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-
INDEX
OCR for page 204
OCR for page 205
Index
A
Acquired immune deficiency
syndrome (AIDS), 33, 80
Active immunization, 14
Adenovirus vaccine, 18, 47, 161
Adverse reactions. See Vaccine
injury and specific vaccines
Agency for International
Development, 133
American Academy of Pediatrics,
4, 22, 66, 94, 188
American College of Physicians,
4, 22, 66
American Medical Association
(AMA), 186, 189
Anaphylaxis, 73, 78, 79
Anthrax vaccine, 19, 47, 62,
161
Anti-idiotype antibodies, 24-25
Antitoxin therapy, 15-16
Armed Forces Epidemiological
Board, 4, ~3
Army, Department of, 4,~22-23,
125
Arthritis, 15, 76, 77
Attenuated infectious vaccines,
14, 24
Australia antigen r 33
B
Bacillus Calmette-Guerin (BCG),
14, 47
Bacterial vaccines, 23. See
also specific vaccines
205
Belgium, 192
Biological warfare agents, 4, 22
Biologics Research and Review,
Office of (OBRR), 3, 17, 22,
66, 133
Black lung compensation, 174
C
California, 94-95
Canada, 192
Center for Disease Control
(CDC), 5, 8, 29, 30, 66, 80,
125, 133
Center for Drugs and Biologics,
17
Chicken pox (varicella) vaccine,
19, 32
Cholera vaccine, 47, 62, 161
Compensation. See Liability and
compensation
Congenital rubella syndrome, 76
Consent forms, 106, 157
Convulsions, 69, 70
Costs. See Economic issues
-
Cowpox, 15
Cross-reacting immunity, 14
Cytomegalovirus vaccine, 19, 32
D
Dawson's encephalitis, 75
Deafness, 77
Defense Department, 3, 133
Denmark, 176-177, 192
OCR for page 206
206
Development of vaccines. See
Vaccine availability
Diabetes mellitus, 77
Diphtheria
antitoxin, 15-17
incidence, 18-19
Diphtheria toxoid, 14, 18, 19
adverse reactions, 72-73
producers and license holders,
47, 161-162
stockpile, 30
Diphtheria-tetanus-pertussis
(DTP) vaccine
adverse reactions, 67-72
availability, 5, 27-28, 30,
46, 55
litigation cited, 114-115
producers and license holders,
47, 161
vaccine policy and, 127
Drug Price Competition and
Patent Restoration Act
of 1984, 51
Duty to warn, 9, 87-93, 116
E
Economic issues
disincentives to innovation
and production, 7, 33-34, 41
industry decline, 7, 46, 48,
61, 63
market size, 34, 52
new product introduction, 46,
48, 50
pricing data, 57
property rights, 34, 50-51
regulatory costs, 52
research and development, 46,
49, 61-63
sales figures, 45-46, 55-57
vaccine development costs, 45
see also Liability and
compensation
Encephalopathy, 70-71, 75, 76
Export sales, 34
F
Federal Immunization Insurance 45
Corporation, 190-191
Fever, 15, 69, 70, 73, 75
Food and Drug Administration, 3,
8, 17, 66, 80, 125
Foreign manufacturers, 5, 31,
148, 192-193
France, 178, 193
Funding
for injury compensation
proposal, 156, 158
for national vaccine
commission, 133
for vaccine stockpiles, 29-30
G
Generic drugs, 51
Genetic engineering, 23-24
Germany, 177-178, 193
Gonorrhea vaccine, 19, 32
Government actions
vaccine production, 5-6, 31-32
vaccine purchases, 57, 58 .
see also Legal issues,
~ .. ..
Liability and compensation
Guillain-Barre syndrome, 22, 67,
72, 78
swine flu vaccine litigation,
93-113
H
Health Belief Model (HBM), 7,
35-36, 39, 41
Health Care Financing
Administration, 133
Health care providers.
attitudes toward immunization,
6-7, 34-40, 126-127
liability, 9.,.117, 153
Hemolytic anemia, 72
Hemophilus influen.zae type b
vaccine, 19, 45
Hepatitis A vaccine, 19, 32
Hepatitis B vaccine, 14, 24, 33
adverse reactions, 80
producers and license holders,
47, 62, 162 .
Hepatitis incidence., 15, 33
Herpes simplex v;accines,-19, 32,
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207
I
Immune serum globulin, 15
Immunization
active, 14
committee reco~runendation, 4,
22, 66
current status, 4, 19-20, 23-
25
historical background, 2-3,
15-19
lay and professional
attitudes, 6-7, 34-40, 52,
126-127
major achievements, 18-19
military use, 4, 17, 22-23
passive, 14-15
preparation used, 14-15
Immunization Committee, 4, 22
Immunization Practices Advisory
Committee, 4, 22, 66, 116
Immunodeficiencies
and administration of live
vaccines, 74, 76, 77
AIDS, 33, 80
Infectious Diseases Committee,
4, 22, 66
Influenza vaccines, 14, 47, 162
adverse reactions, 78
litigation cited, 113
see also Swine flu vaccine
Insurance coverage
for immunization, 35, 125
see also Liability and
compensation
Interagency Group to Monitor
Vaccine Development,
Production, and Usage, 124
126
J
Japan, 29, 127, 179-180, 193
L
Lederle Laboratories, 27, 46
Legal issues
patent protection, 34, 50-51,
63
regulatory costs, 52
testing and licensing
procedures, 21-23
vaccine regulation, 3, lS-17
see also Liability and
compensation
Legionnaires' disease, 33
Liability and compensation, 2,
34
compensation options, 12-13,
136-150, 159, 164-170, 183
191
compensation system proposal,
152-159
as economic disincentive, 9
11, 53, 117-119
existing compensation systems,
171-175
federal assumption of
liability, 138, 147
foreign programs, 176-182
health care providers, 9, 117
153
legal situation su~runarized, 8
9, 85-93, 114-117
legislative proposals, 183-191
miscellaneous cases, 113-115
no-fault insurance, 137, 138,
143, 144, 166-170
polio vaccine cases, 86-93,
113-116
price increase to cover, 138,
148
punitive damages, 115-116
rationale for providing
compensation, 13, 136, 148,
151-152, 159-160
swine flu vaccine cases, 93
113, 171
tort law changes, 137, 138,
145, 146
vaccine supply insurance, 137,
138, 142, 144, 164-165
M
Malpractice claims, 9, 119
Manufacturers
foreign, 5, 31, 148,`192-193
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208
producers and license holders,
19, 27, 28, 47-48, 54, 62-
63, 161-163
Market size, 34, 52, 61
Maryland, 94
Massachusetts, 28
Measles incidence, 18
Measles vaccine, 14, 18, 19
adverse reactions, 74-76
producer and license holder,
46, 47, 62, 162
stockpile, 30
Media coverage, 52, 127
Medicare, 35, 125
Meningitis, 19, 45
Meningococcal vaccines, 14, 18,
47, 62, 79, 162
Meningoencephalitis, 77
Michigan, 28
Military use of vaccines, 4, 17,
22-23
Mumps incidence, 18
Mumps vaccine, 14, 18, 19
adverse reactions, 77
producer and license holder,
46, 47, 62, 162, 163
stockpile, 30
N
National Childhood Vaccine
Injury Compensation Act,
183-186
National Immunization
Conference, 123
National Immunization Work
Groups, 4, 27
National Institute of Allergy
and Infectious Diseases, 3,
125, 128, 133
National Institutes of Health
(NIH), 17
National Microbiological
Institute, 17
National Pediatric Vaccine-
Injury Compensation Act,
186-188
National vaccine commission, 1,
6, 11-12, 32, 40, 128-134,
201
Netherlands, 193
Notice of Claimed Exemption for
Investigation of New Drug, 3
o
Orchitis, 77
Orphan vaccines, 31
p
Parasitic vaccines, 19, 23
Passive immunization, 14-15
Patent protection, 34, 50-51, 63
Peripheral neuropathy, 72, 73,
77
Pertussis incidence, 19
Pertussis vaccine, 14, 18, 19,
33, 46
adverse reactions, 67-72
producer and license holders,
47, 162
stockpile, 30
vaccine policy and, 127
Plague vaccine, 47, 162
Pneumococcal vaccine, 14, 20,
35,
45, 125
adverse reactions, 78-79
producers and license holders,
47, 62, 162
vaccine policy and, 128
Pneumonia, 75, 78
Poliomyelitis incidence, 19
vaccine-induced, 74
Poliovirus vaccines, 14, 18,
19, 24
adverse reactions, 74
litigation cited, 86-93, 113
116
producers and license holders,
46, 47, 162
stockpile, 30
Polypeptide synthesis, 24
Pregnancy, and vaccine
administration, 75-77
Pricing data. See Economic
Issues
Production of vaccines. See
Vaccine availability
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209
Public Health Service, 4, 22,
124
Public Health Service Act of
1944, 17
Punitive damages, 9, 115-116
Purpura, 76
R
Rabies vaccines, 15, 18, 21,
114, 128
adverse reactions, 79
producers and license holders,
47, 62, 162
Recombinant DNA techniques, 23
24
Regulation. See Legal issues
Reporting systems, 8, 66, 80
Research and development, 46,
49, 50, 61, 62
Retrovirus, 33
Rotavirus diarrhea vaccine, 19,
32
Rubella incidence, 18
Rubella vaccine, 14, 18, 19
adverse reactions, 76-77
producers and license holders,
46, 47, 62, 63, 162, 163
stockpile, 30
S
Sabin vaccine. See Poliovirus
vaccines
Sales figures. See Economic
issues
Salk vaccine. See Poliovirus
vaccines
Serum hepatitis, 33
Serum sickness, 15, 73, 79
Serum therapy, 15-16
Smallpox incidence, 18
Smallpox vaccine, 14-17, 48,
162, 163
Social Security Disability
compensation, 174-175
Squibb-Connaught Laboratories,
27-30, 55
Stockpiling of vaccines, 5, 29-
30. See also specific
-
vaccines
Streptococci group B vaccine, 19
Subacute sclerosing
panencephalitis, 75
Sudden infant death syndrome
(SIDS), 71-72
Supply of vaccines. See Vaccine
availability
Sweden, 127, 193
Swine flu vaccine, 22, 67
litigation cited, 93-113, 171
Switzerland, 180, 193
T
Tetanus antitoxin, 15, 17
Tetanus incidence, 16, 17, 19
Tetanus toxoid, 14, 17, 19, 125
adverse reactions, 73
producers and license holders,
48, 163
stockpile, 30
Thrombocytopenia, 72
Tort law. See Liability and
compensation
Toxoids, 14
Transverse myelitis, 72
Tropical diseases, 4, 22
Tuberculosis, 14
Typhoid vaccine, 48, 114, 163
U
United Kingdom, 28, 127, 180
182, 193
V
Vaccination. See Immunization
Vaccine Act of 1813, 15
Vaccine availability
barriers to innovation, 6-7,
32-34, 40-41
development, testing, and
licensing mechanisms, 3, 20-
23
DIP shortage, 27-29
federal production, 31-32
foreign manufacturers, 5, 31,
148, 192-193
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210
manufacturers and license
holders, 19, 27, 28, 47-48 r
54, 62-63, 161-163
overview, 1-2, 4-6, 27, 40
reasons for supply
interruption, 29
stockpiling of vaccines, 29-30
types of preparations used,
14-15
Vaccine commission, 1, 6, 11-12,
32, 40, 128-134, 201
Vaccine injury, 8
establishing cause-and-effect
relationship, 65-68, 80-81
identifying high-risk
individuals, 68-69
see also specific vaccines
~ . ,
Vaccine policy, 1, 123-128, 134,
194-195
Vaccine use. See Immunization
Vaccine-Injury Compensation Act
of 1983, 189
Vaccinia virus vaccine, 14
Varicella (chicken pox) vaccine,
19, 32
Veterans Administration, 133
Viral antigens, 24
Viral vaccines, 18, 23. See
also specific vaccines
Virus-toxin act of 1902, 16, 17
W
Workers' compensation, 172-174
Wyeth Laboratories, 27, 55
y
Yellow fever vaccine, 14, 48,
163
Representative terms from entire chapter:
license holders
