The Smallpox Vaccination Program Public Health in an Age of Terrorism (2005) / Chapter Skim
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Appendix E: Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation Letter Report #4
Appendix E: Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation Letter Report #4
Pages 203-251
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the committee's advice regarding offering vaccination to members of the general public who insist on receiving it; and (3) an examination of selected aspects of smallpox vaccination program implementation.
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Selected Aspects of Smallpox Vaccination Program Implementation. INTEGRATING SMALLPOX PREPAREDNESS INTO OVERALL PUBLIC HEALTH PREPAREDNESS State health departments have been actively involved in planning and pre paring for the possibility of a bioterrorist event.
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These have been resource-intensive, giving rise to concerns about the opportunity costs (i.e., to essential public health services) of the smallpox vaccination program and about the optimal balance of investment of public health funds (e.g., are smallpox-related activities funded at the expense of a more wide-ranging kind of preparedness?
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The committee hopes that this report will provide some useful direction toward that end. 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 public health preparedness in a systematic and comprehensive manner and with some public visibility.
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The question of what exactly is involved in preparedness to respond to a smallpox attack has been a recurrent theme at committee meetings and in presentations to the committee. Many of the requirements for smallpox preparedness apply to preparedness in general; there are necessary components of the public health infrastructure including workforce, surveillance and laboratory capacity, information technology, legal authority, and communication networks.
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The smallpox preparedness metrics/indicators will be the subject of the committee's meeting on September 4, 2003, and the committee hopes this effort will help to establish a minimum standard of smallpox preparedness. 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 Study Staff, 2003; NACCHO, 2003a)
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Although the committee recognizes that the CDC has publicly acknowledged that preparedness is not about numbers (see page 1) , it is clear that there is lingering confusion about the vaccination program's aims.
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. 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 include the important role of the health care community in overall public health preparedness and the role of public and media communication. Preparing Key Responders The first element of smallpox preparedness described in the CDC/Department of Health and Human Services (DHHS)
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The committee hopes that CDC and DoD could collaborate to maintain contact with vaccinees, particularly those who enter civilian life, and to link them to any mechanism developed to include as many as possible in planning for preparedness. Contact also should be maintained with health care or public health workers who received a smallpox vaccine because of exposure to a case of monkeypox, so they could be utilized for response to a smallpox event.
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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 and health care communities, and between public health and traditional emergency response agencies. Communication between all relevant partners is essential, including mechanisms for notification and information sharing.
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as "disease surveillance for rash illnesses and laboratory analysis to rapidly detect a single case of smallpox and any subsequent cases." Building capacity for rapid response requires strengthening communication and information networks, training and education of public health, health care and other relevant personnel, and the review of legal authority and public health law. Communication and information networks needed for rapid public health response require many components, including connectivity among levels of the public health infrastructure (agencies and laboratories)
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The Role of the Health Care Community in Public Health Preparedness Good communication and information systems (within and among public health agencies, and at the interface with the health care sector) form the core of smallpox and overall public health preparedness (IOM, 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 the vaccination program (IOM, 2003d)
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; · provide ongoing staff training on bioterror agents, including smallpox; · develop guidelines for identifying and managing suspicious cases (including suspected smallpox) in their outpatient clinics, emergency departments, laboratories, and other facilities; · link with the local or state jurisdiction's public health preparedness efforts (including the acquisition and distribution of Strategic National Stockpile drugs, vaccines, and supplies, including smallpox vaccine, regionally)
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. In addition to the efforts of public health agencies, accreditation systems could be used to further the engagement of hospitals and health care organizations in bioterrorism and overall public health preparedness.
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Testing Smallpox and Public Health Preparedness Evaluating the readiness of public health and health care systems to mount an effective response is challenging and requires a clear standard and indicators of preparedness to test against (as noted above) and tools with which to test preparedness.
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and the local and state Public Health Preparedness and Response Capacity Inventories (CDC, 2002b, 2002c) , could be used as resources to develop a detailed and quantitative minimum standard (as recommended above)
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Sustaining general public health preparedness requires an array of capabilities and resources, and strategic planning at all levels is needed for long-term smallpox preparedness, if this is determined to be a necessity. Maintaining specific elements of smallpox preparedness includes, but is not limited to, the following activities: For key responders: · Vaccinating and revaccinating select key responders as appropriate to address turnover and decreasing immunity; and · Providing training and education on an ongoing basis to all key responders on the subject of smallpox response plans and on their functional assignments or roles, on smallpox disease and vaccine, etc.
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. Given the current level of threat and the inherent health risks of the vaccine, we have decided not to initiate a broader vaccination program for all Americans at this time" (White House, 2002)
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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
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COMMUNICATION: Communicating about the public health system's readiness and ability to protect the public could greatly influence how many people feel it is necessary to receive the smallpox vaccine prior to any exposure or identified case. If the public is well-informed about the plans that CDC, states and localities have in place to respond to a smallpox attack (e.g., an adequate vaccine supply, plans for mass vaccination clinics, and development of a newer smallpox vaccine)
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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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Compensation Available for Smallpox Vaccine Injuries. Communicating About and Coordinating the Response to Adverse Events Communication among CDC, states, and local jurisdictions is extremely important for identifying every serious adverse event, conducting follow-up of the vaccinee who experiences the adverse event, and providing feedback to states and particularly local jurisdictions about how their reporting efforts help to ensure the overall safety of the national smallpox vaccination program.
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Streamlining Data Collection Of the multiple data systems being used concurrently during the preevent 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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The committee also encourages CDC to plan for streamlining or limiting the data collected from vaccinees, should an outbreak occur, in order to keep things moving more efficiently. Ease of Use and Value Gained from PVS As effective as these data systems have been at helping to identify serious adverse events following smallpox vaccination, state and local vaccination programs appear to be experiencing continuing difficulty in using these systems.
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Utility of the Active Surveillance System As described 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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In its first letter report (IOM, 2003b) , the committee identified its reasons for recommending the creation and use of an active surveillance system: Considering the anticipated risks of the vaccination program and the currently unknown benefit, it is extremely important that all adverse reac tions from the smallpox vaccine (both known and suspected)
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Thus, the Active Surveillance System may have more value during the expansion of the vaccination program, especially if proactive communication about the specific data systems being used during the smallpox vaccination program, the purpose of each one, and how they are linked together is provided to those who will be responsible for data entry and management. Pregnancy Screening On May 2, 2003, CDC described women who had been exposed to smallpox vaccine during pregnancy and their enrollment in the National Smallpox Vaccine in Pregnancy Registry in an article appearing in the Morbidity and Mortality Weekly Report (CDC, 2003k)
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. Even though some women have been inadvertently exposed to smallpox vaccine during the civilian vaccination program, the lower than expected rate of unknown pregnancies and conception in the 4 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 recommended 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 followup data on the pregnancies exposed to smallpox vaccine because of contact with monkeypox will contribute to evaluation of the other pregnancies included in the registry.
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have placed a high priority on safety in the national smallpox vaccination program. When safety concerns have arisen, CDC and the working group have responded promptly, as evidenced by the emergency meeting of the full Advisory Committee on Immunization Practices and the working group on March 28, 2003.
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of the working group recommended that CDC "[c] ontinue with the current pre-event volunteer program, to vaccinate and maintain vaccination status of selected public health and first response health care workers with careful screening for known risk factors with a goal of meeting and maintaining state and local health department readiness needs," in addition to the entire working group recommending, "No member favors beginning phase 2 of the vaccination program" (Neff, 2003)
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CDC has stated that "studies to evaluate possible biologic mechanisms for cardiac adverse events following 4 Less than a week after the ACIP released its statement on the national smallpox vaccination program, the National Vaccine Advisory Committee (NVAC) issued a letter to the acting assistant secretary for health and director of the National Vaccine Program containing a resolution that was unanimously passed by the NVAC: "The National Vaccine Advisory Committee reaffirms the necessity for the nation's health system to be prepared for biological threats, man-made or natural, and encourages continued efforts in this regard.
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. Knowing now that at least one state is using different screening criteria from 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.
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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. The use of such control groups would greatly aid the investigations of the recently reported cases of cardiomyopathy (CDC, 2003n)
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The committee also suggests that CDC and the ACIP consider holding periodic invitational workshops on the science of smallpox vaccine safety and efficacy to update and disseminate new findings in these areas. The results of these workshops could be actively disseminated to CDC's state and local partners in the smallpox vaccination program to update them on the latest research.
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The committee believes that, although still important, studies on the reasons why people declined vaccination, tracking rarer adverse events, improving adverse event classification, and tracking persons with missing data should be considered next-tier priorities. Compensation Available for Smallpox Vaccine Injuries As stated in the committee's third letter report, "the committee notes the need for additional clarification by CDC to the states on the provisions of the [Smallpox Emergency Personnel Protection Act of 2003 (P.L.
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The ACIP Smallpox Vaccine Safety Working Group has concluded that "Smallpox vaccination increases risk of myo-pericarditis" (Neff, 2003)
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CONCLUDING REMARKS The committee offers its assistance in the future in any areas that would prove useful to CDC. Two possible areas include developing a research agenda to support and evaluate the implementation of the smallpox preparedness program and exploring how to better integrate smallpox preparedness into overall public health preparedness.
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· Fifth, 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. The committee wishes to thank you for the continuing opportunity to be of assistance to the Centers for Disease Control and Prevention and its partners as they work to protect the nation's health.
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2003d. Notice to readers: supplemental recommendations on adverse events following smallpox vaccine in the pre-event vaccination program: recommendations of the Advi sory Committee on Immunization Practices.
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Conversations with Public Health Agencies About the Smallpox Vaccination Program and Smallpox Preparedness: Synthesis and Detailed Notes. Connolly C
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2003. Transcript from the IOM's Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:54-82.
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2003. Transcript from the IOM's Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:173-189.
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2003. Transcript from the IOM's Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:82-106.
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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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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. 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.
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APPENDIX E 251 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.
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