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Cover, Front Matter, and Table of Contents

Epidemiology and Prevention of Vaccine-Preventable Diseases

The Pink Book: Course Textbook - 12th Edition Second Printing (May 2012)

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On the Cover

image of book cover as discussed in On the Cover section

Four scientists who made major contributions to vaccine research and development (clockwise from top left): Emil von Behring (1854-1917) – developed the first effective diphtheria antitoxin. For this work he received the first Nobel Prize for Medicine or Physiology in 1901; Gaston Ramon (1886-1963) – French veterinarian who in the 1920s developed methods for inactivating diphtheria and tetanus toxins, a critical discovery for the development of diphtheria and tetanus toxoids; Maurice Hilleman (1919-2005) – researcher who developed numerous vaccines at Merck including hepatitis B., mumps, and MMR vaccines; John Enders (1897-1985) – developed a method to grow poliovirus using tissue culture media which led to the development of the first successful polio vaccines. He and his coworkers received the Nobel Prize in Medicine in 1954 for this discovery. Dr. Enders was also the first to isolate measles virus in 1954, which led to the first measles vaccine.

Images of these scientists appear in the animated “gallery” shown at the beginning of all NCIRD broadcasts and video productions.

 

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Front Matter

This book was produced by the Education, Information and Partnership Branch, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, who is solely responsible for its content. It was printed and distributed by the Public Health Foundation. For additional copies, contact the Public Health Foundation web site or call 877–252–1200.

E-mail address for comments, questions or suggestions about the contents of this book: nipinfo@cdc.gov.

Edited by: William Atkinson, MD, MPH; Charles (Skip) Wolfe; Jennifer Hamborsky, MPH, CHES

Contributions from: Patricia Beckenhaupt, RN, MS, MPH; Pamela Bryant, MS; Andrew Kroger, MD, MPH; JoEllen Wolicki, RN, BSN; Pascale Wortley, MD, MPH; Donna Weaver, RN, MN

Suggested citation

Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe S, Hamborsky J, eds. 12th ed., second printing. Washington DC: Public Health Foundation, 2012.

Disclaimer: Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Services or the U.S. Department of Health and Human Services. References to non-CDC sites on the Internet are provided as a service to readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of these sites. URL addresses were current as of the date of publication.

Life is a series of hellos and goodbyes
I’m afraid it’s time for goodbye again…

        - Billy Joel, Say Goodbye to Hollywood, 1976

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Table of Contents

Chapters

Chapter 1: Principles of Vaccination

Immunology and Vaccine-Preventable Diseases... 1
Classification of Vaccines... 4
Selected References... 7

Chapter 2: General Recommendations on Immunization

Timing and Spacing of Vaccines... 9
Adverse Reactions Following Vaccination... 15
Contraindications and Precautions to Vaccination... 17
Invalid Contraindications to Vaccination... 23
Screening for Contraindications and Precautions to Vaccination... 27
Selected References... 29

Chapter 3: Immunization Strategies for Healthcare Practices and Providers

The Need for Strategies to Increase Immunization Levels... 31
The AFIX Approach... 33
Other Essential Strategies... 38
Selected References... 43

Chapter 4: Vaccine Safety

The Importance of Vaccine Safety Programs... 45
Sound Immunization Recommendations and Policy... 46
Methods of Monitoring Vaccine Safety... 47
Vaccine Analytic Unit... 52
Vaccine Injury Compensation... 52
The Immunization Provider’s Role... 54
Selected References... 58

Chapter 5: Vaccine Storage and Handling

Vaccine Storage Temperatures... 61
Storage and Handling Plans... 62
Personnel, Training and Education... 63
Vaccine Storage Equipment... 64
Temperature Monitoring... 66
Vaccine Placement and Labeling... 67
Vaccine Storage Troubleshooting... 68
Vaccine Inventory Control... 70
Receiving and Unpacking Vaccine Shipments... 70
Vaccine Transport to Off-site Clinics... 71
Vaccine Preparation... 73
Vaccine Disposal... 73
Selected References... 74

Chapter 6: Diphtheria

Corynebacterium diphtheriae... 75
Pathogenesis... 75
Clinical Features... 75
Complications... 77
Laboratory Diagnosis... 77
Medical Management... 78
Epidemiology... 79
Secular Trends in the United States... 80
Diphtheria Toxoid... 81
Vaccination Schedule and Use... 82
Contraindications and Precautions to Vaccination... 83
Adverse Reactions Following Vaccination... 83
Vaccine Storage and Handling... 84
Suspect Case Investigation and Control... 84
Selected References... 85

Chapter 7: Haemophilus influenzae

Haemophilus influenzae... 87
Pathogenesis... 87
Clinical Features... 89
Laboratory Diagnosis... 89
Medical Management... 90
Epidemiology... 90
Secular Trends in the United States... 91
Haemophilus influenzae type b Vaccines... 92
Vaccination Schedule and Use... 94
Combination Vaccines... 96
Contraindications and Precautions to Vaccination... 97
Adverse Reactions Following Vaccination... 97
Vaccine Storage and Handling... 98
Surveillance and Reporting of Hib Disease... 98
Selected References... 98

Chapter 8: Hepatitis A

Hepatitis A Virus... 101
Pathogenesis... 101
Clinical Features... 102
Complications... 102
Laboratory Diagnosis... 102
Medical Management... 103
Epidemiology... 103
Secular Trends in the United States... 105
Case Definition... 106
Hepatitis A Vaccine... 106
Vaccination Schedule and Use... 107
Contraindications and Precautions to Vaccination... 112
Adverse Reactions Following Vaccination... 112
Vaccine Storage and Handling... 112
Postexposure Prophylaxis... 112
Selected References... 113

Chapter 9: Hepatitis B

Hepatitis B Virus... 115
Clinical Features... 116
Complications... 117
Laboratory Diagnosis... 117
Medical Management... 119
Epidemiology... 119
Secular Trends in the United States... 121
Hepatitis B Prevention Strategies... 123
Hepatitis B Vaccine... 123
Vaccination Schedule and Use... 126
Serologic Testing of Vaccine Recipients... 131
Postexposure Management... 134
Contraindications and Precautions to Vaccination... 137
Adverse Reactions Following Vaccination... 137
Vaccine Storage and Handling... 138
Selected References... 138

Chapter 10: Human Papillomavirus

Human Papillomavirus... 139
Pathogenesis... 139
Clinical Features... 140
Laboratory Diagnosis... 140
Medical Management... 141
Epidemiology... 141
Disease Burden in the United States... 142
Prevention... 143
Human Papillomavirus Vaccine... 143
Vaccination Schedule and Use... 145
Contraindications and Precautions to Vaccination... 147
Adverse Reactions Following Vaccination... 148
Vaccine Storage and Handling... 148
Selected References... 149

Chapter 11: Influenza

Influenza Virus... 151
Pathogenesis... 153
Clinical Features... 153
Complications... 154
Impact of Influenza... 154
Laboratory Diagnosis... 155
Epidemiology... 156
Secular Trends in the United States... 157
Influenza Vaccine... 158
Vaccination Schedule and Use... 160
Contraindications and Precautions to Vaccination... 163
Adverse Reactions Following Vaccination... 164
Vaccine Storage and Handling... 167
Strategies for Improving Influenza Vaccine Coverage... 167
Antiviral Agents for Influenza... 168
Nosocomial Influenza Control... 169
Influenza Surveillance... 169
Selected References... 170

Chapter 12: Measles

Measles Virus... 173
Pathogenesis... 173
Clinical Features... 174
Complications... 174
Laboratory Diagnosis... 176
Epidemiology... 177
Secular Trends in the United States... 178
Measles Vaccine... 181
Vaccination Schedule and Use... 182
Contraindications and Precautions to Vaccination... 186
Adverse Reactions Following Vaccination... 189
Vaccine Storage and Handling... 191
Selected References... 191

Chapter 13: Meningococcal Disease

Neisseria meningitidis... 193
Pathogenesis... 194
Clinical Features... 194
Laboratory Diagnosis... 195
Medical Management... 195
Epidemiology... 196
Secular Trends in the United States... 196
Meningococcal Vaccines... 197
Vaccination Schedule And Use... 199
Contraindications and Precautions to Vaccination... 201
Adverse Reactions Following Vaccination... 201
Vaccine Storage and Handling... 202
Surveillance and Reporting of Meningococcal Disease... 202
Antimicrobial Chemoprophylaxis... 203
Selected References... 203

Chapter 14: Mumps

Mumps Virus... 205
Pathogenesis... 205
Clinical Features... 205
Complications... 206
Laboratory Diagnosis... 207
Epidemiology... 207
Secular Trends in the United States... 208
Mumps Vaccine... 209
Vaccination Schedule and Use... 210
Contraindications and Precautions to Vaccination... 211
Adverse Reactions Following Vaccination... 213
Vaccine Storage and Handling... 213
Selected References... 213

Chapter 15: Pertussis

Bordetella pertussis... 215
Pathogenesis... 215
Clinical Features... 215
Complications... 216
Laboratory Diagnosis... 217
Medical Management... 218
Epidemiology... 219
Secular Trends in the United States... 219
Pertussis Vaccines... 220
Vaccination Schedule and Use... 222
Combination Vaccines Containing DTaP... 225
Other DTaP Issues... 226
Contraindications and Precautions to Vaccination... 227
Adverse Reactions Following Vaccination... 228
Vaccine Storage and Handling... 230
Selected References... 230

Chapter 16: Pneumococcal Disease

Streptococcus pneumoniae... 233
Clinical Features... 234
Laboratory Diagnosis... 236
Medical Management... 236
Epidemiology... 237
Secular Trends in the United States... 237
Pneumococcal Vaccines... 238
Vaccination Schedule and Use... 240
Contraindications and Precautions to Vaccination... 244
Adverse Reactions Following Vaccination... 244
Vaccine Storage and Handling... 245
Goals and Coverage Levels... 245
Selected References... 246

Chapter 17: Poliomyelitis

Poliovirus... 249
Pathogenesis... 249
Clinical Features... 250
Laboratory Diagnosis... 251
Epidemiology... 251
Secular Trends in the United States... 252
Poliovirus Vaccines... 253
Vaccination Schedule and Use... 255
Polio Vaccination of Adults... 257
Contraindications And Precautions To Vaccination... 258
Adverse Reactions Following Vaccination... 258
Vaccine Storage and Handling... 259
Outbreak Investigation and Control... 260
Polio Eradication... 260
Postpolio Syndrome... 261
Selected References... 261

Chapter 18: Rotavirus

Rotavirus... 263
Pathogenesis... 263
Clinical Features... 264
Complications... 264
Laboratory Diagnosis... 264
Epidemiology... 265
Secular Trends in the United States... 266
Rotavirus Vaccines... 266
Vaccine Effectiveness... 268
Duration of Immunity... 268
Vaccination Schedule and Use... 269
Contraindications and Precautions to Vaccination... 270
Adverse Reactions Following Vaccination... 272
Vaccine Storage and Handling... 273
Rotavirus Surveillance... 273
Selected References... 274

Chapter19: Rubella

Rubella Virus... 275
Pathogenesis... 275
Clinical Features... 275
Complications... 276
Congenital Rubella Syndrome... 276
Laboratory Diagnosis... 277
Epidemiology... 278
Secular Trends in the United States... 279
Rubella Vaccine... 280
Vaccination Schedule and Use... 281
Rubella Immunity... 283
Contraindications and Precautions to Vaccination... 284
Adverse Reactions Following Vaccination... 285
Rubella Vaccination of Women of Childbearing Age... 286
Vaccine Storage and Handling... 287
Strategies to Decrease Rubella and CRS... 288
Selected References... 288

Chapter 20: Tetanus

Clostridium tetani... 291
Pathogenesis... 292
Clinical Features... 292
Complications... 293
Laboratory Diagnosis... 293
Medical Management... 293
Wound Management... 294
Epidemiology... 294
Secular Trends in the United States... 295
Tetanus Toxoid... 296
Vaccination Schedule and Use... 297
Contraindications and Precautions to Vaccination... 298
Adverse Reactions Following Vaccination... 299
Vaccine Storage and Handling... 299
Selected References... 300

Chapter 21: Varicella

Varicella Zoster Virus... 301
Pathogenesis... 301
Clinical Features... 301
Complications... 303
Laboratory Diagnosis... 304
Epidemiology... 306
Secular Trends in the United States... 307
Vaccines Containing Varicella Virus... 308
Vaccination Schedule and Use... 311
Varicella Immunity... 315
Contraindications and Precautions to Vaccination... 316
Zoster Vaccine... 318
Adverse Reactions Following Vaccination... 319
Transmission of Varicella Vaccine Virus... 321
Vaccine Storage and Handling... 321
Varicella Zoster Immune Globulin... 322
Selected References... 323

Appendices

Appendix A: Schedules and Recommendations[776 KB, 28 pages]

Immunization Schedules on the Web... A-1
Childhood Immunization Schedule 2012... A-2
Adult Immunization Schedule 2012... A-6
Recommended Minimum Ages and Intervals... A-11
Summary of Recommendations for
Childhood & Adolescent Immunizations... A-13
Summary of Recommendations for Adult Immunizations... A-17
Antibody–Live Vaccine Interval Table... A-21
Healthcare Worker Vaccination Recommendations... A-22
Immunization of Immunocompromised Patients Tables... A-23
Contraindications Tables... A-25

Appendix B: Vaccines[8.5 MB, 40 pages]

U.S. Vaccines... B-1
Selected Discontinued U.S. Vaccines. B-5
Vaccine Excipient and Media Summary, by Vaccine... B-7
Latex in Vaccine Packaging... B-10
Thimerosal Table... B-12
Foreign Language Terms... B-14

Appendix C: Vaccine Storage and Handling[811 KB, 10 pages]

Checklist for Safe Vaccine Handling and Storage... C-1
Vaccine Handling Tips... C-3
Recording Refrigerator Temperatures... C-4
Vaccine Storage Temperature Recommendations... C-5
Safeguard Your Power Supply... C-6
Vaccine Storage and Handling Resources... C-7
Vaccine Manufacturer Contact Information... C-8

Appendix D: Vaccine Administration[2.8 MB, 24 pages]

"Vaccine Administration" Guidelines... D-1
Administering Vaccines... D-18
Medical Management of Vaccine Reactions (Children & Teens)... D-20
Medical Management of Vaccine Reactions (Adults)... D-23

Appendix E: Vaccine Information Statements[700 KB, 10 pages]

It’s Federal Law... E-1
Instructions for Use of VISs... E-3
VIS Questions and Answers... E-4
CDC’s Vaccine Information Statement Webpage... E-8

Appendix F: Vaccine Safety[637 KB, 8 pages]

The Vaccine Adverse Event Reporting System (VAERS)... F-1
Table of Reportable Events Following Vaccination... F-2
The Vaccine Injury Compensation Program (VICP)... F-4
The VICP Vaccine Injury Table... F-6

Appendix G: Data and Statistics[420 KB, 12 pages]

Reported Cases and Deaths from Vaccine-Preventable Diseases: 1950–2011... G-1
Impact of Vaccines in the 20th & 21st Centuries... G-7
Vaccine Coverage Levels: 1962–2010... G-8

Appendix H: Immunization Resources[584 KB, 12 pages]

CDC Immunization Contacts & Resources... H-1
Other Immunization Resources... H-2
State and Local Immunization Grantee Contact Information... H-3

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Vaccines and Related Products Distributed in the United States - 2012

See also information on vaccine shortages.

Vaccine/Biologic Brand Name Manufacturer Type How Supplied
Anthrax, adsorbed BioThrax® Bioport inactivated multi-dose vial
Botulism immune globulin (BIG-IV) BabyBIG® Mass Biologic Labs human immunoglobulin single-dose vial
Diphtheria, Tetanus, acellular Pertussis Infanrix® GlaxoSmithKline inactivated single-dose vial or syringe
Diphtheria, Tetanus, acellular Pertussis Tripedia® sanofi pasteur inactivated single-dose vial
Diphtheria, Tetanus, acellular Pertussis Daptacel® sanofi pasteur inactivated single-dose vial
Diphtheria, Tetanus, acellular Pertussis+HepB+IPV Pediarix® GlaxoSmithKline inactivated single-dose vial or syringe
Diphtheria, Tetanus, acellular Pertussis+Hib+IPV Pentacel® sanofi pasteur inactivated single-dose vial
Diphtheria, Tetanus, acellular Pertussis+IPV Kinrix® GlaxoSmithKline inactivated single-dose vial or syringe
Diphtheria, Tetanus (DT, ped, < 7 yrs) generic sanofi pasteur inactivated single-dose vial
Tetanus, Diphtheria, adsorbed (Td > or = 7 years) Decavac® sanofi pasteur inactivated syringe
Tetanus, Diphtheria, adsorbed (Td > or = 7 years) Tenivac® sanofi pasteur inactivated single-dose vial or syringe
Tetanus, Diphtheria, adsorbed (Td > or = 7 years) generic Mass Biologic Labs inactivated 15-dose vial
Tetanus, Diphtheria, acellular Pertussis (Tdap > or = 10 yrs) Boostrix® GlaxoSmithKline inactivated single-dose vial or syringe
Tetanus, Diphtheria, acellular Pertussis (Tdap 11-64 yrs) Adacel® sanofi pasteur inactivated single-dose vial
Tetanus toxoid, adsorbed (TT > o r = 7 yrs) generic sanofi pasteur inactivated 10-dose vial
Tetanus toxoid, adsorbed (TT, adult booster use only) generic sanofi pasteur inactivated 15-dose vial
Tetanus immune globulin (TIG) HyperTET® Talecris human immunoglobulin single-dose syringe
Haemophilus influenzae type b (PRP-T) ActHIB® sanofi pasteur inactivated single-dose vial
Haemophilus influenzae type b (PRP-OMP) PedvaxHIB® Merck inactivated single-dose vial
Haemophilus influenzae type b (PRP-T) (booster dose) Hiberix® GlaxoSmithKline inactivated single-dose vial
Haemophilus influenzae type b (PRP-OMP)+HepB Comvax® Merck inactivated single-dose vial
Hepatitis A, ped/adol & adult formulations Havrix® GlaxoSmithKline inactivated single-dose vial or syringe
Hepatitis A, ped/adol & adult formulations Vaqta® Merck inactivated single-dose vial or syringe
Hepatitis B, ped/adol & adult formulations Engerix-B® GlaxoSmithKline inactivated single-dose vial or syringe
Hepatitis B, ped/adol & adult formulations Recombivax HB® Merck inactivated single-dose vial
Hepatitis B dialysis formulation Recombivax HB® Merck inactivated single-dose vial
Hepatitis B immune globulin (HBIG) HyperHEP B® Talecris human immunoglobulin 1 ml syringe, 1 ml or 5 ml vial
Hepatitis B immune globulin (HBIG) ped formulation HyperHEP B® Talecris human immunoglobulin single-dose 0.5 ml neonatal syringe
Hepatitis B immune globulin (HBIG) Nabi-HB® Nabi single-dose vial
Hepatitis A & B adult formulation Twinrix® GlaxoSmithKline inactivated single-dose vial or syringe
Human papillomavirus, quadrivalent (HPV4) Gardasil® Merck inactivated single-dose vial or syringe
Human papillomavirus, bivalent (HPV2) Cervarix® GlaxoSmithKline inactivated single-dose vial or syringe
Influenza, trivalent inactivated (TIV) (normal) multiple multiple inactivated multiple
Influenza, trivalent inactivated (TIV) (High-Dose > or = 65 yrs) Fluzone High Dose® sanofi pasteur inactivated syringe
Influenza, trivalent inactivated (TIV) (Intradermal) Fluzone Intradermal® sanofi pasteur inactivated syringe
Influenza, lilve attenuated (LAIV) FluMist® MedImmune live intranasal single-use sprayer
Japanese encephalitis Ixiaro® Intercell inactivated single-dose syringe
Measles, Mumps, Rubella (MMR) M-M-R II® Merck live attenuated single-dose vial
Measles, Mumps, Rubella, Varicella (MMRV) ProQuad® Merck live attenuated single-dose vial
Meningococcal conjugate, quadrivalent Menactra® sanofi pasteur inactivated single-dose vial
Meningococcal conjugate, quadrivalent Menveo® Novartis inactivated single-dose vial
Meningococcal polysaccharide, quadrivalent Menomune® sanofi pasteur inactivated single-dose vial
Pneumococcal conjugate, 13-valent Prevnar-13® Pfizer inactivated single-dose vial
Pneumococcal polysaccharide, 23-valent Pneumovax-23® Merck inactivated single-dose or 5-dose vial
Poliovirus inactivated (IPV) IPOL® sanofi pasteur inactivated single-dose syringe or 10-dose vial
Rabies Imovax® sanofi pasteur inactivated single-dose vial
Rabies RabAvert® Novartis inactivated single-dose vial
Rabies immune globulin (RIG) Imogam Rabies-HT® sanofi pasteur human immunoglobulin 2 mL and 10 mL vial
Rabies immune globulin (RIG) HyperRAB® Talecris human immunoglobulin 2 mL and 10 mL vial
Rotavirus, pentavalent (RV5) RotaTeq® Merck live oral single-dose tube
Rotavirus, pentavalent (RV1) Rotarix® GlaxoSmithKline live oral single-dose tube
Typhoid Vi polysaccharide Typhim Vi® sanofi pasteur inactivated syringe and 20-dose vial
Typhoid, live oral Ty21a Vivotif® Berna live attenuated 4-capsule pack
Varicella Varivax® Merck live attenuated single-dose vial
Varicella Zoster immune globulin (VZIG) (IND) VariZIG® Cangene human immunoglobulin 25-U vial
Yellow Fever VF-Vax® sanofi pasteur live attenuated single- and 5-dose vial
Zoster Zostavax® Merck live attenuated single-dose vial

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