the goals of the National Vaccine Plan” (NVPO, 2009). The website lists the following NVPO functions:
Coordinate and integrate activities of all federal agencies involved in immunization efforts,
Ensure that these agencies collaborate, so that immunization activities are carried out in an efficient, consistent, and timely manner,
Develop and implement strategies for achieving the highest possible level of prevention of human diseases through immunization and the highest possible level of prevention of adverse reactions to vaccines, and
Ensure that minimal gaps occur in federal planning of vaccine and immunization activities.
The committee believes that NVPO is capable of playing several very specific roles in fulfilling its statutory responsibilities, some in conjunction with and in support of NVAC. Some of these roles are currently part of NVPO’s scope of work but can be considerably strengthened and expanded. Others are consistent with statutory framework provided by the 1986 law and denote areas of potential NVPO activity. These roles include
Facilitating expert guidance on emerging issues characterized by high level of uncertainty, unfolding in real-time, and requiring rapid response,
Public engagement on major topics in vaccines and immunization,
Convening a diverse range of stakeholders to discuss complex challenges in the field,
Funding certain types of research through its fund for the SIVR program (proposals are peer-reviewed by NVAC),
Assisting in the formation of communication strategy and coordinating department-level/interagency messages to the public about vaccine issues,
Through NVAC, providing a unique forum in which industry representatives can fully participate, and
Spotlight special critical issues (examples include the measles White Paper that represented an analysis of system failures leading to the measles epidemic of 1989-1990 [NVAC, 1991], influenza vaccine shortages, and topics in vaccine research and development) and effectively communicate them to diverse audiences including the public.
NVPO’s functions would not involve micromanaging or second-guess-ing specific aspects of vaccine regulation or research spearheaded by other agencies. PHS agencies (e.g., CDC, FDA, NIH) have their own strategic plans, agendas, priorities, and budgets. NVPO’s coordinating role would be limited to issues of a high (policy) level and great importance that require joint action and input or assistance from the stakeholders.
Finally, as it is frequently noted, everyone likes coordination but no one
wants to be coordinated. Given NVPO’s lack of authority and resources that could serve as incentives for agencies to work together on specific issues, it seemed apparent to the committee that there has been some understandable resistance by various agencies to become fully involved in the type of coordination described in the 1986 act. For example, the committee heard at its first meeting in March 2008 that because agencies’ primary commitments are to their mission and their own strategic plans, that will inevitably affect how they will view a call to interagency coordination (IOM, 2008). The committee also heard statements suggesting that government collaboration may be most effective and productive:
in response to a crisis (e.g., SARS, H5N1, and current H1N1 experience); and
when there is a congressional mandate, as was the case with the successful effort to accelerate acellular pertussis vaccine development that involved NIH/NIAID, FDA, and support from NVPO (Klein, 1995).
Although sympathetic to the intense challenges and demanding agendas that face federal agencies, the committee believes that NVPO can and should be more proactive in assuming responsibility for implementation of the National Vaccine Plan, and the agencies more receptive to NVPO’s coordination than has been the case in the past. The committee asserts that a fundamental contribution of an effective strategic plan for coordination is that it positions partners (e.g., agencies and stakeholders) both to be proactive and to be strategically and synergistically reactive. The challenging contemporary environment on matters related to vaccine communication and vaccine safety is something akin to a crisis that in the committee’s view warrants collaboration and coordination. Also, limited high-level support for NVPO and the plan as evident in inadequate funding of the office and in the 14 years that passed between the first and second plans, the lack of clarity about NVPO’s functions and relationships with agencies, and the lack of a clear vision in the draft plan may all contribute to agency reluctance to fully participate in the plan.
FIXING THE COORDINATION GAP
Although coordination is not always possible, or even necessary, there are areas where it is critical. For example, using a vaccine research agenda to spur the efficient development of priority vaccines requires coordination at a high level. Building a structured way of identifying and addressing emerging safety information, where appropriate, useful, and realistic, requires input from multiple agencies and external stakeholders. Each agency has its own fairly distinct responsibilities in the area of vaccines and vaccination, but
there are areas where it is important to ensure cost-effective use of finite funds available to the federal government and to address redundancy and duplication of effort. There also are areas where one agency’s efforts are not enough to reach an important goal, and where coordination between the federal government and stakeholders is necessary.
Based on its information-gathering, including input from national stakeholders, and on its review of the evidence, the committee believes that the absence or gap at the heart of the nation’s vaccine program is at least a partial hindrance to addressing some of the most important challenges facing the program, including addressing public concern about the safety of vaccines, taking full advantage of the national health information technology effort (to support the data and scientific needs of the immunization program), and ensuring that the national effort to transform health care strengthens the availability, quality, and access to immunization services.
The committee asserts that because vaccines and immunization constitute a major public health matter that involves multiple government agencies and has great importance to the public’s health, an effective coordinating entity is needed, and effectiveness is dependent on authority and funding commensurate with the task at hand. A strengthened NVPO could play the role intended by the 1986 statute in coordinating the nation’s actions related to vaccines and immunization. As described in this and previous chapters, coordination could occur in several ways and may involve NVPO in extending, amplifying, or complementing the functions of other HHS agencies with vaccine-related responsibilities by serving as a convener of effective, action-oriented9 meetings; a resource for strategic planning and evaluation; a funding source for strategic topics in vaccine research (i.e., the SIVR program); and as a better resourced secretariat to support the activities of NVAC. Because it is not part of CDC, NIH, FDA, CMS, or the Health Resources and Services Administration, NVPO occupies a somewhat independent place in the program and has a unique vantage point. Given adequate authority, staff, and funding, it could cultivate its ability to develop the potential afforded to it by that vantage point. An example of NVPO’s potential as promoter of interagency coordination may be found early in its history. In 1991, 3 years before its funding and staff were sharply reduced, NVPO provided 8 FTEs and almost $1.9 million to FDA, and that support resulted in development of a safer pertussis vaccine and other vaccine-related activities (IOM, 1993). A contemporary example of NVPO’s potential may be found in the assignment to and evolving responsibility of NVPO to coordinate a national response in the monitoring of H1N1 vaccine safety.
Recommendation 6-1: The Secretary of HHS should actively demonstrate the Department’s support for the National Vaccine Plan by:
clarifying its primacy as the strategic planning tool applicable to all federal agencies with roles in the National Vaccine Program, and
allocating the resources necessary to assure robust planning and implementation, with coordination by the National Vaccine Program Office.
It is important to note here that a plan is a paper document that cannot mobilize action or facilitate coordination by simply being. A stronger, well-resourced NVPO is needed to breathe life into the plan, facilitating initial coordination necessary to bring agencies and stakeholders to the table to finalize and implement the plan, and overseeing the periodic updating of the plan and evaluation of what is achieved.
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