Initial Guidance for an Update of the National Vaccine Plan A Letter Report to the National Vaccine Program Office (2008) / Chapter Skim
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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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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)
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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.
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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)
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. Novel vaccines introduced include vaccines against pediatric pneumococcal disease, meningococcal disease, and human papilloma virus.
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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.
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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)
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. 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)
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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.
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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.
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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)
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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)
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. 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.
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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.
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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.
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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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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)
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