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Title page
Contents
FOREWORD 4
EXECUTIVE SUMMARY 7
ACKNOWLEDGEMTNE 8
INTRODUCTION 9
CHAPTER 1. VACCINE ATTRIBUTES 13
1.1. Introduction 14
1.2. Vaccine types 14
1.3. Vaccine matching and criteria for selection of vaccine strains 14
1.4. Vaccine quality 15
1.4.1. Requirements during manufacturing process 15
1.4.2. Requirements for vaccine registration process 16
1.5. Considerations when purchasing vaccine 16
1.5.1. Vaccine purchase through a tender procedure 16
1.5.2. Vaccine supply to the tenderer 17
1.6. Checklist for vaccine selection 17
CHAPTER 2. VACCINE PROGRAMME, DELIVERY, SCHEDULE AND COVERAGE 18
2.1. Introduction 19
2.2. Objectives of a vaccination programme 19
2.3. Vaccine delivery 20
2.3.1. Packaging 20
2.3.2. Cold chain and logistics management 20
2.4. Vaccination schedule 20
2.5. Vaccine coverage 21
2.6. Checklist for implementing vaccination 22
CHAPTER 3. EVALUATION OF THE IMMUNE RESPONSE 24
3.1. Introduction 25
3.2. Use of serological tests for post-vaccination monitoring 27
3.2.1. Antibody responses to structural proteins 27
3.2.2. Correlation between structural protein antibody responses and protection 28
3.2.3. Antibody responses to non-structural proteins 28
3.3. Small-scale trial for the evaluation of vaccine quality 28
3.3.1. Vaccination protocol and blood sampling 29
3.3.2. Antibody testing 29
3.3.3. Interpretation of the results 29
3.4. Evaluation of immune responses in vaccinated animals under field conditions 31
3.5. Post-vaccination monitoring to assess immunity at population level 32
3.5.1. Post-vaccination monitoring to assess population immunity at individual animal level 35
3.5.2. Post-vaccination monitoring to assess population immunity at herd level 36
3.6. Checklist for post-vaccination monitoring of immunity 37
CHAPTER 4. MONITORING THE IMPACT OF VACCINATION AND OTHER CONTROL MEASURES 38
4.1. Introduction 39
4.2. Vaccine efficacy and effectiveness 39
4.3. Investigating outbreaks in vaccinated animals 40
4.4. Effectiveness of a foot and mouth disease control programme 41
4.5. Monitoring 42
4.6. Status at the start of implementation 42
4.7. Expected outcomes 43
REFERENCES 44
ANNEX 1. MONITORING VACCINE COVERAGE 48
ANNEX 2. STATISTICAL METHODS FOR DESIGNING FIELD SURVEYS OF POPULATION IMMUNITY 54
ANNEX 3. STRENGTHENING VETERINARY SERVICES 66
ANNEX 4. VACCINE EFFECTIVENESS 67
Table I. Overview of the components of post-vaccination monitoring by chapter 10
Table II. Overview of post-vaccination monitoring of immunity as discussed in Chapter 3 11
Table III. Effect of antigenic differences on serological test results 27
Table IV. List of variables that can affect the reliability of serological results and possible control measures to consider 27
Table V. Summary of titre values that correlate with protection from Barnett et al. (3) 28
Table VI. Liquid-phase blocking ELISA antibodies titre that correlate with 75% expected percentage protection 28
Table VII. Strategic purpose of a control programme and indicators of success 42
Fig. 1. Considerations and approaches for independent testing of vaccine batches and calibration of serological tests for post-vaccination monitoring 26
Fig. 2. Use of serology to set thresholds for monitoring vaccine induced immunity 30
Fig. 3. Example of a vaccine trial interpretation of likelihood of protection based on the level of antibody elicited 30
Fig. 4. Example population to illustrate non-vaccinated, vaccinated and vaccinated but not immune components 33
Fig. 5. The elements of control of foot and mouth disease 39
Fig. 6. Disease outbreak investigation - Considerations and contributory factors 40
Fig. 7. Disease outbreak investigation Determining the relation between timing of the vaccination campaign and the incubation period of the outbreak 41
Boxes
BOX 1. FMD case (OIE Terrestrial Code, Chapter 8.6.1) 43
BOX 2. FMDV infection (OIE Terrestrial Code, Chapter 8.6.1) 43
BOX 3. FMDV circulation (OIE Terrestrial Code, Chapter 8.6.42) 43
Annex Tables
Table 1. The relationship between rate of transmission in thepopulation and vaccination coverage needed to halt virus spread (f × h = 1 - 1/R0) 48
Table 2. Batches and doses registration book 52
Table 3. Vaccination campaign indicators 53
Table 4. Sample numbers required 56
Table 5. Hypothetical results obtained 61
Table 6. Cluster results using the PPS method 61
Table 7. Cluster results for weighted prevalence 62
Table 8. Weighted values to solve equation 17 63
Table 9. Information collected during a retrospective cohort vaccine effectiveness investigation 68
Annex Figures
Fig. 1. Vaccination card 50
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