Index
A
ACAM2000 trials, 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
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
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
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
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
See also Bioterrorism, preparing for
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
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
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
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
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
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
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
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
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
Drugs
reactions confused with smallpox, 12
Strategic National Stockpile of, 217
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
defined, 286n
role of modeling in the development of, 309–310
Exposures, occupational, 23
F
False alarms, 257
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
Forensic Epidemiology training program, 297
France, possible stocks of smallpox virus in, 26
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
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
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
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
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
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
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
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
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
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
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
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
Iraq Survey Group, 91
Isolation procedures, 261, 278, 280, 310
J
JCAHO. See Joint Commission on Accreditation of Healthcare Organizations
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
SAMHSA. See Substance Abuse and Mental Health Services Administration
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
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 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 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
Smallpox vaccination programs, xv
administered to members of the military, xv, 184
break in the course of, 199
costs of, 54
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
Smallpox Vaccine Adverse Event Active Surveillance System, 116, 119, 177–183, 198, 227–231
recommendations regarding, 116, 119
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
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
as only one component of smallpox preparedness, 205–206
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
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
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
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
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
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
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