Index

A

ACAM2000 trials, 48

Acambis, Inc., 16, 47–48

Access

equity of, 2

to medical records, 278

to vaccines, prioritizing, 282

Accidental inoculation, 132.

See also Inadvertent inoculation;

Transmission of vaccinia to contacts

Accountability.

See also Responsibility

democratic principle of public, 87

ACEP. See American College of Emergency Physicians

ACIP. See Advisory Committee on Immunization Practices

Active Surveillance System. See Smallpox Vaccine Adverse Event Active Surveillance System

Administrative leave, 32, 111, 135

Adverse events associated with smallpox vaccination among civilians, 3, 50.

See also Eczema vaccinatum;

Erythema multiforme major;

Generalized vaccinia;

Inadvertent inoculation;

Myo/pericarditis;

Ocular vaccinia;

Post-vaccinial encephalitis;

Progressive vaccinia;

Vaccinia keratitis

rates of, 2, 158

reporting, 216

Advisory Committee on Immunization Practices (ACIP), 3, 5, 22–34, 40, 47, 49, 57, 60, 82, 88–90, 111, 116, 130, 134–135, 148, 166n, 211, 239

meetings, 3, 27–29, 32–33

recommendation to end the smallpox vaccination program, 3, 57–58

Smallpox Vaccine Safety Working Group, 47, 59–60, 183–185, 234, 241

Advisory Committee on Immunization Practices Smallpox Vaccine Safety Working Group (ACIP SVS WG), 234–236

Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction, 293, 298

Aerosols, transmission of variola virus by, 12

Africa, smallpox in, 11, 13

Agency for Healthcare Research and Quality (AHRQ), 121, 218, 288, 317, 326

Evidence-based Practice Center, 313

Agents that could be used in bioterrorism, 205.

See also individual biowarfare agents

AHA. See American Hospital Association

AHRQ. See Agency for Healthcare Research and Quality

AIDS. See HIV infection



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Index A ACAM2000 trials, 48 Acambis, Inc., 16, 47–48 Access equity of, 2 to medical records, 278 to vaccines, prioritizing, 282 Accidental inoculation, 132. See also Inadvertent inoculation; Transmission of vaccinia to contacts Accountability. See also Responsibility democratic principle of public, 87 ACEP. See American College of Emergency Physicians ACIP. See Advisory Committee on Immunization Practices Active Surveillance System. See Smallpox Vaccine Adverse Event Active Surveillance System Administrative leave, 32, 111, 135 Adverse events associated with smallpox vaccination among civilians, 3, 50. See also Eczema vaccinatum; Erythema multiforme major; Generalized vaccinia; Inadvertent inoculation; Myo/pericarditis; Ocular vaccinia; Post-vaccinial encephalitis; Progressive vaccinia; Vaccinia keratitis rates of, 2, 158 reporting, 216 Advisory Committee on Immunization Practices (ACIP), 3, 5, 22–34, 40, 47, 49, 57, 60, 82, 88–90, 111, 116, 130, 134–135, 148, 166n, 211, 239 meetings, 3, 27–29, 32–33 recommendation to end the smallpox vaccination program, 3, 57–58 Smallpox Vaccine Safety Working Group, 47, 59–60, 183–185, 234, 241 Advisory Committee on Immunization Practices Smallpox Vaccine Safety Working Group (ACIP SVS WG), 234–236 Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction, 293, 298 Aerosols, transmission of variola virus by, 12 Africa, smallpox in, 11, 13 Agency for Healthcare Research and Quality (AHRQ), 121, 218, 288, 317, 326 Evidence-based Practice Center, 313 Agents that could be used in bioterrorism, 205. See also individual biowarfare agents AHA. See American Hospital Association AHRQ. See Agency for Healthcare Research and Quality AIDS. See HIV infection

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Alexander, E. Russell, 343 “All-hazards” approach, 56, 292n American Academy of Family Physicians, 89 American Accreditation HealthCare Commission, 218 American College of Emergency Physicians (ACEP), 52 American College of Occupational and Environmental Medicine, 52 American Hospital Association (AHA), 52 American Medical Association, 218 American Medical Group Association, 217 American Nurses Association (ANA), 52 American Public Health Association, 24, 52, 89, 305 ANA. See American Nurses Association Announcement, of the smallpox vaccination program, 41–42 Anthrax bioterrorism attacks within the U.S., xv, 23, 305 Antiviral agents, need for development of, 11 Antiviral T-cell response, 14 Areas of potential future inquiry, 158–159 Assessment of Future Scientific Needs for Variola Virus, 11 Assessment of safety profile, 142–149 Association of Federal, State, County, and Municipal Employees, 52 Association of Professionals in Infection Control, 218 Association of Public Health Laboratories, 24 Association of State and Territorial Health Officials (ASTHO), 24, 49, 51, 54, 83, 86, 91, 94, 98, 100, 197, 236n ASTHO. See Association of State and Territorial Health Officials Atlanta, Georgia, official repository for live variola virus, 11 Authority. See also Responsibility CDC needing to speak with, 82–83, 89, 95–96, 101, 114, 155, 209–210 for decision-making, clear lines of, 257, 299 documentation of, 278 Availability of compensation, notification about, 189–190 of vaccinations for the general public, 31, 33 of vaccine supplies in the United States, 15–16 Aventis Pasteur vaccine, 15, 17 B Background rates, of conditions that could be confused with adverse reactions, 146–147 Bangladesh, smallpox in, 18 Baxter Healthcare Corp., 16 Bayer, Ronald, 344 Bifurcated needle call for a safer, 52 inoculation using, 14 invention of, 10 Biopreparedness, 65, 97. See also Bioterrorism, preparing for money spent on, 43, 260 Bioterrorism. See also Biopreparedness agents that could be used in, 205 contrasting roles of public health and traditional responders in, 291 funding for, 33–34 grants for, 87 media role in, 218 only one public health threat, 268 possibility of future, 23 preparing for, 34–35, 81, 172–174, 217, 266 response competencies, 281 university-based centers for studying, 218 Blood donation forms, 141 Bush, George W., xv, 9, 26, 41, 52, 84, 124–125, 137, 222 C Cardiac adverse events, 40, 46–48, 90 Cardiac disease, basic pathophysiology of, 236 Cardiomyopathy, 229 dilated, 241 Category A pathogens, 23 CDC. See Centers for Disease Control and Prevention CDC-American Medical Association First National Congress on Public Health Readiness, 99 CDC Clinician Information Line, 176, 178, 180, 230 CDC/Department of Health and Human Services (DHHS) guidance, 211, 214–215, 281

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC policy options draft versions of, 28 regarding lab workers and other specific occupational groups, 28 regarding vaccinating members of the general public, 28 CDC Public Health Performance Assessment for Emergency Preparedness, 267 Cell-culture smallpox vaccine, 47 Cellular immunity, a surrogate measure of immunity, 14 Center for Biosecurity, 15 Center for Civilian Biodefense Studies, 15 Centers for Disease Control and Prevention (CDC), xvi, 2–6, 15–16, 22–23, 25, 27–34, 42, 49, 55–71, 85–102, 111–122 constraints upon, 83 Cooperative Agreement on Public Health Preparedness and Response, 34, 294 Council on Public Health Preparedness, 99 draft policy options, 28 Evidence-Based Performance Goals for Public Health Disaster Preparedness, 99, 122, 288, 308, 318, 320, 326 Health Alert Network, 305 Hospital Infection Control Practices Advisory Committee, 29 independence of, 30 Laboratory Response Network, 307 liaison to the FBI, 297 needing to speak authoritatively as the nation’s public health leader, 82–83, 89, 95–96, 101, 114, 155, 209–210 Office of Terrorism Preparedness and Emergency Response, 99 providing guidance to state public health agencies, 207–208 public fora held by, 30 readiness indicators document, 277–283 role in providing scientific and public health reasoning for policy, 93–96 safety system guidance to states, 114, 149 Secure Data Network, 180 Smallpox Response Plan and Guidelines, 24–25, 138, 156 supporting, xvii as a target, 318 Centers for Medicare and Medicaid Services (CMS), 270 Centers for Public Health Preparedness, 218, 286 Central Intelligence Agency, 92 Challenges in defining and assessing public health preparedness, 6, 204–210 smallpox preparedness as only one component of overall public health preparedness, 206 a standard for smallpox preparedness, 207–210 vaccination as only one component of smallpox preparedness, 205–206 Challenges in integrating public health into a broader field, 292–299 common definitions and terminology needed, 297–299 coordination issues, 292–297, 299 the Lexicon Project, 298–299 Charo, R. Alta, 344 Chemical Stockpile Emergency Preparedness Program (CSEPP), 315–316 Chemotherapy, impairment of immune systems due to, 18, 128 Cheney, Dick, 29 CHER-CAP. See Community Hazards Emergency Response Capability Assurance Program Chickenpox, confused with smallpox, 12 China, monkeypox in, 55–56 Chronology, 4 Cidofovir, 17, 138, 142, 149, 234 Civilian smallpox vaccination program, 3, 196, 222, 226. See also Public interest; Vaccination of members of the general public who insist on receiving smallpox vaccine beginning of, 15–16, 163 much smaller cohort than military, 170 policy options regarding, 28 safety of, 224–243 voluntary, 9, 48, 128, 188, 213 Clarity issues, 131 Clinician Information Line (CDC), 176, 178, 180, 230 Closing institutions, timing of, 261 CMS. See Centers for Medicare and Medicaid Services Coates, Thomas, 344–345 Collecting data on adverse reactions, 2, 4, 113 age of existing data, 10, 19, 213 for safety, 152

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Columbia University, 219 Committee on Emerging Microbial Threats to Health in the 21st Century, 205 Committee on Orthopoxvirus Infections, 11 Committee on Smallpox Vaccination Program Implementation, xvi, 2, 84, 98–99, 123, 125, 195, 203, 252, 255, 286 Communicating about and coordinating the response to adverse events, 2, 6, 119, 154–155, 172–173, 226–227 need for greater redundancy in, 62 recommendations regarding, 119 Communication, 154–158, 170–175 with the general public, 171–174 with health care workers and others, 174–175 with the media, 174 overarching issues of, 2, 171 public and media, role of in smallpox preparedness, 218–219 recommendations regarding, 115 regarding vaccination of members of the general public who insist on receiving smallpox vaccine, 224 specifics of, 171–175 Communication planning, 2, 154–158 recommendations regarding, 2, 114, 207 Community Hazards Emergency Response Capability Assurance Program (CHER-CAP), 315–316 Compatibility, ensuring, between the DHS exercise doctrine and public health preparedness exercises, 319–320 Compensation, 2, 187–190, 277–278 for adverse reactions to the smallpox vaccine, 2, 61, 131–134 available for smallpox vaccine injuries, 2, 61, 240–242 “covered injuries,” 241 failure to provide, 4 issues, 277–278 lack of compensation impeding program progress, 188–189 notification about availability of compensation or lack of compensation, 189–190 plan, 51–53 recommendations regarding, 2, 61, 111–112, 117 timeline for, 53 workers’ compensation, 187–188 Comprehension of screening materials, 139–140 recommendations regarding, 112–113 Confusion, about program goals and timeline, 45–46 Congressional appropriations, 34 Congressional interest and involvement, in the smallpox vaccination program, 3, 58 Consent forms, 278 Consistency in screening materials, 139–142 comprehension of screening materials, 139–140 educating household contacts, 140–141 reasons for declining vaccine, 141–142 Constituencies. See Key constituencies “Contacts,” transmission of vaccinia virus to, 9, 12, 48, 59, 135, 144–145, 186, 196, 256 Containment. See “Search and containment” strategies; Surveillance and containment activities Contraindications screening, 2, 32, 61, 112, 116, 136–139, 186 Controlling and eradicating smallpox, 13 Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism, 25, 34, 254, 295 compliance, measuring, 274 Continuation Guidance for, 195, 206, 210 Coordinated mass vaccination, 10 Coordination issues, 292–297, 299 cross-jurisdictional, 305 example of intersectoral tension and collaboration, 296–297 Coronavirus, 55. See also Severe acute respiratory syndrome Council of State and Territorial Epidemiologists (CSTE), 24, 30, 86 Council on Public Health Preparedness, 99, 286, 311 Smallpox Modeling Working Group, 311 “Covered injuries,” 241 Cowpox, 10 Credibility issues, 86, 89, 101 Cross-jurisdictional coordination, 305 CSEPP. See Chemical Stockpile Emergency Preparedness Program CSTE. See Council of State and Territorial Epidemiologists Current program context, 163–164

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism D Data and safety monitoring boards (DSMBs), 147–149, 185 establishment of, 114, 147–149 Data collection, streamlining, 227–228 Data safety and quality monitoring boards (DSQMBs), 147 Data systems used in smallpox vaccination program, 227–231 challenges of, 62 ease of use and value gained from PVS, 228–229 streamlining data collection, 227–228 utility of the Active Surveillance System, 116, 229–231 Data to assess vaccine and program safety, 177–187. See also Collecting data on adverse reactions ACIP Working Group on Smallpox Vaccine Safety, 183–185 active surveillance for serious adverse events and monitoring common adverse events, 179–182 Active Surveillance System, 116, 119, 180–181 Hospital Smallpox Vaccination Monitoring System, 181–182 implications of program expansion for collection of data on adverse events, 182–183 pre-event vaccination system, 177–178 recommendations regarding, 116–117 reporting adverse events, 185–187 survey to assess common adverse reactions, 178–179 Deaths. See Disaster Mortuary Operational Response Teams; Remains, disposal of Decision-making aiding, 120, 213 clear lines of authority for, 257, 261, 283 questioning rationale used in, xvi, 5–6, 92 Declaration Regarding Administration of Smallpox Countermeasures, 242 Declining the vaccine, reasons given for, 113, 141–142 Defense Medical Surveillance System. See Smallpox vaccination programs Democratic principle, of public accountability, 87 Dennehy, Penelope, 345 Department of Defense (DoD), 16, 23, 59–60, 117, 134, 147, 170, 184–186, 212, 219, 232, 237, 239, 270 Serum Repository, 60, 213 Smallpox Vaccination Program Safety Summary, 60 Department of Health and Human Services (DHHS), 16, 23, 26, 29, 31, 33, 40, 42–44, 54, 57, 84, 91–93, 112, 131, 163, 187 Council on Public Health Preparedness, 99, 286, 311 Metropolitan Medical Response System program, 267 modeling workgroup of, 286 National Public Health Performance Standards, 267 National Vaccine Advisory Committee, 29, 236n Office of Public Health Emergency Preparedness, 236n Department of Homeland Security (DHS), 165n, 293–295 exercise-related activities of, 315–316 experiences with exercises, 286 Lexicon Project, 298 Office of Domestic Preparedness, 121, 287, 294, 304, 314–315, 325–326 Department of Justice, 297 CDC Public Health Performance Assessment for Emergency Preparedness, 267 Department of Veterans Affairs (VA), 270 Developing countries, reaction rate of vaccinees in, 17 Development of indicators, dual purpose in, 264 DHHS. See Department of Health and Human Services DHS. See Department of Homeland Security Dilated cardiomyopathy, 241 Disaster Mortuary Operational Response Teams (DMORT), 258, 274 Disaster research, what has been learned from, 300–303 Disasters causes of, 292n contrasting roles of public health and traditional responders in, 291 defined, 327 lessons learned in, 303–304 research on, 299–303

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Diseases. See also individual disease conditions infectious, only now emerging, 305 Distribution of vaccines, 167, 209, 215 sites in the community, lists of contact information for, 279 DMORT. See Disaster Mortuary Operational Response Teams Documentation, of authority, 278 DoD. See Department of Defense Draft policy options (CDC), 28 Draft readiness indicators, 262–274 draft smallpox indicators, 277–283 Drills, 283, 288, 315 defined, 286n, 328 Drugs reactions confused with smallpox, 12 Strategic National Stockpile of, 217 Dryvax®, 13–16, 143 DSMBs. See Data and safety monitoring boards DSQMBs. See Data safety and quality monitoring boards DynPort Corp., 16 E Eczema vaccinatum, 17, 132, 196, 233 Educational training materials, 61, 152, 177. See also Training and education culturally appropriate, 115 testing for ease of comprehension, 116 18th World Health Assembly, 10 Elements of smallpox preparedness, 210–219 preparing key responders, 210–213 protecting the public, 211, 215 rapid public health response, 210–211, 214 the role of public and media communication in, 218–219 the role of the health care community in, 215–218 11th World Health Assembly, 10 Emergency and disaster preparedness and response, the diverse field of, 291–292 Emergency Management Institute, 312 Emergency manager, defined, 328 Emergency medical services (EMS), 272–273, 290 Emergency Nurses Association, 89 Emergency response community, 30, 64, 131, 168 defined, 328 intersectoral relationships with the public health care system, 268 preparing, 118, 200, 210–213, 225 steep rise in bioterrorism-related activities in, xv Employee orientation handbooks, preparing new, 278 EMS. See Emergency medical services Encephalitis, post-vaccinial, 17, 132, 240 Environmental Protection Agency, 290 Epidemic Assistance Investigations (Epi-Aid), 236, 307 Epidemiology investigation teams targeted for immediate smallpox vaccination, local and/or state, public health identification of, 281–282 Equity of access, 2 Eruption stage, of smallpox, 12 Erythema multiforme major, 50 Evaluation need for, 169–170 recommendations regarding, 115, 120 of risk factors for known adverse reactions, recommendations regarding, 113 Evidence base from disaster research and practice, 299–304 examples of gaps in disaster research, 301–303 key lessons learned in disaster practice, 303 key research findings and recurring themes, 300–301 learning from disaster practice, 303–304 learning from disaster research, 300–303 nature of, 299 a resource for learning from past experience, 303–304 Evidence-Based Performance Goals for Public Health Disaster Preparedness, 99, 122, 288, 308, 318, 320, 326 recommendations regarding use of, 288, 326 Evidence-based Practice Center, 313 Evidence of increased preparedness, absence of, 98–100 Exercise Evaluation Guides, 320

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Exercises, 283, 288, 294, 315 defined, 286n role of modeling in the development of, 309–310 Expert input, 83, 150 Exposures, occupational, 23 F False alarms, 257 Fatality, rates of, 11, 16 Fauci, Anthony, 94 Favorable outcomes, of the smallpox vaccination program, 65 FBI. See Federal Bureau of Investigation FDA. See Food and Drug Administration Federal, state, and local jurisdictions, distinct indicators needed for, 264–265 Federal Bureau of Investigation (FBI) interagency bioterrorism unit, 297 liaison to the CDC, 297 Federal Emergency Management Agency (FEMA), 286n, 292, 294 Community Hazards Emergency Response Capability Assurance Program, 315–316 Emergency Management Institute, 312 incorporated into DHS, 315–316 FEMA. See Federal Emergency Management Agency Fetal vaccinia, 49, 146, 231–232 “First responders.” See Emergency response community Flu. See Swine influenza campaign Focus areas, of training and education, 114, 150–153 Focus on preparedness, 165–169 Food and Drug Administration (FDA), 15, 48, 142–143, 234, 265 Food-borne disease, 220, 305 Forensic Epidemiology training program, 297 France, possible stocks of smallpox virus in, 26 Frist, Bill, 58, 91 Fulginiti, Vince, 345 Funding, 190–191 recommendations regarding, 117 supplementary, for the smallpox vaccination program, 54–55 The Future of the Public’s Health in the 21st Century, 86 Future of the vaccination program changing circumstances, 198–199 considerations for, 197–199 overall smallpox preparedness, 199 safety, 198 G GAO. See General Accounting Office (Government Accountability Office after July 2004) Gaps and needs of public health preparedness identified by stakeholders, 272–274 panelist comments about mental health, 274 panelist comments about populations with special needs, 274 panelist comments about resources (e.g., human, equipment and supplies, communication), 273 panelist comments about surge capacity, 273–274 panelist comments about training and education, 272 Gaps in disaster research, examples of, 301–303 Gebbie, Kristine M., xvii, 159, 192, 201, 243, 275, 321, 342–343 General Accounting Office (GAO) (Government Accountability Office after July 2004), 40, 53, 58, 91, 305 early assessment of program progress, 53–54 General public. See also Civilian smallpox vaccination program communicating with, 171–174 legal information sheets for, 278 policy options regarding vaccinating members of, 28 protecting, 211, 215 trust of, 7, 95, 154 Generalized vaccinia, 17, 132 Georgia, 11, 289 Gerberding, Julie, xvi, 29, 51, 57, 91, 93, 123, 162, 195, 203, 252, 285 Goals. See also Evidence-Based Performance Goals for Public Health Disaster Preparedness of the CDC, 45

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism needing to reflect the best available scientific and public health reasoning, 6 never clarified or substantially revised, 6 of public health preparedness, 319 Goals of the program, overall progress at achieving, 158 Government policies and funding CDC’s efforts to inform, 30 steep rise in bioterrorism-related, xv Grantees, 263. See also Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism Gregg, Judd, 58, 91 Guidance. See also Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism, Continuation Guidance for; National Bioterrorism Hospital Preparedness Program Cooperative Agreement Guidance; Supplemental Guidance for Planning and Implementing the National Smallpox Vaccination Program comments about, 200–201 to states, 158 Guillain-Barré syndrome, 147 H HAN. See Health Alert Network Harper, Jay, 345–346 Health Alert Network (HAN), 305 Health care disconnect from public health community, 216 ensuring continuity of, 290 steep rise in bioterrorism-related activities in, xv Health care workers, 151–152, 175–176, 235–236. See also Emergency response community communicating with, 174–175 contact lists for, 280 involved in clinical trials using recombinant vaccinia virus vaccines, 23 nonpracticing, when to mobilize, 273 notification system for contacting, 281–282 reluctant to report for duty, 273 smallpox unfamiliar to, 10, 173 surveillance and reporting by, 216 Health Resources and Services Administration (HRSA), 121, 267, 269–270, 283, 287, 292, 325 National Bioterrorism Hospital Preparedness Program Cooperative Agreement Guidance, 216, 294 Healthy People 2010, 318 Heart attack, 46–47. See also Myocardial infarction Heart inflammation, 40, 46–48, 65, 93, 235. See also Myo/pericarditis Henderson, D. A., 29, 31, 57 Hepatitis A virus, 306 Herd immunity, 18 History, of public health disaster response, 288–289 HIV infection impairment of immune systems due to, 18, 128, 235 testing for, 237 Homeland Security Act, 43, 52, 132, 138 threat levels under, 91, 165 Homeland Security Advisory Council (HSAC), 298 Homeland Security Council (HSC), 293 Policy Coordination Committee, 293 Homeland Security Exercise and Evaluation Program (HSEEP), 294–295, 315 Building Block Approach, 314, 319 Exercise Evaluation Guides, 320 Homeland Security Grant Program, 294–295 Hospital Infection Control Practices Advisory Committee, 29 Hospital Smallpox Vaccination Monitoring System (HSVMS), 116, 177, 179, 181–182, 227–228 Hospitals acute care, 88, 208n anticipated degree of participation, 44 preparedness plans for, 208 public, 191 Household contacts educating, 140–141 recommendations regarding, 113 HRSA. See Health Resources and Services Administration HSAC. See Homeland Security Advisory Council HSC. See Homeland Security Council

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism HSEEP. See Homeland Security Exercise and Evaluation Program HSVMS. See Hospital Smallpox Vaccination Monitoring System Human remains, handling, 273 Hypothetical scenarios, learning from, 255–256 I IAEM. See International Association of Emergency Managers ICS. See Incident Command System Identification, of adverse reactions, 143 IHS. See Indian Health Service Immunity herd, 18 suppressed, 128 surrogate measures of, 14 Immunization. See also Advisory Committee on Immunization Practices; National Immunization Program; Smallpox Immunization Safety System guidelines for administering, 223 Implementation of the smallpox vaccination program, 3, 39–80, 226–242 Congressional interest and involvement, 3, 58 extraordinary rapidity of, 3–4, 45–46 facilitating partnerships among public health agencies and the first responder communities, 64–65 factors compromising, 5, 60–61 major milestones and relevant events, xvii, 41–58 noteworthy features of the program, 58–60 opportunities for learning, 63–65 other favorable outcomes, 65 program challenges, 60–63 relationship between the civilian and military vaccination programs, 59–60 smallpox vaccination program timeline, 39, 66–71 success factors for, 7 Inadvertent inoculation, 231, 234, 250. See also Transmission of vaccinia to contacts Incident Command System (ICS), research needed on, 302 Incubation stage, of smallpox, 12–13 IND. See Investigational New Drug protocols Indian Health Service (IHS), 270 Indicators. See also Contraindications screening; The Ten (draft) Smallpox Indicators concise and simple, 274 pilot testing of, 283 of readiness, 275 sentinel, 283 from the World Health Organization, 267 Infectious diseases, emergence of, 305 Influenza. See also Swine influenza campaign pandemic, 64, 146, 261 Information about the policy and the program confusing and contradictory, 89–90 great need for among key constituencies, xvi, 1, 82 Informed consent process, 2, 61, 112, 136–139 challenges of, 2, 61 recommendations regarding, 112 Institute of Medicine (IOM), xvi, 11, 24–25, 86, 91, 93 Committee on Emerging Microbial Threats to Health in the 21st Century, 205 Committee on Smallpox Vaccination Program Implementation, xvi, 2, 84, 98–99, 123, 125, 195, 203, 252, 255, 285 The Future of the Public’s Health in the 21st Century, 86 Tools for Evaluating the Metropolitan Medical Response System Program: Phase I Report, 267 Institutions policy context of smallpox preparedness in, 217 when to close, 261 Integrating smallpox preparedness into overall public health preparedness, 204–222 challenges in defining and assessing public health preparedness, 6, 204–210 elements of smallpox preparedness, 210–219 sustaining smallpox and overall public health preparedness, 221–222

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism testing smallpox and public health preparedness, 219–221 Integration of public health into disaster preparedness and response, 288–292 contrasting roles of public health and traditional responders in bioterrorism and other disasters, 291 the diverse field of emergency and disaster preparedness and response, 291–292 history of public health disaster response, 288–289 unique role of public health in disasters, and primary role in response to bioterrorism, 289–291 Intensified Smallpox Eradication Program, 10 International Association of Emergency Managers (IAEM), 296 Internet, 62, 182, 304 Intersectoral tension, example of, 296–297 Investigational New Drug (IND) protocols, 142–143, 234, 265 IOM. See Institute of Medicine Iraq possible stocks of smallpox virus in, 26 war in, 26, 39, 50–51, 90 Iraq Survey Group, 91 Isolation procedures, 261, 278, 280, 310 J JCAHO. See Joint Commission on Accreditation of Healthcare Organizations Jenner, Edward, 10, 14 Johns Hopkins University, Center for Civilian Biodefense Studies, 15 Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 218, 220, 263, 295 “Just-in-time” training and information, 175, 272, 280 K Key constituencies, 3 expecting to play vital roles in implementation of the vaccination program, 5 great need for information among, 1 perceptions of, 4, 41 questioning unknown rationale used in decision-making, xvi, 5–6 requesting information and clarification, xvi, 1, 82 Kivlahan, Coleen, 346 L Laboratories. See also individual organizations biosafety level in, 271 policy options regarding workers in, 28 surge capacity needs of, 280 Laboratory Response Network, 307 Leadership, 207 Legal authority to mandate employees to work, 278 needed in public health emergencies, 214 Legal issues, related to smallpox vaccination, 277–278 Lessons learned from the public health response to proxy events, 100, 288, 304–308 Lessons learned from the smallpox vaccination program, 4, 63–64, 81–107 absence of explicit scientific and public health rationale for the program, 81–96 administrative, need to review, 6 need to develop measures and indicators for smallpox preparedness, 6 opportunities for scientific research, 6, 225, 242 push for rapid implementation without adequate preparation, challenges posed by, 60–61 questioning the enhancement of smallpox preparedness, 5, 96–100 using to test preparedness, 220–221 Lessons Learned Information Shared (LLIS; see www.llis.org), 304 Letter Report #1, 123–161, 167, 187 areas of potential future inquiry, 158–159 assessment of safety profile, 142–149 background information and committee process, 124–127 CDC safety system guidance to states, 149

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism clarity issues, 131 communication, 154–158 communication planning, 2, 154–158 compensation for adverse reactions to the smallpox vaccine, 2, 61, 131–134 consistency in screening materials, 139–142 general considerations, 127–136 guidance to states, 158 informed consent process, 136–139 issues of timing, 129–130 key messages, 127 national security concerns and the unknown balance of risks and benefits, 127–129 opportunity costs, 136 overall progress at achieving the goals of the program, 158 recommendations from, 111–114 screening potential vaccinees, 139 specific considerations, 136–159 training and education, 150–153 treatment of vaccine complications, 149 workforce issues resulting from vaccination, 134–135 Letter Report #2, 162–194 current program context, 163–164 focusing on preparedness, 165–169 key messages, 164 need for evaluation, 169–170 overarching issues of preparedness and evaluation, 164–170 programmatic issues, 170–191 recommendations, 115–117 Letter Report #3, 195 comments about the guidance, 200–201 considerations for next steps in the vaccination program, 197–199 general comments, 196–197 recommendations, 117–118 Letter Report #4, 203–251 Advisory Committee on Immunization Practices Smallpox Vaccine Safety Working Group, 234–236 communicating about and coordinating the response to adverse events, 226–227 compensation available for smallpox vaccine injuries, 2, 61, 240–242 data systems used in smallpox vaccination program, 227–231 evaluation and safety studies, 236–240 integrating smallpox preparedness into overall public health preparedness , 204–222 pregnancy screening, 146, 231–233 recommendations, 118–120 selected aspects of smallpox vaccination program implementation, 226–242 vaccination of members of the general public who insist on receiving smallpox vaccine, 222–226 Letter Report #5, 252–284 applicability of scenarios to decision-making and management structure of a smallpox response, 260–262 applicability of scenarios to specific local circumstances, 259–260 caveats to consider in proposed “scenarios,” 258–259 comments about the draft readiness indicators, 262–274 committee tasks, 255 description of the Public Health Preparedness Project, 253–255 draft smallpox indicators and suggested criteria, 277–283 essential capabilities needed for preparedness, 284 general parameters of four scenarios to assess smallpox readiness indicators, 255–262 learning from real-life experiences and hypothetical scenarios, 255–256 little variability in types of planning activities across scenarios, 260 purpose, development, and use of four smallpox “scenarios,” 256–258 recommendations, 120–121, 283–284 utility of smallpox scenarios, 255–256 Letter Report #6, 285–328 challenges and opportunities inherent in integrating public health into a broader field, 292–299 charge to the committee, 4, 286–287 common definitions and terminology needed, 297–299 coordination issues, 292–297, 299 the evidence base from disaster research and practice, 299–304 integrating public health into disaster preparedness and response, 288–292 learning from the public health response to proxy events, 100, 288, 304–308

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism the Lexicon Project, 298–299 recommendations, 121–122, 287–288, 325–326 usefulness of exercises, 312–320 usefulness of modeling, 308–312 “Letter” reports background, xvi Levine, Jeffrey, 346–347 Lexicon Project, 298–299 Liability issues, 51–52, 87, 216, 277–278 Licensure issues, 277–278 LLIS. See Lessons Learned Information Sharing (www.llis.org) Local and State Public Health Preparedness and Response Capacity Inventories, 320 Local circumstances, specific, applicability of scenarios to, 259–260 Local health departments, 88 local plans to respond to smallpox and other threats, 2, 192 Logistics, for vaccination of members of the general public who insist on receiving smallpox vaccine, 223 “Low-likelihood, high-consequence” events, 1, 7 M Mass mailings, 157 Mass media references, 4, 41, 45, 172 Mass vaccination, 211, 215, 310 coordinated, 10 McIntosh, Kenneth, 347 Mechanisms for communication, challenges of, 62 Media, communicating with, 174 Media contacts. See also Mass media references training in, 155 Media role, in bioterrorism, 218 Medical and Public Health Preparedness PCC (Policy Coordinating Committee), 293 Medical Group Management Association, 217 Medical records, access to, 278 Mental health, panelist comments about, 274 Meta-scenarios, 259 Metropolitan Medical Response System (MMRS) program, 267 Milestones in implementing the smallpox vaccination program, xvii, 41–58 announcement of the policy, 41–42 beginning of the program, 43–46 cardiac adverse events, 40, 46–48, 90 the compensation plan, 51–53 confusion about program goals and timeline, 45–46 the General Accounting Office report, early assessment of program progress, 53–54 June 2003 ACIP recommendation to end the smallpox vaccination program, 3, 57–58 the monkeypox outbreak, 55–56 selected adverse events associated with smallpox vaccination among civilians, 3, 50 supplementary funding for the smallpox vaccination program, 54–55 timeline of smallpox vaccination program with number of weekly vaccinations and key events, 40 vaccination program safety profile, 48–50 the war in Iraq, 26, 39, 50–51, 90 Military smallpox vaccination program, 3, 9, 40–41 in Finland, 47 pregnancy screening in, 231 size of cohort (much larger than civilian), 170, 212 Millennium Cohort Study, 60, 239 MIPT. See National Memorial Institute for the Prevention of Terrorism MMRS. See Metropolitan Medical Response System program MMWR. See Morbidity and Mortality Weekly Report Model smallpox vaccination clinic, setting up, 25 Model State Public Health Act, 214 Modeling workgroup, of DHHS, 286 Modlin, John, 27, 33, 88 Monitoring, for rare adverse reactions, 145–146 Monkeypox, 40, 55–56, 65, 204, 209, 216, 220, 225, 233, 306 in China, 55–56 Morbidity and Mortality Weekly Report (MMWR), 22, 46, 116, 185, 231, 241 Murane, Elizabeth, 347

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Myo/pericarditis, 40, 46–48, 65, 93, 235, 241. See also Heart inflammation Myocardial infarction, 46. See also Heart attack N NACCHO. See National Association of County and City Health Officials National Academy of Sciences, 124 Public Access and Records Office, 126 National Ambulatory Medical Care Survey, 147 National Association of County and City Health Officials (NACCHO), 24, 54, 87, 94, 197, 219 National Bioterrorism Hospital Preparedness Program Cooperative Agreement Guidance, 216, 294 National Commission for Quality Assurance, 218 National Hospital Discharge Survey, 147 National Immunization Program, 51, 91 National Incident Management System, 302 National Institute of Allergy and Infectious Disease (NIAID), 15, 94 National Institutes of Health, 23, 147 National Library of Medicine, PubMed search engine, 313 National Memorial Institute for the Prevention of Terrorism (MIPT), 304 National Pharmaceutical Stockpile, 149 National plans to respond to smallpox and other threats, 2 National Public Health Performance Standards, 206, 220, 267 National security concerns and the unknown balance of risks and benefits, 127–129 National security program health component of, 5 imperatives of, 6, 210 National Smallpox Vaccination Program, xv, 96, 184 National Smallpox Vaccine in Pregnancy Registry, 231, 233 National Vaccine Advisory Committee (NVAC), 29, 236n National Vaccine Program, 236n Neurological disability, 132 Neutralizing antibody, a surrogate measure of immunity, 14 New York, smallpox outbreak in, 17 New York City Board of Health (NYCBH) strain of vaccinia, 15–16 New York Times, 30–31 Newspapers. See Mass media references; individual publications Next steps in the vaccination program changing circumstances, 198–199 considerations for, 197–199 overall smallpox preparedness, 199 safety, 198 NIAID. See National Institute of Allergy and Infectious Disease “No case” scenario, 257, 260 North Korea, possible stocks of smallpox virus in, 26 Novosibirsk, Russia, official repository for live variola virus , 11 Nuclear Regulatory Commission, 315 Numbers, focus on, instead of preparedness, 96–98 NVAC. See National Vaccine Advisory Committee NYCBH. See New York City Board of Health O Oak Ridge National Laboratories, 316 Occupational groups exposures of, 23 policy options regarding specific, 28 Ocular vaccinia, 186 ODP. See Office of Domestic Preparedness Office of Domestic Preparedness (ODP), 121, 287, 294, 304, 314–315, 325–326 Homeland Security Grant Program, 294–295 Urban Area Security Initiative Grant Program, 294 Office of Public Health Emergency Preparedness, 236n Office of Terrorism Preparedness and Emergency Response (OTPER), 99 Offit, Paul, 31 Opinon surveys. See Public interest Opportunities inherent in integrating public health into a broader field, 292–299 common definitions and terminology needed, 297–299

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism coordination issues, 292–297, 299 the Lexicon Project, 298–299 Opportunity costs, 136 recommendations regarding, 112 Orenstein, Walter, 91 Organ transplantation, impairment of immune systems due to preparation for, 18 Orthopoxvirus, 9, 28, 65 OTPER. See Office of Terrorism Preparedness and Emergency Response P Pakistan, smallpox in, 18 Participation rates. See Smallpox vaccination programs Partnerships among public health agencies and the first responder communities, facilitating, 64–65 Past experience, learning from, 303–304 Patient safety literature, 317 Patient Vaccination Number (PVN), 144, 178, 182 PCC. See Policy Coordination Committee Performance in a proxy event, evaluating, 306–308 Pericarditis. See Myo/pericarditis Phases of smallpox vaccination programs, 42, 49, 93, 111–113, 126, 140, 145, 182 Pilot program, 119 “Placebo-controlled” trials, 316 Planning activities, training-related, 153 Planning assumptions, 302 Policy context of smallpox preparedness, 1, 3, 22–38 CDC’s draft policy options, 28 CDC’s efforts to inform government policy, 30 CDC’s smallpox vaccination and preparedness activities, 24–25 early news of the DHHS plan, 30–31 evolution of the smallpox vaccination policy, 25–26 funding for bioterrorism and smallpox, 33–34 institutional policy, 217 June 2002 ACIP meeting, 3, 27–29 October 2002 ACIP meeting, 32–33 the policy, 33 rationale for the policy, 5, 26–27 reported viewpoints of top officials, 29 role of public health organizations, 24 steps toward readiness for a smallpox virus release, 24–34 Policy Coordination Committee (PCC), 293 Policy decisions, role of modeling in, 308–309 Polymerase-chain-reaction assay, 12 Post-event vaccination options, 28, 125 never going beyond, 85 Post-vaccinial encephalitis, 17, 132, 240 Postvaccination fact sheet, 240 Postvaccination symptoms, 44 Pre-event smallpox vaccination early discussion of, 29 implementation of, 2, 42–43, 81–82, 124, 129 Pre-event Vaccination System (PVS), 48, 62, 113, 144–147, 177–178, 180, 227–229 for collecting data on adverse reactions, 143–145 ease of use and value gained from, 228–229 using to collect data on adverse reactions, recommendations regarding, 113 Pre-Vaccination Information Packet, 190, 198 Pregnancy screening, 146, 231–233. See also National Smallpox Vaccine in Pregnancy Registry recommendations regarding, 120, 146 Preparedness, 165–169. See also Biopreparedness; Chemical Stockpile Emergency Preparedness Program; Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism; Council on Public Health Preparedness; Evidence-Based Performance Goals for Public Health Disaster Preparedness; National Bioterrorism Hospital Preparedness Program Cooperative Agreement Guidance; Office of Public Health Emergency Preparedness; Policy context of smallpox preparedness; Public Health Competencies for Bioterrorism and Emergency Preparedness and Response

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Inventories; Public Health Performance Assessment for Emergency Preparedness ; Public health preparedness; Public Health Preparedness and Response Capacity Inventories; Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Smallpox preparedness; State and local preparedness activities concerns about program expansion and implications for preparedness, 168–169 defining, 166–168 essential capabilities needed for, 284 of key responders, 210–213 recommendations regarding, 115 recommendations regarding strengthening, by applying research findings and experience in bioterrorism preparedness, 287–288, 326 Pretesting, 140 Previously vaccinated Americans, 13 Prodromal stage, of smallpox, 12–13 Program expansion concerns about, and implications for preparedness, 168–169 lack of compensation impeding, 188–189 Programmatic issues, 170–191 additional data gathering needed, 191 communication, 170–175 compensation, 2, 187–190 data to assess vaccine and program safety, 177–187 funding, 190–191 training and education, 2, 114, 150–153, 175–177, 270, 272 Progressive vaccinia, 17, 132, 196 Prospective vaccines, materials for, 4 Proxy events learning from the public health response to, 100, 288, 304–308 sample questions, strategies, and methodologies for evaluation research on, 100, 306–307, 316–317 Psychological management, 280 The public. See General public Public Access and Records Office, 126 Public accountability, democratic principle of, 87 Public health care system ability to protect the public’s health, 7 intersectoral relationships with the emergency response community, 268 interventions by, 165 response capacity of, 269 steep rise in bioterrorism-related activities in, xv Public health challenges, studying the response to, 304–306 Public health community health care disconnected from, 216 responsibility of, 217 supporting, xvii, 64, 101–102 Public Health Competencies for Bioterrorism and Emergency Preparedness and Response Inventories, 165, 320 Public health emergencies, 207, 288–289 legal authority needed in, 214 Public health laws copies of relevant, 278 information about relevant, 278 Public health organizations, policy role of, 24 Public Health Performance Assessment for Emergency Preparedness, 267 Public health practice, success dependent on constituency persuasion, xvi, 86–87. See also Skepticism Public health preparedness goals of, 319 integrating smallpox preparedness into overall, 204–222 the role of the health care community in, 215–218 strengthening, xvii, 84 sustaining, 221–222 testing, 219–221 Public Health Preparedness and Response Capacity Inventories, 220 Public health preparedness exercises, sample questions, strategies, and methodologies for evaluation research on, 100, 306–307, 316–317 Public Health Preparedness Project, 252–255, 272 description of, 253–255 Public Health Ready project, 219 Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 23 Public Health Service Act, 43

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Public health services, curtailments in, 88 Public health strategy, 4 Public health threats assessing likelihood of, 174, 301n resurgence of TB as, 221 speculation about specific types of, xv Public hospitals, 191 Public interest, surveying, 225 Public safety community, steep rise in bioterrorism-related activities in, xv PubMed search engine, 313 PVN. See Patient Vaccination Number PVS. See Pre-event Vaccination System Q Quality improvement, continuous, 263–264 Quarantine procedures, 261, 278 Questioning the enhancement of smallpox preparedness, 5, 96–100 absence of evidence of increased preparedness, 98–100 focus on numbers instead of preparedness, 96–98 R Radiological Emergency Preparedness Program (REP), 315–316 Rapid public health response, 210–211, 214 Rapidity, of the implementation of the smallpox vaccination program, 3–4, 45–46 Rare adverse reactions, monitoring for, 145–146 Rash, distinctive, a stage of smallpox, 13 Rationale for the smallpox preparedness policy, 5, 26–27. See also Scientific and public health rationale for the smallpox vaccination program lack of updating or reiteration of, 90–92 Readiness indicators. See also Preparedness collaboration and communication among federal agencies with health responsibilities, 269–270 continuous quality improvement, 263–264 distinct indicators needed for federal, state, and local jurisdictions, 264–265 draft, 262–274 dual purpose in developing indicators, 264 elements not reflected in, 267–270 framework for, 266–267 gaps and needs of public health preparedness identified by stakeholders, 272–274 issues related to surge capacity, 270–271 purpose of, 264–265 training and education, 270 Readiness indicators document, 277–283. See also The Ten (draft) Smallpox Indicators Real-life experiences, learning from, 255–256 Recommendations, xvi, 3, 115–122, 283–284, 287–288, 325–326 CDC safety system guidance to states, 114 communicating about and coordinating the response to adverse events , 115, 119 communication planning, 2, 114, 207 compensation for adverse reactions to the smallpox vaccine, 2, 61, 111–112, 117 comprehension of screening materials, 112–113 data to assess vaccine and program safety, 116–117 educating household contacts, 113 to end the smallpox vaccination program, 3, 57–58 establishment of a Data Safety and Monitoring Board, 114 evaluation and safety studies, 120 evaluation of risk factors for known adverse reactions, 113 federal entities concerned with bioterrorism preparedness coordinating guidance and funding activities, 287, 325–326 focus areas of training and education, 114 focusing on preparedness, 115 funding, 117 informed consent process, 112 issues of timing, 111 from Letter Report #1, 111–114 from Letter Report #2, 115–117

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism from Letter Report #3, 117–118 from Letter Report #4, 118–120 from Letter Report #5, 120–121 from Letter Report #6, 121–122 need for evaluation, 115 opportunity costs, 112 pregnancy screening, 120, 146 preparing key responders, 118 reasons for declining vaccine, 113 a standard for smallpox preparedness, 118 strengthening preparedness by applying research findings and experience in bioterrorism preparedness, 287–288, 326 training and education, 115–116 using scenarios to test preparedness, 118 using the Evidence-Based Performance Goals for Public Health Disaster Preparedness, 288, 326 using the pre-event vaccination system to collect data on adverse reactions, 113 utility of the Active Surveillance System, 116, 119 vaccination of members of the general public who insist on receiving smallpox vaccine, 29, 118–119 workforce issues resulting from vaccination, 112 Red Cross, 290 Remains, disposal of, 280 REP. See Radiological Emergency Preparedness Program Reporting adverse events, 185–187, 216 web page for, 186 Research findings on exercises, 313–314 and recurring themes, 300–301 Resources (e.g., human, equipment and supplies, communication) panelist comments about, 273 for vaccination of members of the general public who insist on receiving smallpox vaccine, 223–224 Respiratory-droplet nuclei, transmission of variola virus by, 12 “Response teams.” See Emergency response community Response to smallpox. See Smallpox response Responsibility, establishing, 207, 275, 283, 299 Retrospective analyses, 304 Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation. See Letter Report #1, Letter Report #2, etc. Ring vaccination, 10–11 Risk-benefit, of vaccination of members of the general public who insist on receiving smallpox vaccine, 224–225 Risk factors, for known adverse reactions, evaluation of, 145 Risks communicating, 268 factors screened for, 47, 139 ratio to benefits, 1, 27, 84, 165, 223 Rosen, Peter, 347–348 Russia, possible stocks of smallpox virus in, 26 S Safety, 198 collecting data on adverse reactions for, 152 recommendations regarding further studies, 114, 120 of vaccination of members of the general public who insist on receiving smallpox vaccine, 224, 243 Safety profile assessment of, 142–149 establishment of a data and safety monitoring board, 147–149 evaluation of risk factors for known adverse reactions, 145 gathering data on background rates of conditions that could be confused with adverse reactions, 146–147 identifying adverse reactions, 143 monitoring for rare adverse reactions, 145–146 using the pre-event vaccination system to collect data on adverse reactions, 143–145 Safety system guidance to states, recommendations regarding, 114 Salmonella attack, xv Salvation Army, 290

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism SAMHSA. See Substance Abuse and Mental Health Services Administration Sarin gas attack, xv, 23 SARS. See Severe acute respiratory syndrome “Scenarios” used to assess readiness indicators, 2, 118, 219–220, 255–262 applicability to decision-making and management structure of a smallpox response, 260–262 applicability to specific local circumstances, 259–260 caveats to consider in proposed, 258–259 designing detailed, 256 learning from real-life experiences and hypothetical scenarios, 255–256 limited number of confirmed smallpox case(s)/known presence of virus in United States, 258 outside of own jurisdiction, 258 limited number of confirmed smallpox case(s)/known presence of virus outside United States, 258 little variability in types of planning activities across scenarios, 260 meta-scenarios, 259 multiple confirmed smallpox case(s)/known presence of virus in multiple U.S. jurisdictions, with at least one case in one’s own jurisdiction, 258 no smallpox case(s)/known presence of virus, 257 utility of, 255–256 “Scenarios” used to test preparedness, 219–220 recommendations regarding, 118 Scientific and Policy Considerations in Developing Smallpox Vaccination Options, 30 Scientific and public health rationale for the smallpox vaccination program, 81–96 CDC’s role in providing scientific and public health reasoning for policy, 93–96 confusing and contradictory information about the policy and the program, 89–90 input of key constituencies, 85–88 lack of updating or reiteration of, 90–92 lacking any rationale for the existence of the vaccination program, 83–88 of review of the program’s course and reassessment of starting assumptions , 92–93 for the structure of the vaccination program, 88–89 Screening potential vaccinees, 139 SDN. See Secure Data Network “Search and containment” strategies, initial response to a smallpox outbreak using, 282 Secure Data Network (SDN), 180 SEIU. See Service Employees International Union Senate Committee on Health, Education, Labor, and Pensions, 52, 54, 58 Senate Intelligence Committee, Report on the U.S. Intelligence Community’s Prewar Intelligence Assessments on Iraq, 50–51, 92 Senate Subcommittee on Labor, Health, and Human Services, and Education Appropriations, 24 SEPPA. See Smallpox Emergency Personnel Protection Act of 2003 Serum Repository (DoD), 60, 213 Service Employees International Union (SEIU), 52 Severe acute respiratory syndrome (SARS), 56, 196, 209, 220, 224, 256, 305–306, 310 Sheltering in place, 316 SISS. See Smallpox Immunization Safety System Skepticism, among key constituencies, 5–6, 83 Skin conditions, confused with smallpox, 12 Skin reactions, a surrogate measure of immunity, 14 Smallpox, 11–19. See also Indicators; Variola virus conditions confused with, 12 contemporary circumstances of, 18–19 controlling and eradicating, 13 a disease that does not exist, 1, 11 funding for, 33–34 in the historical context, 3, 9–21 identifying, 12, 217

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism infectivity of, 12, 19 stages of, 12 surveillance and containment, 18 vaccine and vaccination for, 14–15 vaccine efficacy, 13–14 vaccine safety, 16–17 vaccine supplies available in the United States, 15–16 weaponized, possible existence of, 19, 271 Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), 52–53, 196, 240–241 “Smallpox hospitals,” 33, 88 Smallpox Immunization Safety System (SISS), 142 Smallpox indicators. See also Readiness indicators differential diagnosis of smallpox syndrome, 279–280 draft, 277–283 initial response to a smallpox outbreak using search and containment strategies, 282 legal issues related to smallpox vaccination, 277–278 local and/or state public health identification of members of epidemiology investigation teams targeted for immediate smallpox vaccination, 281–282 medical care and monitoring for potential victims of a smallpox outbreak, 280 possible additional indicators, 282–283 surge capacity at mass distribution sites for medical countermeasures, 278–279 Smallpox Modeling Working Group, 311–312 Smallpox outbreak defining, 281 medical care and monitoring for potential victims of, 280 notification of, 281 possibility of, 7, 11, 24, 26, 89, 208, 218, 261, 280 responding to, 283 Smallpox preparedness, 2, 210–219 assessing, 204 funding, 260 in the mental health area, 274, 280 need to define, 6, 54 need to develop measures and indicators for, 2, 6 as only one component of overall public health preparedness, 206 overall, 199 preparing key responders, 210–213 protecting the public, 211, 215 rapid public health response, 210–211, 214 the role of public and media communication in, 218–219 the role of the health care community in, 215–218 a standard for, 207–210 sustaining, 221–222 testing, 219–221 Smallpox response, applicability of scenarios to decision-making and management structure of, 260–262 Smallpox Response Plan and Guidelines, 24–25, 138, 156 Smallpox site care, CDC standards for, 175 Smallpox syndrome, differential diagnosis of, 279–280 Smallpox vaccination evaluating performance in a proxy event, 306–308 legal issues related to, 277–278 studying the response to public health challenges, 304–306 using the “what if?” scenario approach, 306–308 Smallpox vaccination program. See also Lessons learned from the smallpox vaccination program considerations for next steps in, 197–199 milestones in implementing, xvii, 41–58 Smallpox vaccination program challenges, 60–63 the data system, 62 the informed consent process, 2, 61 mechanisms for communication, 62 a push for rapid implementation without adequate preparation, 60–61 strain the health care system is under, 63 Smallpox Vaccination Program Safety Summary, 60

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Smallpox vaccination programs, xv administered to members of the military, xv, 184 beginning of, 43–46, 65 break in the course of, 199 costs of, 54 expansion of, 164, 168 funding for, 33–35 lack of scientific and public health rationale for the existence of, 85–88 lessons learned from, 4, 63–64, 81–107 likely complications of, 17, 23, 29 offered to some categories of civilians, xv opposition to, 29, 58, 89, 169 participation in, xvi, 6, 82, 238 phases of, 42, 49, 112, 126, 182 pre-event, implementation of, 2 prophylactic value of, 13 safety of, 48–50 timeline for, 39, 66–71 Smallpox Vaccine Adverse Event Active Surveillance System, 116, 119, 177–183, 198, 227–231 recommendations regarding, 116, 119 utility of, 116, 229–231 Smallpox Vaccine Safety Working Group, 47, 59–60, 183, 234, 241 Smallpox-vaccine-specific memory B cells, 14 Smallpox victims, treatment of, 280 Smallpox virus release, steps toward readiness for, 24–34 Somalia, smallpox in, 11 Soviet Union, fall of, 84 Special needs, panelist comments about populations with, 274 Specific considerations, 136–159 Stakeholders. See also Key constituencies gaps and needs of public health preparedness identified by, 272–274 Standard for smallpox preparedness, recommendations regarding, 118 State and local preparedness activities, 2. See also Local and State Public Health Preparedness and Response Capacity Inventories instituting a pause in, 198 steep rise in bioterrorism-related, xv State public health agencies CDC providing guidance to, 207–208 coordinating, 118 Stochastic models, 311 Strains within the health care system, challenges posed by, 63 Strategic National Stockpile, of drugs and vaccines, 217 Streamlining data collection, 227–228 Strom, Brian L., xvii, 159, 192, 201, 243, 275, 321, 342 Structure of the vaccination program, lack of scientific and public health rationale for, 88–89 Studies large-scale needed, 301 sample sizes for, 238 Substance Abuse and Mental Health Services Administration (SAMHSA), 270, 274 Success factors, for the smallpox vaccination program, 7 Supplemental Guidance for Planning and Implementing the National Smallpox Vaccination Program, 25 Surge capacity environmental sampling, 280 issues related to, 270–271 at mass distribution sites for medical countermeasures, 278–279 panelist comments about, 273–274 strengthening, 269 Surveillance and containment activities, 10, 18, 33–34, 146, 216, 310 Surveys. See also Public interest to assess common adverse reactions, 178–179 Swine influenza campaign, 26, 86, 130, 261 T Task Force on Community Preventive Services, 299 TB. See Tuberculosis Team members, notification system for contacting, 281–282 Telebriefings, 42 Telephone follow-up survey, 178 The Ten (draft) Smallpox Indicators, 260, 263 The Ten Essential Public Health Services, 98, 266–267, 279–283, 306 Terrorist attacks against the U.S., xv, 1, 23, 58, 84, 205 jurisdictions affected, 259

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Testing smallpox and public health preparedness, 219–221 using lessons learned, 220–221 using scenarios, 219–220 Thompson, Tommy, 29, 41–42, 44, 91, 204 Threats. See Public health threats Three-Mile Island Incident, 315 Timeline of smallpox vaccination program, with number of weekly vaccinations and key events, 40 Timing issues, 129–130 recommendations regarding, 111 Tourism, damage to, 55 Training activities and initiatives, 61, 152, 177, 217 Training and education, 2, 114, 150–153, 175–177, 270, 272 additional training areas and training-related planning activities, 153 focus areas of training and education, 150–153 panelist comments about, 272 recommendations regarding, 115–116 Transmission of vaccinia to contacts, 9, 12, 48, 59, 135, 144–145, 186, 196, 256 Treatment of vaccine complications, 149 Triage plans, 280 Trigger points, 234–235 Trust, of the general public, 7, 95, 154 Tuberculosis (TB), resurgence of, 221 Turning Point Public Health Statute Modernization Collaborative, 214 U University of Pittsburgh Medical Center, Center for Biosecurity, 15 Urban Area Security Initiative Grant Program, 294 U.S. Army, 316 USA Today, 31 Usefulness of exercises, 312–320 ensuring compatibility between the DHS exercise doctrine and public health preparedness exercises , 319–320 exercise-related activities of the Department of Homeland Security, 315–316 a framework for performance evaluation using exercises, 318–319 and rationale for exercises, 312 research on exercises, 313–314 sample questions, strategies, and methodologies for evaluation research on public health preparedness exercises and proxy events, 100, 306–307, 316–317 Usefulness of modeling, 308–312 role in exercise development, 309–310 role in policy decisions, 308–309 Smallpox Modeling Working Group, 311–312 V VA. See Department of Veterans Affairs Vaccination, 10. See also Previously vaccinated Americans; Smallpox vaccination programs data about, 197 an effective public health tool, 16 evolution of the smallpox vaccination policy, 25–26 mass, 10, 211, 215, 310 as only one component of smallpox preparedness, 205–206 rates of, 57, 65 for smallpox, 14–15 Vaccination number. See Patient Vaccination Number Vaccination of members of the general public who insist on receiving smallpox vaccine, 222–226 communication, 224 logistics, 223 recommendations regarding, 29, 118–119 resources, 223–224 risk-benefit, 224–225 safety of, 224, 243 Vaccination program safety profile, 48–50 Vaccinators, training, 56 Vaccine Adverse Events Reporting System (VAERS), 113, 116, 142–144, 146, 178, 180–182, 227–228, 230 Vaccine efficacy, for smallpox, 13–14 Vaccine Information Statement (VIS), 150, 197n, 240 revised, 189–190 Supplement E, 233 Vaccine Injury Compensation Program, 133, 138 Vaccine Safety Datalink, 147

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Vaccinees, 93, 138 in developing countries, reaction rate of, 17 insufficient numbers of, 179 military, 60 prospective, 215 Vaccines case-fatality rate of, 16 compensation for injuries caused by, 52 distributing, 167, 209, 215 Dryvax®, 13–16, 143 effective and stable, 13–14 materials for prospective, 4 need for development of novel, 11, 49 prioritizing access to, 282 rates of coverage, 2 reasons given for declining, 141–142 safety of, 16–17 stockpiles of, 23, 127, 215, 282 Strategic National Stockpile of, 217 supplies available in the United States, 15–16 “take,” 14 withdrawn from the civilian marketplace, 22 Vaccinia immune globulin (VIG), 17, 138, 142, 180, 234 Vaccinia keratitis, 132 Vaccinia-specific antibody, 14 Vaccinia-virus, 126 New York City Board of Health strain of, 15 transmission of, 9, 12, 48 VAERS. See Vaccine Adverse Event Reporting System Variola virus, 9 identifying, 12 live, official repositories for, 11 major and minor, 11–12 planned coordinated destruction of all stockpiles of, 11 transmission, 9, 12, 48 uniqueness of bioterror threat posed by, 9–10, 290, 304 Variolation, 10 VIG. See Vaccinia immune globulin Viral gastroenteritis, 146 Virginia Commonwealth University Health System, 208–209 VIS. See Vaccine Information Statement Vistide. See Cidofovir W Wallace, Robert B., xvii, 159, 192, 243, 275, 321, 343 War in Iraq, 26, 39, 50–51, 90 Washington Post, 31, 57, 91 Waxman, Henry, 187 Weaponized smallpox, possible existence of, 19, 271 Weapons of mass destruction (WMD), 51, 91 West Nile virus, 56, 216, 220, 305–306, 310 Weston, William, 348 “What if?” scenario approach, using, 306–308 White House, news releases from, 40–41, 44 WHO. See World Health Organization WMD. See Weapons of Mass Destruction Woolson, Robert, 348 Workers’ compensation, 187–188 Workforce issues resulting from vaccination, 134–135 recommendations regarding, 112 Working Group on Civilian Biodefense, 15 Working Group on Smallpox Vaccination, 47 World Health Assemblies, 10 World Health Organization (WHO), 10–11, 22, 125 Committee on Orthopoxvirus Infections, 11 indicators from, 267 World War II, 10 Wyeth laboratories, 15, 22