Click for next page ( 204


The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 203
- INDEX

OCR for page 203

OCR for page 203
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 203
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,

OCR for page 203
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

OCR for page 203
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

OCR for page 203
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

OCR for page 203
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