Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation Letter Report #4 (2003) / Chapter Skim
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Contents of Letter Report
Contents of Letter Report
Pages 1-34
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an examination of selected aspects of smallpox vaccination program implementation. In a previous report (IOM, 2003c)
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" Tommy Thompson, Secretary of the Department of Health and Human Services, in reference to the monkeypod outbreak (CD C, 2003aJ The discussion of integration of smallpox preparedness into overall public health preparedness is organized around four main topics: (~) Challenges in Defining and Assessing Public Health Preparedness; (2)
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Smallpox Preparedness: Only One Component of Overall Public Health Preparedness The national smallpox vaccination program may well be the first disease-specific test of implementing oublic health orenareciness in a systematic and comprehensive manner. and with ~ ~ ~ .& .
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perhaps at the expense of other aspects of smallpox preparedness, as well as overall public health preparedness to respond to any threat. A Standard for Smallpox Preparedness "The federal government should consider playing a more concerted role in providing resources and instituting unified standards for the common defense against the microbial threat, while giving state anct local authorities the J`ex`~'ty to implement programs in a manner that will best meet local needs.
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Smallpox preparedness activities conducted in the first months of 2003 have enhanced the readiness of state and local public health agencies to respond to a potential smallpox attack (Committee on Smallpox Vaccination Program Implementation Stucly Staff, 2003; NACCHO, 2003a) , but as noted above, vaccination alone the focus of most of these activities is not sufficient for preparedness.
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Elements of Smallpox Preparedness At the committee's May 2003 meeting, one presenter described the essentials for improving smallpox preparedness as planning, training to the plan, exercising to the plan, and revising the plan (Selecky, 2003~. In presentations and conversations with several state and local health departments, the committee heard similar comments about what program administrators believe are the "ingredients" of smallpox preparedness (Committee on Smallpox Vaccination Program Implementation Study Staff, 2003~.
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These themes are consistent with the three elements of smallpox preparedness identified in Annex A of the DHHS/CDC Continuation Guidance for Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism (CDC, 2003b) and discussed in greater detail below: Preparing key responders with a section devoted to health care responders and preparedness in the health care sector (includes the relationship-building, training, and planning described above)
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Contact should also be maintained with health care or public health workers who received a smallpox vaccine because of exposure to a case of monkeypod, so they could be utilized for response to a smallpox event. The committee recommends that CDC support the establishment of state and/or local, and if appropriate, national, voluntary registries of indivi(luals who have undergone vaccination to be mobilized, trained, and assigned as needed in the event of a smallpox attack.
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Previously, emergency management officials, police, and fire departments had not consiclered public health agencies to be emergency responders, and health departments typically have not counted emergency and fire personnel among the ranks of public health responders. The committee has heard at every meeting about the importance of building relationships with a wide range of partners in the community; a common outcome of the smallpox vaccination program has been the forging of linkages between the public health ant!
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To apply this element of smallpox preparedness to comprehensive public health preparedness for all threats, the same sites could be used to distribute other vaccines or countermeasures, and provide other services in response to an outbreak or other threat. Furthermore, the circumstances of an attack and available resources may not allow the immediate vaccination of the entire population, so plans for prioritizing categories of vaccinees shouicl be worked out pre-event, perhaps taking as guidelines the definition of essential personnel, the needs of medically at-risk groups, and those of groups at high risk of exposure (rock et al., 2002~.
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Nevertheless, the preparedness efforts of state and local public health agencies should engage all hospitals and health care systems, not just those participating in vaccination program (IOM, 2003cl)
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in their outpatient clinics, emergency departments, laboratories, and other facilities; link with the local or state juriscliction's public health preparedness efforts (including the acquisition and distribution of Strategic National Stockpile drugs, vaccines, and supplies, including smallpox vaccine, regionally) ; and exercise, test, and revise pianist as needed.
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This includes communicating about the smallpox vaccine, its risks and benefits, its availability, and plans for its rapist distribution when needed, as notes! above.
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Existing tools, such as the state and local assessment instruments developed by the National Public Health Performance Standards Program (CDC, 2003c) and the local and state Public Health Preparedness anti Response Capacity Inventories (CDC, 2002b; CDC, 2002c)
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Sustaining Smallpox and Overall Public Health Preparedness The resurgence of tuberculosis (TB) as a public health threat in the last two decades strikingly illustrates the importance of sustaining public health capacity.
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Sustaining general public health preparedness requires an array of capabilities and resources, and strategic planning at all levels is neecle(1 for long-term smallpox prepareclness, if this is determined to be a necessity. Maintaining specific elements of smallpox preparedness includes.
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Given the current level of threat and the inherent health risks of the vaccine, we have clecidect not to initiate a broacler vaccination program for all Americans at this time" (White House, 20024. Because of the possible threat, he said that "the military and other personnel who serve America in high-risk parts of the worm" would be vaccinated ant!
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RESOURCES: The committee has noted several times in previous reports that many public health agencies are stressed to their limits in trying to implement the smallpox vaccination program for the target professional populations, executing the other elements of preparedness, cleating with adverse events following vaccination, improving communication, enhancing the various vaccine surveillance programs, and addressing competing public health mandates, such as SARS. It is possible that the development and execution of a robust public vaccination program at this time wouici severely cleplete human anc!
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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.
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Vaccinating members of the general public beyond the key personnel states deem necessary for preparedness should proceed only under the aegis of smallpox vaccine clinical research trials or other wett-structured clinical arrangements that meet the basic requirements of medical and public health ethics. SELECTED ASPECTS OF SMALLPOX VACCINATION PROGRAM IMPLEMENTATION In the following section of the report, the committee discusses several important components of the national smallpox vaccination program: (1)
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Streamlining Data Collection Of the multiple data systems being used concurrently during the pre-event smallpox vaccination program, PVS, the Active Surveillance System, and HSVMS were all created uniquely for the pre-event smallpox vaccination program; VAERS is a data system that was previously established to collect reports of adverse events following any vaccination. For the purposes of the smallpox vaccination program, these data systems have been designed to work together.
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Utility of the Active Surveillance System As clescribec} above, the data systems that CDC has utilized during the pre-event smallpox vaccination program seem to have been effective at identifying serious adverse events following smallpox vaccination. However, the committee cannot be completely certain of how effective the Active Surveillance System has been at identifying these serious adverse events until all vaccinees are entered into the system.
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, the committee identified its reasons for recommending the creation and use of an active surveillance system: "Consiclering the anticipated risks of the vaccination program ant! the currently unknown benefit, it is extremely important that all adverse reactions from the smallpox vaccine (both known and suspected)
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be used to monitor outcomes of Women vaccinated through the military smallpox vaccination program, the civilian smallpox vaccination program, and recent clinical research studies are included in the registry. In pregnant women, the smallpox vaccine can cause fetal vaccinia, a rare but serious condition that can lead to premature delivery, skin rash with scarring, stillbirth, or death of an infant after delivery (CDC, 2003O)
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. Even though some women have been inadvertently exposed to smallpox vaccine during the civilian vaccination program, the tower than expected rate of unknown pregnancies and conception in the four weeks after vaccination in women vaccinated in the civilian program reassures the committee that the pregnancy screening practices have been relatively effective thus far.
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These women will not have experienced an "inadvertent" smallpox vaccine exposure, because smallpox vaccination will have been recommencled due to their contact with a monkeypox case. As these issues begin to be worked out, the committee encourages CDC to describe how data on them will be combined with or separated from the pregnancies exposed to smallpox vaccine stemming from the pre-event smallpox vaccination program, and how foflow-up data on the pregnancies exposed to smallpox vaccine because of contact with monkeypod will contribute to evaluation of the other pregnancies included in the registry.
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. As the working group has followecl the safety data from the civilian and military smallpox vaccination programs, they have paid increased attention to the myo/pericarclitis cases reported in both programs.
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As CDC has acknowleciged, evaluation of the cardiac adverse events reporter! following smallpox vaccination is very important to safely continue the smallpox vaccination program.
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Knowing now that at least one state is using different screening criteria than what was recommended by CDC, the committee suggests that CDC collect data on the screening practices of other states, and use these data to supplement the overall evaluation of the implementation of the civilian smallpox vaccination program. DoD has stated that they wilt conduct follow-up of the myo/pericarditis cases seen among people vaccinated through the DoD program at 6 weeks, 6 months, and 12 months.
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The committee again encourages CDC to develop concurrent control groups for as many of their studies as possible, given the current realities of the pace of the smallpox vaccination program. T he use of such control groups would greatly ail!
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Considering the extent of evaluation and research efforts that CDC could propose for the smallpox vaccination program as it moves forward, and the limited resources available to support all needed evaluation efforts, the committee encourages CDC to consider requesting the use of Public Health Service 1% Evaluation funds for this nuroose (if this approach has not been pursued aireatly)
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To ensure that potential vaccinees are aware of the compensation available to them for any adverse events that are ctetermined to be connected to the smallpox vaccine, the committee encourages CDC to update the VIS as soon as possible, and publicize the existence of the fact sheet. When the interim final rule implementing SEPPA is published, this fact sheet should be expander!
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* The development of a research agenda for the smallpox vaccination program is important to ensuring the long-term success of smallpox preparedness efforts, as well as providing useful information for overall public health preparedness.
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Gebbie, Committee Vice Chair Robert B Wallace, Committee Vice Chair Committee on Smallpox Vaccination Program Implementation .~ 34
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