the effective response to SARS both at the national and local level was at least in part facilitated by smallpox preparedness efforts, in particular the improved communication and collaboration among parties.

The committee has noted that the safety system implemented by CDC worked as intended, bringing the cardiac adverse events to the immediate attention of the ACIP Smallpox Vaccine Safety Working Group and program administrators at CDC who responded promptly by modifying screening procedures and informed consent materials. The program has progressed with deliberation and caution. Thus far, the screening of potential vaccinees may have played a role in preventing several of the historically expected moderate-to-severe adverse events (e.g., eczema vaccinatum, progressive vaccinia) to the vaccine in 36,217 people vaccinated in the civilian program as of May 9, 2003 (CDC, 2003c). Also, it appears that vaccinee education on the risk of vaccinia transmission to contacts and measures taken to prevent it with appropriate bandaging and site care have worked well, and may in part account for the absence of reported cases of vaccinia transmission from civilian vaccinees to either healthcare or personal contacts.

Although safety data to date have not revealed many of the moderate-to-severe adverse events or transmission that historically have been associated with smallpox vaccination, this does not necessarily mean that more robust trends will not be discovered later in the process, as vaccination numbers increase and more occupationally diverse volunteers consider vaccination.

The enactment of the smallpox vaccination compensation legislation (Smallpox Emergency Personnel Protection Act of 2003; P.L. 108-20) is likely to remove one of the barriers to vaccination identified by the committee and others (APHA, ASTHO and NACCHO, 2003).2 As this is a complex matter, the committee notes the need for additional clarification by CDC to the states on the provisions of the law, and for fact sheets or other explanatory materials for potential vaccinees. These fact sheets should clearly explain the provisions of the legislation and protections enacted, and refer potential vaccinees to additional information sources, such as their own state health department.

Considerations for Next Steps in the Vaccination Program

It is imperative that before continuing to expose individuals to a vaccine that is effective, but not without some risks, the national and state programs determine what level of pre-event vaccination is needed for preparedness. In its first report (IOM, 2003a), the committee recommended that “sufficient time should be allowed between the two phases to ensure adequate assessment and plan revision by CDC and its partners” and in its second report (IOM, 2003b), recommended that the evaluation of “the effectiveness of implementation and the safe use of the vaccine” be carried out as extensively as allowed by “the mandates and realities of the vaccination program.” At the program’s beginning, it appeared that a wide variety of data about the process and the outcomes of the first phase of vaccination would be available, and that comprehensive evaluation could be conducted between phases. Although the initially expected civilian numbers have not been reached, pausing to evaluate remains an important component of

2  

At the time of the writing of this report, the compensation language in CDC’s Vaccine Information Statement had not yet been updated to reflect the newly enacted legislation.



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the effective response to SARS both at the national and local level was at least in part facilitated by smallpox preparedness efforts, in particular the improved communication and collaboration among parties. The committee has noted that the safety system implemented by CDC worked as intended, bringing the cardiac adverse events to the immediate attention of the ACIP Smallpox Vaccine Safety Working Group and program administrators at CDC who responded promptly by modifying screening procedures and informed consent materials. The program has progressed with deliberation and caution. Thus far, the screening of potential vaccinees may have played a role in preventing several of the historically expected moderate-to-severe adverse events (e.g., eczema vaccinatum, progressive vaccinia) to the vaccine in 36,217 people vaccinated in the civilian program as of May 9, 2003 (CDC, 2003c). Also, it appears that vaccinee education on the risk of vaccinia transmission to contacts and measures taken to prevent it with appropriate bandaging and site care have worked well, and may in part account for the absence of reported cases of vaccinia transmission from civilian vaccinees to either healthcare or personal contacts. Although safety data to date have not revealed many of the moderate-to-severe adverse events or transmission that historically have been associated with smallpox vaccination, this does not necessarily mean that more robust trends will not be discovered later in the process, as vaccination numbers increase and more occupationally diverse volunteers consider vaccination. The enactment of the smallpox vaccination compensation legislation (Smallpox Emergency Personnel Protection Act of 2003; P.L. 108-20) is likely to remove one of the barriers to vaccination identified by the committee and others (APHA, ASTHO and NACCHO, 2003).2 As this is a complex matter, the committee notes the need for additional clarification by CDC to the states on the provisions of the law, and for fact sheets or other explanatory materials for potential vaccinees. These fact sheets should clearly explain the provisions of the legislation and protections enacted, and refer potential vaccinees to additional information sources, such as their own state health department. Considerations for Next Steps in the Vaccination Program It is imperative that before continuing to expose individuals to a vaccine that is effective, but not without some risks, the national and state programs determine what level of pre-event vaccination is needed for preparedness. In its first report (IOM, 2003a), the committee recommended that “sufficient time should be allowed between the two phases to ensure adequate assessment and plan revision by CDC and its partners” and in its second report (IOM, 2003b), recommended that the evaluation of “the effectiveness of implementation and the safe use of the vaccine” be carried out as extensively as allowed by “the mandates and realities of the vaccination program.” At the program’s beginning, it appeared that a wide variety of data about the process and the outcomes of the first phase of vaccination would be available, and that comprehensive evaluation could be conducted between phases. Although the initially expected civilian numbers have not been reached, pausing to evaluate remains an important component of 2   At the time of the writing of this report, the compensation language in CDC’s Vaccine Information Statement had not yet been updated to reflect the newly enacted legislation.

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the overall program of safely building smallpox preparedness. Also, by combining the safety data from both civilian and military vaccinations (totaling over 460,000 vaccinees) a great deal can be learned, shared, and disseminated (CDC, 2003a; DoD, 2003). CDC acknowledges that there is “a natural pause that occurs between stage one and stage two” (Henderson, 2003). The committee recognizes that pausing also involves potential risks. A pause implies slower vaccination of the number of responders a jurisdiction may require for preparedness, a loss of momentum, and perhaps vulnerability in the event of a potential smallpox event. However, given that the smallpox threat level, as it is publicly described, has not changed, the committee continues to believe that the benefits of the pause likely outweigh the risks. The committee is aware that some jurisdictions have already begun offering the vaccine to a wider population of potential vaccinees, but reaffirms the need for a pause. The committee recognizes that it is important for states to finish the vaccination of volunteers to complete health care and public health response teams according to state plans. However, in reiteration of its previous recommendations, the committee recommends CDC facilitate the efforts of states that wish to pause to evaluate the process and outcomes of their vaccination efforts to date, and plan for next steps before deciding whether and when to begin vaccination of new personnel. CDC should provide states with a target date for when CDC expects to have completed its revision of materials, data systems (adding new occupational categories, etc.), and guidelines. States that have identified a need for more vaccinated volunteers to carry out specific smallpox response functions will then be able to set their own timeline for vaccinating these new groups. The pause is important for three programmatic reasons. Safety. First, a pause is needed to evaluate the vaccination program’s processes and outcomes to date, and thus ensure that expanded vaccination continues to be as safe as possible for both vaccinees and their contacts. The fact that by April 29, 2003, only 34% of vaccinees3 were included in the Smallpox Vaccine Adverse Event Active Surveillance System (Mootrey, 2003) is an example of the additional work needed to help provide more data for a national view of the program. Some adverse events might not arouse concern on a state level, but aggregated nationally, new patterns could emerge. The cardiac complications were unexpected adverse events, and there may be others. That is why it is important to ascertain whether or not the vaccine played a role in the cardiac events, and rule out any other reasons for concern before vaccination is expanded to other populations. Changing circumstances. Second, a pause would allow time for CDC and the states to modify vaccination plans, data systems, and materials in response to changing circumstances (i.e., a new population of potential vaccinees). At the committee’s second and third meetings, states commented on the need to revise educational materials before expanding vaccination to new types of volunteers (Bresnitz, 2003; Toomey, 2003; Pezzino, 2003). Furthermore, the Pre-Vaccination Information Packet has not been updated since March 31, 2003 (CDC, 2003b). It would be helpful for many states if these 3   Of vaccinees at 28 or more days post-vaccination.

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changes and revisions were made before they proceeded with vaccination, in part to avoid the difficulty of implementing changes midcourse (ASTHO, 2003; Pezzino, 2003). Overall smallpox preparedness. Third, vaccination is not a goal in itself, but a component of overall smallpox preparedness. Therefore, a pause is needed to re-evaluate the vaccination program’s implications for and integration into overall smallpox preparedness nationally and locally (i.e., to determine what level of pre-event vaccination is needed, and what personnel should be vaccinated to play specified roles in smallpox response). Some issues to be addressed before deciding whether and how to proceed with vaccination include tasks to be accomplished in the short-term, before moving on to new types of vaccinees: The completion of an in-depth analysis and investigation of all known serious adverse events to date and possible risk factors; The determination of what numbers and types of vaccinated personnel are needed to achieve preparedness; The update of educational and training materials by CDC; The revision of program data systems to include new types of vaccinees and to account for differences in data entry anticipated in expanding to a wider range of occupational contexts and personnel; and The development of guidelines regarding vaccine “take” readings, vaccination site checks and site care, and other issues related to vaccination follow-up of new types of vaccinees. There are also tasks to be addressed on an ongoing basis and that are also significant to smallpox preparedness in general: The establishment of communication and collaboration with other partners (e.g., first responders, security personnel, health care and hospital systems, community-based health care providers); The revision by state and local programs of response plans that lay out clear roles and activities for teams responding to a potential event; and The need for strategic planning and reconciliation of the smallpox vaccination program with other bioterrorism programs and other public health priorities. A break in the course of the vaccination program may help prevent vaccinating potentially large numbers of additional volunteers (e.g., health care workers, traditional first responders, and others) less safely than in the first phase of vaccinations, without adequate time to implement or update safeguards (e.g., screening, training and education) that would be appropriate to new types of vaccinees and their contacts.