Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation Letter Report #1 (2003) / Chapter Skim
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Contents of Letter Report
Contents of Letter Report
Pages 1-30
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overall progress at achieving the goals of the nro~rnm ~7 C7 ~ ~ (= ~ Given the rapid pace of planning for the smallpox vaccination program, the committee realizes that while it has been working on this report, CDC has been moving ahead, and at the time of the report's release, it is possible that CDC has already accomplished some of the components the committee is recommending. In addition to CDC's partners, many in the general public will be interested in this communication.
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entered into a contract with the Institute of Medicine (IOM) of the National Academies to provide targeted advice on the implementation of a "pre-event" or precautionary smallpox vaccination program.
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The TOM's Committee on Smallpox Vaccination Program Implementation met for the first time December ~ 8-20, 2002 to begin adcires sing their charge, states} most succinctly as providing advice on how best to implement the policy as announced by Presiclent Bush. The committee has not been asked to, and will not, comment on the President's policy decision to recommenc} voluntary smallpox vaccination to health care, public health, and emergency personnel under a precautionary program, and to allow but not recommend access to the vaccine by people not included within those groups.
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SUMMARY OF KEY MESSAGES The committee urges CDC to: T Highlight the unique nature of the smallpox vaccination program as a public health component of a national bioterrorism preparedness policy, focusing on the delivery of clear, consistent, science-based information.
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Furthermore, it is assumed that with rigorous efforts at screening those at risk and with intensive efforts at educating vaccinees about caring for the vaccination site, accidental inoculation of high-risk contacts of vaccinees can be minimized. However, the actual risks will only be known after the vaccination program is operative.
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The committee hopes that local health department and hospital readiness will dictate the launch date for phase ~ in each state or community, and duration of each state vaccination program. Furthermore, sufficient time should be allowed between the two phases to ensure adequate assessment and plan revision by CDC and its partners at the state and local levels.
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In this regard, the pre-event program must be explained as part of a general program of public health preparedness for bioterrorism and other threats to the public's health. It is clear to the committee and other interested parties that the stated policy of the President is an absolutely voluntary vaccination program for hospitals that may choose whether to have a smallpox response team an(1 for public health and health care workers who may volunteer to be members of a response team, but this matter bears continual emphasis in communications ant!
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· · . n1s nas encouraged ~~u~;~u~ a~u va`;~;~u Urn sites to pan~c~pa~e In the pre-event vaccination program, as it reduces their liability exposure for adverse reactions.
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The committee recommends that CDC and its state and local public health partners immediately work to clarify each state's worker's compensation program's position on coverage for smallpox vaccinerelated injuries and illnesses for workers covered under their programs. At the time of the issuance of this report, the implications of the Homeland Security Act were not fully understood by many of the state and local public health and health care partners in the smallpox vaccination program.
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met in October 2002, members discusser! the issue of administrative leave for health care workers who would receive the vaccine in the pre-event vaccination program.
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concerns from CDC's state and local partners that the smallpox vaccination program will incur great costs that are hard to document (AMA, 2002; Altman and O'Connor, 2002; ANA, 2002; Burstein, 2002; Connoly, 2002a; Connoly, 2002b; Hardy, 2002; NACCHO, 2002; Associated Press, 2003; Mitchell, 2003; Richmoncl, 2003) — these costs include items such as: fewer resources (e.g., time, staffing, money, public service announcements, etc.)
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SPECIFIC CONSIDERATIONS Informed Consent Process As noted above, the committee believes that it should be recognized that the pre-event smallpox vaccination program is not a typical public health program, but rather, a matter of national public health preparedness against a national security threat. Given the difficulty in characterizing or quantifying the actual threat, the benefit to vaccinees is unknown, and this reality should be recognized and communicated to potential vaccinees to enable an informed decision regarding vaccination.
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Understanding that the issues surrounding compensation for adverse reactions to the vaccine will most likely not be resolved before vaccinations are scheduled to begin, health care workers need to know this information before making a decision about whether or not to be vaccinated. If there are any developments in the availability of adverse reaction compensation for recipients of the smallpox vaccine (or their contacts)
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Subsequent pages of the informed consent form shouIct contain a space for the vaccinee's initials. The committee also encourages CDC to pre-test the informed consent materials in populations with different educational, socioeconomic, and cultural backgrounds before these materials are used for the first phase of the pre-event smallpox vaccination program, if this is possible given the time frame.
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The committee believes this model could be considered for the pre-event smallpox vaccination program. Vaccinees should not feel any pressure to receive the vaccine, for fear that a medical condition that they do not want to disclose may be discovered by the 15
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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 Potential vaccinees will have different reasons for declining the vaccine, ranging from personal contraindications, contraindications in household} and other close contacts, fear about adverse reactions of the vaccine, or apprehension about the benefit of receiving the vaccine.
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Early recognition, evaluation, and appropriate treatment of adverse reactions to the smallpox vaccine will be critical to limiting the adverse consequences of the smallpox vaccination program, and to ensuring the public's continued acceptance of the program. Detecting adverse reactions and evaluating them early will be the first step in this process.
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Analysis of where the vaccine is distributed, how much is distributed, and how much vaccine is wasted will be intrinsic to making mid-course revisions to the implementation plan. The committee encourages CDC to use PVS for detailed monitoring of vaccine distribution, since this will be important for evaluating the overall implementation of the vaccination program.
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The committee also was asked to provide advice on whether the proposed telephone survey of 10,000-20,000 vaccinees is an appropriate mechanism to obtain data on common adverse reactions, vaccinee satisfaction with the vaccination program, and the effect of vaccination on time lost from work. The committee suggests that if CDC decides to mollify the PVS to make it an active surveillance system and utilize it as the primary mode of gathering data on adverse reactions, then the previously planned survey would become redundant.
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The committee suggests that CDC consider using mortality surveillance to supplement the adverse reaction surveillance occurring through VAERS and PVS. To reach this end, the committee encourages CDC to reach out to and coordinate with medical examiners and coroners to educate them about the pre-event smallpox vaccination program and to provide guidelines that can be used for determining whether a death was the result of a serious adverse reaction from the smallpox vaccine or from a random unconnected cause.
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Where possible, the committee encourages CDC to share with their state and local partners any data or lessons learned from the DoD smallpox vaccination experience thus far. The committee first describes what it perceives to be the special considerations for such a board involved in the pre-event smallpox vaccination program.
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CDC Safety System Guidance to States CDC asked the committee to provide advice on whether the proposed safety system will provide for the clevelopment of state capacity, such that states will be able to manage smallpox vaccine adverse events if smallpox vaccination becomes routine. The committee felt that they did not have enough (letailecl information about the state plans to adequately a(lclress this question.
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Training and Education CDC's five training focus areas in preparation for the first phase include smallpox vaccination clinics processing, adverse events training for designated physician experts, data management for safety/VAERS, laboratory diagnostics for rash illness and smallpox, and surveillance for rash illness (Quick et al., 2002~. Based on its review of planning material, the committee noted a need to broaden the audiences for certain training, expand the range of material covered, and most importantly, extend the timeline of training itself.
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The committee commends CDC on the development of the 16-page color brochure providing infonnation on smallpox vaccination and common and serious adverse reactions to the vaccine, and encourages CDC to distribute this brochure as widely as possible. Furthermore, if guidance has not been developecl already, the committee encourages CDC to develop guidance for vaccination clinics (some of which may not be locates!
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be integrated into overall bioterrorism preparedness, and as much as possible, measures taken to strengthen surveillance, staff training, and communication wouIcl be more broadly conceived as clually applicable to smallpox and other public health efforts. A possible strategy to optimize resources and broaden the impact of smallpox vaccination preparations may be collaboration with Centers for Public Health Preparedness to enhance various (limensions of the smallpox program, an opportunity not explicitly considered by CDC planners at the time of the committee's first meeting (Strikes, 2002)
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The next steps in the development of a pre-event communication plan require greater clarity and more specific details about the methods and channels to be usect, and the outcomes expected. Second, the committee believes it is important that the CDC communications effort strictly address the public health aspects of the smallpox vaccination policy, and focus on 26
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The nation's ability to prepare and respond to a smallpox attack or other potential bioterror threat, depends heavily on the content and influence of media outputs before an outbreak occurs. A well-informed public is also essential to the success of the smallpox vaccination program, and to public health preparedness in general.
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All communication materials and strategies targeting potential vaccinees an(1 the ~en~rn1 nilbli~. ~h~lilrl r~mnh~ci7P the `~^lilnt~r-~l'" ~~+h~ vaccination program.
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about the disease, the vaccine, and the vaccination campaign, available on the website; and crisis material, prepared to respond to a news event/vaccine crisis or smallpox release. Although the first phase of the vaccination program involves only health care workers, it is never too soon to begin educating the general public, therefore, 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 committee is unable to assess CDC's progress at this time, but will do so as program implementation experience allows. Areas of Potential Future Inquiry There are a number of important matters the committee recognized, but was unable to address in this report, and some additional areas on which CDC may wish to request guidance as the implementation of the vaccination program begins and progresses.
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