Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation Letter Report 2 (2003) / Chapter Skim
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Contents of Letter Report
Contents of Letter Report
Pages 1-25
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In particular we note that a number of recommendations have been implemented or their implementation is planned, including, but not limited to: creating and implementing active surveillance for adverse events; cleveloping an information sheet for contacts of vaccinees; · adcling information about the status of compensation issues in the Vaccine Information Statement; and enhancing evaluation extorts. We hope that our second report proves useful to you and your partners.
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The committee extends its congratulations and expresses its admiration to CDC and the thousands of state and local partners in health departments, hospitals, and elsewhere involved in this program. The vaccination program has thus far progresses} cautiously and with great deliberation, with states, local jurisdictions, and hospitals taking locally appropriate steps (Henclerson, 2003~.
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define and progress toward smallpox preparedness, and (2) evaluate the effectiveness of implementation and the safe use of the vaccine as extensively as the mandates and realities of the vaccination program will allow.
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Although original estimates were useful in planning and initiating the program, the practical experience acquired by states and localities in the first several weeks of the program suggests that other benchmarks are equally,: if not more important. CDC will now be able to consider both the realities of operationalizing the vaccination program and a more cared!
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CDC and its state and local partners face the need to determine how to best and most rapidly integrate a new set of potential vaccinees into efforts toward smallpox preparedness. CDC's goals for the entire vaccination program (i.e., preparedness/ capacity to respond, protection of those who will investigate and treat suspected cases, and gaining experience with vaccination, [Anderson, 20033)
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Expanding the vaccination program may negatively affect other aspects of smallpox preparedness, bioterrorism preparedness in general, and even the delivery of essential public health services. At the time this report is being written, it is not clear when or even if additional funcling will be made available to state and local programs for the expansion of smallpox vaccination.
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a much larger cohort than the civilian vaccination program to clate, it is hoped that data on adverse events in DoD's vaccination program will be incorporated, to the extent possible, in the overall evaluation of vaccine safety. As the committee has stated previously, evaluation is a matter of data analysis, not specifically of time, and would entail, among other issues, the necessary reasoned analysis of the strengths and weaknesses of the procedures used to ensure patient and contact safety in the first phase.
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The planning, implementation, and evaluation of strategic communication activities for the smallpox vaccination program could begin to form a foundation for broacier communication about bioterrorism. s Communication, training, and education have overlapping meanings.
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Some adverse events following smallpox vaccination have been reported in the media before CDC has formally described these adverse events. There seems to be a range of perceptions, both reflected in and by the media, about the program ant} the vaccine.
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It is not easy to reconcile the program's present focus on public health and health care response teams with the need to communicate with and to the public. Although the public needs information and education on the subject of smallpox, this would ideally be accomplished without creating or confirming a sense of crisis and anxiety hence the need for sufficient.
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Communicating with the Media. Furthermore, while media reports provide the valuable service of informing the public about the vaccination program's progress, they sometimes include inaccurate information (e.g., misrepresenting the severity of adverse reactions)
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and their effectiveness in increasing target group knowledge (e.g., increasing familiarity with CDC smallpox site care in clinicians and vaccinees, clinician and vaccinee knowledge of expected reactions to vaccinia, health care provider familiarity with local smallpox response plans and their personal roles, and clinician awareness of clinical resources, such as the CDC Clinician information Line)
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Special attention is needed to highlight uncertain compensation for adverse reactions, and simplifying legal explanations currently provided on the informed Consent form. The dissemination of training and education materials to physicians and other health care providers is a vitally important component of the vaccination program, and CDC should take steps to determine the most effective ways to reach clinicians.
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Through the Smallpox Vaccine Adverse Events Monitoring and Response System (which includes the Hospital Smallpox Vaccination Monitoring System, the Smallpox Vaccine Adverse Event Active Surveillance System [both described in detail below] , the Vaccine Adverse Events Reporting System, inquiries received through CDC's Clinician information Line, and requests for vaccinia immune globulin and cidofovir)
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to accomplish active surveillance for serious adverse events following smallpox vaccination among all vaccinees during phase ~ of the vaccination program. The Active Surveillance System (and other coordinated data systems)
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.; . For serious adverse events that are identified through the Active Surveillance System, CDC requests that a VAERS report be filed (if one was not filed already)
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The HSVMS data will be only one component of the overall evaluation plan, but these data will be essential to the analysis anal evaluation of the ongoing vaccination program. The Active Surveillance System, HSVMS, and VAERS will all provide valuable data on vaccinees' experiences following vaccination.
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. Implications of Program Expansion for Collection of Data on Adverse Events The relatively quick expansion of the vaccination program to include all healthcare workers, firefighters, law enforcement, and emergency workers creates a number of implications for the capacity to collect data on serious adverse events, common adverse events, and vaccinees' experiences following smallpox vaccination.
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. Adverse events reported following smallpox vaccination may be causally associated with the vaccine, or they may be coincidental illnesses that woulc!
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. The committee understands that the MMWR will be the definitive source for information about adverse events reported following smallpox vaccination.
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Regular disclosure of adverse events could assure the public that the vaccination program is worthy of their trust. (As of March 19, 2003, CDC has upclatec3 its adverse event report web page every Thursclay; DoD has not upclate(1 its adverse event report web page since February 12, 2003.)
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in some states, a provisional decision about coverage for smallpox vaccine adverse reactions by a state workers' compensation board may not be tested until an initial case is 22
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be a continuing barrier to full implementation of the pre-event smallpox vaccination program if a smallpox vaccination compensation program is not created. Consequently, the nation's preparedness to respond to a smallpox attack could be hindered.
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Such a test could involve testing for a vaccinee's comprehension of a short list of key facts (e.g., (tecision is voluntary, major contraindications, types of adverse events that are possible, current lack of compensation for adverse events, what to do if a suspected adverse event occurs)
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From page 25... ...
The committee was pleased to find out that CDC intends to conduct an assessment of the smallpox vaccination program's costs. However, 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 cost estimates of expanding the vaccination program to additional health care and public health workers, and emergency first responders.
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