APPENDIX A
Committee on Smallpox Vaccination Program Implementation

SUMMARY OF RECOMMENDATIONS

REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION

Letter Report #1

GENERAL CONSIDERATIONS

Issues of Timing

The committee recommends that CDC develop and communicate the criteria (e.g., types and rates of adverse reactions) that would trigger a reconsideration of the current systems in place to protect vaccinees and their contacts (e.g., the October 2002 Advisory Committee on Immunization Practices (ACIP) recommendations on contraindications, screening, care of the vaccination site, and administrative leave).

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.

Compensation for Adverse Reactions to the Smallpox Vaccine

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 vaccine-related injuries and illnesses for workers covered under their programs.

The committee recommends that CDC and the Department of Health and Human Services support all efforts, some of which might be administratively or legislatively bold and creative, to bring this issue of compensation for smallpox vaccine adverse reactions—including those reactions that occur despite non-negligent manufacture and administration of the vaccine—to speedy resolution.

Workforce Issues Resulting from Vaccination

The committee recommends that during phase I, CDC assess the effects of the current situation regarding administrative leave, disseminate the analysis widely, and before phase II begins, decide whether the ACIP recommendation needs to be reassessed. Any evidence of transmission of vaccinia virus to a patient from an immunized health care worker should lead to an active case investigation or to an immediate reassessment of policy.



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APPENDIX A Committee on Smallpox Vaccination Program Implementation SUMMARY OF RECOMMENDATIONS REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION Letter Report #1 GENERAL CONSIDERATIONS Issues of Timing The committee recommends that CDC develop and communicate the criteria (e.g., types and rates of adverse reactions) that would trigger a reconsideration of the current systems in place to protect vaccinees and their contacts (e.g., the October 2002 Advisory Committee on Immunization Practices (ACIP) recommendations on contraindications, screening, care of the vaccination site, and administrative leave). 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. Compensation for Adverse Reactions to the Smallpox Vaccine 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 vaccine-related injuries and illnesses for workers covered under their programs. The committee recommends that CDC and the Department of Health and Human Services support all efforts, some of which might be administratively or legislatively bold and creative, to bring this issue of compensation for smallpox vaccine adverse reactions—including those reactions that occur despite non-negligent manufacture and administration of the vaccine—to speedy resolution. Workforce Issues Resulting from Vaccination The committee recommends that during phase I, CDC assess the effects of the current situation regarding administrative leave, disseminate the analysis widely, and before phase II begins, decide whether the ACIP recommendation needs to be reassessed. Any evidence of transmission of vaccinia virus to a patient from an immunized health care worker should lead to an active case investigation or to an immediate reassessment of policy.

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Opportunity Costs The committee recommends that CDC work with their public health partners to document as well as possible the true costs of the smallpox program. SPECIFIC CONSIDERATIONS Informed Consent Process The committee recommends that all consent documents include a statement that the risks of the smallpox vaccine, while very low, are predictably higher than the risks associated with most other vaccines, but that the benefit is presently unknown—possibly very low (absent exposure to smallpox) or very high (in the event of exposure). The committee further recommends that informed consent forms include explicit notification of the availability, or lack thereof, of compensation for adverse reactions. Comprehension of Screening Materials Understanding that different populations may interpret the educational and screening materials somewhat differently, the committee recommends that CDC pre-test the educational and screening 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. If not, then material should be evaluated after phase I, and modified before phase II. Educating Household Contacts The committee recommends that CDC develop specific educational materials for household contacts of potential vaccinees. The committee recommends that the materials also include instructions about how household members can avoid accidental infection with vaccinia, should the household member choose not to disclose the contraindication to the vaccinee. 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 The committee recommends that CDC collect data on the reasons why potential vaccinees choose not to be vaccinated.

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Using the Pre-Event Vaccination System (PVS) to Collect Data on Adverse Reactions The committee strongly recommends that active surveillance for adverse reactions be employed, rather than relying exclusively on the passive surveillance systems that already exist (e.g., VAERS). The committee recommends that CDC use the Pre-Event Vaccination System (PVS) as the primary data collection system for adverse reactions. The committee recommends a follow-up on a subset of individuals in PVS rather than a telephone survey of vaccine recipients. The follow-up survey could be used to gather information on long-term effects from the vaccine, as well as information on cases of accidental vaccinia infection in household members of vaccinees, rather than focusing on obtaining data on common adverse reactions. Evaluation of Risk Factors for Known Adverse Reactions The committee strongly recommends analysis of the phase I PVS data as a series of nested case-control studies, with results available before moving on to phase II of the vaccination program. Establishment of a Data Safety and Monitoring Board (DSMB) If CDC is unable to assure this independent functioning of the DSMB, the committee recommends that the proposed organizational arrangement be reconsidered. CDC Safety System Guidance to States The committee recommends CDC evaluate each state’s capacity for managing adverse reactions before indicating that a state is ready to begin vaccinations. Focus Areas of Training and Education The committee recommends that CDC expand the scope of their training and education regarding the identification, treatment, and reporting of serious adverse reactions to all clinicians. The committee recommends that the first communication clinicians should receive is basic information about the details of the pre-event smallpox vaccination program.

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Communication Planning The committee recommends that CDC’s communication efforts about smallpox vaccination clearly separate public health issues from national security matters. The latter are best addressed by representatives of the administration more directly involved in such matters, and not by representatives of scientific agencies. Therefore, the responsibility of CDC is to deliver clear, consistent, and science-based public health communications. The committee recommends that CDC identify a single “voice” for the national vaccination program, a credible individual with a strong scientific background and an experienced communicator who can serve as the key CDC spokesperson. Additionally, the agency should develop several back-up sources for the media who can offer the same level of informed comment and thoughtful observation as the program's primary "voice." 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.