Vaccination Programmes Epidemiology, Monitoring,

Evaluation 1st Edition

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First published 2022
by Routledge
2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN
and by Routledge
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Routledge is an imprint of the Taylor & Francis Group, an informa business
© 2022 Susan Hahné, Kaatje Bollaerts and Paddy Farrington
The right of Susan Hahné, Kaatje Bollaerts and Paddy Farrington to be identified as authors
of this work has been asserted by them in accordance with sections 77 and 78 of the
Copyright, Designs and Patents Act 1988.
All rights reserved. No part of this book may be reprinted or reproduced or utilised
in any form or by any electronic, mechanical, or other means, now known or
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storage or retrieval system, without permission in writing from the publishers.
Trademark notice: Product or corporate names may be trademarks or registered trademarks,
and are used only for identification and explanation without intent to infringe.
British Library Cataloguing-​in-​Publication Data
Names: Hahné, Susan, author. | Farrington, Paddy, author. | Bollaerts, Kaatje, author.
Title: Vaccination programmes : epidemiology, monitoring, evaluation/
Susan Hahné, Paddy Farrington, Kaatje Bollaerts.
Description: Milton Park, Abingdon, Oxon; New York, NY: Routledge, 2021. |
Includes bibliographical references and index. |
Identifiers: LCCN 2021008974 (print) | LCCN 2021008975 (ebook) |
ISBN 9781138054844 (hardback) | ISBN 9781138054851 (paperback) |
ISBN 9781315166414 (ebook)
Subjects: LCSH: Vaccination. | Vaccines. | Epidemiology. |
Monitoring. | Evaluation.
Classification: LCC RA638 .H34 2021 (print) |
LCC RA638 (ebook) | DDC 614.4/7–dc23
LC record available at https://lccn.loc.gov/2021008974
LC ebook record available at https://lccn.loc.gov/2021008975
ISBN: 978-​1-​138-​05484-​4 (hbk)
ISBN: 978-​1-​138-​05485-​1 (pbk)
ISBN: 978-​1-​315-​16641-​4 (ebk)
DOI: 10.4324/​9781315166414
Typeset in Times New Roman
by Newgen Publishing UK
Contents

List of acronyms and abbreviations vii

List of boxes xi
Preface xxi
Acknowledgements xxiii

Introduction 1

PART I: Background 3
1 Vaccines 5

2 How vaccines work: immune responses and vaccine failure 18

3 Vaccination programmes: aims and strategies 34

4 Dynamics of vaccine-​preventable infectious diseases 55

5 Impact of mass vaccination programmes 75

6 Vaccination: a societal perspective 97

vi Contents

PART II: Field tools for monitoring vaccination programmes 113

7 Monitoring vaccine coverage and attitudes towards vaccination 115

8 Surveillance of vaccine-​preventable diseases and pathogens 131

9 Serological surveillance 154

10 Assessing and monitoring impact 172

11 Outbreak investigation of vaccine-​preventable diseases 195

PART III: Vaccine effectiveness 221

12 Vaccine effectiveness 223

13 Estimating vaccine effectiveness: general methodological principles 245

14 Estimating vaccine effectiveness: cohort and household

contact studies 264

15 Estimating vaccine effectiveness: case-​control and screening studies 289

16 Waning vaccine effectiveness and modes of vaccine action 309

PART IV: Risks associated with vaccination programmes 337

17 Vaccine safety: an introduction 339

18 Surveillance of adverse events following immunisation 347

19 Estimating vaccination risks: general methodological principles 364

20 Epidemiological study designs for evaluating vaccine safety 383

PART V: Benefit–​risk assessment of vaccination programmes 405

21 Benefit–​risk assessment of vaccination programmes 407

Index 437
Acronyms and
abbreviations

AEFI Adverse event following immunisation

AF Attributable fraction
AFP Acute flaccid paralysis
AIN anal intraepithelial neoplasia
AR Attributable risk
aVDPV Ambiguous vaccine-derived poliovirus
AWD Acute watery diarrhoea
BCG Bacille Calmette-​Guérin
BRAT Benefit risk action team
BRR Benefit risk ratio
BSE Bovine spongiform encephalopathy
CDC Centers for Disease Control and Prevention
CI Confidence interval
CIN Cervical intraepithelial neoplasm
CIR Cumulative incidence ratio
CLL Complementary log-​log link
CNS Central nervous system
COPD Chronic obstructive pulmonary disorder
COVID-​19 Coronavirus disease 2019
CPRD Clinical Practice Research Datalink
CRS Congenital rubella syndrome
cVDPV Circulating vaccine-derived poliovirus
DALY Disability-​adjusted life year
DHS Demographic health survey
DIVA Differentiating infected from vaccinated animals
DTaP Diphtheria, tetanus, acellular pertussis
viii acronyms and abbreviations

EC European Commission
ECDC European Centre for Disease Prevention and Control
EDS Excessive daytime sleepiness
EIA Enzyme-​linked immunosorbent assay
ELISA Enzyme-​linked immunosorbent assay
EMA European Medicines Agency
EPI Expanded Programme on Immunization
EU European Union
FAIR Findable, accessible, interoperable and reusable
FDA Food and Drug Administration
FNI First Nation and Inuit
GACVS Global Advisory Committee on Vaccine Safety
GAVI Global alliance for vaccination and immunisation
GBD Global burden of disease
GBS Guillain-​Barré syndrome
GMP Good manufacturing practice
GMT Geometric mean titre
GP General practitioner
GPEI Global polio eradication initiative
GPS Global positioning system
HAV Hepatitis A virus
HBsAg Hepatitis B surface antigen
HBV Hepatitis B virus
Hib Haemophilus influenzae type b
HIV Human immunodeficiency virus
HMO Health maintenance organisation
HPV Human papillomavirus
HR Hazard ratio
ICD International classification of diseases
IgA/​D/​E/​G/​M Immunoglobulin A/​D/​E/​G/​M
ILI Influenza-​like illness
IMPACT Immunization monitoring programme, active
IPD Invasive pneumococcal disease
IR Incidence rate
IRR Incidence rate ratio
IS Intussusception
ITP Idiopathic thrombocytopenic purpura
iVDPV Immunodeficiency-​associated vaccine derived poliovirus
JRF Joint reporting form
LMIC Low-​and middle-​income country
LQAS Lot quality assurance sampling
MAH Marketing authorisation holder
MCC Meningococcal serogroup C conjugate
MenC Meningococcal serogroup C
MHC Major histocompatibility complex
 acronyms and abbreviations ix

MICS Multiple indicator cluster survey

MIV Monovalent inactivated vaccine
MMR Measles, mumps, rubella
MMRV Measles, mumps, rubella, varicella
MR Measles and rubella
MS Multiple sclerosis
MSM Men who have sex with men
NHB Net health benefit
NID National immunisation day
NITAG National immunisation technical advisory group
NNH Number needed to harm
NNV Number needed to vaccinate
NRA National regulatory authority
NUTS Nomenclature of territorial units for statistics
OR Odds ratio
PAHO Pan American Health Organization
PBMC Peripheral blood mononuclear cell
PCR Polymerase chain reaction
PCVn n-​valent pneumococcal conjugate vaccine
PFU Plaque forming unit
POCT Point of care test
PPV Positive predictive value
PrOACT-​URL Problems, objectives, alternatives, consequences, trade-​offs,
uncertainty, risk attitudes, and linked decisions
PRR Proportional reporting ratio
PT Programme impact on transmission
QALY Quality-​adjusted life year
RBR Risk benefit ratio
RCA Rapid cycle analysis
RDD Regression discontinuity design
RI Relative incidence
RIVM Netherlands Institute for Public Health and the Environment
RNA Ribonucleic acid
RR Relative risk
RSV Respiratory syncytial virus
RT-​PCR Reverse transcriptase polymerase chain reaction
RVGE Rotavirus gastroenteritis
SAGE Strategic advisory group of experts
SAR Secondary attack rate
SARS-​CoV-​2 Severe acute respiratory syndrome coronavirus 2
SBA Serum bactericidal antibody
SCCS Self-​controlled case series
SCRI Self-​controlled risk interval
SIA Supplementary immunisation activity
SIDS Sudden infant death syndrome
x acronyms and abbreviations

SIR Susceptible infected recovered

SmPC Summary of product characteristics
SMS Short message service
SNID Subnational immunisation day
Tdap Tetanus, diphtheria, acellular pertussis
TIV Trivalent influenza vaccine
UI Uncertainty interval
UN United Nations
UNICEF United Nations Children’s Fund
US(A) United States (of America)
USAID United States Agency for International Aid
VAED Vaccine-​associated enhanced disease
VAERS Vaccine Adverse Event Reporting System
VAPP Vaccine-​associated paralytic polio
VDPV Vaccine-derived poliovirus
VE Vaccine effectiveness
VI Vaccine effectiveness against infectiousness
VLP Virus-​like particle
VP Vaccine effectiveness against progression
VP Virus protein
VPDI Vaccine-​preventable disease incidence
VSD Vaccine Safety Datalink
VZV Varicella zoster virus
WHA World Health Assembly
WHO World Health Organization
WPV Wild poliovirus
WPV1/​2/​3 Wild poliovirus type 1/​2/​3
WUENIC WHO/​UNICEF estimate of national immunisation coverage
YLD Years lived with disability
YLL Years of life lost
Boxes

1.1 Variolation, immunisation, vaccination and inoculation 6

1.2 The four types of antigenic components used in currently
licensed vaccines 8
1.3 The four types of vaccine platforms used in currently licensed
vaccines 9
1.4 Vaccine potency 10
1.5 The vaccine ‘cold chain’ 11
1.6 High-titre measles vaccines 12
1.7 Vaccine administration routes with examples 13
1.8 Vaccine trials: phase I, II, III and IV 14
1.9 The development and licensure of Ebola vaccines 15
1.10 Vaccine licensing authorities: examples 16
2.1 The main components of the immune system 19
2.2 Cross-​reactivity 20
2.3 B cell responses to vaccination: T-​dependent and
T-​independent antigens 21
2.4 Maternal antibodies 22
2.5 Maturation of antibodies: affinity, avidity maturation
and isotype switching 23
2.6 Antigen recognition in T cell responses 24
2.7 Long-​lasting protection induced by vaccination 26
2.8 Priming and boosting 27
2.9 Antibody tests: antibody-​binding, avidity and functional assays 29
2.10 Differentiating vaccine-​induced immunity from immunity
induced by natural infection 30
2.11 Vaccine failure types 31
2.12 Laboratory testing to differentiate between primary and
secondary vaccine failure 31
3.1 Variolation and vaccination programmes for military purposes 35
3.2 The smallpox eradication programme 36
xii Boxes

3.3 The programme to eradicate poliomyelitis 37

3.4 Eradication, elimination or containment: definitions 39
3.5 Factors favouring the possibility of elimination and eradication 39
3.6 WHO Regional Office for Europe definitions for the
elimination of measles (WHO, 2014) 40
3.7 Indications for selective vaccination programmes 41
3.8 Maternal vaccination 42
3.9 Role of national or subnational immunisation days in the
eradication of poliomyelitis 43
3.10 Eliminating measles from the Americas: ‘catch-​up, keep-​up,
follow-​up’ 44
3.11 Ring vaccination 45
3.12 Reducing the number of doses in pneumococcal and HPV
vaccination schedules 47
3.13 The WHO Strategic Advisory Group of Experts and the
Vaccine Position Papers 48
3.14 The Global Alliance for Vaccination and Immunisation 49
3.15 Monitoring and evaluation of vaccination programmes:
key areas and tools 49
3.16 Ceasing the RotaShield rotavirus vaccination programme
in the United States 51
4.1 Routes of transmission of infectious diseases 56
4.2 Indirect effect of vaccination 57
4.3 Factors affecting the magnitude of the indirect effect of
vaccination 58
4.4 Epidemic cycles for directly transmitted immunising
infections 59
4.5 Outbreak of measles in healthcare workers 60
4.6 Ranges of values of R0 for selected infections 62
4.7 The basic reproduction number and critical immunisation
threshold 63
4.8 Proportion susceptible in a homogeneously mixing population 66
4.9 R0 and critical immunisation threshold for hepatitis
A in Bulgaria 67
4.10 Effect of heterogeneity of contacts on R0 68
4.11 Contact surveys for close-​contact infections 69
4.12 The SIR and other compartmental models 71
4.13 Impact of childhood vaccination on influenza in the elderly 72
5.1 Pertussis vaccination in England and Wales 76
5.2 Rubella vaccination in China 76
5.3 Protection of unvaccinated children against cholera
by herd immunity 78
5.4 Herd immunity masking vaccine failure of Hib vaccine 78
5.5 Herd immunity and human papillomavirus vaccination 79
 Boxes xiii

5.6 Ranges of values of R0 , vaccine effectiveness and the

critical immunisation and vaccination threshold for selected
infections 80
5.7 A post-​honeymoon outbreak of measles in Muyinga, Burundi 82
5.8 Mumps vaccination in England and Wales 83
5.9 Chickenpox vaccination and shingles 85
5.10 Adult pertussis in the Netherlands 85
5.11 Impact of mass vaccination on the average age at
infection in the United States 87
5.12 Persistence of CRS cases in Greece following mass
rubella vaccination 87
5.13 Impact of vaccination on the dynamics of measles and
whooping cough in Senegal 88
5.14 Pertussis in the Netherlands 90
5.15 Pneumococcal vaccination and serotype replacement 90
5.16 Contrasting socio-​economic impacts of rotavirus vaccination 91
5.17 Hospital admissions due to rotavirus gastroenteritis in
Bangladesh 92
5.18 Reduction in gonorrhoea hospitalisation following introduction
of meningococcal B vaccination in New Zealand 93
5.19 The impact of live-​attenuated influenza vaccine in reducing
amoxicillin prescribing for children 93
6.1 Extension of compulsory vaccination in France in 2018 98
6.2 Opposition to smallpox vaccination in the United Kingdom in
the 19th century 98
6.3 Whole-​cell pertussis vaccine and brain damage 100
6.4 MMR vaccine and autism 101
6.5 The northern Nigerian polio vaccine boycott 102
6.6 Thiomersal and autism 103
6.7 Vaccine hesitancy and the life cycle of vaccination
programmes 105
6.8 Measles vaccination worldwide: one step forward,
two steps back? 106
6.9 Global levels of confidence in vaccines 106
6.10 Vaccine hesitancy in Europe 107
6.11 Is the MMR vaccine safe? 108
6.12 Setting out risks and benefits 109
7.1 Reporting vaccine coverage estimates 116
7.2 Monitoring vaccine coverage: register-​based, survey and
administrative methods 117
7.3 Demographic health surveys and multiple-​indicator cluster
surveys 118
7.4 Vaccine coverage estimates in Greece 119
7.5 The ‘EPI coverage survey’ and subsequent WHO guidance
for vaccine coverage surveys 121
xiv Boxes

7.6 A population-​based vaccine register in Norway 122

7.7 Monitoring vaccine coverage through health insurance
claims data in Germany 123
7.8 WHO/​UNICEF vaccine coverage estimates 125
7.9 Repeated surveys of parental attitudes towards vaccination
in England, 2001–​2015 126
7.10 Analyses of internet reports to assess public concerns about
vaccines 127
7.11 Monitoring of vaccination-​related social media messages in
the Netherlands 128
8.1 Measures of validity of a case definition: sensitivity,
specificity and positive predictive value 133
8.2 Clinical case definitions for measles: positive predictive value
depends on the level of measles control achieved 134
8.3 Use of multiple data sources for the surveillance of rotavirus
in the Netherlands 136
8.4 EuroMOMO: monitoring excess deaths due to respiratory
diseases in Europe 137
8.5 Influenza sentinel surveillance in Australia 139
8.6 ‘GrippeNet’, an example of citizen science-​based
surveillance in France 140
8.7 Descriptive analyses of the incidence of invasive
Haemophilus influenzae type b infection in the
United Kingdom 142
8.8 Surveillance to assess the impact of pneumococcal
vaccination in Kenya 145
8.9 Surveillance for acute flaccid paralysis 148
8.10 The contribution of molecular surveillance to the elimination
of poliomyelitis from India 149
8.11 Wild poliovirus type 2 infection in a laboratory worker after a
spill, the Netherlands, 2017 150
9.1 Hepatitis A seroprevalence in Madagascar 155
9.2 Rubella immunity among women and the burden of
congenital rubella syndrome in Cambodia 156
9.3 Monitoring immunity to polio in Kano state, Nigeria 158
9.4 Meningococcal serogroup C conjugate vaccination in the
United Kingdom 159
9.5 The UK measles and rubella vaccination campaign 160
9.6 Human papillomavirus vaccine coverage in the
United Kingdom 162
9.7 Mechanistic and non-​mechanistic correlates of protection 163
9.8 Serological surveys based on residual sera and random
sampling 165
9.9 Standardisation of hepatitis A assay results 166
9.10 Obtaining seroprevalence and GMTs 168
 Boxes xv

9.11 Analysis of varicella zoster virus seroprevalence data with

mixture models 169
10.1 Individual effects and population impact of mass vaccination
programmes 173
10.2 Impact of cholera vaccination in South Sudan 176
10.3 Impact of vaccinating school-​age children against influenza
in England 177
10.4 Impact of Haemophilus influenzae type b vaccination in the
Gambia 178
10.5 Impact of human papillomavirus vaccination on anogenital
warts in Québec 180
10.6 Obtaining evidence of indirect effects of vaccination 182
10.7 Impact of vaccination on diphtheria and poliomyelitis in the
Netherlands 183
10.8 Impact of rotavirus vaccination in Kenya 185
10.9 Impact of herpes zoster vaccination in the United Kingdom 186
10.10 The RDD for estimating impact at cut-​off 187
10.11 Early impact of HPV vaccination in Ontario, Canada 188
10.12 Measles surveillance post-​elimination in the United States in
the 1990s 190
10.13 WHO measles elimination status in the United Kingdom 192
11.1 A large measles outbreak in Pakistan 197
11.2 Diphtheria outbreaks in newly independent states of the
former Soviet Union in the 1990s 198
11.3 A rubella outbreak due to failure to vaccinate 199
11.4 A poliomyelitis outbreak in Nigeria caused by a boycott
of the vaccine 200
11.5 A measles outbreak in Polynesia due to cold chain problems 201
11.6 A mumps outbreak among vaccinated students in Norway,
2015 to 2016 202
11.7 Post-​honeymoon outbreaks 203
11.8 A measles outbreak in northern Pakistan 205
11.9 The 10 steps of an outbreak investigation 206
11.10 Delays in laboratory diagnosis of cholera hampering
outbreak control 207
11.11 Examples of case definitions used in vaccine-​preventable
disease outbreak investigations 208
11.12 Outbreak of meningococcal serogroup C disease in MSM 209
11.13 Descriptive epidemiology of a meningococcal disease
outbreak investigation 211
11.14 An outbreak investigation assessing risk factors for failure to
vaccinate 212
11.15 Relevant study questions during the meningococcal
W outbreak investigation among Hajj pilgrims 214
xvi Boxes

11.16 A polio outbreak investigation assessing risk factors for dying 215
11.17 Public health campaign during mumps outbreak in Canada 217
12.1 Calculating vaccine effectiveness 225
12.2 Confidence intervals for VE 225
12.3 Influenza vaccine effectiveness in the community and in
households 226
12.4 The potential impact of programmatic errors 227
12.5 The stepped-​wedge design: hepatitis B vaccination in the
Gambia 228
12.6 The Guinea Ebola ring vaccination trial 229
12.7 Efficacy and effectiveness of rotavirus vaccines vary by
population studied 230
12.8 Effectiveness of Hib conjugate vaccination against
colonisation 231
12.9 Effectiveness of influenza vaccines against hospitalisation in
Canada 232
12.10 Effectiveness of pneumococcal polysaccharide vaccines
against bacteraemia 233
12.11 The effectiveness of pertussis vaccination against progression
to severe disease 234
12.12 Influenza vaccine effectiveness against influenza-​like illness in
pilgrims to the Hajj 236
12.13 Using the cholera vaccine as a probe in Bangladesh 236
12.14 Conjugate vaccines and nasopharyngeal carriage of
bacterial infections 237
12.15 Effectiveness against infectiousness: mumps vaccine in the
Netherlands 238
12.16 Impact of mumps vaccination on household transmission in
the Netherlands 240
12.17 Is elimination of mumps achievable? 241
13.1 Pertussis vaccine effectiveness: the influence of case definitions 246
13.2 Measles vaccine effectiveness under routine conditions in
Tanzania 248
13.3 Pertussis vaccine effectiveness and notifications in Wales 249
13.4 Sensitivity, specificity, PPV and bias in vaccine effectiveness 250
13.5 Case definition and ascertainment for the Tanzanian measles
vaccine study 252
13.6 Measles vaccine effectiveness in Pakistan 253
13.7 Confounding bias in vaccine effectiveness studies 254
13.8 Effectiveness of rotavirus vaccination in the United Kingdom 255
13.9 Does vaccination against seasonal influenza reduce all-​cause
mortality? 256
13.10 Effectiveness and bias-​indicator study of oral cholera
vaccination in rural Haiti 257
13.11 Risks and rates 259