Plotkin's Vaccines

8th Edition - December 21, 2022
Authors: Walter A. Orenstein, Paul A. Offit, Kathryn M. Edwards, Stanley A. Plotkin
Language: English
Hardback ISBN:
9 7 8 - 0 - 3 2 3 - 7 9 0 5 8 - 1
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 7 9 0 5 9 - 8

From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin’s Vaccines, 8th Edition,… Read more

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From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin’s Vaccines, 8th Edition, covers every aspect of vaccination. Now completely revised and updated from cover to cover, this award-winning text continues to provide reliable information from global authorities, offering a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as "an indispensable guide to the enhancement of the well-being of our world," Plotkin’s Vaccines is a must-have reference for current, authoritative information in this fast-moving field.

Cover Image
Title Page
Copyright
Dedication
Contributors
Foreword
Preface to the First Edition
Preface to the Eighth Edition
Acknowledgments
Table of Contents
Section I General Aspects of Vaccination
Chapter 1 A Short History of Vaccination
EARLY DEVELOPMENTS
FIRST HALF OF THE 20TH CENTURY
SECOND HALF OF THE 20TH CENTURY
RECOMBINANT PROTEIN VACCINES
21ST CENTURY
KEY REFERENCES
REFERENCES
Chapter 2 Vaccine Immunology
WHAT ARE THE MAIN EFFECTORS OF VACCINE RESPONSES?
HOW DO VACCINES MEDIATE PROTECTION?
FROM INNATE TO ADAPTIVE IMMUNITY ACTIVATION: THE FIRST STEPS AFTER IMMUNIZATION
VACCINE ANTIBODY RESPONSES
KEY REFERENCES
REFERENCES
Chapter 3 Non-specific Effects of Vaccines
INTRODUCTION
EVIDENCE FROM CLINICAL STUDIES
GENERAL CONSIDERATIONS
IMMUNOLOGICAL AND MOLECULAR MECHANISMS
FUTURE PERSPECTIVES
KEY REFERENCES
REFERENCES
Chapter 4 Correlates of Protection
PRINCIPLES OF PROTECTION
STATISTICAL ISSUES IN DEVELOPING IMMUNE CORRELATES OF PROTECTION
COMPLEXITY OF CORRELATES
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 5 The Vaccine Industry
VACCINE DEVELOPMENT
ROLE OF PARTNERS
RESPONSE TO COVID-19 PANDEMIC
FUNDING SOURCES FOR VACCINE RESEARCH AND DEVELOPMENT
PRICING OF VACCINES
ACKNOWLEDGMENTS
REFERENCES
Chapter 6 Vaccine Manufacturing
MANUFACTURING BASICS
EXAMPLES OF VACCINE PRODUCTION
PRODUCT DEVELOPMENT
INDUSTRY’S RESPONSE TO NEW CHALLENGES
REFERENCES
Chapter 7 Evolution of Adjuvants Across the Centuries
CHANCE AND NECESSITY: THE DISCOVERY OF ADJUVANTS
A TURNING POINT: BETTER UNDERSTANDING OF IMMUNOLOGY AND ITS IMPACT ON THE DEVELOPMENT OF ADJUVANTS
DEFINING ADJUVANTS: CLASSIFICATION AND EVALUATION
THE CASE OF COVID 19
FUTURE DIRECTIONS
ACKNOWLEDGMENT
REFERENCES
Chapter 8 Vaccine Additives and Manufacturing Residuals in Vaccines Licensed in the United States
VACCINE ADDITIVES
MANUFACTURING RESIDUALS
SENSITIZING SUBSTANCES
SUMMARY
REFERENCES
Chapter 9 Passive Immunization
MATERNAL ANTIBODIES: THE ORIGINAL PASSIVE IMMUNOTHERAPY
CRITICAL PARAMETERS FOR PASSIVE IMMUNOTHERAPY
PASSIVE IMMUNITY TO SMALLPOX AND HEMORRHAGIC FEVER VIRUSES
PASSIVE IMMUNITY AGAINST RESPIRATORY AND ENTERIC PATHOGENS
PASSIVE IMMUNIZATION: A PARADIGM SHIFT IN PROGRESS?
FUTURE OF PASSIVE IMMUNIZATION
KEY REFERENCES
REFERENCES
Section II Licenced Vaccines and Vaccines in Development
Chapter 10 General Immunization Practices
VACCINE STORAGE AND HANDLING
VACCINE ADMINISTRATION
ALLEVIATION OF PAIN AND DISCOMFORT ASSOCIATED WITH VACCINATION
AGES FOR ADMINISTRATION OF IMMUNOBIOLOGICS
SPACING OF VACCINE DOSES
SIMULTANEOUS ADMINISTRATION OF DIFFERENT VACCINES
INTERFERENCE BY IMMUNOGLOBULINS
RECOMMENDATIONS FOR SPACING ADMINISTRATION OF VACCINES AND IMMUNOGLOBULINS
INTERCHANGEABILITY OF VACCINES FROM DIFFERENT MANUFACTURERS
HYPERSENSITIVITY TO VACCINE COMPONENTS
VACCINE COMPONENTS CAUSING HYPERSENSITIVITY
MANAGEMENT OF ACUTE VACCINE ADVERSE REACTIONS
SPECIAL CONSIDERATIONS
BREASTFEEDING AND IMMUNIZATION
VACCINATION DURING PREGNANCY
VACCINATION OF HOUSEHOLD CONTACTS
VACCINES RECEIVED OUTSIDE THE UNITED STATES
VACCINATION OF PERSONS WITH A PERSONAL OR FAMILY HISTORY OF SEIZURES
VACCINATION DURING ACUTE ILLNESS
CONTRAINDICATIONS TO AND PRECAUTIONS REGARDING VACCINATION
KEY REFERENCES
REFERENCES
Chapter 11 Human Adenovirus Vaccines
HISTORY OF DISEASE
WHY THE DISEASE IS IMPORTANT
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
DOSAGE AND ROUTE: INTRAMUSCULAR, SUBCUTANEOUS, AND ORAL
IMMUNOGENICITY OF VACCINE
EFFICACY AND EFFECTIVENESS OF VACCINE
INDICATIONS FOR VACCINE—WHO AND WHY
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 12 Anthrax Vaccines
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 13 Biodefense Vaccines, Vaccines for Emerging Infectious Diseases, and Coalition for Epidemic Preparedness Innovations (CEPI)
BIODEFENSE AND SPECIAL PATHOGEN VACCINES
VACCINES AGAINST VIRAL DISEASES
LIMITED-USE VACCINES AGAINST BACTERIAL DISEASES
PART 2: COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS (CEPI)
FUTURE ASPECTS ON VACCINE DEVELOPMENTS FOR BIODEFENCE AND EMERGING INFECTIONS
REFERENCES
Chapter 14 Cancer Vaccines
INTRODUCTION
GENERAL CONCEPTS OF CANCER VACCINES
THERAPEUTIC CANCER VACCINE TYPES
CONCLUSIONS AND FUTURE DIRECTIONS
REFERENCES
Chapter 15 Cholera Vaccines
HISTORY OF DISEASE
WHY THE DISEASE IS IMPORTANT
CLINICAL DESCRIPTION AND COMPLICATIONS
BACTERIOLOGY
PATHOGENESIS AS IT RELATES TO PREVENTION
MODES OF TRANSMISSION
DIAGNOSIS
CASE MANAGEMENT
EPIDEMIOLOGY
IMMUNITY AND IMMUNE MECHANISMS
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
ACKNOWLEDGMENT
KEY REFERENCES
REFERENCES
Chapter 16 Combination Vaccines
TERMINOLOGY
PRINCIPLES OF COMBINED VACCINES
COMBINATIONS BASED ON DTWP (OR ITS COMPONENTS)
COMBINATIONS BASED ON ACELLULAR PERTUSSIS VACCINE
COMBINATIONS BASED ON HEPATITIS VACCINE, WITHOUT DTP OR DTAP
COMBINATIONS BASED ON MMR VACCINE
COMBINATIONS INCORPORATING MENINGOCOCCAL OR PNEUMOCOCCAL CONJUGATE VACCINES
FUTURE COMBINATION VACCINES
PRACTICAL ISSUES IN THE USE OF COMBINATION VACCINES
PUBLIC HEALTH CONSIDERATIONS
KEY REFERENCES
REFERENCES
Chapter 17 Coronavirus Vaccines
INTRODUCTION: CORONAVIRUSES IN GENERAL
COVID-19
VACCINE STRATEGIES FOR COVS OF DOMESTIC AND COMPANION ANIMALS
IMMUNE RESPONSES ELICITED BY COV
DEVELOPMENT OF VACCINES FOR SARS-COV AND MERS-COV
SARS-COV-2 VACCINE DEVELOPMENT
WANING OF THE IMMUNE RESPONSE AND BOOSTER
OUTSTANDING ISSUES IN COVID-19 VACCINE DEVELOPMENT
FUTURE GOALS
ACKNOWLEDGMENTS
REFERENCES
Chapter 18 Cytomegalovirus Vaccines
CORRELATES OF CYTOMEGALOVIRUS IMMUNITY: IMPLICATIONS FOR VACCINE DESIGN
VACCINES IN CLINICAL TRIALS
SUBUNIT VACCINES
VECTORED VACCINES
VACCINES IN PRE-CLINICAL DEVELOPMENT
SUMMARY AND FUTURE PERSPECTIVE
KEY REFERENCES
REFERENCES
Chapter 19 Dengue Vaccines
INTRODUCTION
DISEASE, VIRUS, EPIDEMIOLOGY, AND PATHOGENESIS
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF VACCINE
EFFICACY AND EFFECTIVENESS
EXCRETION OF VACCINE VIRUS, IF ANY
DURATION OF IMMUNITY AND PROTECTION, INCLUDING DESCRIPTION OF REINFECTION IF ANY
DENGUE HUMAN INFECTION MODEL (DHIM)
SAFETY (ADVERSE EVENTS)
INDICATIONS FOR VACCINE—WHO AND WHY
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES (BRIEF)
KEY REFERENCES
REFERENCES
Chapter 20 Vaccines Against Diarrhea Caused by Noncholera Bacteria
MECHANISMS OF DISEASE AND IMMUNITY
MUCOSAL VERSUS PARENTERAL VACCINATION
SPECIFIC VACCINES
PUBLIC HEALTH PERSPECTIVES, INDICATIONS, AND CHALLENGES FOR VACCINATION
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 21 Diphtheria Toxoid
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF VACCINE
EFFICACY AND EFFECTIVENESS OF VACCINE
DURATION OF IMMUNITY AND PROTECTION
POSTEXPOSURE PROPHYLAXIS AND THERAPEUTIC VACCINATION
SAFETY
INDICATIONS FOR VACCINE—WHO AND WHY
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 22 Ebola Vaccines
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
VACCINES IN CLINICAL USE OR ADVANCED CLINICAL DEVELOPMENT
VACCINE EFFICACY
PUBLIC HEALTH CONSIDERATIONS
ACKNOWLEDGMENT
REFERENCES
Chapter 23 Nonpolio Enteroviruses
HISTORY OF DISEASE
CLINICAL DESCRIPTION
VIROLOGY
EPIDEMIOLOGY
SIGNIFICANCE AS A PUBLIC HEALTH BURDEN
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
HISTORY OF ENTEROVIRUS D68 VACCINE DEVELOPMENT
KEY REFERENCES
REFERENCES
Chapter 24 Epstein–Barr Virus Vaccines
CONSIDERATIONS FOR DEVELOPING PROPHYLACTIC EBV VACCINES
PROPHYLACTIC EBV VACCINES TESTED IN CLINICAL TRIALS
PROPHYLACTIC EBV VACCINES UNDER DEVELOPMENT
THERAPEUTIC EBV VACCINES UNDER DEVELOPMENT
SUGGESTIONS FOR FUTURE DEVELOPMENT OF EBV VACCINES
BARRIERS TO EBV VACCINE DEVELOPMENT
CONCLUSIONS
ACKNOWLEDGMENTS
REFERENCES
Chapter 25 Haemophilus influenzae Type b Vaccines
INTRODUCTION
HISTORY
BACKGROUND (BOX 25.1)
EPIDEMIOLOGY (BOX 25.2)
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION (BOX 25.3)
POLYSACCHARIDE VACCINE
CONJUGATE VACCINES
POSTVACCINE ERA: PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
CONCLUSION (BOX 25.4)
KEY REFERENCES
REFERENCES
Chapter 26 Hepatitis A Vaccines
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
MODES OF TRANSMISSION AND OUTBREAKS
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
VACCINE COVERAGE
PUBLIC HEALTH CONSIDERATIONS
THE GOAL OF THE ELIMINATION OF HEPATITIS A
KEY REFERENCES
REFERENCES
Chapter 27 Hepatitis B Vaccines
BACKGROUND
BURDEN AND EPIDEMIOLOGY
PREVENTION OF HEPATITIS B VIRUS
RESULTS OF VACCINATION
RECOMMENDATIONS FOR HEPATITIS B VACCINATION
POSTEXPOSURE PROPHYLAXIS TO PREVENT HEPATITIS B VIRUS INFECTION
PREVACCINATION AND POSTVACCINATION SEROLOGIC TESTING
REVACCINATION OF THOSE WHO DO NOT SEROCONVERT
SUMMARY
KEY REFERENCES
REFERENCES
Chapter 28 Hepatitis C Vaccines
VIROLOGY
HEPATITIS C VIRUS INFECTION
EPIDEMIOLOGY
IMMUNE RESPONSE TO HEPATITIS C VIRUS
PROTECTIVE IMMUNITY AGAINST HEPATITIS C VIRUS
STRATEGIES FOR A HEPATITIS C VIRUS VACCINE
FUTURE DIRECTIONS
REFERENCES
Chapter 29 Hepatitis E Vaccines
CLINICAL DESCRIPTION
VIROLOGY AND PATHOGENESIS
DIAGNOSIS
TREATMENT
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
PRECLINICAL TRIALS: SAFETY, IMMUNOGENICITY, AND EFFICACY
CLINICAL TRIALS: SAFETY, IMMUNOGENICITY, AND EFFICACY
PROSPECTS FOR THE FUTURE
REFERENCES
Chapter 30 Herpes Simplex Virus Vaccines
BACKGROUND
EPIDEMIOLOGY
ACTIVE IMMUNIZATION
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 31 Human Immunodeficiency Virus Vaccines
DISEASE BURDEN AND EPIDEMIOLOGY
VIROLOGY
VIRUS VARIABILITY
VIRUS–CELL INTERACTIONS
CLINICAL DISEASE
HIV PREVENTION
IMMUNE CORRELATES OF PROTECTION
SUMMARY AND CONCLUSIONS
ACKNOWLEDGMENTS
CONFLICT OF INTEREST STATEMENT
KEY REFERENCES
REFERENCES
Chapter 32 Human Papillomavirus Vaccines
CLINICAL DESCRIPTION
VIROLOGY
PATHOGENESIS
EPIDEMIOLOGY AND TRANSMISSION
DIAGNOSIS
PROPHYLACTIC VACCINES
CURRENT VACCINES
TRIALS IN ADOLESCENTS
IMMUNOGENICITY BRIDGING TRIALS
COADMINISTRATION WITH OTHER VACCINES
MECHANISM OF PROTECTION
DURATION OF PROTECTION
INDICATIONS
RECOMMENDATIONS
PRECAUTIONS AND CONTRAINDICATIONS
CERVICAL CANCER SCREENING AMONG VACCINATED FEMALES
PUBLIC HEALTH CONSIDERATIONS
EPIDEMIOLOGIC IMPACT OF VACCINATION
SECOND-GENERATION PROPHYLACTIC VACCINES
THERAPEUTIC VACCINES
WHY THERAPEUTIC HUMAN PAPILLOMAVIRUS VACCINES HAVE HAD MODEST SUCCESS
KEY REFERENCES
REFERENCES
Chapter 33 Inactivated and Recombinant Influenza Vaccines
HISTORY AND IMPORTANCE
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNE RESPONSE TO VACCINATION AND CORRELATES OF PROTECTION
EFFICACY AND EFFECTIVENESS
CHALLENGES AND OTHER DIRECTIONS FOR INFLUENZA VACCINES
PUBLIC HEALTH CONSIDERATIONS
KEY REFERENCES
REFERENCES
Chapter 34 Influenza Vaccine—Live
WHY THE DISEASE IS IMPORTANT
INFLUENZA
VIROLOGY
PATHOGENESIS AS IT RELATES TO PREVENTION
LIVE ATTENUATED VACCINES
HISTORY AND DEVELOPMENT OF COLD-ADAPTED (CA) INTRANASAL LIVE ATTENUATED VACCINE
CHARACTERISTICS AND FORMULATIONS OF LIVE ATTENUATED INFLUENZA VACCINE
EFFICACY AND EFFECTIVENESS OF LIVE ATTENUATED INFLUENZA VACCINE
IMMUNE CORRELATES OF PROTECTION FOR LIVE ATTENUATED INFLUENZA VACCINE
EFFICACY OF LIVE ATTENUATED INFLUENZA VACCINE COMPARED WITH TRIVALENT INACTIVATED INFLUENZA VACCINE
LIVE ATTENUATED VACCINES AGAINST PANDEMIC INFLUENZA
INDICATIONS FOR USE OF LIVE ATTENUATED INFLUENZA VACCINE TO PREVENT INFLUENZA
SPECIAL CONSIDERATIONS AND CONTRAINDICATIONS
TIMING OF LIVE ATTENUATED INFLUENZA VACCINE ADMINISTRATION
CONCLUSIONS
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 35 Japanese Encephalitis Vaccines
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF JE VACCINES
EFFICACY AND EFFECTIVENESS
EXCRETION OF VACCINE VIRUS AND RISK OF SPREAD TO CONTACTS
DURATION OF IMMUNITY AND PROTECTION
SAFETY
CONTRAINDICATIONS AND PRECAUTIONS
INDICATIONS FOR VACCINE
PUBLIC HEALTH CONSIDERATIONS
JE VACCINES IN DOMESTIC OR LIMITED REGIONAL USE
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 36 Lyme Disease Vaccines—The Journey Continues
INTRODUCTION
CLINICAL DESCRIPTION
BACTERIOLOGY
PATHOGENESIS
DIAGNOSIS
ECOLOGY
PASSIVE IMMUNIZATION
FUTURE CONSIDERATIONS
CANINE VACCINES TO PREVENT LYME DISEASE
SUMMARY
REFERENCES
Chapter 37 Malaria Vaccines
BACKGROUND
EPIDEMIOLOGY AND BURDEN OF DISEASE
PARASITE LIFE CYCLE
CLINICAL COURSE OF DISEASE
RATIONALE AND STRATEGIES FOR VACCINE DEVELOPMENT
CONTROLLED HUMAN MALARIA INFECTION MODEL
VACCINES TARGETING THE PREERYTHROCYTIC STAGE
VACCINES TARGETING THE ASEXUAL BLOOD STAGES
VACCINES TARGETING THE SEXUAL STAGES
VACCINE DEVELOPMENT AGAINST P. VIVAX
PASSIVE IMMUNIZATION
TRADEMARK STATEMENT
CONFLICTS OF INTEREST
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Online Supplements
ONLINE SUPPLEMENT 1
ONLINE SUPPLEMENT 2
ONLINE SUPPLEMENT 3
ONLINE SUPPLEMENT 4
ONLINE SUPPLEMENT 5
REFERENCES
Chapter 38 Measles Vaccines
INTRODUCTION
GLOBAL PUBLIC HEALTH IMPORTANCE OF MEASLES
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF MEASLES VACCINES
PUBLIC HEALTH CONSIDERATIONS
FUTURE MEASLES VACCINES
ACKNOWLEDGMENT
KEY REFERENCES
REFERENCES
Chapter 39 Meningococcal Capsular Group A, C, W, and Y Conjugate Vaccines
BACKGROUND
EPIDEMIOLOGY
MENINGOCOCCAL VACCINE DEVELOPMENT
IMMUNOGENICITY OF MENINGOCOCCAL CONJUGATE VACCINES
MENINGOCOCCAL CONJUGATE VACCINE EFFECTIVENESS
SAFETY OF MENINGOCOCCAL CONJUGATE VACCINES
RECOMMENDATIONS FOR THE USE OF MENINGOCOCCAL CONJUGATE VACCINES
PUBLIC HEALTH CONSIDERATIONS
FUTURE MENINGOCOCCAL CONJUGATE VACCINES
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 40 Meningococcal Vaccines Directed at Capsular Group B
CAPSULAR B MENINGOCOCCAL DISEASE BURDEN
HISTORY OF GROUP B VACCINE DEVELOPMENT
MENB VACCINE COMPOSITION
DISCOVERY AND CHARACTERIZATION OF GROUP B VACCINE ANTIGENS
IMMUNOGENICITY
SURROGATES FOR PREDICTING VACCINE COVERAGE OF DISEASE-CAUSING STRAINS
EFFECT OF VACCINATION ON COLONIZATION
VACCINE SAFETY AND TOLERABILITY
COST EFFECTIVENESS
VACCINE RECOMMENDATIONS
CONTRAINDICATIONS AND PRECAUTIONS IN SPECIAL POPULATIONS
PUBLIC HEALTH PERSPECTIVE
NEXT GENERATION MENINGOCOCCAL B VACCINES
KEY REFERENCES
REFERENCES
Chapter 41 Mumps Vaccines
HISTORY OF THE DISEASE
WHY THE DISEASE IS IMPORTANT
BACKGROUND
DIAGNOSIS
TREATMENT
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
AVAILABILITY IN COMBINATIONS
SIMULTANEOUS ADMINISTRATION WITH OTHER VACCINES
STABILITY OF VACCINE
IMMUNOGENICITY OF VACCINES
CORRELATES OF PROTECTION
IMMUNOCOMPROMISED PERSONS
EFFICACY AND EFFECTIVENESS
HERD IMMUNITY (COMMUNITY PROTECTION)
EXCRETION OF VACCINE VIRUS
DURATION OF IMMUNITY AND PROTECTION
RISK FACTORS FOR VACCINE FAILURE AND RECENT OUTBREAKS
POSTEXPOSURE PROPHYLAXIS
SAFETY
INDICATIONS FOR VACCINATION
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
DISEASE CONTROL STRATEGIES AND POSSIBLE ERADICATION
FUTURE VACCINES
REFERENCES
Chapter 42 Noninfectious Disease Vaccines
INTRODUCTION
OVERCOMING THE IMMUNE SYSTEM’S SAFETY MECHANISMS—UNRESPONSIVENESS AND TOLERANCE
INDUCTION OF B-CELL RESPONSES
LONGEVITY OF THE RESPONSE AND GENERAL SAFETY CONSIDERATIONS
TARGETS FOR THERAPEUTIC B-CELL VACCINATION
VACCINE APPROACHES FOR DEMENTIA
PARKINSON DISEASE
VACCINES AGAINST ADDICTION
TYPE 1 DIABETES AND TOLEROGENIC VACCINES
TYPE 2 DIABETES AND B-CELL VACCINES
HYPERTENSION
ANTICYTOKINE VACCINES
COMPANION ANIMALS, A BRIDGE BETWEEN MICE AND HUMANS
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 43 Norovirus
HUMAN NOROVIRUSES
NOROVIRUS TRANSMISSION AND DISEASE
HISTO-BLOOD GROUP ANTIGENS AND OTHER ESSENTIAL COFACTORS
CHALLENGES TO NOROVIRUS VACCINE DEVELOPMENT
NOROVIRUS IMMUNITY
VACCINES IN DEVELOPMENT
VIRUS-VECTOR DELIVERED AND RECOMBINANT VIRUS-LIKE PARTICLE VACCINES
COMBINATION VACCINES
FUTURE VACCINES
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 44 Parasitic Disease Vaccines
ANTHELMINTIC VACCINES
ANTIPROTOZOAN VACCINES
KEY REFERENCES
REFERENCES
Chapter 45 Pertussis Vaccines
INTRODUCTION
WHY THE DISEASE IS IMPORTANT
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
RESULTS OF VACCINATION: WHOLE-CELL PERTUSSIS VACCINES
RESULTS OF VACCINATION: ACELLULAR PERTUSSIS VACCINES
SAFETY OF TDAP DURING PREGNANCY
INDICATIONS, RECOMMENDATIONS, AND COVERAGE RATES
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 46 Plague Vaccines
HISTORY OF PLAGUE PANDEMICS
EPIDEMIOLOGY OF PLAGUE IN THE 20TH AND 21ST CENTURIES
PLAGUE FORMS
POTENTIAL USE AS AN AGENT OF BIOTERRORISM
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
LIVE-ATTENUATED WHOLE-CELL Y. PESTIS STRAINS AS VACCINES
LIVE-VECTORED VACCINES
VIRAL VECTORS
ACELLULAR VACCINES
IMMUNE RESPONSE TO VACCINATION
CORRELATES OF PROTECTION LEADING TO IDENTIFICATION OF SURROGATE MARKERS OF EFFICACY FOR CLINICAL USE
FUTURE DEVELOPMENTS
KEY REFERENCES
REFERENCES
Chapter 47 Pneumococcal Conjugate Vaccine and Pneumococcal Common Protein Vaccines
PATHOGENESIS
BACKGROUND
EPIDEMIOLOGY
HISTORY OF VACCINE DEVELOPMENT AND VACCINE FORMULATIONS
IMMUNOGENICITY
EFFICACY AND EFFECTIVENESS
SAFETY
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 48 Pneumococcal Polysaccharide Vaccines
BACKGROUND
EPIDEMIOLOGY OF PNEUMOCOCCAL INFECTION
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF 23-VALENT PNEUMOCOCCAL POLYSACCHARIDE VACCINE
EFFICACY OF PNEUMOCOCCAL POLYSACCHARIDE VACCINES
VACCINE SAFETY
INDICATIONS FOR 23-VALENT PNEUMOCOCCAL POLYSACCHARIDE VACCINE
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 49 Poliovirus Vaccine—Inactivated
HISTORICAL INTRODUCTION
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
DOSE RESPONSES, DOSING, AND ROUTE OF ADMINISTRATION
RESULTS OF VACCINATION
ADVERSE EVENTS
CONTRAINDICATIONS TO INACTIVATED POLIOVIRUS VACCINE
SIMULTANEOUS USE WITH OTHER VACCINES
PUBLIC HEALTH CONSIDERATIONS
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 50 Poliovirus Vaccine–Live
INTRODUCTION
WHY IS THE DISEASE IMPORTANT?
BACKGROUND
PATHOGENESIS AS IT RELATES TO PREVENTION
DIAGNOSIS
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNE RESPONSE (IMMUNOGENICITY OF VACCINE)
VACCINE EFFICACY-EFFECTIVENESS
EXCRETION OF VACCINE VIRUS AND SPREAD TO CONTACTS
DURATION OF IMMUNITY
POSTEXPOSURE PROPHYLAXIS AND THERAPEUTIC VACCINATION
SAFETY (ADVERSE EVENTS)
INDICATIONS FOR VACCINE
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
CONCLUSION
KEY REFERENCES
REFERENCES
Chapter 51 Lyssaviruses and Rabies Vaccines
HISTORICAL PERSPECTIVE
CLINICAL PRESENTATION
APPLIED VIROLOGY
PATHOGENESIS AS IT RELATES TO PREVENTION
DIAGNOSIS
EPIDEMIOLOGY
NONBITE TRANSMISSION
HUMAN RABIES
VACCINATION
CELL CULTURE RABIES VACCINES
IMMUNIZATION SCHEDULES
SERUM AND VACCINE PROPHYLAXIS
RESULTS OF HISTORICAL IMMUNIZATION
PERSISTENCE OF IMMUNITY AND BOOSTER DOSES
VACCINATION OF IMMUNOSUPPRESSED PERSONS
PROTECTION AGAINST “RABIES-RELATED” LYSSAVIRUSES
CORRELATES OF IMMUNOPROTECTION
PROPHYLAXIS FAILURES
ADVERSE REACTIONS
INDICATIONS FOR VACCINATION
CONTRAINDICATIONS TO VACCINATION
PUBLIC HEALTH CONSIDERATIONS IN PREVENTION AND CONTROL
THE “NEXT-GENERATION” RABIES VACCINES?
MONOCLONAL ANTIBODIES
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 52 Respiratory Syncytial Virus Vaccines and Monoclonal Antibodies
BACKGROUND
EPIDEMIOLOGY
MECHANISMS OF IMMUNITY AND CORRELATES OF PROTECTION
PASSIVE IMMUNIZATION AGAINST RSV
VACCINE DEVELOPMENT
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 53 Rotavirus Vaccines
CLINICAL DISEASE
VIRUS
PATHOGENESIS
IMMUNITY AND CORRELATES OF PROTECTION
DIAGNOSIS
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
DETECTION OF PORCINE CIRCOVIRUSES IN ROTAVIRUS VACCINES
PUBLIC HEALTH CONSIDERATIONS
RECOMMENDATIONS FOR ROTAVIRUS VACCINE USE IN THE EXPANDED PROGRAM ON IMMUNIZATION
ACKNOWLEDGMENT
KEY REFERENCES
REFERENCES
Chapter 54 Rubella Vaccines
RUBELLA
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
PUBLIC HEALTH CONSIDERATIONS
THE FUTURE
KEY REFERENCES
REFERENCES
Chapter 55 Smallpox and Vaccinia
HISTORY OF DISEASE
BACKGROUND
EPIDEMIOLOGY
SIGNIFICANCE AS A PUBLIC HEALTH PROBLEM
PASSIVE IMMUNIZATION (VACCINIA IMMUNOGLOBULIN)
ACTIVE IMMUNIZATION
CONSTITUENTS OF CURRENT VACCINES
PROCESS OF VACCINE MANUFACTURE
IMMUNOGENICITY OF VACCINE
EFFICACY AND EFFECTIVENESS
EXCRETION OF VACCINE VIRUS, IF ANY
DURATION OF IMMUNITY AND PROTECTION
POSTEXPOSURE PROPHYLAXIS AND THERAPEUTIC VACCINATION
SAFETY (ADVERSE EVENTS)
INDICATIONS FOR VACCINE—WHO AND WHY
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
DESTRUCTION OF THE VIRUS
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 56 Staphylococcus aureus Vaccines
HISTORICAL PERSPECTIVE
CLINICAL MANIFESTATIONS
PATHOGENESIS
ANTIMICROBIAL RESISTANCE AND CONTEMPORARY EPIDEMIOLOGY
THE NEED FOR A STAPHYLOCOCCUS AUREUS VACCINE
CHARACTERISTICS OF S. AUREUS VACCINE ATTEMPTS TO DATE
BARRIERS TO THE DEVELOPMENT OF A SUCCESSFUL STAPHYLOCOCCUS AUREUS VACCINE
PROSPECTS AND PUTATIVE TARGETS FOR A STAPHYLOCOCCUS AUREUS VACCINE
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 57 Streptococcus Group A Vaccines
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
ACTIVE IMMUNIZATION
VACCINE-INDUCED INDIRECT EFFECTS
FUTURE STEPS AND CHALLENGES
KEY REFERENCES
REFERENCES
Chapter 58 Streptococcus Group B Vaccines
HISTORY OF DISEASE
BACKGROUND
EPIDEMIOLOGY
HISTORY OF GBS CONJUGATE VACCINE DEVELOPMENT
CONJUGATE VACCINE DEVELOPMENT
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
ACKNOWLEDGMENTS
REFERENCES
Chapter 59 Tetanus Toxoid
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF VACCINE
EFFICACY AND EFFECTIVENESS
DURATION OF IMMUNITY AND PROTECTION, INCLUDING REINFECTION
POSTEXPOSURE PROPHYLAXIS AND VACCINATION
SAFETY (ADVERSE EVENTS)
INDICATIONS FOR VACCINE - WHO AND WHY
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 60 Tickborne Encephalitis Vaccines
BACKGROUND
EPIDEMIOLOGY
ACTIVE IMMUNIZATION
KEY REFERENCES
REFERENCES
Chapter 61 Tuberculosis Vaccines
TUBERCULOSIS—A BRIEF OVERVIEW
BACTERIOLOGY
PATHOGENESIS
CLINICAL FEATURES
TREATMENT
NEW TUBERCULOSIS VACCINES
ACKNOWLEDGMENT
KEY REFERENCES
REFERENCES
Chapter 62 Typhoid Fever Vaccines
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
IMMUNOGENICITY OF TYPHOID VACCINES
EFFICACY AND EFFECTIVENESS
EXCRETION OF VACCINE STRAIN
DURATION OF IMMUNITY AND PROTECTION
POSTEXPOSURE PROPHYLAXIS AND THERAPEUTIC VACCINATION
SAFETY (ADVERSE EVENTS)
INDICATIONS FOR VACCINE (WHO AND WHY)
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
KEY REFERENCES
REFERENCES
Chapter 63 Varicella Vaccines
INTRODUCTION
BACKGROUND
EPIDEMIOLOGY
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION: THE OKA VACCINE STRAIN
IMMUNOGENICITY OF VARICELLA VACCINE
EFFICACY AND EFFECTIVENESS
EXCRETION/TRANSMISSION OF VACCINE VIRUS
SAFETY, VACCINE ADVERSE EVENTS
INDICATIONS FOR VACCINATION
CONTRAINDICATIONS AND PRECAUTIONS
PUBLIC HEALTH CONSIDERATIONS
FUTURE VACCINES
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 64 Yellow Fever Vaccine
HISTORY OF DISEASE
BACKGROUND OF YFV AND DISEASE
EPIDEMIOLOGY
PASSIVE IMMUNIZATION AND PASSIVE-ACTIVE IMMUNIZATION
ACTIVE IMMUNIZATION
RESULTS OF VACCINATION
EVIDENCE THAT 17D VACCINE PROTECTS AGAINST DISEASE
DURATION OF IMMUNITY
REVACCINATION
CORRELATES OF PROTECTION
PRIMARY VACCINE FAILURE
ADVERSE EVENTS
INDICATIONS, CONTRAINDICATIONS, AND PRECAUTIONS FOR VACCINATION
PUBLIC HEALTH CONSIDERATIONS
FUTURE YF VACCINES AND YF-VECTORED VACCINES
REFERENCES
Chapter 65 Zika Virus Vaccines
INTRODUCTION
HISTORY OF DISEASE AND EPIDEMIOLOGY
VIROLOGY
CLINICAL DISEASE
CELLULAR IMMUNITY
HUMORAL IMMUNITY
VACCINE DEVELOPMENT
CONCLUSIONS
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 66 Zoster Vaccines
INTRODUCTION
PATHOGENESIS
EPIDEMIOLOGY
TREATMENT
PASSIVE IMMUNIZATION
ACTIVE IMMUNIZATION
LIVE-ATTENUATED VZV VACCINE TO PREVENT HERPES ZOSTER
INDICATIONS
CONTRAINDICATIONS
CONCOMITANT ADMINISTRATION
PERSISTENCE OF THE EFFICACY OF THE RECOMBINANT HZ VACCINE
INDICATIONS AND CONTRAINDICATIONS FOR THE RECOMBINANT HZ VACCINE
ADMINISTRATION OF THE RECOMBINANT HZ VACCINE TO PATIENTS WITH IMMUNE COMPROMISE
ISSUES RELEVANT TO BOTH HZ VACCINES
REFERENCES
Section III New Technologies
Chapter 67 Technologies for Making New Vaccines
INTRODUCTION
COVID-19 VACCINES
ACTIVE IMMUNIZATION
ANTIBODY PREPARATIONS
MONOCLONALS TARGETING SARS-COV-2 AND OTHER MERGING INFECTIONS
CONCLUSIONs
ACKNOWLEDGEMENT
KEY REFERENCES
REFERENCES
Chapter 68 Genetic-Based Vaccine Vectors
INTRODUCTION
VIRAL VECTOR SYSTEMS
PRIME-BOOST EMERGENCE
NONVIRAL VECTORS: NUCLEIC ACID VACCINES
SUMMARY/CONCLUSIONS
ACKNOWLEDGMENTS AND FUNDING
KEY REFERENCES
REFERENCES
Chapter 69 Technologies to Improve Immunization
NEW TECHNOLOGIES NEEDED TO REDUCE IMMUNIZATION LOGISTICS HURDLES
POINT-TO-POINT ANTIGEN PACKAGE DELIVERY
NEW TECHNOLOGIES FOR VACCINE STABILIZATION, PACKAGING, STORAGE, SHIPPING, AND ON-SITE PREPARATION: POINTS OF ORIGIN AND DISTRIBUTION POINTS
NEW TECHNOLOGIES FOR VACCINE ADMINISTRATION: VACCINE MACRODELIVERY SYSTEMS AT THE POINTS OF CARE
VACCINE MICRODELIVERY SYSTEMS: ANTIGEN DELIVERY TO DESTINATION-POINT ANTIGEN-PRESENTING CELLS
CONCLUSION
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Section IV Vaccination of Special Groups
Chapter 70 Vaccination of Immunocompromised Hosts
INTRODUCTION
PATIENTS WITH CANCER
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION PATIENTS
SOLID-ORGAN TRANSPLANT RECIPIENTS
PRIMARY IMMUNODEFICIENCY DISEASES
PATIENTS WITH CHRONIC INFLAMMATORY DISORDERS
HOUSEHOLD CONTACTS OF IMMUNOCOMPROMISED PATIENTS
FUTURE DIRECTIONS
KEY REFERENCES
REFERENCES
Chapter 71 Vaccines for International Travel
INTERNATIONAL TRAVEL
GENERAL INFORMATION ABOUT IMMUNIZATIONS FOR INTERNATIONAL TRAVEL
VACCINES FOR TRAVEL
COST-EFFECTIVENESS OF TRAVEL IMMUNIZATIONS
THE FUTURE
KEY REFERENCES
REFERENCES
Chapter 72 Vaccines for Healthcare Personnel
VACCINES RECOMMENDED FOR HEALTHCARE PERSONNEL
PROVIDING VACCINES FOR HEALTHCARE PERSONNEL
IMPROVING VACCINE COVERAGE OF HEALTHCARE PERSONNEL
RECOMMENDATIONS FOR THE USE OF SELECTED VACCINES
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 73 Vaccination of Pregnant Women
WHY MATERNAL VACCINATION?
IMMUNOLOGY OF PREGNANCY
RESPONSE TO VACCINES IN PREGNANCY
PLACENTAL TRANSFER
CLINICAL ISSUES REGARDING VACCINATIONS DURING PREGNANCY
MATERNAL VACCINES IN CLINICAL USE
PRECONCEPTION AND POSTPARTUM VACCINES
MATERNAL VACCINES ON THE HORIZON
RESEARCH CONSIDERATIONS
KEY REFERENCES
REFERENCES
Section V Public Health and Regulatory Issues
Chapter 74 Immunization in the United States
IMMUNIZATION RECOMMENDATIONS
U.S. IMMUNIZATION PROGRAM
ROLES OF THE U.S. IMMUNIZATION PROGRAM
EVIDENCE-BASED STRATEGIES TO IMPROVE COVERAGE
IMPACT OF IMMUNIZATION PROGRAMS
CONCLUSION
KEY REFERENCES
REFERENCES
Chapter 75 Immunization in Europe
POLICY-MAKING PROCESSES IN EUROPEAN COUNTRIES
ORGANIZATIONS WORKING IN IMMUNIZATION IN THE EUROPEAN REGION
EUROPEAN-FUNDED HEALTH RESEARCH IS COORDINATED BY THE DIRECTORATE GENERAL RESEARCH AND INNOVATION (DG RTD)
PROCUREMENT
SURVEILLANCE OF VACCINE-PREVENTABLE DISEASES IN THE EUROPEAN REGION
VACCINES USED AND IMMUNIZATION COVERAGE IN THE EUROPEAN REGION
CHALLENGES TO IMMUNIZATION IN THE EUROPEAN REGION
AVAILABILITY OF VACCINES
VACCINE SAFETY ISSUES
ADOLESCENT AND ADULT IMMUNIZATION PROGRAMS
EUROPEAN REGION STRATEGY FOR STRENGTHENING NATIONAL IMMUNIZATION SYSTEMS
TAILORING IMMUNIZATION PROGRAMS
CONCLUSIONS
KEY REFERENCES
REFERENCES
Chapter 76 Immunization and Vaccine-Preventable Diseases in the Asia-Pacific Region
EVOLUTION OF IMMUNIZATION PROGRAMMES
KEY REFERENCES
REFERENCES
Chapter 77 Immunization in Low- and Middle-Income Countries
IMMUNIZATION AGENDA 2030
PROGRESS WITH ACHIEVING GLOBAL GOALS
OVERCOMING THE CHALLENGES
Looking to the Future
CONCLUSION
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 78 Community Protection
HISTORICAL BACKGROUND
THEORETICAL ARGUMENTS
MASS ACTION APPROACH
CASE REPRODUCTION NUMBERS
ESTIMATION OF R0
IMPLICATIONS OF POPULATION HETEROGENEITY
HETEROGENEITY IN IMMUNE STATUS
THE REAL WORLD
“COVID-19” (SARS-2 Coronavirus)
DIPHTHERIA
HUMAN PAPILLOMAVIRUSES
INFLUENZA
MEASLES
MUMPS
PERTUSSIS
POLIOMYELITIS
ROTAVIRUS
RUBELLA
SMALLPOX
TETANUS
TUBERCULOSIS (AND LEPROSY)
VARICELLA AND ZOSTER (CHICKENPOX AND SHINGLES)
“NON-SPECIFIC EFFECTS”
DISCUSSION
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 79 Economic Analyses of Vaccine Policies
IMPORTANT CONSIDERATIONS IN QUANTITATIVE POLICY ANALYSIS
EXAMPLES OF USES OF QUANTITATIVE POLICY ANALYSIS
OTHER ECONOMIC CONSIDERATIONS
CONCLUSION
REFERENCES
Chapter 80 Regulation and Testing of Vaccines in the US
HISTORICAL PERSPECTIVE
FEDERAL LAWS AND REGULATIONS
FEDERAL REGULATIONS AND FOOD AND DRUG ADMINISTRATION GUIDANCE
COLLABORATIONS BETWEEN THE FOOD AND DRUG ADMINISTRATION AND NATIONAL AND INTERNATIONAL PARTNERS
MANAGED REVIEW PROCESS
MEETINGS WITH SPONSORS
STAGES OF THE REGULATORY REVIEW OF VACCINE PRODUCTS
ADVERSE EVENT MONITORING (POSTLICENSURE FOLLOW-UP)
INNOVATIVE SYSTEMS FOR EVALUATING VACCINE SAFETY POSTMARKETING
SPECIAL CONSIDERATIONS
CONCLUSION
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 81 Regulation of Vaccines in Europe
MARKETING AUTHORIZATION
PRIME, SCIENTIFIC ADVICE AND AUTHORIZATION OF CLINICAL TRIALS
REQUIREMENTS FOR PEDIATRIC MEDICINAL PRODUCTS
MEDICINAL PRODUCTS INTENDED FOR MARKETS OUTSIDE THE EUROPEAN UNION
RISK MANAGEMENT
POST-AUTHORIZATION CHANGES IN THE ANTIGENIC COMPOSITION OF VACCINES
POST-AUTHORIZATION EVALUATION OF BENEFITS AND RISKS
COMMUNICATION OF BENEFITS AND RISKS
THE REGULATORY RESPONSE TO A PUBLIC HEALTH EMERGENCY
CONCLUSION
Disclaimer:
KEY REFERENCES
REFERENCES
Chapter 82 Regulation of Vaccines in Low- and Middle-Income Countries
COVID-19
REGULATION OF VACCINES IN LOW- AND MIDDLE-INCOME COUNTRIES
VACCINES OF ASSURED QUALITY AND FUNCTIONALITY OF NATIONAL REGULATORY AUTHORITIES: GLOBAL STATUS AND TRENDS
WORLD HEALTH ORGANIZATION PREQUALIFICATION PROGRAM FOR VACCINES AND EMERGENCY USE LISTING
INITIATIVES TO STRENGTHEN MEDICINES REGULATORY SYSTEMS IN DEVELOPING COUNTRIES FOR REGULATORY OVERSIGHT OF VACCINES
KEY REFERENCES
REFERENCES
Chapter 83 Vaccine Safety
METHODS OF MONITORING IMMUNIZATION SAFETY
PASSIVE REPORTING SYSTEMS, INCLUDING THE VACCINE ADVERSE EVENT REPORTING SYSTEM
MONITORING SAFETY IN A MASS IMMUNIZATION CAMPAIGN: COVID-19 VACCINES
WEIGHING THE EVIDENCE AND ASSESSING CAUSALITY
SELECTED TOPICS IN VACCINE SAFETY
SAFETY OF THE IMMUNIZATION SCHEDULE AND SIMULTANEOUS VACCINATIONS
SAFETY OF HUMAN PAPILLOMAVIRUS VACCINE
ADMINISTRATION ERRORS AND ADVERSE EVENTS RELATED TO VACCINE ADMINISTRATION
FACTORS THAT CAN INFLUENCE PARENTAL VACCINE ACCEPTANCE
TIMING OF INFORMATION
EVALUATING AND ADDRESSING VACCINE SAFETY CONCERNS: ROLE OF HEALTHCARE PRACTITIONERS AND PUBLIC HEALTH PROFESSIONALS
IMPORTANCE OF COMMUNICATING WITH PARENTS CONCERNED ABOUT VACCINES
FUTURE CONSIDERATIONS
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 84 Vaccine Hesitancy and Behavioral Factors Associated With Vaccine Uptake
HISTORY OF VACCINE HESITANCY
IMPACT OF HESITANCY
THE VACCINE HESITANCY CONTINUUM AND VACCINE COMMUNICATION
MEASURES OF VACCINE HESITANCY
INTERVENTIONS
MISINFORMATION MANAGEMENT
RISK COMMUNICATION
FUTURE BEHAVIORAL RESEARCH TO INCREASE VACCINE ACCEPTANCE
ACKNOWLEDGMENTS
KEY REFERENCES
REFERENCES
Chapter 85 Legal Issues
VACCINE LIABILITY BEFORE 1986
NATIONAL CHILDHOOD VACCINE INJURY ACT
NATIONAL VACCINE INJURY COMPENSATION PROGRAM
VACCINE INJURY COMPENSATION PROGRAM CASES SINCE 1986
MODIFYING THE VACCINE INJURY TABLE
MEDICAL REVIEW OF CLAIMS
ISSUES OF INTEREST
RELATED LIABILITY PROTECTION AND COMPENSATION SCHEMES
VACCINE LIABILITY SINCE 1986
INTERNATIONAL COMPENSATION PROGRAMS
THE POWER TO COMPEL VACCINATION
SUMMARY, CONCLUSIONS, AND FUTURE IMPLICATIONS
ACKNOWLEDGMENTS
REFERENCES
Chapter 86 Ethics
ETHICAL ISSUES PARTICULAR TO VACCINATION
ETHICAL CONSIDERATIONS IN THE VACCINE LIFE CYCLE: AN OVERVIEW
SPECIAL TOPICS IN VACCINE ETHICS
THE FUTURE OF VACCINE ETHICS
KEY REFERENCES
REFERENCES
Chapter 87 Vaccines to Prevent Mpox
INTRODUCTION
EPIDEMIOLOGY
CLINICAL CHARACTERISTICS
VACCINES TO PREVENT DISEASE
RESEARCH GAPS
REFERENCES
Appendix Websites and Applications for Mobile Devices With Information About Immunization
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) WEBSITES
OTHER U.S. GOVERNMENT IMMUNIZATION-RELATED WEBSITES
STATE AGENCIES AND PROGRAMS
INTERNATIONAL IMMUNIZATION-RELATED WEBSITES
PATH
ENGLISH LANGUAGE RESOURCES FROM NON-U.S. ORGANIZATIONS
ORGANIZATIONS WITH IMMUNIZATION-RELATED WEBSITES
ORGANIZATIONS WITH DISEASE-SPECIFIC WEBSITES
Index

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Walter A. Orenstein

Paul A. Offit

Kathryn M. Edwards

Stanley A. Plotkin