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Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
×

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

Suggested Citation:"Index." Institute of Medicine. 2005. The Smallpox Vaccination Program: Public Health in an Age of Terrorism. Washington, DC: The National Academies Press. doi: 10.17226/11240.
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December 13, 2002, the president of the United States announced that smallpox vaccination would be offered to some categories of civilians and administered to members of the military and government representatives in high-risk areas of the world. The events that precipitated that historic announcement included a series of terrorist attacks during the 1990s, which culminated in the catastrophic events of 2001.

Although preparedness for deliberate attacks with biologic weapons was already the subject of much public health planning, meetings, and publications as the twentieth century neared its end, the events of 2001 led to a steep rise in bioterrorism-related government policies and funding, and in state and local preparedness activities, for example, in public health, health care, and the emergency response and public safety communities. The national smallpox vaccination program is but one of many efforts to improve readiness to respond to deliberate releases of biologic agents.

The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation was convened in October 2002 at the request of the Centers for Disease Control and Prevention (CDC), the federal agency charged with implementing the government's policy of providing smallpox vaccine first to public health and health care workers on response teams, then to all interested health care workers and other first responders, and finally to members of the general public who might insist on receiving the vaccine. The committee was charged with providing "advice to the CDC and the program investigators on selected aspects of the smallpox program implementation and evaluation."

The committee met six times over 19 months and wrote a series of brief "letter" reports. The Smallpox Vaccination Program: Public Health in an Age of Terrorism constitutes the committee's seventh and final report, and the committee hopes that it will fulfill three purposes: 1) To serve as an archival document that brings together the six reports addressed to Julie Gerberding, director of CDC, and previously released on line and as short, unbound papers; 2) To serve as a historical document that summarizes milestones in the smallpox vaccination program, and ; 3) To comment on the achievement of overall goals of the smallpox vaccination program (in accordance with the last item in the charge), including lessons learned from the program.

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