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Appendix B: Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation Letter Report #1
Pages 123-161

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From page 123...
... to convene an expert committee to advise it and its public health colleagues on the implementation of a pre-event smallpox vaccination program. The IOM agreed to provide this advice through a series of timely reports.
From page 124...
... 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.
From page 125...
... Vaccination of the general public is specifically not recommended, but the president also announced the intent to provide vaccinations to those members of the public who request the intervention. The IOM's Committee on Smallpox Vaccination Program Implementation met for the first time December 18-20, 2002, to begin addressing their charge, stated most succinctly as providing advice on how best to implement the policy as announced by President Bush.
From page 126...
... . In addition, these sources are supplemented by material presented to the committee by interested partners in the vaccination program and anecdotal information about state, local, and hospital-level response around the country available in recent print media.
From page 127...
... 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.
From page 128...
... 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.
From page 129...
... is truly very low, deliberation is key to ensuring the safest program possible. Issues of Timing The pre-event smallpox vaccination program is a complicated and enormous task.
From page 130...
... 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.
From page 131...
... 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 and 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 and planning.
From page 132...
... . This has encouraged manufacturers and vaccine administration sites to participate in the preevent vaccination program, as it reduces their liability exposure for adverse reactions.
From page 133...
... 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. This led to confusion and concern that individuals who have volunteered to be part of the nation's defense against bioterrorism -- the public health and health care workers who participate in precautionary vaccination and their family members who are at risk of accidental inoculation-are inadequately protected financially from liability, compared to the much smaller group of public health and health care workers who agree to administer the vaccine (AHA, 2002; McDonough, 2003)
From page 134...
... As phase I vaccinations begin, hospital patients could be adversely affected by the absence of health care workers from patient care duties because of adverse reactions or possible administrative leave (Altman, 2002)
From page 135...
... In their recommendation, they stated, "With respect to administrative leave for health care workers, the ACIP does not believe that health care workers need to be placed on leave because they received a smallpox vaccination. Administrative leave is not required routinely for newly vaccinated healthcare workers unless they are physically unable to work due to systemic signs and symptoms of illness, extensive skin lesions which cannot be adequately covered, or if they do not adhere to the recommended infection control precautions.
From page 136...
... The committee has no specific recommendations at this time on how to do this, but a concerted effort to assess these costs is important and could help in shaping the smallpox immunization program as it expands. 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.
From page 137...
... The committee suggests explicitly stating that the benefit of the vaccination program is to increase the nation's public health preparedness, but that the benefit of vaccination to any one individual might be very low (given the current threat assessment)
From page 138...
... The prototype information sheets provided by CDC for the post-event vaccination program guidance clearly state that CDC will NOT cover the costs of treating adverse reactions, other than the cost of vaccinia immune globulin (VIG) or cidofovir (Vistide)
From page 139...
... Consistency in Screening Materials The committee understands that CDC had to develop all of the screening materials and guidance on a very accelerated basis and thus had limited time to compare all documents for overall consistency. Since screening will be the first aspect of the vaccination program that response team volunteers will encounter, any confusion over screening guidelines could have a detrimental effect on the overall communications effort of the pre-event smallpox vaccination program.
From page 140...
... If revisions are indicated, the committee encourages CDC also to pre-test these revised materials on different populations. Educating Household Contacts Because the smallpox vaccine provides an increased risk of adverse events to household members of vaccinees (Neff et al., 2002)
From page 141...
... The committee recommends that CDC consider using the blooddonation opt-out and informed consent processes as models for the preevent 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.
From page 142...
... The committee offers a few recommendations to help ensure that the SISS is as comprehensive, efficient, and effective as possible. 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.
From page 143...
... Relying on passive systems that are dependent on vaccinees and their clinicians to bring the adverse reaction to the attention of the smallpox vaccination program managers will not capture all serious adverse reactions. The current guidance from CDC states that all adverse events (i.e., known serious adverse reactions and serious adverse reactions that are suspected to be related to the vaccine)
From page 144...
... 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. The committee suggests adding a field to PVS that would identify whether the
From page 145...
... The committee also encourages CDC to provide additional training on the PVS to state and local partners so that the quality of data contained in PVS can be maximized. 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.
From page 146...
... 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.
From page 147...
... 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 preevent smallpox vaccination program.
From page 148...
... A perception that the scientists overseeing the actual data on safety (who will have a responsibility for advising CDC whether the vaccinations are as safe as possible and for advising CDC whether to request the administration to halt an unsafe program) are not truly independent of those setting or overseeing policy could quickly imperil the smallpox vaccination program, not to mention the unintended consequences of eroding trust in all vaccination programs or all public health programs.
From page 149...
... CDC should carefully monitor the characteristics of the requests for VIG and cidofovir and use these data as a form of passive surveillance. CDC Safety System Guidance to States CDC asked the committee to provide advice on whether the proposed safety system will provide for the development of state capacity, such that states will be able to manage smallpox vaccine adverse events if smallpox vaccination becomes routine.
From page 150...
... A hasty launch may mean insufficiently trained vaccinators and uninformed vaccinees, leading perhaps to an increased likelihood of poor outcomes. Focus Areas of Training and Education Recommendations made in the screening and safety discussion in preceding pages of the report are relevant to the first training area identified by CDC -- smallpox vaccination clinics processing.
From page 151...
... Rather than just focusing on "practicing physicians," this information should be provided to all types of health care providers -- physicians, physician assistants, nurse practitioners, nurses. The committee recommends that the first communication clinicians should receive is basic information about the details of the pre-event smallpox vaccination program.
From page 152...
... and the health care community (Everett et al., 2002) about multiple components of the smallpox vaccination program.
From page 153...
... . The first phase of smallpox vaccination will provide unprecedented information about the training and education needs of vaccinators, public health and health care workers, prospective vaccinees and their close contacts.
From page 154...
... 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 providing public health and health care workers and the general public with the most complete and scientifically accurate information, while supporting informed decision-making regarding vaccination. Also, the committee recommends that CDC's communication efforts about smallpox vaccination clearly separate public health issues from national security matters.
From page 155...
... A well-informed public also is essential to the success of the smallpox vaccination program, and to public health preparedness in general. Community leaders, community-based organizations, and local civic associations possess human and communications resources that can prove invaluable in assisting the CDC
From page 156...
... The public should be provided with pretested, targeted information about vaccines in general (how they are developed, how they work, their benefits and potential side effects) , and about the smallpox vaccinia immunization in particular (i.e., the reality that the smallpox vaccine is different from other vaccines in its greater risk of adverse reactions and even death, though such risk is relatively low and may be minimized if appropriate screening, site care, and other precautions are taken)
From page 157...
... 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. Furthermore, communication planning and tools should differentiate between pre- and post-event information needs.
From page 158...
... 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.
From page 159...
... Gebbie, Committee Vice Chair Robert B Wallace, Committee Vice Chair Committee on Smallpox Vaccination Program Implementation REFERENCES AHA (American Hospital Association)
From page 160...
... Tran script from the IOM's Committee on Smallpox Vaccination Program Implementation Meeting One on December 19, 2002, Washington, DC: 284-291. IOM (Institute of Medicine)
From page 161...
... 2002. Transcript from the IOM's Committee on Smallpox Vaccination Program Implementation Meeting One on December 19, 2002, Washington, DC: 112-147.


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