The National Vaccine Plan is required by Title III in the 1986 National Childhood Vaccine Injury Act (NCVIA).1 A plan was first released in 1994 and was updated by a draft plan issued in November 2008 (HHS, 1994, 2008). The National Vaccine Program Office (NVPO), located in the Office of the Assistant Secretary for Health in the Department of Health and Human Services (HHS), solicited broad input from stakeholders, including the public, when drafting the plan. NVPO also asked the Institute of Medicine (IOM) to convene a committee to “prepare first a letter report2 on its review of the 1994 plan” and then to prepare a “report with conclusions and recommendations about priority actions within the major components of the draft new plan” (see Box S-1).
This report, Priorities for the National Vaccine Plan, aims to identify a set of actions the committee believes merit primary attention as NVPO and its partners finalize and implement the National Vaccine Plan. Strategic plans typically linked with budgets and resources are rarely sufficient to support every activity that planners may consider important and needed. Although the 2008 draft plan does not provide information about the potential costs of implementing its objectives and strategies, the committee defined “priority actions” as actions that take precedence among many competing claims for resources. The committee made 18 recommendations about “priority actions” distributed among the plan’s five goals, and two additional recommendations, one of which refers to the scope of the National Vaccine Plan
The Charge to the Committee
The federal government issued “Disease Prevention through Vaccine Development 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.
and another that reflects NVPO’s role as a crucial ingredient in implementing the plan and ultimately ensuring that its objectives are achieved.
Vaccination is a fundamental component of preventive medicine and of public health practice. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The contemporary national vaccine program3 is extraordinarily complex in all aspects, from research and development of new vaccines to financing and reimbursement of immunization services. As a medical product, preventive vaccines occupy a unique niche because they are given to healthy individuals, they are purchased in large volume by the federal government as part of the Vaccines for Children entitlement program, and government public health agencies at the federal and state level make policy decisions about how best to use vaccines to protect the public’s health. Similar considerations inform policy for global vaccine efforts.
In the latter part of 2009, the political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding,
and administering safe and effective vaccines for all people. The Introduction highlights key issues in the health care delivery system and in society, and also comments on the significance of the evolving 2009 novel H1N1 influenza pandemic.
THE HISTORY OF THE PLAN
The NCVIA called for the Secretary of Health and Human Services to serve as the director of the National Vaccine Program,4 for a plan outlining the activities of the program to be updated annually,5 an advisory committee to provide guidance to the secretary and the program, and a budget to support specific types of program activities. The act also listed nine responsibilities for the program and its director (Public Law 99-660, Title XXI, Subtitle 1, Section 2102):
Safety and efficacy testing of vaccines
Licensing of vaccine manufacturers and vaccines
Production and procurement of vaccines
Distribution and use of vaccines
Evaluating the need for and the effectiveness and adverse effects of vaccines and immunization activities
Coordinating governmental and non-governmental activities
Funding of federal agencies
Although the National Vaccine Program has had some great successes and there have been examples of effective coordination, neither NVPO (whose stated work is to provide “leadership and coordination among Federal agencies, as they work together to carry out the goals of the National Vaccine Plan”) nor the plan have functioned as intended in the 1986 legislation. This report includes several case studies that illustrate gaps or limitations in the program’s ability to perform important functions without the benefit of a strong, capable, and adequately resourced NVPO. These issues
and some of the reasons NVPO has never become what it was intended to be are discussed in Chapter 6.
GENERAL COMMENTS ABOUT THE 2008 DRAFT PLAN
The committee found that the lack of a coherent vision in the draft plan may be linked with an apparent sense of ambiguity about whether the plan should serve as (a) a collection of ongoing and planned activities that many agencies are already undertaking followed by an assessment of accomplishments at a later date; or (b) a list of critical needs and gaps that require coordinated attention by specific agencies or combinations of agencies and stakeholders; or (c) both a and b? A vision statement could resolve this ambiguity and guide the plan’s drafters, and the stakeholders who contribute to and will help implement the plan, in identifying the plan’s desired outcomes.
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 accomplished in the near future, and activities that are novel, not necessarily represented in any other planning document, and require multi-sectoral coordination and collaboration. However, the committee suggests that NVPO consider 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.6 The committee’s recommendations about “priority areas within major components of the plan” refer to the latter type of objectives and strategies. Additionally, the forthcoming implementation plan NVPO will prepare after finalizing the strategic plan would be strengthened by a clear explanation of how the indicators in each goal relate to the objectives and strategies in that goal (Strikas, 2008).
Below, chapter summaries and recommendations are provided in the order in which they occur in the report with one exception. In view of the importance of NVPO’s coordinating function, which is covered in the report’s final chapter (6), the overview of coordination appears first.
The history of NVPO and the National Vaccine Plan, and how it has influenced interagency coordination and coordination with stakeholders, is reviewed in the sixth chapter. The office’s authority and its human and financial resources have not matched its responsibilities, and the committee
found that this mismatch has resulted in missed opportunities for the National Vaccine Program, and in NVPO’s inability to fully meet its statutory duties.
Coordination is at the heart of the plan’s 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). For this reason, supported by a request from the National Vaccine Advisory Committee (see Appendix B), the committee considered NVPO’s coordinating role with regard to the plan, including intragovernmental coordination and coordination with external stakeholders, in addition to considering the individual elements of the plan.
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 intersectoral 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. However, some areas require coordination to reduce inefficient duplication of effort, and in other areas, one agency’s efforts may not be enough to reach an important goal.
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. However, the committee finds that NVPO, which was envisioned by the 1986 statute to serve as this entity, currently lacks the authority, influence, and profile needed to do so. Recently, NVPO has been given and has seized the opportunity to play a crucial coordinating role with regard to H1N1 pandemic influenza vaccine safety (HHS, 2009; NVAC, 2009a; Vellozzi, 2009). This example illustrates NVPO’s potential as coordinating entity in the face of a major challenge to the National Vaccine Program.
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.
Developing and manufacturing most7 vaccines involves using living organisms and presents unique technical and regulatory challenges. Both industry and regulators are risk averse, and progress in regulatory science in general has been slow; as a result a “tried and true” paradigm characterizes some aspects of vaccine development and regulation (Goldberg and Pitts, 2006; Poland et al., 2009). Furthermore, some barriers to innovation stem from administrative and communication challenges at the interface between regulators and industry, not from concerns about safety, efficacy, or immunogenicity.
Recommendation 1-1: The National Vaccine Plan should incorporate improvements in the vaccine regulatory process that reflect current science and encourage innovation without compromising efficacy and safety.
Strengthening communication with vaccine developers through more frequent workshops and guidance documents.
Revising procedures and standards for developing, licensing, and producing vaccines for infectious diseases that encourage flexibility and innovation.
In order to ensure that the Food and Drug Administration (FDA) can promote vaccine development while protecting safety, the agency must have funding and staffing commensurate with its responsibilities to identify, develop, and apply the best and most current science to the regulation of vaccine products.8
There currently is no ongoing, evidence-based process by which vaccine candidates are identified as priorities shared among various stakeholders. Such a process can accelerate the development of vaccines by identifying the need and the likely market, and should be accompanied by a concerted effort to employ modern techniques to reach the goal of new and improved vaccines.
Recommendation 1-2: The National Vaccine Plan should incorporate the development of an evidence-based approach for prioritizing new and improved vaccine candidates by targeted disease and
develop specifications for high-priority vaccines to accelerate their development.
Specifications, such as target population, will differ for each vaccine, and defining them would increase predictability for manufacturers, reduce financial risk, and perhaps cost. The evidence to be considered would include disease burden and feasibility, and would incorporate data or guidance available from prior published work linking research and funding levels to national priorities.9 An approach to priority setting may include the following:
Supporting disease burden studies (e.g., morbidity and mortality) when needed for vaccine prioritization.
Employing outcome measures that capture both survival gains and quality-of-life improvements.10
Employing cost-effectiveness analysis.
Consider technical and scientific feasibility of vaccine development as a prioritization criterion.
The committee found that the vast majority of National Institutes of Health (NIH)-supported peer-reviewed vaccine research is investigator-initiated and that coordination among federal agencies and with academic and private sector stakeholders could be strengthened. Furthermore, some examples of innovative and productive intersectoral collaboration come from a history of public-private partnerships, from the World War II era collaborations between the Department of Defense, industry, and academia, to contemporary development of vaccines for global health through product development partnerships.
Recommendation 1-3: The National Vaccine Plan should incorporate creation of a strategy for accelerating development of high priority vaccines that (a) engages all relevant institutes within NIH and the Department of Defense, academic investigators, and private sector partners; and (b) adapts lessons learned from past and present innovative public-private partnerships.
This coordinated outcome-focused approach to vaccine development would need to be periodically reassessed to maintain appropriateness.
The distinction between preventive vaccines against infectious disease and other preventive therapeutic vaccines apparent in the 1986 law is not a reflection of 21st-century vaccine science. The committee believes that as long as the statutory requirements are met by the National Vaccine Program, there is nothing that prevents the Secretary of HHS from expanding the program’s mission or finding other ways to link HHS policy and strategy across vaccine categories.
Recommendation 1-4: Future iterations of the National Vaccine Plan should include classes of vaccines (such as therapeutic vaccines and vaccines against non-infectious diseases) beyond those expressly enumerated in the statute, and the Secretary of HHS should explore how best to assign responsibility for coordination in this area.
This broader view of vaccines recognizes the potential value of new vaccines beyond the “traditional” role of preventing infectious diseases and positions the federal government to support coordination on and encourage the broader application of scientific and technologic breakthroughs related to non-traditional vaccines.
Taking every step necessary to maximize vaccine safety is as important as endeavoring to derive the greatest disease-prevention benefits that vaccines can provide. Because vaccines are given to large numbers of healthy people, safety is a great concern and is addressed through a system (consisting of many agencies and stakeholders) that collects vaccine safety data, generates hypotheses, and conducts studies to evaluate safety hypotheses.
Recommendation 2-1: The National Vaccine Plan should establish a process to identify potential vaccine safety hypotheses for further basic, clinical, or epidemiologic research through annual review of data from the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD) project, the Clinical Immunization Safety Assessment (CISA) network, and the Vaccine Injury Compensation Program, and from information available from sources outside the United States.
There is no coordinated vaccine safety research agenda or a periodic, systematic process to prioritize a safety research agenda for the nation
(Klein and Myers, 2006; NVAC, 2009b). Although the Centers for Disease Control and Prevention (CDC) Immunization Safety Office (ISO) has its own research agenda, what is also needed is a national vaccine safety research agenda to help guide and coordinate the efforts of all federal agencies and various stakeholders that conduct activities related to vaccine safety research.
Recommendation 2-2: The National Vaccine Plan should emphasize the development and publication of a framework for prioritizing a national vaccine safety research agenda that spans all federal agencies and includes all stakeholders, including the public.
The scientific criteria of such a framework for prioritization might include, but are not limited to:
Assessment of the nature and extent of existing evidence for a possible association of an adverse event with a vaccine.
Determination of the individual or public health burden of potential adverse events following immunization.
Consideration of the feasibility of scientifically rigorous study of a safety concern.
Assessment of biological plausibility of a causal association between an adverse event and a vaccine.
A national research agenda would call on other agencies, such as NIH (which has historically played a limited role in vaccine safety research), CDC, and FDA, and non-federal stakeholders (such as providers who work with special populations, and vaccine manufacturers) to assume joint responsibility and work collaboratively on high-level challenges in vaccine safety research.
An NVAC-affiliated advisory entity dedicated to vaccine safety has the potential to play a role both as an independent source of guidance on vaccine safety issues and by offering a forum for dialogue on the subject of vaccine safety.
Recommendation 2-3: The National Vaccine Plan should include the establishment and scope of work of a permanent NVAC vaccine safety subcommittee to:
provide guidance on the activities described in Recommendations 2-1 and 2-2 in a public and transparent manner;
provide guidance about the identification and evaluation of potential safety signals; and
publish on a biennial basis a review of potential safety hypotheses; current vaccine safety activities including those of pre-and post-licensure studies, VAERS, VSD, and CISA; and planned priorities for research.
To facilitate rapid response to a safety signal, the subcommittee might convene a relevant array of experts to advise the government and partners on a course of action. For example, neurologists could be convened to discuss the biological mechanisms of a given neurological event, and epidemiologists could discuss studies VSD could undertake.
Recommendation 2-4: The National Vaccine Plan should incorporate concrete steps to expand and strengthen vaccine safety research, including:
enhanced funding for CDC’s Immunization Safety Office activities, including support of extramural research;
enhanced funding for FDA’s safety monitoring activities; and
expansion of NIH vaccine safety activities to include research portfolios, funding through requests for proposals, program announcements, and creation of a study section dedicated to vaccine safety research.
Funding could be allocated to each agency to support activities that implement the identified priorities as appropriate to each agency’s research capabilities and strengths.
The desired outcome of the work of the National Vaccine Program and of the National Vaccine Plan is a population protected from vaccine-preventable death and disease. Society itself has changed in the speed with which information—and misinformation—are transmitted, as well as in an increased patient role in the patient-clinician relationship. Simply promoting the use of vaccines no longer meets the needs of individuals and families seeking to make informed decisions amidst a maelstrom of conflicting messages.
The committee found no evidence of an overarching vaccine communication strategy for the National Vaccine Program. Instead, communication regarding vaccine safety has been largely reactive to crises, and has been
conducted by a small and under-resourced staff at CDC.11 The universe of vaccine information, science, safety research, quality control, and policy decision making is large and complex. Both health care professionals and the public poorly understand many aspects of the system. Pertinent information needs to be communicated in a strategic and comprehensive manner to reach the overarching goal of informed decision making.
Recommendation 3-1: The National Vaccine Plan should incorporate the development of a national communication strategy on vaccines and immunization targeting both the public and health care professionals. Such a strategy should:
Reflect current research on communication;12
Describe how relevant government agencies will coordinate and delineate primary responsibility for specific components and audiences;
Anticipate, plan, and support rapid response to emerging high-profile scientific, safety, policy, or legal developments;
Provide the right information to the right individual(s) or group(s) in the most appropriate manner, with attention to literacy, linguistics, and culture of the target audience(s); and
Receive adequate support of dedicated human and financial resources.
Communication cannot be an afterthought; it requires upfront investment, planning, and implementation. A communication strategy will need to be multi-tiered, with the federal government playing a role in coordinating and directing the overall message, with adequately resourced state and local public health agencies and the medical community on the frontlines.
The committee also finds that there is no coherent effort to apply existing communication science to shape a research agenda that could inform the national vaccine communication strategy.
Recommendation 3-2: The National Vaccine Plan should incorporate a process for identifying research needs to inform the national communication strategy, including research on how the public obtains information about vaccines and immunization, perceives risks, and makes decisions concerning vaccination in the contemporary information environment.
For further discussion see Chapter 3.
See Recommendation 3-2.
A stronger, adequately funded and staffed NVPO could support interagency coordination in the area of communication in part by helping to identify communication needs that span the entire National Vaccine Program.
GOAL 4: VACCINE USE AND SUPPLY
Goal 4 in the draft National Vaccine Plan—ensure a stable supply of recommended vaccines, and achieve better use of existing vaccines to prevent disease, disability, and death in the United States—covers an extraordinarily broad set of issues. The National Vaccine Plan does not provide a clear and coherent vision for Goal 4 (e.g., all adults and children have access to all vaccines recommended by the Advisory Committee on Immunization Practices [ACIP]) nor does it describe the prerequisites for the effective use of vaccines. The committee has suggested a reframing of the goal.
The draft plan contains an objective that addresses supply issues, and the recommendation below reflects the committee’s agreement that this area rises to the level of a priority.
Recommendation 4-1: The National Vaccine Plan should include the development and implementation of strategies to assure a stable and adequate vaccine supply for public health preparedness and recommended routine use purposes.
A gap in the draft Goal 4 is the lack of objectives or strategies linking health care financing with health services performance measures to induce and enable providers to seek out, stock, and administer ACIP-recommended vaccines.
Recommendation 4-2: The National Vaccine Plan should include the development of strategies to eliminate financial barriers such as unreasonable cost-sharing by patients who are unable to afford out-of-pocket costs for vaccines and provider payment mechanisms that discourage full and meaningful participation in the delivery of immunization services.
Recommendation 4-3: The National Vaccine Plan should emphasize the application of research and best practices in the organization and delivery of immunization services to improve patient access (such as location and hours) and service efficiency and quality (such as improved provider knowledge and decrease in missed opportunities for vaccination).
Recommendation 4-4: The National Vaccine Plan should encourage the exploration of non-traditional approaches to disease surveillance, monitoring vaccine safety, and assessing vaccine coverage. Such approaches might leverage the increasing ubiquity of the internet and wireless data services, personal communication devices, and social networking facilities.
Recommendation 4-5: Given the importance placed on the national adoption of certified, interoperable health information technology and electronic health records, the National Vaccine Plan should ensure active involvement of NVPO and relevant partners in the planning and implementation of the national health information initiative.
This involvement should include:
Assuring the development and adoption of standards necessary for effective immunization clinical practice and population surveillance systems;
Assuring that the definition of “meaningful use” considers immunization practice and reporting;
Facilitating use of vaccine-related data by all public health partners (e.g., state and local public health departments); and
Assuring that all public health partners have the expertise and resources to participate in the initiative.
Such efforts would include ongoing attention to needed resources, integration across diseases and programs, and ongoing financial technical assistance.
Recommendation 4-6: The National Vaccine Plan should include strengthening the public health infrastructure to support vaccine delivery, measure immunization practice and performance, intervene to address disparities in access to immunization, and respond to emerging infectious disease threats.
Efforts to strengthen the public health infrastructure could include:
Development of capacity in all health departments to assure the delivery of immunization services to underserved populations in all communities or during an emergency.13
Development of greater public health capacity to identify deficits in access to immunization services.14
Assistance to states to eliminate barriers to the full use of all appropriate personnel in vaccine administration due to restrictions on licensure and scope of practice.
Health care reform legislation will ideally include monitoring immunization and achieving targets as a measure of success. Deficiencies in immunization rates would trigger specific corrective plans. The following recommendation assumes the passage and enactment of national health care reform legislation.
Recommendation 4-7: The National Vaccine Plan should incorporate rapid and comprehensive assessment of the outcomes of national health reform and their implications for the nation’s vaccine and immunization priorities.
Specifically, NVPO, as “owner” of the plan, could contribute by:
Participating in implementation efforts related to the expanded health insurance access for the population.
Participating in implementation efforts related to the design of health insurance coverage and cost-sharing features, administrative matters affecting the actual provision of vaccines, and standards and procedures governing the measurement and reporting of health plan performance.
Promoting the integration of health plan performance and operations with community public health policy and practice in order to assure (a) the availability of community-wide information about population immunization status, disparities in access, and areas of need; (b) access to immunization services; (c) public health agency analytic, management, and other needed capabilities; and (d) the ability of public health workers, health insurers, and health care providers to mount a joint response to emerging public health threats.
Promoting strategies for assuring the full immunization of those who remain uninsured.
GLOBAL VACCINE ISSUES
Many of the issues relevant to Goals 1 through 4 of the draft plan apply to global needs as well—research and development of needed vaccines such as malaria and HIV, safety of vaccines and surveillance of adverse events,
communication needs at user and provider levels, and vaccine use including supply issues.
The health infrastructures in many low- and middle-income countries do not adequately support use of needed vaccines. Causes include inability to pay for vaccines, inadequate infrastructure (ranging from public health laboratories to refrigerators), lack of providers or paraprofessionals to administer vaccines safely, and lack of systems to monitor vaccine use and potential adverse events. Without adequate infrastructure, funding for vaccines alone will not get vaccines to those who need them most.
Recommendation 5-1: The National Vaccine Plan should call for the engagement of U.S. federal agencies and partners to support immunization capacity-building to implement new vaccines in low- and middle-income countries through the provision of expertise and financial resources necessary to incorporate new vaccines, strengthen immunization infrastructure, and achieve higher levels of vaccination. One infrastructure component requiring specific attention is the development and implementation of surveillance systems for vaccination, disease burden, and vaccine safety that are innovative and appropriate for developing countries.
Differential pricing—that is, matching prices to a nation’s ability to pay—can increase global access to vaccines while providing incentives for innovation.
Recommendation 5-2: The National Vaccine Plan should endorse active U.S. engagement in the development of global policy frameworks to further global adherence to differential pricing in order to ensure access to needed vaccines in all countries.
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