Appendixes



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Appendixes

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism A Recommendations from Letter Reports #1-6 RECOMMENDATIONS FROM LETTER REPORT #1 Issues of Timing The committee recommends that the Centers for Disease Control and Prevention (CDC) develop and communicate the criteria (e.g., types and rates of adverse reactions) that would trigger a reconsideration of the current systems in place to protect vaccinees and their contacts (e.g., the October 2002 Advisory Committee on Immunization Practices [ACIP] recommendations on contraindications, screening, care of the vaccination site, and administrative leave). To most effectively evaluate the progress and outcomes of the first phase, the committee recommends that CDC utilize the variation in implementation by hospitals and health departments (e.g., differences in granting administrative leave, types of bandages used, different site care instructions, degree of patient contact, adverse reaction investigation) to obtain safety data, and to analyze these data before embarking on subsequent phases of the vaccination program. Compensation for Adverse Reactions to the Smallpox Vaccine The committee recommends that CDC and its state and local public health partners immediately work to clarify each state’s worker’s compen-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism sation program’s position on coverage for smallpox vaccine–related injuries and illnesses for workers covered under their programs. The committee recommends that CDC and the Department of Health and Human Services support all efforts, some of which might be administratively or legislatively bold and creative, to bring this issue of compensation for smallpox vaccine adverse reactions—including those reactions that occur despite non-negligent manufacture and administration of the vaccine—to speedy resolution. Workforce Issues Resulting from Vaccination The committee recommends that during phase I, CDC assess the effects of the current situation regarding administrative leave, disseminate the analysis widely, and before phase II begins, decide whether the ACIP recommendation needs to be reassessed. Any evidence of transmission of vaccinia virus to a patient from an immunized health care worker should lead to an active case investigation or to an immediate reassessment of policy. Opportunity Costs The committee recommends that CDC work with their public health partners to document as well as possible the true costs of the smallpox program. Informed Consent Process The committee recommends that all consent documents include a statement that the risks of the smallpox vaccine, while very low, are predictably higher than the risks associated with most other vaccines, but that the benefit is presently unknown—possibly very low (absent exposure to smallpox) or very high (in the event of exposure). The committee further recommends that informed consent forms include explicit notification of the availability, or lack thereof, of compensation for adverse reactions. Comprehension of Screening Materials Understanding that different populations may interpret the educational and screening materials somewhat differently, the committee recommends that CDC pretest the educational and screening materials in populations with different educational, socioeconomic, and cultural backgrounds before these materials are used for the first phase of the pre-event smallpox

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism vaccination program, if this is possible given the time frame. If not, then material should be evaluated after phase I, and modified before phase II. Educating Household Contacts The committee recommends that CDC develop specific educational materials for household contacts of potential vaccinees. The committee recommends that the materials also include instructions about how household members can avoid accidental infection with vaccinia, should the household member choose not to disclose the contraindication to the vaccinee. The committee recommends that CDC consider using the blood-donation opt-out and informed consent processes as models for the pre-event smallpox vaccination program. Reasons for Declining Vaccine The committee recommends that CDC collect data on the reasons why potential vaccinees choose not to be vaccinated. Using the Pre-Event Vaccination System (PVS) to Collect Data on Adverse Reactions The committee strongly recommends that active surveillance for adverse reactions be employed, rather than relying exclusively on the passive surveillance systems that already exist (e.g., VAERS). The committee recommends that CDC use the Pre-Event Vaccination System (PVS) as the primary data collection system for adverse reactions. The committee recommends a follow-up on a subset of individuals in PVS rather than a telephone survey of vaccine recipients. The follow-up survey could be used to gather information on long-term effects from the vaccine, as well as information on cases of accidental vaccinia infection in household members of vaccinees, rather than focusing on obtaining data on common adverse reactions. Evaluation of Risk Factors for Known Adverse Reactions The committee strongly recommends analysis of the phase I PVS data as a series of nested case-control studies, with results available before moving on to phase II of the vaccination program.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Establishment of a Data Safety and Monitoring Board (DSMB) If CDC is unable to assure this independent functioning of the DSMB, the committee recommends that the proposed organizational arrangement be reconsidered. CDC Safety System Guidance to States The committee recommends CDC evaluate each state’s capacity for managing adverse reactions before indicating that a state is ready to begin vaccinations. Focus Areas of Training and Education The committee recommends that CDC expand the scope of their training and education regarding the identification, treatment, and reporting of serious adverse reactions to all clinicians. The committee recommends that the first communication clinicians should receive is basic information about the details of the pre-event smallpox vaccination program. Communication Planning The committee recommends that CDC’s communication efforts about smallpox vaccination clearly separate public health issues from national security matters. The latter are best addressed by representatives of the administration more directly involved in such matters, and not by representatives of scientific agencies. Therefore, the responsibility of CDC is to deliver clear, consistent, and science-based public health communications. The committee recommends that CDC identify a single “voice” for the national vaccination program, a credible individual with a strong scientific background and an experienced communicator who can serve as the key CDC spokesperson. Additionally, the agency should develop several backup sources for the media who can offer the same level of informed comment and thoughtful observation as the program’s primary “voice.” The committee recommends that more attention be given to developing a variety of materials and channels to inform and educate the public about the immunization program before vaccinations begin.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism RECOMMENDATIONS FROM LETTER REPORT #2 A Focus on Preparedness The committee recommends that CDC work with states to decide what more is needed to achieve smallpox preparedness, if anything. Further, given the routine turnover in personnel, each state should evaluate what it needs to maintain this preparedness. A Need for Evaluation The committee recommends that CDC comprehensively evaluate the program and its outcomes in order to improve its implementation and to protect the vaccinees and the public. Communication The committee recommends CDC revisit and communicate to the public the program’s objectives in view of state-level realities, and provide a preliminary perspective on the national and state success in reaching those objectives. The CDC should continue to support, as well as build on the experience of state and local health departments who are developing their communication strategies about state and local program implementation. The committee recommends that CDC and its state and local partners develop communications strategies that: Provide adequate quality and quantity of information. Are timely. Reassure the public that efforts are in progress to protect them in the event of a smallpox attack. The committee recommends CDC develop and offer journalists training materials and opportunities specifically designed for the media, explaining the program’s clinical components, providing the best available scientific evidence, and dedicating staff experts to provide technical support to media representatives. Training and Education The committee recommends that all print materials addressed to a diverse audience (e.g., the public) should be easily read and understood by all members of that audience. Also, all communication materials in other languages should be culturally appropriate.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The committee recommends that educational and training materials be tested for ease of comprehension with samples representing a cross-section of the sex, race, ethnicity, and level of education. Data to Assess Vaccine and Program Safety The committee recommends that a data field be added to PVS to indicate which version of the Pre-Vaccination Information Packet was provided to the vaccinee, in order to document what information was given to the vaccinee prior to consent. The committee recommends that CDC consider adding a data field to HSVMS to indicate whether a serious adverse event occurred or whether a VAERS report was filed (understanding that more complete information about circumstances surrounding the adverse event will be entered into VAERS and the Active Surveillance System). The committee recommends that CDC work to ensure that a qualified health professional monitors, conducts a “take” reading, and provides a regular vaccination site inspection for each vaccinee in the program and enters the relevant data into the appropriate smallpox vaccination program data system. The committee recommends that whenever the ACIP working group issues findings/recommendations to the ACIP and through it to the director of CDC, it carefully consider concurrent release to the public and do so if it would be in the interest of transparency and maintaining the public’s trust in the program. The committee recommends that CDC be very clear about what types of adverse events will be reported to the public and when. The committee recommends that the vaccination report webpage use categories that correspond to the categories presented in the MMWR adverse event reports. The committee recommends that CDC report on a regular basis how effective screening practices have been at identifying contraindications (e.g., pregnancy, HIV status, eczema or atopic dermatitis) prior to vaccination.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The committee recommends that CDC work with the Department of Defense (DoD) to decide how adverse events that involve both the civilian and military populations will be reported. Compensation The committee recommends that CDC gather data on the reasons why potential vaccinees are declining vaccination and document the extent to which lack of compensation is identified as a barrier, among other possible barriers (e.g., uncertainty surrounding risk of smallpox, fear of transmitting virus to contacts, extent to which local programs are encouraging vaccination). The committee recommends that the compensation language be easy to read and understandable to a wide range of audiences. The committee recommends that potential vaccinees be reminded of the current compensation situation before they formally give their consent to be vaccinated. Funding The committee recommends that this inquiry be broad in scope and include not only cost to local and state health departments, but also the financial impact on the provision of other essential public health services, the costs incurred by participating hospitals, and estimates of costs of expanding the vaccination program to additional health care and public health workers and emergency first responders. RECOMMENDATION FROM LETTER REPORT #3 The committee recommends CDC facilitate the efforts of states that wish to pause to evaluate the process and outcomes of their vaccination efforts to date, and plan for next steps before deciding whether and when to begin vaccination of new personnel. CDC should provide states with a target date for when CDC expects to have completed its revision of materials, data systems (adding new occupational categories, etc.), and guidelines. States that have identified a need for more vaccinated volunteers to carry

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism out specific smallpox response functions will then be able to set their own timeline for vaccinating these new groups. RECOMMENDATIONS FROM LETTER REPORT #4 A Standard for Smallpox Preparedness The committee recommends that CDC provide guidance to assist state public health agencies (and their partners,1 as appropriate) in establishing a baseline level or a minimum standard of preparedness for a smallpox attack, after which, each state could individually assess its priorities and further expand its preparedness against smallpox and other threats to the public’s health as needed. Preparing Key Responders The committee recommends that CDC support the establishment of state and/or local, and if appropriate, national, voluntary registries of individuals who have undergone vaccination to be mobilized, trained, and assigned as needed in the event of a smallpox attack. Such registries would include all willing vaccinated personnel not associated with a response team, ranging from retired or relocated health care or public health workers to military reservists and former military personnel. Using Scenarios to Test Preparedness The committee recommends that CDC facilitate the development of a range of scenarios for potential smallpox attack(s), including one or more multi-threat scenarios, and urge states to use these to expand and continuously improve their plans to respond to a wide range of possibilities. Vaccination of Members of the General Public Who Insist on Receiving Smallpox Vaccine The committee recommends that CDC proceed with a deliberate and stepwise approach toward meeting the president’s policy of offering vaccine to members of the general public who insist on receiving it by: 1   State partners may include, but not be limited to, emergency management agencies, law enforcement, fire and emergency medical services, hospital and other health care associations.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Conducting brief quantitative surveys to determine public interest and desire for smallpox vaccine. These surveys should include public and private health agencies as well as the general public, in order to understand the potential scope of public interest. Determining the budgetary and other requirements that would meet the demand noted. Identifying, monitoring, and referring people to existing or planned smallpox vaccine clinical research trials or other well-structured clinical arrangements that meet the basic requirements of medical and public health ethics, including assurances for safety of vaccinees and their contacts, acceptable balance between risk and benefit, and acceptable distribution of scarce public health resources to meet all preparedness as well as other public health goals. The committee encourages CDC to consider utilizing a pilot program or some other means of evaluating the initial experiences with this effort. Communicating About and Coordinating the Response to Adverse Events To help ensure that the adverse event reporting and follow-up procedures work as seamlessly as possible, the committee recommends that CDC coordinate better with their state partners and provide feedback to local partners who reported the adverse event. Streamlining Data Collection The committee recommends that CDC pursue ways to streamline the data systems that are used in the smallpox vaccination program, improving user-friendliness and integrating the multiple systems to avoid duplicate data entry, especially considering that any future expansion of the vaccination program would require a larger number and greater diversity of data system users, some of whom may be using these systems for the first time. Utility of the Active Surveillance System Because the civilian smallpox vaccination program is a true partnership between CDC, states, and local jurisdictions, the committee recommends that CDC continue and expand their communication with states and local jurisdictions about the imperativeness of their participation in the Active Surveillance System, stressing that the safety of the vaccination program cannot be guaranteed without their full participation and cooperation.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Pregnancy Screening Considering that the rate of inadvertent exposure to smallpox vaccine during pregnancy is lower than expected and it is impossible to detect all pregnancies at the time of vaccination, the committee does not recommend extra pregnancy screening efforts at this time. Evaluation and Safety Studies The committee recommends that CDC begin developing a structured, prioritized research agenda that can aid decision-making as the smallpox preparedness program moves forward. The committee recommends that in the short term, studies of the serious adverse events should receive the highest priority. For safety-related questions, in the longer term, studies examining long-term outcomes for those who experienced both serious and mild adverse events and studies of how mild adverse events contributed to lost work or social function should be a high priority. For system-related questions, in the longer- term, studies of cost and opportunity costs should be a high priority. RECOMMENDATIONS FROM LETTER REPORT #5 If CDC intends to use scenarios as a planning tool, the committee recommends that the scenarios represent a range of possible situations, be used to help guide state and local planning activities, and facilitate state and local assessment of their level of preparedness. The committee recommends that a flexible, incremental, science-based decision-making and management structure for smallpox response that includes all levels of government be developed and communicated to state and local agencies so that the consequences of a smallpox outbreak can be managed effectively. The committee recommends that CDC consider conducting the preparedness assessments on a multi-year basis. The committee recommends that CDC address its immediate need of measuring cooperative agreement compliance with a concise and simple set of indicators, and then use this set of indicators as the foundation of a longer, deliberative, national process to develop measures that address the full range and appropriate balance of preparedness activities.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The committee recommends that federal agencies and CDC, specifically, be held accountable for their unique federal responsibilities in an emergency response and assessed on their progress in facilitating national public health emergency preparedness. The committee recommends that CDC consider utilizing the 10 Essential Public Health Services as a framework for the readiness indicators. The committee recommends that CDC collaborate with Health Resources and Services Administration (HRSA) to integrate the preparedness indicators into one document, in order to help the health care and public health communities work hand-in-hand to plan, implement plans, and evaluate their readiness to respond to threats (including, but not limited to, a smallpox attack) and to avoid requiring duplicate reporting from states. RECOMMENDATIONS FROM LETTER REPORT #6 The committee recommends that all federal entities concerned with bioterrorism preparedness (e.g., CDC, HRSA, and ODP) should more actively coordinate guidance and funding activities. Federal agencies should also work together to develop mechanisms that facilitate coordination and collaboration among their grantees at the state and local levels. Federal efforts should include the clarification of primary responsibility and authority in bioterrorism events, to ensure that CDC can fulfill its unique role as the nation’s public health agency. The committee recommends that CDC should collaborate with all of its partners to strengthen preparedness by applying research findings and experience in public health emergency response, bioterrorism preparedness, and disaster management. In order to strengthen the evidence base for public health preparedness, CDC should: Strengthen the link between public health research and practice; participate in and promote interdisciplinary research about preparedness; support a system to assure the ongoing collection, synthesis, and sharing of lessons learned and best practices from public health preparedness exercises and public health response to proxy events; and in coordination with the appropriate federal-level partners, such as AHRQ, evaluate the effectiveness, design, and opportunity costs of preparedness strategies, such as exercises.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The committee recommends that CDC should use the Evidence-Based Performance Goals for Public Health Disaster Preparedness to develop standards against which CDC, states, and localities may regularly measure their performance in exercises and in response to proxy events. Public health agency performance in exercises and proxy events should be used to identify gaps in preparedness and to improve planning, communication, and coordination at the agency and interagency levels, as part of a process of continuous quality improvement in preparedness planning and response. Preparedness drills and exercises should not be evaluated individually, but their cumulative and long-term impact on preparedness, such as generalizability to other potential hazards, must be considered in the evaluation process.