investigation of vaccination coverage in children …

INVESTIGATION OF VACCINATION COVERAGE

IN CHILDREN AGED 12–23 MONTHS IN REGION 5

OF TSHWANE, GAUTENG PROVINCE

A mini-dissertation submitted by

DN Montwedi (201200300)

in partial fulfilment of the requirements for the degree of

Master of Pharmacy

in the

School of Pharmacy

at the

Sefako Makgatho Health Sciences University

Supervisor: Prof. JC Meyer

Co-supervisor: Prof. RJ Burnett

2019

DECLARATION

I declare that the mini-dissertation hereby submitted to the Sefako Makgatho Health

Sciences University, for the degree of Master of Pharmacy, in the School of

Pharmacy has not previously been submitted by me for a degree at this or any other

university; that it is my work in design and execution, and that all material contained

herein has been duly acknowledged.

01 May 2019 ____________________ _________________ Montwedi, DN (Mr) Date

DEDICATION

This research is dedicated to everyone who made this study possible and gave me the

courage and determination throughout the study.

Special thanks to my family, especially my lovely wife, Kgomotso, and two beautiful children,

Kgolalgano and Kgalalelo; siblings; niece, Nneilwe and loved ones for their unending love,

encouragement and support. Their constant love has sustained me throughout my life.

To my mother-in-law, MmaKgwele, I know you were looking forward to my graduation day

but it was not to be, May your soul rest in peace.

To my mother, Shila Montwedi and father-in-law, Silas Kgwele, your words of wisdom and

encouragement kept me going.

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TABLE OF CONTENTS

DEDICATION........................................................................................................................ ii

ACKNOWLEDGEMENTS .................................................................................................... iv

DISSEMINATION OF STUDY FINDINGS ............................................................................. v

LIST OF TABLES ................................................................................................................ vi

LIST OF FIGURES ............................................................................................................. vii

LIST OF APPENDICES ..................................................................................................... viii

ABBREVIATIONS AND ACRONYMS ................................................................................. ix

ABSTRACT ......................................................................................................................... xi

INTRODUCTION ............................................................................................. 1

1.1 BACKGROUND TO THE STUDY .......................................................................... 1

1.2 PROBLEM AND RATIONALE FOR THE STUDY .................................................. 2

1.3 RESEARCH QUESTIONS ..................................................................................... 3

1.4 AIM OF THE STUDY ............................................................................................. 4

1.5 OBJECTIVES OF THE STUDY ............................................................................. 4

1.6 IMPORTANCE OF THE STUDY ............................................................................ 4

1.7 OUTLINE OF THE DISSERTATION ...................................................................... 4

LITERATURE REVIEW ................................................................................... 6

2.1 INTRODUCTION ................................................................................................... 6

2.2 IMMUNITY ............................................................................................................. 6

Active immunity .............................................................................................. 6

Passive immunity ........................................................................................... 7

2.3 VACCINES ............................................................................................................ 7

Types of vaccines .......................................................................................... 7

2.4 IMMUNISATION .................................................................................................... 9

2.5 EXPANDED PROGRAMME ON IMMUNISATION ................................................. 9

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2.6 THE SOUTH AFRICAN EXPANDED PROGRAMME ON IMMUNISATION ........... 9

Successes of the South African Expanded Programme on Immunisation .... 11

Diseases targeted by the EPI-SA ................................................................. 12

Road to Health Card (RtHC) ........................................................................ 22

2.7 IMMUNISATION COVERAGE ............................................................................. 22

Importance of immunisation coverage data .................................................. 24

Methods of collecting data on immunisation coverage ................................. 24

Reasons for partial or non-vaccination ......................................................... 27

Interventions to improve immunisation coverage ......................................... 29

2.8 SUMMARY .......................................................................................................... 30

METHODOLOGY .......................................................................................... 31

3.1 INTRODUCTION ................................................................................................. 31

3.2 STUDY DESIGN .................................................................................................. 31

3.3 STUDY SITE ....................................................................................................... 31

3.4 STUDY POPULATION AND SAMPLE ................................................................. 31

Sample selection.......................................................................................... 32

3.5 DATA COLLECTION ........................................................................................... 33

Data collection period .................................................................................. 33

Data collection training ................................................................................. 33

Enrolment and data collection ...................................................................... 33

Data collection process and instruments ...................................................... 34

3.6 DATA ENTRY AND ANALYSIS ........................................................................... 35

3.7 RELIABILITY AND VALIDITY .............................................................................. 35

3.8 ETHICAL CONSIDERATIONS ............................................................................ 36

3.9 SUMMARY .......................................................................................................... 36

RESULTS AND DISCUSSION ...................................................................... 38

4.1 INTRODUCTION ................................................................................................. 38

4.2 LETTER TO THE EDITOR .................................................................................. 38

4.3 MANUSCRIPT FOR PUBLICATION .................................................................... 40

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LIMITATIONS, RECOMMENDATIONS AND CONCLUSIONS ...................... 57

5.1 INTRODUCTION ................................................................................................. 57

5.2 LIMITATIONS OF THE STUDY ........................................................................... 57

The number of households in Region 5 ........................................................ 57

Access to households .................................................................................. 57

Households with no-one at home ................................................................. 57

Caregivers not having the child’s RtHC with them ........................................ 58

Refusal to participate in the study ................................................................ 58

Verification of information ............................................................................. 58

5.3 RECOMMENDATIONS ....................................................................................... 58

5.4 CONCLUSIONS .................................................................................................. 59

REFERENCES ................................................................................................................... 61

APPENDICES..................................................................................................................... 75

iv

ACKNOWLEDGEMENTS

I would like to express my gratitude to the following people who helped me throughout the

course of the study. I am sincerely grateful to them for the assistance and guidance they

offered. This study would not have been possible without their help.

Prof JC Meyer, my supervisor, for her inspiration, guidance, motivation, knowledge and

patience during this research project. She taught me a lot and I genuinely appreciate her

and her efforts. She pulled me through even when I had given up.

Prof RJ Burnett, my co-supervisor, for her expert advice, knowledge and assistance in

this project, including the statistical analysis of the data. She also provided the finances

for this project through one of her grants.

The participants for their willingness to participate in this study. The study would not

have been possible without them.

The Community Members who were willing to go out of their way in order to ensure the

success of the data collection.

Data collectors, Ms S Mahori and Ms RN Montwedi for their huge efforts.

Ms T Ndhlovu and Mr M Sibanda for assisting with the data collection training.

Ms VV Nkwinika for being the data collection team leader, and for reviewing and

validating the captured data.

National Research Foundation for funding this project.

School of Pharmacy at Sefako Makgatho Health Sciences University for the opportunity

to do my Master’s degree and for logistical support.

South African Vaccination and Immunisation Centre for their support.

My friends and family for their love, support and encouragement.

v

DISSEMINATION OF STUDY FINDINGS

A. NATIONAL CONFERENCES

Montwedi DN, Meyer JC, Nkwinika VV, Burnett R. Investigation of vaccination coverage in

children aged 12–23 months in Tshwane Region 5 of the Gauteng Province, South Africa.

Public Health Association of South Africa (PHASA) Conference, Khaya iBhubesi, Parys, 10-

12 September 2018. Podium presentation.

Montwedi DN, Meyer JC, Nkwinika VV, Burnett R. Modifiable health facility factors result in

sub-optimal vaccination coverage of 12-23 month old children in Tshwane Region 5 of the

Gauteng Province South African Association of Hospital and Institutional Pharmacists 33rd

Annual Conference, Champagne Sports Resort, Drakensberg, 7-9 March 2019. Podium

presentation.

B. INTERNATIONAL CONFERENCES

Montwedi DN, Meyer JC, Nkwinika VV, Burnett R. Investigation of vaccination coverage in

children aged 12–23 months in Tshwane Region 5 of the Gauteng Province, South Africa.

Fourth Training Workshop and Symposium MURIA Group in conjunction with ISPE,

University of Namibia, Windhoek, 18 – 21 June 2018. Podium presentation.

Montwedi DN, Meyer JC, Nkwinika VV, Burnett RJ. Very little evidence of vaccine hesitancy

in Tshwane Region 5 of Gauteng Province, South Africa. 12th Vaccine Congress. Novotel

Budapest City & Budapest Congress Center, Budapest, Hungary. 16-19 Sept 2018. Poster

presentation.

vi

LIST OF TABLES

Table 1.1: WHO estimates of 2016 global and South African vaccine coverage .......... 1

Table 2.1: National Department of Health EPI revised schedule, as from 2015 ......... 10

Table 3.1: Distribution of 30 clusters in Region 5 of Tshwane .................................... 32

Manuscript:

Table 1: Distribution of sample within 30 clusters in Tshwane Region 5 ................. 46

Table 2: Frequency distribution of vaccines received and missed (n=276) .............. 47

Table 3: The coverage of individual vaccines .......................................................... 48

Table 4: Subsequent dose recorded in the absence of a prior dose ........................ 48

Table 5: Frequencies of vaccination combinations and drop-out rates .................... 49

vii

LIST OF FIGURES

Figure 1.1: Outline of the dissertation ........................................................................... 5

viii

LIST OF APPENDICES

Appendix 1A: Participant questionnaire ........................................................................... 75

Appendix 1B: Participant questionnaire for partially- or non-immunised children ............. 76

Appendix 2: SMUREC clearance certificate .................................................................. 78

Appendix 3: City of Tshwane clearance certificate ........................................................ 79

Appendix 4: SAMJ Author Guidelines ........................................................................... 80

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ABBREVIATIONS AND ACRONYMS

aP Acellular pertussis vaccine

AVL Anti-vaccination lobbying

BCG Bacillus Calmette-Guérin

DHB District Health Barometer

DTaP Diphtheria, tetanus, acellular pertussis vaccine

DTaP-IPV/Hib Diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b vaccine

DTaP-IPV-Hib-HepB Diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b vaccine and hepatitis B vaccine

DTP Diphtheria, tetanus, pertussis vaccine

DTwP Diphtheria, tetanus, whole-cell pertussis vaccine

EPI Expanded Programme on Immunisation

EPI-SA Expanded Programme on Immunisation of South Africa

FIC Fully immunised under one year-old coverage

GAPPD Global Action Plan for Pneumonia and Diarrhoea

GIVS Global Immunization Vision and Strategy

GPEI Global Polio Eradication Initiative

GPS Global positioning system

GVAP Global Vaccine Action Plan

HBV Hepatitis B virus

HepB Hepatitis B vaccine

Hib Haemophilus influenzae type b

IMCI Integrated Management of Childhood Illness

IPV Inactivated poliovirus vaccine

MCV Measles-containing vaccine

MDGs Millennium Development Goals

MICS Multiple Indicators Cluster Survey

MNT Maternal and neonatal tetanus

MPH Master of Public Health

NDoH National Department of Health

x

NICD National Institute for Communicable Diseases

NHLS National Health Laboratory Service

NNT Neonatal tetanus

OPV Oral poliovirus vaccine

PCV Pneumococcal conjugate vaccine

RtHB Road to Health Booklet

RtHC Road to Health Card

RV Rotavirus vaccine

SAVIC South African Vaccination and Immunisation Centre

SDGs Sustainable Development Goals

SMUREC Sefako Makgatho Health Sciences University Research Ethics

Committee

TB Tuberculosis

Td Tetanus toxoid and reduced strength diphtheria toxoid vaccine

TT Tetanus toxoid vaccine

UNDP United Nations Development Programme

UNICEF United Nations International Children’s Emergency Fund

VAPP Vaccine-associated paralytic polio

VDPV Vaccine-derived poliovirus

VPD Vaccine preventable disease

WHA World Health Assembly

WHO World Health Organization

WUENIC WHO and UNICEF Estimates of National Immunization Coverage

xi

ABSTRACT

Introduction: Childhood immunisation remains one of the most cost-effective public health

interventions for the prevention, control, elimination and eradication of vaccine-preventable

diseases (VPDs). Despite providing free universal infant immunisation against 10 VPDs, in

South Africa there are still sporadic outbreaks of VPDs and areas with low immunisation

coverage.

Objectives: This study determined (i) the under one year-old immunisation status according

to the Expanded Programme on Immunisation of South Africa (EPI-SA) schedule, and (ii) the

reasons for not being fully vaccinated, in children aged 12–23 months in Region 5 of

Tshwane, Gauteng Province.

Method: A household survey was conducted based on the World Health Organization’s

(WHO) Vaccination Coverage Cluster Surveys reference manual. Consenting caregivers of

children aged 12-23 months with available Road to Health Cards (RtHCs), were surveyed.

RtHCs were checked for missing vaccinations, and reasons given by caregivers for missed

vaccinations were recorded digitally and in writing. Cellular phone photographs of RtHCs

were emailed to the supervisor. Data captured using Microsoft Excel 2013 (Microsoft Office,

USA) were imported to Epi InfoTM 7 (Centers for Disease Control and Prevention, USA) for

descriptive statistical analysis. Ethical clearance was obtained from the Sefako Makgatho

University Research Ethics Committee and the City of Tshwane granted permission to

conduct the study.

Results: Of the 8 060 houses visited, 327 had eligible children. Of these, 84.4% (276/327)

caregivers consented and were surveyed. Immunisation coverage for individual vaccines

ranged from 99.64% (275/276) for the oral poliovirus vaccine birth dose, to 87.3% (241/276)

for the pneumococcal conjugate vaccine third dose. Fully immunised under one year-old

coverage (FIC) was 78.3% (216/276), with all other children being partially vaccinated. A

total of 123 vaccinations were missed by 59 children; reasons for 121 of the missed

vaccinations were provided. The most common reasons were lack of awareness (22.3%

[27/121]); the caregiver being too busy (19.0% [23/121]); vaccines not available at clinics

(15.7% [19/121]); and time of immunisation being inconvenient (13.2% [16/121]). One (1.7%

[1/59]) caregiver had lost faith in vaccinations. Many houses/housing complexes were

enclosed by security fencing, with access being denied by guard dogs, residents or security

guards.

xii

Conclusion: The 78.3% FIC is below the international target of 90% set by the WHO. The

majority of reasons for missed vaccinations are due to modifiable healthcare facility

obstacles. While a low prevalence of vaccine hesitancy was found, the results are biased

towards caregivers who do not live in security complexes or gated communities.

Recommendations: The FIC can be improved through (a) providing programmes aimed at

empowering vaccinators with more information about immunisation and vaccines including

ensuring availability of vaccines and making caregivers aware of missed doses and the need

to return for another dose; and (b) extending clinic hours to include early evenings and

weekends. Online surveys are recommended to reach caregivers in gated communities, who

may be more affluent and educated, with higher rates of vaccine hesitancy.

Chapter 1: Introduction

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INTRODUCTION

This chapter describes the background and rationale for the study. The research question

is provided, followed by the aim and objectives for the study. The chapter ends with the

significance or importance of the study and a short overview of the outline of the

dissertation.

1.1 BACKGROUND TO THE STUDY

In 2000, the Millennium Summit of the United Nations adopted eight international

development goals known as the Millennium Development Goals (MDGs) aimed at

improving the lives of poor people worldwide by improving health and healthcare (United

Nations Development Programme [UNDP], 2000). One of those goals (MDG4) was aimed

specifically at reducing child mortality (World Health Organization [WHO], 2015a).

To ensure that the MDG4 was met, the WHO and United Nations International Children's

Emergency Fund (UNICEF) developed the Global Immunization Vision and Strategy

(GIVS) in 2005, followed by the Global Vaccine Action Plan (GVAP) in 2012. The main

focus of GIVS (WHO, 2006a) and GVAP (WHO, 2013a;) was to increase immunisation

coverage, reduce child morbidity and mortality, strengthen and sustain all national

immunisation plans, develop new vaccines and sustain the provision of effective and

quality immunisations to all.

In 2015, the Sustainable Development Goals (SDGs) were developed in order to build

upon the successes of the MDGs, help achieve the goals which were not met and address

new challenges (UNDP, 2015). The third SDG was to ensure healthy lives and promote

the well-being for all. One of its objectives was to increase access to quality essential

healthcare services and access to safe, effective, quality and affordable essential

medicines and vaccines for all (UNDP, 2015).

Immunisation remains one of the most powerful and cost-effective public health

interventions to prevent and control childhood vaccine-preventable diseases (VPDs)

(Wiysonge, Ngcobo, Jeena, Madhi, Schoub, Hawkridge, Shey, Hussey, 2012; Maurice,

Bates, Bilous, Brenzel, Greco, Lydon, Matthews, 2009). However, it is important to note

that vaccines remain effective only when all the required doses are received (Cohen,

White, Savage, Glynn, Choi, Andrews, Brown, Ramsay, 2007). VPD outbreaks occur in


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places with low vaccine coverage, e.g. mumps outbreak in the Netherlands (Karagiannis,

van Lier, van Binnendijk, Ruijs, Ruijs, Fanoy, Conyn-Van Spaendonck, de Melker, Hahné,

2008); polio outbreaks in the Congo (Patel, Konde, Didi-Ngossaki, Ndinga, Yogolelo,

Salla, Shaba, Everts, Armstrong, Daniels, Burns, Wassilak, Pallansch, Kretsinger, 2012),

Syria (Aylward & Alwan, 2014), Tajikistan (Macdonald & Hebert, 2010), and Namibia

(WHO, 2006b); diphtheria outbreaks in South Africa in 2015, 2016 (National Institute for

Communicable Diseases [NICD], 2016) and 2017 (NICD, 2017a).

The WHO aims to attain at least 90% fully immunised under one year-old coverage (FIC)

nationally and 80% FIC per district or equivalent administrative unit by 2020 (WHO,

2013a). In South Africa, FIC currently includes a birth dose of Bacille Calmette-Guérin

(BCG) vaccine against disseminated tuberculosis (TB); 2 doses of oral poliovirus vaccine

(OPV) at 0 and 6 weeks; 3 doses of a hexavalent vaccine against diphtheria, tetanus,

pertussis (acellular pertussis vaccine [aP]), polio (inactivated poliovirus vaccine [IPV]),

Haemophilus influenzae type b (Hib) and hepatitis B (hepatitis B vaccine [HepB]) (DTaP-

IPV-Hib-HepB) at 6, 10 and 14 weeks; 2 doses of rotavirus vaccine (RV) at 6 and 14

weeks; 3 doses of pneumococcal conjugate vaccine (PCV) at 6, 14 weeks and a booster

dose at 9 months; and 1 dose of measles-containing vaccine (MCV) at 6 months (Aung &

Dlamini, 2017). High FIC will help with elimination of measles and polio, control of VPDs

and reduction of child mortality and morbidity.

Globally, pneumonia and diarrhoea are among the leading causes of child mortality,

accounting for 29% of all child deaths. These deaths can be averted by immunisation

against pertussis, measles, Hib disease, pneumococcal disease and rotavirus diarrhoea

(WHO, 2013b). According to WHO estimates in 2016, global and South African vaccine

coverage did not reach the 90% target for any of the vaccines used to measure FIC (see

Table 1.1). This shows that there is a need to intensify immunisation programmes and/or

performance of supplemental immunisation activities especially in South Africa (WHO,

2018a; WHO, 2018b).


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Table 1.1: WHO estimates of 2016 global and South African vaccine coverage

Vaccine Global coverage

South Africa coverage

Diphtheria, tetanus, pertussis third dose (DTP3) 86% 66%

Hib third dose (Hib3) 70% 66%

MCV first dose (MCV1) 85% 75%

PCV third dose (PCV3) 42% 69%

RV second dose (RV2) 25% 73%

HepB third dose (HepB3) 84% 66%

Polio vaccine third dose 3 85% 66%

BCG 88% 74%

Source: WHO, 2018a; WHO, 2018b

Measles immunisation coverage was used as a tool to monitor the progress towards

achieving MDG4 (Bamford, 2015). It was estimated that measles deaths reduced globally

from 535 000 in 2000 to 89 780 by 2016 (WHO, 2018c), which further stresses the

importance of immunisation. Despite an average of 80% immunisation coverage rates in

South Africa in the last decade (Massyn, Day, Barron, Haynes , English, Padarath, 2013),

there have been reports of sporadic measles outbreaks with a major outbreak occurring

from 2009 – 2011 with 18 431 cases (Shibeshi, Masresha, Smit, Biellik, Nicholson,

Muitherero, Shivute, Walker, Reggis, Goodson, 2014; Ntshoe, McAnerney, Archer, Smit,

Harris, Templa, Mashele, Singh, Thomas, Cengimbo, Blumberg, Puren, Moyes, van den

Heever, Schoub, Cohen, 2013; Sartorius, Cohen, Chirwa, Ntshoe, Puren, Hofman, 2013;

Burnett, Larson, Moloi, Tshatsinde, Meheus, Paterson, François, 2012; le Roux, le Roux,

Nuttall, Eley, 2012; Verguet, Jassat, Hedberg, Tollman, Jamison, Hofman, 2012; Schoub,

2011; Albertyn, Van Der Plas, Hardie, Candy, Tomoka, LeePan, Heckmann, 2011). The

most recent measles outbreak started in 2017, and by 24 November 2017 there were 203

cases of measles reported in South Africa with 95 of those cases occurring in the Gauteng

Province (NICD, 2017b).

In South Africa, with the adoption of the MDGs, GIVS, GVAP and later the SDGs by the

National Department of Health (NDoH), the aim of the Expanded Programme on

Immunisation of South Africa (EPI-SA) was to increase FIC to at least 90% nationally and


2

80% in all districts by 2010, and then to further increase it to 95% by 2013 (NDoH, 2010).

The target of EPI-SA is 92% FIC nationally by 2017 (Aung & Dlamini, 2017).

According to official administrative immunisation coverage figures, the national FIC was

82.3% during 2016/17. However, this estimate might have been incorrect due to an under-

estimation of the target population (Aung & Dlamini, 2017). The data quality of

immunisation coverage estimates reported annually by EPI-SA has been questioned by

WHO and UNICEF, which jointly consolidate and review data and information to produce

their own WHO and UNICEF Estimates of National Immunization Coverage (WUENIC).

For many years, coverage rates reported by EPI-SA have been much higher than

WUENIC (WHO, 2017b). However, the FIC estimate of 53% reported by the South

African Demographic and Health Survey (SADHS) conducted in 2016 (NDoH, Statistics

South Africa, South African Medical Research Council, ICF, 2017), was closer to the 2016

WUENIC figures. The SADHS collected data on child, maternal, adult and reproductive

health; nutrition; domestic violence; and behavioural health determinants (NDoH et al.,

2017).

A number of reasons or explanations for low immunisation coverage in South Africa have

been suggested. They included anti-vaccination rumours; insufficient knowledge on

vaccines and immunisation; insufficient financial and human resources (Wiysonge et al.,,

2012), poor ordering practices and/or other supply chain shortcomings (Burnett, Mmoledi,

Ngcobo, Dochez, Seheri, Mphahlele, 2018; le Roux, Akin-Olugbade, Katzen, Laurenzi,

Mercer, Tomlinson, Rotheram-Borus, 2017; Ngcobo & Kamupira, 2017; NICD, 2014;

Botha, 2013).

1.2 PROBLEM AND RATIONALE FOR THE STUDY

Many organisations including the WHO, UNICEF and United Nations all emphasise the

importance of vaccination to prevent disease, hence it should be easily and freely

accessible to everyone who is eligible to receive it (UNDP, 2015; WHO, 2012; WHO,

2006a; UNDP, 2000). Despite evidence on the importance of immunisation, there have

been reports of sub-optimal immunisation coverage in some areas of South Africa

(Burnett et al., 2018; Aung & Dlamini, 2017; Ramraj & Chirinda, 2016; Motloung, 2016;

Comley, Nkwanyana, Coutsoudis, 2015; Bamford, 2015; Ndlovu, 2014; Fadnes, Jackson,

Engebretsen, Zembe, Sanders, Sommerfelt, Tylleskär, 2011; Sehume, 2011; Wright,

Maja, Furaha, 2011; Corrigall et al., 2008; Fonn, Sartorius, Levin, Likibi, 2003).

Furthermore, discrepancies between EPI-SA immunisation coverage data and WUENIC


3

estimates, suggest sub-optimal data quality (WHO, 2017). The 2016/17 District Health

Barometer (DHB) reported 82.3% FIC, which was lower than the national target of 92%.

The Gauteng Province reported coverage exceeding 100% (101.9%) with 107.7%

coverage for the Tshwane district specifically, suggesting poor data quality (Aung &

Dlamini, 2017).

From the above it was evident that there is a need to obtain more accurate data on

immunisation coverage, using methods with high validity such as a household survey,

using the WHO’s Immunization coverage cluster survey-Reference manual (WHO

protocol). The household survey also provides the opportunity to reach unvaccinated

children, eligible for childhood immunisation. Furthermore, reasons for partial or non-

vaccination can be determined using the WHO protocol (WHO, 2015a).

Based on the above, the need for a household survey to be conducted in Region 5 of

Tshwane, Gauteng Province was identified. The region includes one of the poorly

performing areas (Metsweding district) in terms of immunisation coverage before it was

incorporated into Tshwane district in 2011 (Bamford, 2015; Gerritsen, 2014). The

Metsweding district was divided into Kugwini and Nokeng Tsa Taemane municipalities

prior to its incorporation into Tshwane district in 2011. Region 5 now forms the bulk of the

then, Nokeng Tsa Taemane municipality (City of Tshwane [CoT], 2015). It was envisaged

that the results obtained from a household immunisation coverage survey will provide

insight into the immunisation coverage and reasons for non-vaccination, of children

between the ages of 12-23 months from Region 5 of Tshwane, Gauteng Province. These

results can also be used to validate official administrative immunisation coverage data

collected at healthcare facilities in Region 5.

1.3 RESEARCH QUESTIONS

Two research questions were formulated for the purpose of this study:

What is the FIC and immunisation coverage of individual vaccines administered to

under one year-olds according to the EPI-SA schedule, amongst children aged 12–23

months in Region 5 of Tshwane, Gauteng Province?

What are the reasons for children aged 12–23 months in Region 5 of Tshwane,

Gauteng Province not being fully vaccinated?


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1.4 AIM OF THE STUDY

The aim of the study was to investigate immunisation coverage of vaccines administered

to under one year-olds according to the EPI-SA schedule, in children aged 12–23 months

in Region 5 of Tshwane, Gauteng Province.

1.5 OBJECTIVES OF THE STUDY

The objectives of the study were as follows:

To determine the proportions of children aged 12–23 months in Region 5 of Tshwane,

Gauteng Province who are i) fully vaccinated with the vaccines scheduled for under

one year-olds according to the EPI-SA schedule, or ii) partially immunised or iii) not

vaccinated

To investigate the reasons for children aged 12–23 months in Region 5 of Tshwane,

Gauteng Province not being fully vaccinated with the vaccines scheduled for under

one year-olds as per EPI-SA schedule.

1.6 IMPORTANCE OF THE STUDY

The results of this survey can be used to validate immunisation administrative data

collected at healthcare facilities in Region 5 of Tshwane. The results of the study

combined with other community-level surveys throughout South Africa can help

strengthen the WHO/UNICEF call for a large national survey.

Some of the reasons for non-vaccination can help EPI-SA to implement innovative

strategies to improve service delivery, thereby reducing or preventing morbidity and

mortality from vaccine preventable diseases.

1.7 OUTLINE OF THE DISSERTATION

This dissertation consists of five chapters as illustrated in Figure 1.1. Chapter 1 serves as

an introduction to the dissertation, which includes the background and rationale, research

question, and the aim and objectives of the study. It also includes an overview of the

importance of the study. The focus of Chapter 2 is on the literature review relating to the

study. Chapter 3 discusses the detailed methodology used in this study. This includes the

study design, study site, study population and the sample selection. It further elaborates

on the period in which the study was conducted and the process that was followed when


5

data were collected, how the data were analysed, the reliability and validity of the study

and all the ethical principles that were taken into consideration during the study. Chapter 4

presents the manuscript that will be submitted for publication, containing the results of the

study followed by the discussion of the results. Finally, Chapter 5 concludes the

dissertation with the limitations of the study, recommendations and a conclusion.

Figure 1.1: Outline of the dissertation

Chapter 1• Introduction

Chapter 2• Literature Review

Chapter 3• Methodology

Chapter 4 • Journal manuscript

Chapter 5• Limitations, Recommendations and Conclusion

Chapter 2: Literature Review

6

LITERATURE REVIEW

2.1 INTRODUCTION

Chapter 2 provides a review of relevant literature obtained from different studies relating

to this specific study. Section 2.2 starts off with a short description of immunity, while

Section 2.3 discusses the different vaccines. This is followed by a discussion of

immunisation and the Expanded Programme on Immunisation (EPI) in Sections 2.4 and

2.5. Section 2.6 covers a detailed description of the South African Expanded Programme

on Immunisation (EPI-SA). The chapter is concluded with Section 2.7 on immunisation

coverage, including the importance of immunisation coverage data, methods of collecting

data, reasons for non-vaccination and interventions to improve immunisation coverage.

2.2 IMMUNITY

Immunity is when the body is able to protect itself from infections, disease, or other

unwanted biological invasion. The body elicits an immune response when it is first

exposed to an antigen through natural infection by a pathogen, or vaccination. After this

first exposure, the body can respond in several ways, of which one is being primed to

mount a neutralising immune response with subsequent exposure to the same antigen

either through vaccination or natural infection. Immunity is either specific (adaptive or

acquired) or non-specific (innate). With specific immunity, the response is antigen-specific

and dependent; and immunologic memory is developed for subsequent exposure whereas

the non-specific memory is neither antigen-specific nor dependent, and there is no

immunologic memory towards subsequent exposure. Specific immunity can either be

active or passive (WHO, 2013c).

Active immunity

Active immunity refers to the process whereby the body is exposed to an antigen and it

generates adaptive immune response such as developing antibodies against that antigen.

The subsequent immune response may be long lasting - even lifelong (WHO, 2013c).

Natural specific immunity occurs when exposure to an antigen through natural infection

triggers the immune system to produce antibodies and mount an immune response

against that antigen. After recovery, one becomes immune to subsequent exposure as

seen with a person who was previously diagnosed with measles.


7

In a similar manner, artificial specific immunity occurs with the administration of all the

required doses of a vaccine; for example three doses of HepB, generates a specific active

immune response leading to long-lasting protection against hepatitis B (Hamborsky,

Kroger, Wolfe, 2015).

Passive immunity

Passive immunity is acquired when antibodies are transferred to an individual for

protection against infection. Passive immunity gives an immediate short-lived protection,

and can occur naturally or artificially. An example of natural passive immunity is the

transfer of maternal antibodies across the placenta to provide immunity for the foetus. For

example, if the mother received tetanus toxoid vaccine (TT) during pregnancy, the

maternal antibodies would be transferred to the foetus and the new-born will be immune

for several weeks until receiving the first dose of the hexavalent vaccine, which contains

TT.

In contrast, artificial passive immunity refers to the process of obtaining serum from

immune individuals, as seen with human immune globulin (Ig) that is produced by

combining the IgG antibody fraction from donors to produce immunity against diseases

such as hepatitis A and measles, which will then be administered to a person who has

been exposed to a pathogen and is in need of post-exposure prophylaxis (PEP)

(Hamborsky et al., 2015).

2.3 VACCINES

Immunity can be induced in children through administration of vaccines. Vaccines are

preparations of live attenuated, inactivated or killed organisms that are administered to

induce immunity against a particular VPD. Just like an infection, their introduction into the

body stimulates formation of specific antibodies, enabling the body to develop the ability to

mount a neutralising immune response with subsequent exposure to that specific antigen

(Hamborsky et al., 2015; NDoH, 2015; WHO, 2013c).

Types of vaccines

Live attenuated vaccines

Live attenuated vaccines contain a weakened version of the pathogenic microbe so that it

cannot cause disease. They elicit a strong immune response and mostly provide lifelong

immunity with only one or two doses, because they have similar antigens and can also


8

replicate in a similar manner as natural infections thus resulting in a prolonged exposure

of the recipient as compared to inactivated vaccines. Examples include vaccines against

measles, mumps, polio and rubella (National Institute of Allergy and Infectious Diseases

[NIAID], 2008).

Inactivated vaccines

Inactivated vaccines are produced by inactivating the disease-causing microbe. They are

composed of either whole or fractions of micro-organisms e.g. toxoids, subunits;

recombinant or conjugate vaccines (Hamborsky et al., 2015). These vaccines are more

stable and safer than live vaccines because the inactivated microbes can’t mutate back to

their disease-causing state. However, they stimulate a weaker immune system response

as compared to live vaccines. Thus several additional booster doses will be required to

maintain a person’s immunity. Examples include vaccines against diphtheria, tetanus, and

pertussis (Hamborsky et al., 2015; NDoH, 2015).

i) Subunit vaccines

Subunit vaccines contain specific purified antigens that can elicit a neutralising immune

response. They mostly produce less adverse reactions because the antigens that cause

the adverse reactions are not included in the vaccine. Examples include acellular

pertussis vaccine (Hamborsky et al., 2015).

ii) Toxoid vaccines

Toxoid vaccines are produced from bacteria that secrete toxins, or harmful chemicals. The

actual toxins are treated and inactivated so that they cannot cause disease. The

antibodies are then produced upon administration of a toxoid vaccine. Vaccines against

diphtheria and tetanus are examples of toxoid vaccines (WHO, 2013c).

iii) Conjugate vaccines

Polysaccharide encapsulated bacteria elicit poor immune responses because the

underlying cell surface structures are masked, hence they are poorly recognised as an

antigen/pathogen. This poor recognition by the immune system is especially problematic

in children below 18 months of age. Conjugate vaccines enhance the immunogenicity of

polysaccharide antigens by binding them to a strongly immunogenic protein antigen

(Corbett & Roberts, 2009; Goldblatt, 2000). These proteins can be antigens or toxoids

used in other vaccines that are recognised by immature immune systems. Examples


9

include the vaccines that protect against Hib, which are conjugated with diphtheria or

tetanus toxoids (Hamborsky et al., 2015).

2.4 IMMUNISATION

Immunisation occurs when a person becomes immune or resistant to an infectious

disease through infection or vaccination. However, it must be noted that vaccination does

not always result in immunisation even although the two terms are used interchangeably.

Vaccination is a process whereby vaccines are administered to an individual with the aim

of stimulating the immune system to produce neutralising antibodies, whereas

immunisation is when the immune system actually produces antibodies against a specific

antigen, and is able to mount a neutralising immune response against subsequent

exposures. Immunisation through vaccination prevents illness, disability and death from

VPDs such as diphtheria, measles and polio (WHO, 2018a).

2.5 EXPANDED PROGRAMME ON IMMUNISATION

It is estimated that more than 60 million deaths due to smallpox occurred during the 17th

century (Baker, 2010). To stop the scourge, Edward Jenner developed a vaccine against

smallpox in 1796. In 1967, WHO embarked on a global campaign to eradicate smallpox

with the use of the smallpox vaccine, and achieved this in 1979. Progress made in the

eradication of smallpox, led to the establishment of the EPI by WHO at the World Health

Assembly in 1974, with the aim of vaccinating all children below the age of one year

against six killer diseases, namely polio, diphtheria, tuberculosis, pertussis (whooping

cough), measles and tetanus. Prior to 1974, only 5% of children from developed countries

were being vaccinated. By 1990, WHO reported that about 80% of children below the age

of 1 year were vaccinated, thus leading to the prevention of at least 3 million deaths per

year due to VPDs (Baker, 2010).

To build on the successes of EPI, the WHO has set targets for the eradication of

poliomyelitis and measles, and the significant reduction of incident cases of other VPDs

and infectious diseases through immunisation programmes (Baker, 2010; WHO, 2013a).

2.6 THE SOUTH AFRICAN EXPANDED PROGRAMME ON IMMUNISATION

Since the inception of the EPI, the WHO has provided guidelines and recommendations to

health authorities of their member states on how to design, develop and manage


10

immunisation services in their respective countries. This led to the inception of EPI-SA in

1995, with vaccines against tuberculosis, polio, diphtheria, tetanus, pertussis, measles

and hepatitis B on the immunisation schedule (Baker, 2010). EPI-SA is concerned with

the provision of vaccination to children against childhood illnesses (NDoH, 2015; Baker,

2010) and it currently provides infant immunisation against 10 diseases which includes

Hib disease (introduced in 1999), pneumococcal disease (2009), and rotavirus diarrhoea

(2009). The current EPI-SA immunisation schedule, as revised in December 2015, is

shown in Table 2.1.

Table 2.1: National Department of Health EPI revised schedule, as from 2015

Source: National Institute for Communicable Diseases (2015), available at: http://www.nicd.ac.za/assets/files/Measles%20vaccine.pdf

http://www.nicd.ac.za/assets/files/Measles%20vaccine.pdf


11

To achieve the objectives of MDG4, which was aimed at reducing child mortality, the

NDoH used the Integrated Management of Childhood Illnesses (IMCI) programme and the

EPI-SA (UNDP, 2000). The IMCI is focused on the prevention and management of the

causes of morbidity and mortality while promoting improved growth and development

among children under five years of age. One way of achieving this is to ensure that

children are fully immunised (NDoH, 2015). Globally, about 2 million deaths are annually

averted through immunisation. The WHO together with UNICEF and the United Nations

developed strategies such as GIVS and Reach Every District (RED) (WHO, 2006a);

GVAP and Reach Every Community (REC) (WHO, 2013a); MDGs (UNDP, 2000) and now

the SDGs (UNDP, 2015), to make sure that every child in the world has equal access to

safe, effective and quality vaccines.

Successes of the South African Expanded Programme on Immunisation

This programme has been successful in reducing the spread and occurrence of childhood

diseases. Since its introduction, the following achievements are evident:

South Africa became the first African country to include Hib vaccine, PCV and RV in

the EPI schedule. The introduction of these vaccines has resulted in a significant

decrease in the number of cases of invasive Hib, pneumococcal diseases and

rotavirus diarrhoea (Dlamini & Maja, 2016).

South Africa eliminated maternal and neonatal tetanus (MNT) in 2002, and has

maintained MNT elimination status to the present. In 2017, there were 16 countries

globally that are still to eliminate MNT (UNICEF, 2017).

South Africa was declared polio-free in 2006 (Dlamini & Maja, 2016).

In March 2014, a human papillomavirus (HPV) vaccine was introduced in public sector

schools for grade 4 girls aged 9 years and above, to prevent cervical cancer. This is a

joint effort between NDoH and Department of Basic Education through the Integrated

School Health Programme (NDoH, 2015).

To ensure the continued success of the programme, South Africa continues to spend

millions of Rands (South African currency) on EPI-SA without the help of Gavi, The

Vaccine Alliance (Visser, Hoosen, Hussey, 2012).


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Diseases targeted by the EPI-SA

Diphtheria

Diphtheria is an acute bacterial disease caused by Corynebacterium diphtheriae.

Diphtheria is transmitted through inhalation of respiratory droplets and/or close physical

contact (Hamborsky et al., 2015; NDoH, 2015). It can occur as a local infection (non-

invasive) and symptoms may include sore throat, barking cough and enlarged lymph

nodes in the neck. If left untreated, it can develop into a more serious systemic infection in

which the heart and nervous system may be affected (Hamborsky et al., 2015).

There has been a drop in the incidence of diphtheria cases in developed countries

compared to developing countries in which diphtheria remains endemic (WHO, 2006a;

Johnston, 2011). In South Africa the number of reported diphtheria cases declined from

29 cases in the 1990s to less than 5 in the 2000s (Liebenberg et al., 2009). Between 2008

and 2010, three laboratory-confirmed cases were reported: two from Western Cape

Province (March 2008 and January 2010), and one from Eastern Cape Province (March

2009). Thereafter, 11 laboratory-confirmed cases occurred in KwaZulu-Natal Province

from March to June 2015 (du Plessis, Wolter, Allam, de Gouveia, Moosa, Ntshoe,

Blumberg, Cohen, Smith, Mutevedzi, Thomas, Horne, Moodley, Archary, Mahabeer,

Mahomed, Kuhn, Mlisana, McCarthy, von Gottberg, 2017), with a further two cases

identified in 2016 (NICD, 2016a). Furthermore, in 2017 four confirmed cases with one

fatality were reported from the Western Cape Province (NICD, 2017a) and in 2018, three

fatal cases were reported in Kwazulu-Natal Province (NICD, 2018).

Of the 11 patients with laboratory-confirmed cases in Kwazulu-Natal in 2015, six patients

were not up-to-date with the South African vaccination schedule while two had received all

scheduled vaccines recommended for their age group (du Plessis et al., 2017). This

illustrates the importance of optimal immunisation coverage.

Vaccination strategy: Diphtheria vaccine is given by EPI-SA as part of the hexavalent

vaccine at 6, 10 and 14 weeks, with a booster dose at 18 months. The hexavalent vaccine

which contains 6 antigens (preventing diphtheria, tetanus, pertussis, polio, Hib and

hepatitis B) was introduced in 2015 to replace the pentavalent (DTaP-IPV-Hib) vaccine

and HepB. Two additional doses are given at 6 and 12 years of age in the form of Td,

which is a combined vaccine consisting of TT plus reduced strength diphtheria toxoid

vaccine (NDoH, 2015).


13

Tetanus

Tetanus (lockjaw) is a non-communicable bacterial disease caused by Clostridium tetanii

(Hamborsky et al., 2015; NDoH, 2015). Transmission occurs when these bacteria, that are

commonly found in soil and unsterilised objects, enter wounds (Hamborsky et al., 2015;

WHO, 2010a). The toxins released during infection cause muscle rigidity and spasms.

Tetanus can affect children and adults, either following birth in an unsanitary environment

(MNT or neonatal tetanus [NNT]) or through an exposed wound (Hamborsky et al., 2015;

NDoH, 2015; WHO, 2010a).

Vaccination strategy: The tetanus vaccine is a toxoid vaccine that contains a modified

neurotoxin which induces protective antitoxin. In many countries including South Africa,

tetanus vaccine is given at 6, 10 and 14 weeks as part of the hexavalent vaccine, with a

booster dose at 18 months and two additional doses at 6 and 12 years of age as Td

vaccine. TT or Td is also administered to pregnant women in order to ensure that the

elimination status of MNT and NNT is maintained. It is given at least once in the first

pregnancy if the woman has previously received four doses or three times in the first

pregnancy if the childhood immunisation status is unknown or unreliable. To achieve

lifelong protection against tetanus, five adequately spaced doses of TT should be received

(NDoH, 2015; WHO, 2006c).

In 1989 the WHA announced plans to eliminate NNT globally. By 2013, NNT deaths had

decreased from more than 400 000 in 1994 to 49 000 deaths (Khan, Vandelaer, Yakubu,

Raza Zulu, 2015). The NNT deaths decreased to 34 000 in 2015. By July 2018, 45

countries had eliminated MNT between 2000 and July 2018 thus leaving 14 countries still

to eliminate MNT (UNICEF, 2017). In South Africa NNT cases dropped from 177 in 1988

to a range of 6-0 cases in 1998 to 2006 (Ngcobo, 2008a). In 2002, the WHO declared

South Africa as having eliminated MNT and NNT through high levels of maternal tetanus

immunisation coverage (Dlamini & Maja, 2016; NDoH, 2015; Ngcobo, 2008a).

Pertussis

Pertussis (whooping cough) is a highly infectious respiratory bacterial disease caused by

Bordetella pertussis. Pertussis spreads from person to person through respiratory droplets

during coughing, sneezing or through direct contact with infected secretions from the nose

and mouth. Adults are a common source of pertussis infections for infants. Pertussis

infections commonly occur among children aged between 1-5 years; however the disease


14

is severe and even fatal in infants. In adolescents and adults, it is often unrecognised

because its course is frequently asymptomatic (USAID, 2003; Cherry, 2005; NDoH, 2015).

Symptoms in the first week following infection are usually mild and may resemble those of

a common cold. After 1 to 2 weeks symptoms may become severe, due to thick mucus

accumulation inside the lung airways causing uncontrollable coughing (NDoH, 2015;

WHO, 2010c).

WHO estimates that in 2008, about 16 million cases of pertussis occurred globally, 95% of

which were in developing countries, with about 195 000 child deaths (WHO, 2010a). In

2011 more than 160 000 cases of pertussis were reported worldwide, with about 5 800

cases reported in the African region (WHO, 2010a; WHO, 2013d). Between April 2008

and June 2011, 311 laboratory confirmed cases of pertussis were reported in South Africa

(National Health Laboratory Services [NHLS], 2011).

Though the true burden of pertussis disease in South Africa is unknown because of poor

reporting and/or recognition of the disease, it is often picked up through the Severe Acute

Respiratory Illness (SARI) surveillance. From April 2012 to May 2015, the NICD

conducted an active, prospective, hospital-based sentinel surveillance for SARI in two

sites (Edendale and Klerksdorp-Tshepong Hospital Complex). Of the 152 pertussis cases

identified in the surveillance programme, 13 cases were found in children under one year

old. All age groups were affected except for people over 65 years (NICD, 2015a). Also,

183 cases were identified in a retrospective review of records of children presenting with

clinical features suggestive of pertussis between 2008 and 2015 in Bloemfontein hospitals

(Hallbauer, Joubert, Goosen, 2016). In this study, infants aged <18 weeks constituted

57% of the cases (Hallbauer et al., 2016). In addition, 17 pertussis cases in children with a

median age of 8 months were identified between September 2012 to September 2013 in a

study from Cape Town (Muloiwa, Dube, Nicol, Zar, Hussey, 2016). Furthermore, 37

pertussis cases were identified in a retrospective study which tested respiratory samples

collected from infants <6 months old with symptoms of respiratory illness during a

maternal influenza vaccine trial in Soweto in 2011 (Nunes, Downs, Jones, van Niekerk,

Cutland, Madhi, 2016). This illustrates the importance of vaccinating pregnant women in

order to confer passive immunity to the children because often children who are too young

to being fully vaccinated against the disease are the ones affected (Centers for Disease

Control and Prevention (CDC), 2017).


15

Vaccination strategy: EPI-SA currently uses the acellular pertussis vaccine (aP), which

contains highly purified individual pertussis antigens and has a better safety profile than

the whole cell pertussis vaccine (DTwP) ( WHO, 2010c; USAID, 2003) which it replaced in

2009 (Dlamini & Maja, 2016). It is available as part of the hexavalent vaccine, which is

given at 6, 10 and 14 weeks, with a booster dose at 18 months (NICD, 2015b; NDoH,

2015).

Tuberculosis

TB is an infectious bacterial disease caused by the bacillus Mycobacterium tuberculosis.

TB commonly affects the lungs (pulmonary TB), but it can affect various other parts of the

body (extra-pulmonary TB) including the brain and kidneys. TB is spread from person to

person through respiratory droplets that are produced when a person with pulmonary or

laryngeal tuberculosis (active respiratory disease) coughs, sneezes, talks or sings. These

droplets can be inhaled by another person thus leading to either latent or active infection.

Progression from latent infection to active TB disease will depend on the immune status of

the individual, with the most at risk being the elderly, children <5 years of age and

individuals with suppressed immunity (e.g. human immunodeficiency virus [HIV] positive

individuals). Children can also be infected through the placenta or during birth if the

mother has disseminated TB (NDoH, 2014b; NDoH, 2013).

The general symptoms of active pulmonary TB include cough for two or more weeks

which is sometimes accompanied by blood-stained sputum, chest pains, weight loss,

persistent fever, fatigue, chills, night sweats and failure to thrive in children. TB is treatable

with a six months course of antibiotics. Immunisation of neonates against TB is important

as it helps prevent disseminated TB in children (WHO, 2004; NDoH, 2014b; NDoH, 2013).

The WHO reports that TB is the ninth leading cause of death worldwide and the leading

cause of death from a single infectious agent (ranking above HIV/AIDS). It is estimated

that about one-third of the world’s population is infected with Mycobacterium tuberculosis,

with 5-10% at risk of developing active TB (WHO, 2017b; NDoH, 2014b; WHO, 2004).

Despite the availability of effective anti-TB treatment and a vaccine, TB remains a major

global health problem with over 1.3 million deaths and 6.3 million new cases in 2016

(WHO, 2017b). The 2017 Global Tuberculosis Report reported South Africa as one of the

countries with the highest number of incident cases; it was also reported as having the

largest number of HIV associated TB cases (WHO, 2017b).


16

Vaccination strategy: The BCG vaccine developed in 1921 remains the only vaccine

against disseminated TB. It contains a live attenuated strain of Mycobacterium bovis.

However, it must be noted that BCG only offers minimal protection against the active

disease state (Roy, Harris, Rodrigues, Sridhar, Habermann, Snell, Mangtani, Adetifa,

Lalvani, Abubakar, 2014). The WHO (2004) recommends that a single dose of BCG be

given to all infants as soon as possible after birth, in all countries with a high burden of TB.

BCG is the most widely used vaccine, reaching over 80% of neonates and infants in most

developing countries (WHO, 2017b).

Polio

Poliomyelitis (polio) is a highly infectious viral disease caused by the poliovirus that can

result in irreversible paralysis or death. In countries where polio is still endemic, it occurs

mostly in young children under five years of age (NDoH, 2015; WHO, 2014). There are

three serotypes of the wild poliovirus; type 1, type 2 and type 3. Unfortunately having

immunity to one type does not confer immunity to the other types (Hamborsky et al., 2015;

NDoH, 2015).

Poliovirus is commonly transmitted from person to person through the faecal-oral route in

environments where there is poor sanitation (Robertson, 1993; WHO, 2014; Hamborsky et

al., 2015). Infection can result in fever, headaches, sore throat and acute flaccid paralysis

(AFP) (Hamborsky et al., 2015; WHO, 2014). Infected people can excrete the virus in their

stools even if they have asymptomatic infections, hence areas with poor sanitation and

low immunisation coverage are at a higher risk of polio transmissions (WHO, 2014; NDoH,

2015).

Globally, the continued use of polio vaccines has resulted in a significant decrease of

more than 99% in wild poliovirus (WPV) cases from an estimated 350 000 cases in 1988

to 22 cases in 2017 (WHO, 2018d). In 2017 only three countries namely Afghanistan,

Nigeria and Pakistan, remained polio endemic, with 8 and 14 WPV cases reported in

Pakistan and Afghanistan respectively, while Nigeria had its last WPV case in 2016

(WHO, 2018d).

From January 2017 to 4 December 2018, a total of 50 WPV cases were reported globally

and all occurred in two endemic countries (WHO, 2018e). In 2017, 14 and 8 WPV cases

were reported in Afghanistan and Pakistan, respectively. By 4 December 2018, 20 and 8

WPV cases were reported in Afghanistan and Pakistan, respectively (WHO, 2018e).


17

The steady decline of polio incidence can be attributed to scheduled and supplemental

immunisation activities (SIAs) (WHO, 2018b). The last confirmed case of WPV in South

Africa was in 1989 and the continued high levels of OPV coverage and good adherence to

the WHO’s certification standard surveillance led to South Africa being certified polio-free

in 2006 (NICD, 2017e). It is also important for the polio-free countries to have optimum

immunisation coverage as the virus can still be imported from endemic countries (WHO,

2018b).

Vaccination strategy: There are two types of polio vaccines available worldwide; the IPV

and the live attenuated OPV (WHO, 2014). Because OPV contains live attenuated

polioviruses, it can under very rare circumstances result in vaccine-associated paralytic

polio (VAPP) or circulating vaccine-derived polio virus (VDPV). In 2011, a child with

agammaglobulinaemia (a rare and severe congenital immune system disorder) from

Gauteng Province developed VAPP. This case was one of 23 cases worldwide since the

introduction of OPV (which is highly effective in interrupting poliovirus transmission)

(NICD, 2011). Over 90% of circulating VDPV and approximately 40% of all VAPP cases

are caused by the type 2 component of trivalent OPV (tOPV) hence the global switch from

tOPV to bivalent OPV (bOPV) in 2016, which only contains type 1 and 3 polio serotypes.

Currently the EPI-SA offers both these vaccines; a bOPV dose is given at birth and 6

weeks; and IPV which is offered as part of the hexavalent given at 6, 10, 14 weeks and 18

months (NDoH, 2015).

During 2017, the WHO’s Global Polio Eradication Initiative vaccinated 438 million under 5

year-old children in 39 countries, using OPV (WHO, 2018d).

Measles

Measles is a highly contagious disease caused by the measles virus. It is spread through

the inhalation of infected respiratory droplets from coughing, sneezing or breathing. The

measles virus can also be spread through direct contact with infected upper respiratory

tract secretions (WHO, 2009b; Hamborsky et al., 2015).

Common symptoms following infection are fever, red eyes, coughing and runny nose,

followed by the appearance of a rash 3 to 5 days later. Measles related complications

such as encephalitis, severe diarrhoea and pneumonia are most common in children

under the age of 5 years, especially those who are malnourished and have a vitamin A

deficiency (WHO, 2009b; Hamborsky et al., 2015).


18

Pre-measles vaccine era, the disease was globally responsible for an estimated 2.6

million deaths annually. Death due to measles has globally decreased from an estimated

550 100 in 2000 to 89 780 in 2016 (WHO, 2018b). South Africa has experienced multiple

measles outbreaks due to failure to reach optimal vaccine coverage (McMorrow et al.,

2009). Major outbreaks occurred between 2003 and 2005, involving 1 676 lab confirmed

cases, and also between 2009 and 2011, with 18 431 laboratory confirmed cases

(McMorrow et al., 2009; Ntshoe et al., 2013). Recently, there were 203 cases of measles

reported by 24 November 2017 with 91.13% (185/203) of the measles cases occurring in

three provinces (Gauteng, KwaZulu-Natal and the Western Cape) (NICD, 2017b).

Vaccination strategy: There are several live, attenuated MCVs licensed for use worldwide.

These include monovalent measles vaccines, and combinations of measles with rubella

(MR); rubella and mumps (MMR); and rubella, mumps and varicella (MMRV) (WHO,

2009b; Hamborsky et al., 2015). The EPI-SA used to offer the monovalent measles

vaccine (Rouvax®) at 9 months with a second dose at 18 months of age (NDoH, 2015).

Currently, the monovalent MeasBio® is being used. Measbio® was introduced in the EPI-

SA schedule in 2015, and is given at 6 and 12 months (NICD, 16b).

There are a few reasons for the change in schedule, the main reason being that Rouvax®

is no longer being manufactured. Secondly, Rouvax®’s successor (MeasBio®) cannot be

administered with other vaccines. Thirdly, MeasBio® is given from six months to prevent

the high morbidity and mortality associated with the disease in young infants (NICD,

2016b).

It must be noted that the first dose is only 85% effective, hence a booster dose is needed

in order to reach at least 95% effectiveness (Aung & Dlamini, 2017). Furthermore, the

vaccine’s efficacy becomes optimal when the child is at least one year-old hence another

dose is given at 12 months (NICD, 2016b).

Hepatitis B

Hepatitis B is a highly infectious disease caused by the hepatitis B virus (HBV) (Previsani

& Lavanchy, 2002; WHO, 2009a). HBV is commonly transmitted from person to person

through the exchange of bodily fluids during sexual intercourse, unscreened blood

transfusions, the use of needles contaminated with HBV infected blood and from mother

to child during pregnancy and birth (WHO, 2009a; Block et al., 2007). In the sub-Saharan

region, the most common route of transmission before the introduction of universal infant

vaccination against hepatitis B was horizontal transmission between young children


19

(Tabor et al., 1985; Karim et al., 1988). Individuals who are infected with HBV perinatally

are at a higher risk of developing chronic HBV infection (80%-90%), followed by children

infected before the age of 6 years (30%) (Previsani & Lavanchy, 2002; WHO, 2009a).

The WHO estimated that globally, in 1995 more than 2 billion people had been infected

with HBV, and that in 2015, approximately 257 million people were living with chronic HBV

infection (WHO, 2017e). Prior to the introduction of HepB into the EPI-SA, the prevalence

of HBV ranged from 0.3% to 15%. Because chronic HBV infection is a major cause of liver

cancer, South Africa has one of the highest rates of liver cancer in the world (NICD,

2016c) especially in the black population where the prevalence of chronic carriage was

9.6% before vaccine introduction. Since introduction of HepB, HBV chronic carriage rates

have decreased (Amponsah-Dacosta, 2014; Burnett, Kramvis, Dochez, Meheus, 2012).

Vaccination strategy: HepB has been available since 1986. It is highly effective for both

pre-exposure and post-exposure prophylaxis (Ott & Aruda, 1999; WHO, 2009a; Burnett et

al., 2012b). The EPI-SA introduced the monovalent HepB in 1995, which was

administered to infants intramuscularly at 6, 10 and 14 weeks (Burnett et al., 2012b;

NDoH, 2015). Since 2015, in an effort to reduce the number of injections administered to

children, HepB has been given as part of the hexavalent vaccine, which is given at 6, 10

and 14 weeks, with a booster dose at 18 months (NDoH, 2015).

Haemophilus influenzae type b infection

Haemophilus influenzae type b (Hib) is a bacterium which is a major cause of severe

meningitis, pneumonia, and other invasive diseases especially in children under the age

of 5 years (Obonyo & Lau, 2006; WHO, 2013e). Transmission is from person to person

through inhalation of respiratory droplets by susceptible individuals (WHO, 2014).

More than 90% of invasive Hib disease occurs in children <5 years of age. In this age

group, globally 8.13 million children suffered severe disease with 371 000 deaths

occurring in 2000, compared to 203 000 deaths in 2008. This decline correlates with the

incorporation of the Hib vaccine into the EPI of WHO members states, with only 62 having

done so by 2000, compared to 136 in 2008 (WHO, 2013d).

Since the introduction of Hib vaccine, there has been a steady decrease in the number of

Hib cases. In South Africa, 89 cases were reported to the national surveillance system

among children <5 years of age in 1999-2000, 43 in 2000/01, 27 in 2001/02, 33 in

2002/03 and 26 in 2003/04 (WHO, 2006b). However, from 2003 to 2009 the detection rate


20

increased from 0.7 to 1.3 cases per 100 000 in children <5 years of age and with the

majority being fully immunised.

In 2015, 35 Hib cases were confirmed with 17/35 cases reported amongst children <5

years (NICD, 2015b) while 42 and 57 cases were reported in 2014 (NICD, 2014) and

2013 (NICD, 2013), respectively

Vaccination strategy: A Hib conjugate vaccine was introduced into to the EPI-SA

immunisation schedule in 1999 when it was given at 6, 10 and 14 weeks of age. The

findings that Hib incidence increased from 2003 supported the decision to add a booster

dose of Hib at 18 months of age (Visser et al., 2012). Currently it is given at 6, 10 and 14

weeks, with a booster dose at 18 months by EPI-SA as part of the hexavalent vaccine

(NDoH, 2015).

Pneumococcal disease

Pneumococcal disease is caused by multiple serotypes of the Streptococcus pneumoniae

bacteria (pneumococcus). Transmission occurs through inhalation of contaminated

respiratory tract droplets when an infected individual coughs, talks or sneezes. The

population at risk of infection includes the elderly, children under 2 years of age and

children in group childcare settings such as a crèche (NDoH, 2015; WHO, 2012).

Infection may lead to common ear and sinus infections but in severe cases it can cause

invasive pneumococcal infections such as severe pneumonia and meningitis (WHO,

2012).

Morbidity and mortality caused by pneumococcal disease is a major cause for concern

worldwide. Among children younger than five years, it caused an estimated 411 000

bacterial pneumonia deaths in 2010 and 335 000 bacterial pneumonia deaths in 2015

globally (Izu, Solomon, Nzenze, Mudau, Zell, O’Brien, Whitney, Verani, Groome, Madhi,

2017).

A study conducted in South Africa by von Gottenberg et al (2013) showed a significant

decline in the incidence of invasive pneumococcal disease from 54.8% during the pre-

vaccine era to 17.0% following introduction of PCV into the EPI-SA (von Gottenberg et al.,

2013). In another South African study conducted at Chris Hani Baragwanath Academic

Hospital from 2006 to 2014, there were 81 791 admissions of children under five years, of

which 26 778 (33%) were categorised as pneumonia hospitalisations. Thereafter, there


21

was a decline from 33% in 2006 to 10% in 2014 for pneumonia hospitalisations of children

under five years and this reduction was attributed to the use of PCV (Izu et al., 2017).

Vaccination strategy: There are several pneumococcal conjugate vaccines (PCVs) that

are licensed for use against pneumococcal infections that may be caused by more than

90 serotypes of the pneumococcal bacteria. In 2009, PCV 7 was introduced into EPI-SA

and was given at 6 and 14 weeks, with a booster dose at 9 months of age (Madhi et al.,

2012; NDoH, 2015). It was replaced by PCV 13 in 2011, using the same schedule.

It is also important to improve the FIC if the goals of GAPPD are going to be realised

(WHO, 2013b). The 2016 global PCV coverage was 42% with South Africa at 94% (WHO,

2018a).

Rotavirus disease

Rotavirus is a highly infectious virus that causes gastroenteritis. Rotavirus infection is the

leading cause of severe diarrhoea among children under the age of 5 years worldwide

(WHO, 2013e). The rotavirus is transmitted through the faecal-oral-route, when infected

individuals shed the virus in their stool into the environment. Once in the environment, it

can be spread through contaminated hands, objects, food and water (NDoH, 2015; WHO,

2013e; PATH, 2014).

Rotavirus infections mostly occur in children under the age of 5 years, especially infants

and children between the ages of 3 months and 2 years. Symptoms include vomiting, very

watery diarrhoea, fever, abdominal pain and dehydration. Symptoms can be managed

through proper replacement of body fluids by oral rehydration. Severe rotavirus infection

can be prevented through immunisation (NDoH, 2015; WHO, 2013e; PATH, 2014).

The WHO estimates that worldwide, around 525 000 children die annually due to

diarrhoeal disease, which is mostly caused by rotavirus and Escherichia coli, thus making

it the second leading cause of death in children under five years old (WHO, 2017d).

Rotavirus infection was also responsible for millions of hospitalisations and clinic visits

(WHO, 2013e; Tate et al., 2012). In South Africa death due to the enteric infectious

diseases (diarrheal-causing disease) was ranked second in children under one-year while

first for 1 – 4 year olds from 2013 to 2015 (Stats-SA, 2017b).

Various South African studies concluded that the use of the RV has reduced severe

rotavirus disease (death or hospitalisation due to diarrhoea) especially in children under 1-


22

year (NICD, 2017f; Groome, Zell, Solomon, Nzenze, Parashar, Izu, Madhi, 2016; Page,

Kruger, Seheri, Peenze, Quan, Groome, Madhi, 2016; Msimang, Page, Groome, Moyes,

Cortese, Seheri, Kahn, Chagan, Madhi, Cohen, 2013; Seheri, Page, Mothahadini,

Mawela, Mphahlele, Steele, 2012). When comparing the pre-vaccine and post-vaccine

prevalence of rotavirus disease hospitalisations in children under five years old, Groome

et al. (2016) reported an average of 54.4% hospitalisations from 2006 – 2008 (pre-vaccine

era) as compared to 22.3% hospitalisations from 2010 – 2014 (post-vaccine introduction)

in children under one year. To further highlight the impact of RV, a 2014/15 rotavirus

disease surveillance report showed a decline from 30% prevalence in 2013 to 23% and

20% prevalence in 2014 and 2015 respectively (Page et al., 2016). Whilst, a 2009

prospective hospital-based surveillance system for diarrhoea at three sentinel sites (2

hospitals in Gauteng Province: Chris Hani Baragwanath-, Soweto- and Dr George

Mukhari Academic-; and Matikwana- and Mapulaneng hospitals in Limpopo Province),

reported that 46% of diarrhoeal hospitalisations in children under five years old tested

positive for rotavirus disease, but the number decreased to 33% and 29% in 2010 and

2011 respectively (Msimang et al., 2013).

Vaccination strategy: Worldwide there are two RVs licensed for use routinely in

immunisation programmes, the Rotarix® and the Rotateq™ vaccines. The EPI-SA

introduced RV in 2009, and uses the Rotarix® vaccine, given orally in two doses at 6 and

14 weeks of age (NDoH, 2015).

Road to Health Card (RtHC)

The Road to Health Card (RtHC) is a tool which is used to monitor the child’s health and

development. It is given immediately after birth to mothers in public hospitals and clinics

(Tarwa & De Villiers, 2007; NDoH, 2009). The RtHC is an important tool because it

contains information on the growth of a child, milestones reached, immunisation, vitamin A

supplementation, guidelines for infant feeding, deworming and other illnesses and a brief

family history, the mother’s antenatal care history and details about the labour and birth of

the child (Kitenge, 2011; Tarwa & De Villiers, 2007). Furthermore, the RtHC shows

whether the child is fully, partially or not vaccinated (Tarwa & De Villiers, 2007).

2.7 IMMUNISATION COVERAGE

Immunisation coverage is the percentage of people who have received particular vaccines

of interest in relation to the overall population. High immunisation coverage is important in

the eradication, elimination and/or control of VPDs as seen with the eradication of


23

smallpox and elimination of NNT (WHO, 2006a). High immunisation coverage also helps

in achieving herd immunity, which helps provide protection for individuals who have not

developed immunity, cannot be immunised or experience immunisation failures (Ngcobo,

2008b).

There are various targets set by WHO through their GVAP strategy in 2012, that were not

met by 2015 as anticipated. For example, the GVAP target for DTP3 was 90% global

coverage but by 2016 WUENIC reported a 86% coverage which is a slight improvement to

the annual coverage of 85% since 2010, with South Africa among the low performing

countries at 66% (WHO, 2018a).

In an effort to keep in line with the RED strategy, a 95% national FIC target with every

district achieving at least 80% coverage was set in the National Health Strategic Plan

2010/11 to 2012/2013 of South Africa, to be achieved by the end of 2013 (NDoH, 2015). It

is yet to meet that target as it reported FIC estimates of 83.6% (2012/13), 84.4%

(2013/14), 89.8% (2014/15), 89.2% (2015/16) and 82.3% (2016/17) (Aung & Dlamini,

2017). However, four of nine provinces consistently achieved over 80% FIC over the five

years, with Gauteng Province averaging 104.5%. At district level, eight of fifty-two districts

(including four of the five districts in Gauteng Province) managed to meet the revised FIC

target of 92% with 119.4% in Xhariep (Free State Province) while 52.7% was reported in

Waterberg (Limpopo Province). However, the decline in the 2016/17 FIC can be attributed

to the global shortage of hexavalent that lasted approximately 9 months until it was

resolved in October 2016 (Aung & Dlamini, 2017).

In 2010, the WHA endorsed annual national targets of 95% immunisation coverage of

MCV1 and MCV2 with the aim of global measles elimination. Unfortunately, by 2016 this

target was not reached as evidenced by reports of 85% and 64% for MCV1 and MCV2

global coverage, respectively (Feldstein, Mariat, Gacic-Dobo, Diallo, Conklin, Wallace,

2017).

Researchers report that outbreaks occur because of failure to achieve adequate

immunisation coverage (Karagiannis et al., 2008; Patel et al., 2012; Aylward & Alwan,

2014; Macdonald & Hebert, 2010; WHO, 2006b). South Africa is not an exception as it

also experienced measles outbreak in 2003–2005 (Corrigall et al., 2008), 2009–2011

(Ntshoe et al., 2013) and 2017 (NICD, 2017b). The 2009 - 2010 outbreak in the Western

Cape came as a surprise because the reported measles coverage in children <1 year of


24

age was 102.8%, 99.7% and 102.8% for the years 2007–2009, which was much higher

than the 2010 figure of 81.6% (Bernhardt et al., 2013).

Importance of immunisation coverage data

Immunisation coverage data are important because they give an estimation and monitor

performance of immunisation services at regional, national, provincial, district or facility

levels (Burton et al., 2015). The aim of immunisation coverage data is to establish

baseline information, provide a comparison with administrative estimates and assess

equity in immunisation with reference to factors such as place of residence, regions or

demographic data (such as sex, maternal education, economic status) (WHO, 2016b).

Immunisation coverage data help to identify areas and groups at risk of contracting VPDs

and assist country programmes, such as EPI-SA, to develop strategies to increase or

improve the coverage (WHO, 2016a; WHO, 2013c). Furthermore, the data on

immunisation coverage help to identify or establish the link between immunisation service

delivery and disease occurrence (WHO, 2006a) and are used by health authorities for the

purpose of strengthening immunisation policies, future resource allocation and health

programmes (WHO, 2016b).

Methods of collecting data on immunisation coverage

Immunisation coverage is one of the key measures of the performance of immunisation

programmes. Two methods that are recommended by the WHO for measurement or

estimation of immunisation coverage are the administrative method and immunisation

coverage surveys (WHO, 2016b). The WHO Member states annually submit national

immunisation coverage reports to WHO/UNICEF joint reporting team, who then produce

their own estimates. The WUENIC figures are country-specific and are calculated and/or

consolidated in consultation and collaboration with national authorities and WHO/UNICEF

regional and national staff. The government reports are supplemented by survey results

from the published and grey literature. Most of the time, the numbers provided by the

governments are more than the WUENIC estimates because factors such as over or

under-estimation of the target population due to out-dated censuses and poor population

projections; general immunisation coverage trends and/or patterns; disease burden; and

recall bias adjustment in case of surveys; and local events/incidents such as civil unrest,

vaccine shortage, donor withdrawal, change in management or policies are taken into

consideration (Burton, Monasch, Lautenbach, Gacic-Dobo, Neill, Karimov, Wolfson,

Jones, Birmingham, 2009).


25

Administrative method

With the administrative method, the number of doses administered to the target population

is divided by the total estimated number of people in the target population in order to get a

percentage. Data are collected from service providers such as clinics and hospitals

(WHO, 2016b).

Survey methods

Household surveys are the most common method to collect immunisation coverage data.

Immunisation history is determined by reviewing the client’s immunisation record. The

main household survey methods are the following:

The WHO’s Immunization coverage cluster survey: The cluster sampling method is

achieved by dividing the target area into clusters then choosing a predetermined

number of dwellings in each cluster to conduct the study at (WHO, 2015a).

The UNICEF Multiple Indicators Cluster Survey (MICS): This is an initiative by

UNICEF to assist countries in conducting household surveys. The design of a MICS

survey depends on the objectives for conducting the survey. The government

concerned will identify indicators and submit them to UNICEF. UNICEF will then

develop a template or design for the study (UNICEF, 2016a).

The WHO’s Immunization coverage cluster survey is the most frequently used survey

method (WHO, 2015a).

South African immunisation coverage surveys

i) Household surveys

Household surveys are very important because they provide the opportunity to reach

unvaccinated children who are eligible for childhood immunisation. They also provide an

opportunity for researchers to encourage and inform caregivers about vaccination. It is

also easy for caregivers to ask questions (WHO, 2015a).

The majority of South African household surveys designed to measure FICs found that

these were below the district target of 80%. The lowest FIC of 53.8% was reported in a

study conducted in Bela-Bela Township (Limpopo Province) (Simango, 2013); while

Wright et al. (2011) reported 69.9% in a study conducted in Ga-Rankuwa Township


26

(Gauteng Province). However, there were a few studies that reported FICs closer to the

80% district target. These include studies conducted in Mmakaunyane village (North West

Province), with an FIC of 76.2% (Sehume, 2011); Cape Town (Western Cape Province)

with an FIC of 76.8%, (Corrigall et al., 2008); Gauteng Province with an FIC of 79.1%

(Fonn, 2003); and Muldersdrift (Gauteng Province) with an FIC of 79.5% (Ndlovu, 2014).

There were also some studies which reported FICs higher than the district target of 80%.

These include a study conducted in Refilwe Township (Gauteng Province), which reported

89% FIC (Motloung, 2016), and one conducted in a semi-urban area of KwaZulu-Natal

Province, which reported 92.9% FIC (Comley et al., 2015).

There are also South African studies that report on immunisation coverage of older age

groups. These include studies conducted in Cape Town (Western Cape Province)

(Corrigall et al., 2008) and Ga-Rankuwa Township (Gauteng Province) (Wright et al.,

2011), which reported 53.2% and 19.5% immunisation coverage for under five years old

children, respectively. Also, 88.5% immunisation coverage for 18-month old children and

44.4% for six year old children were reported in a study conducted in a semi-urban area of

KwaZulu-Natal Province (Comley et al., 2015).

In addition, some South African studies have focused on specific vaccines. A study

conducted in three locations concentrated on immunisation coverage of the first eight EPI-

SA recommended vaccines (BCG, OPV, HepB and pentavalent vaccines).The study

reported on immunisation coverages of 94% in Paarl, 88% in Umlazi and 62% in Rietvlei

(Fadnes et al., 2011). Another study from rural KwaZulu Natal Province measured

immunisation coverage of 5 vaccines, and reported 89.3% for BCG; 87.3% for polio3;

84.9% for DTP3; 81.7% for HepB3 and 77.3% for MCV1 (Ndirangu et al., 2009). Finally, a

study on children under 10 months of age reported 97.0% and 89.1% MCV1 coverage in

Soweto (Gauteng Province) and Edendale (Kwazulu-Natal Province), respectively

(Mthiyane, 2016). The same study also reported 98.4% and 88.2% DTP3 coverage for

children under five years in Soweto and Edendale, respectively (Mthiyane, 2016).

ii) Health facility-based surveys

One of the disadvantages of health facility-based surveys is that they are biased

towards caregivers who use healthcare facilities, and as a result those who use

traditional healers instead and may not vaccinate their children are missed.


27

While 99% vaccine coverage for birth vaccines was reported in a study conducted at Dr

George Mukhari Academic Hospital (DGMAH) in Gauteng Province. Only 55% FIC was

reported in the same study (Burnett et al., 2018). In a study conducted in OR Tambo

District (Eastern Cape Province), mothers giving birth at Zithulele Hospital were followed

up at home. This study reported immunisation coverage of 48.6% at 3 months, 73.3% at 6

months, 83.9% at 9 months, 73.3% at 12 months and 73.2% at 24 months (le Roux, Akin-

Olugbade, Katzen, Laurenzi, Mercer, Tomlinson, Rotheram-Borus, 2017).

Reasons for partial or non-vaccination

Despite the success of vaccines, some South African children have not received all their

vaccinations (Burnett et al., 2018; le Roux et al., 2017; Lockett, 2016; Motloung, 2016;

Mthiyane, 2016; Comley et al., 2015; Maseti, 2015; Ndlovu, 2014; Bernhardt et al., 2013;

Simango, 2013; Fadnes et al., 2011; Sehume, 2011; Wright et al., 2011; Ndirangu et al.,

2009; Corrigall et al., 2008; Fonn, 2003). Several South African studies have examined

the reasons for missed vaccinations, mostly from a caregiver perspective. These reasons

can be grouped under the broad categories of lack of information, lack of motivation,

health facility obstacles and personal obstacles (WHO, 2015a).

Lack of information

Reasons such as caregivers not knowing that they needed to come back for another

dose, being unaware of the need for vaccination, and incorrect ideas about

contraindications were cited in studies conducted in OR Tambo District (Eastern Cape

Province) (le Roux et al., 2017); Site B Khayelitsha, Philippi, Mbekweni, Delft and Du

Noon (Western Cape Province) (Bernhardt et al., 2013); and Cape Town (Western Cape

Province) (Corrigall et al., 2008). In addition, fear of side effects was reported in a study

conducted in Mmakaunyane village (North-West Province) (Sehume, 2011). Also, a study

conducted in Soweto (Gauteng Province) and Pietermaritzburg (KwaZulu-Natal Province)

reported that 0,6% (6/1061) of caregivers said that it was not necessary to vaccinate

children (Mthiyane, 2016).

Lack of motivation

A general lack of motivation has also been reported as a reason for non-vaccination in

studies conducted at DGMAH in Gauteng Province (Burnett et al., 2018); in Refilwe

township (Gauteng Province) (Motloung, 2016); Mmakaunyane village (North West


28

Province) (Sehume, 2011) and Cape Town (Western Cape Province) (Corrigall et al.,

2008).

Facility obstacles

Facility obstacles such as the inconvenient and restrictive immunisation times that are

combined with long waiting times were named as some of the reasons given for partial or

non-vaccination of children in studies conducted in OR Tambo District (Eastern Cape

Province) (le Roux, 2017); the Eastern sub-district of Cape Town (Western Cape Province

(Lockett, 2016); Refilwe township (Gauteng Province (Motloung, 2016); Soweto (Gauteng

Province) and Pietermaritzburg (KwaZulu-Natal Province) (Mthiyane, 2016) and

Muldersdrift (Gauteng Province) (Ndlovu, 2014). Also unavailability of vaccines in the

clinics was another reason reported as the cause of partial vaccination (Burnett et al.,

2018; le Roux, 2017; Motloung, 2016; Mthiyane, 2016; Simango, 2013; Corrigall et al.,

2008). In addition, other studies conducted in the City of Tshwane (Gauteng Province)

(Maseti, 2015) and Mmakaunyane village (North West Province) (Sehume, 2011) reported

that caregivers were discouraged by negative health workers’ attitudes, while a study

conducted in Muldersdrift (Gauteng Province) reported that vaccinations were missed

because of the absence of a vaccinator (Ndlovu, 2014).

Personal obstacles

Various family problems (such as mothers being too busy to take the child to the clinic,

mothers are sometimes too sick or weak to take their children to the clinic to be

immunised, no one available to take the child for immunisation) were reported in studies

conducted at DGMAH in Gauteng Province (Burnett et al., 2018); in the Eastern sub-

district of Cape Town (Western Cape Province) (Lockett, 2016); Refilwe township

(Gauteng Province) (Motloung, 2016); Soweto (Gauteng Province) and Pietermaritzburg

(KwaZulu-Natal Province) (Mthiyane, 2016); Site B Khayelitsha, Philippi, Mbekweni, Delft

and Du Noon (Western Cape Province) (Bernhardt et al., 2013) and rural KwaZulu-Natal

(KwaZulu-Natal Province) (Ndirangu et al., 2009). In addition, a few caregivers in a study

conducted at DGMAH in Gauteng Province (Burnett et al., 2018); and in Soweto (Gauteng

Province) and Pietermaritzburg (KwaZulu-Natal Province) reported to have lost the RtHC,

while others reported that the child was ill at the time of immunisation (Mthiyane, 2016).


29

Reasons given by healthcare workers

A study conducted on healthcare workers in Limpopo Province reported that they agree

with some of the health facility problems identified in other studies, and furthermore

reported other obstacles such as staff shortage and mothers not complying with

scheduled return dates for immunising their children, as reasons for poor immunisation

coverage (Mothiba & Tladi, 2016). In a 2012 study, 9 of 10 EPI-SA managers reported

insufficient knowledge of vaccines and EPI practices among staff; staff shortages and high

staff turn-over; insufficient financial and human resources; resistance from parents; and

anti-immunisation rumours as some of the reasons (Wiysonge et al., 2012).

Reasons unknown

There were few instances where the caregivers did not give reasons or reasons were not

recorded in the RtHCs or health facility records (Burnett et al., 2018). It is imperative for

healthcare workers to indicate in the RtHC the reason for non-vaccination. Knowing

whether the missed vaccination was due to a vaccine shortage or contra-indication or

vaccine hesitancy will enable health authorities to develop and implement strategies to

address the problem (Tarwa & De Villiers, 2007).

Interventions to improve immunisation coverage

In an effort to assess the effectiveness of patient reminder or recall systems in improving

immunisation rates, Jacobson Vann and Szilagyi conducted a global study where they

reviewed several studies from various countries. The review established that

immunisation coverage especially in developed countries, increased by 1 to 20% due to

reminders such as postcards, letters, telephone or auto-dialer calls (Jacobson Vann &

Szilagyi, 2005). Similarly, in a study conducted in Georgia (United States of America), an

improvement in immunisation coverage was reported when using reminder-recall

interventions (LeBaron, Starnes, Rask, 2004). Another global review which included

studies that were published in and before January 2017 concluded that various national

immunisation coverages were likely to increase by about 8% due to reminder-recall

interventions (Jacobson Vann, Jacobson, Coyne-Beasley, Asafu-Adjei, Szilagyi, 2018).

Currently, South Africa does not have a vaccination reminder service but it has a similar

service for pregnant women, called “MomConnect”. MomConnect is an interactive NDoH

initiative whereby pregnant women are registered on a database to receive weekly SMS

messages regarding their pregnancy and until the baby turns one year. The women can


30

also send free SMS messages to ask questions) (NDoH, 2014c). This service can be

upgraded to include vaccination visits.

2.8 SUMMARY

The WHO, UNICEF and United Nations all agree that vaccination is very important and it

should be easily and freely accessible to everyone who is eligible to receive it. There are

various modifiable reasons for non-vaccination which can be addressed in order to

improve FIC. There is also a report from HCWs that parents are refusing vaccinations.

However, South African studies that collected data from caregivers on reasons why their

children had missed vaccinations, did not identify vaccine refusal as a reason.

Nonetheless, immunisation refusals pose a significant problem for EPI-SA and the control

of VPDs. Unvaccinated children put those who cannot be vaccinated for medical or other

reasons at risk. The literature also stresses the importance of household surveys as they

help to obtain demographic data and validate immunisation administrative data collected

at healthcare facilities. Despite facing challenges such as having areas with sub-optimal

vaccination coverage, and poor immunisation data and not being funded by Gavi, the

Vaccine Alliance, South Africa must be commended for being in the forefront for the

introduction of HepB, Hib, PCV, RV and HPV vaccine in the EPI schedule.

Chapter 3: Methodology

31

METHODOLOGY

3.1 INTRODUCTION

This chapter presents the methodology of this study in detail. It describes the study design

and study site in Sections 3.2 and 3.3. The study population and the sample selection used

are discussed in Section 3.4. Section 3.5 includes a detailed description of the data

collection procedures and the data collection instruments. This is followed by the description

of how data were entered and analysed in Section 3.6, as well as methods put in place to

ensure reliability and validity of the data collected in Section 3.7. The chapter is concluded

with Section 3.8, which covers the ethical considerations of this study.

3.2 STUDY DESIGN

The study was a household survey, with the methodology adapted from the WHO protocol to

determine immunisation coverage and reasons for non-vaccination (WHO, 2015a).

3.3 STUDY SITE

The study was conducted in Region 5 of Tshwane in the Gauteng Province. Region 5 is

approximately 1 555 km² with an estimated population of 49 397 according to the 2011

Census. Only 14.2% of the population in the region are economically active, with

approximately 20% permanently unemployed. Region 5 consists of both rural and urban

areas. The main dwelling areas are Baviaanspoort, Cullinan, Kameeldrift, Onverwacht,

Pebble Rock, Rayton, Refilwe, Roodeplaat, Sable Hills and Derdepoort. The region is

bordered by the Magaliesberg Mountain range and the N1 to the west and the N4 freeway to

the south. The region borders on Mpumalanga Province to the east and Limpopo Province to

the north (CoT, 2016).

3.4 STUDY POPULATION AND SAMPLE

The study population was caregivers of children aged 12–23 months who were staying or

had spent the night prior to the survey in Region 5 of Tshwane. A caregiver refers to a

person who provides direct care to the child.


32

Sample selection

The WHO protocol was used for sample selection (WHO, 2015a). A sample size powered at

no less than 80% with 95% confidence was the minimum requirement. However, a sample

size powered at 90% with 95% confidence was aimed for. Thus both sample sizes obtained

from the WHO protocol (WHO, 2015a) are shown here:

Assuming 50% FIC, with a desired precision of ±5% (90% power) at 95% confidence and

a design effect of 2 for 30 clusters, 26 eligible participants from each cluster was to be

sampled, thus giving a target of 780 participants.

Assuming 50% FIC, with a desired precision of ±10% (80% power) at 95% confidence

and a design effect of 2 for 30 clusters, 7 eligible participants from each cluster was to be

sampled, thus giving a target of 210 participants.

According to the 2011 census, Region 5 had an estimated total population of 49 397 (Stats-

SA, 2011). The population was spread over several residential areas which include informal

settlements, farms, estates, urban and rural areas (CoT, 2015). For the purpose of the study,

Region 5 was divided into 30 clusters (~400-510 houses per cluster), based on the

residential areas and the number of households per residential area. Areas with fewer

households were combined to form one cluster, provided they were situated close to one

another. For the purpose of this study, farms and security estates were not surveyed,

because of anticipated difficulty in gaining access (Fonn, 2003). The 30 clusters were made

up of either existing extensions or blocks bordered by roads (see Table 3.1).

Table 3.1: Distribution of 30 clusters in Region 5 of Tshwane

Area(s) Number of

households Number of

clusters

Baviaanspoort, Derdepoort and Roodeplaat 966 2

Cullinan 1 627 4

Kameeldrift 2 527 5

Onverwacht 428 1

Rayton 2 610 6

Refilwe 5 636 12

Total 13 794 30

A map showing all the households in Region 5 of Tshwane was obtained from the CoT,

Town Planning Department. The first household visited in each cluster was randomly

selected from the map using Research Randomiser Software® for the areas with house

numbers. For informal settlements, the first house from the main road was chosen as a

starting point. Thereafter, the nearest household on the right side was visited. The nearest


33

household meant the household reachable in the shortest time on foot from the household

just visited and needed to be in direct line of vision or on the same side of the street or road.

The households were visited until the target (26 successful interviews were aimed for in

each cluster) was reached, or all the households were visited (WHO, 2015a). If there was

no-one home, the house was revisited the following day or weekend if the neighbours

reported that there was an eligible child in the house.

The following inclusion criteria were used for sample selection:

Consenting caregiver of at least one child aged 12–23 months.

Child who had been staying or had spent the night prior to the survey in Region 5 of

Tshwane.

Caregiver who was in possession of the RtHC for the child.

RtHCs were used to identify the immunisation status of the child and to exclude potential

response and/or recall bias from the caregivers who did not have the RtHCs with them. All

caregivers of children who did not meet the above criteria were excluded from the study.

3.5 DATA COLLECTION

Data collection period

The data were collected for a period of 30 days as per WHO protocol (WHO, 2015a). Data

were collected daily, starting from 02/07/2017 up to and including 31/07/2017.

Data collection training

The training was provided by the supervisors and a qualified social worker who was also a

Master of Public Health (MPH) graduate with experience in using the WHO immunisation

coverage cluster survey methodology, prior to the commencement of data collection. The

MPH graduate also accompanied the data collectors into the field on the first day of data

collection as an observer.

Enrolment and data collection

There were two data collection teams with each team led by masters students who were

both fluent in English and Setswana. Each team consisted of two data collectors and had to

cover at least one cluster daily as per WHO protocol (WHO, 2015a), in order to ensure

accuracy of the data and that the data were collected as close as possible to one point in


34

time. The team leader explained the aim and objectives of the study to the caregivers. Data

collection commenced after the caregivers gave verbal consent to participate in the study.

Data collection process and instruments

On agreement to participate in the study, two researcher-administered questionnaires,

adapted from the WHO protocol (WHO, 2015a) were used to conduct face-to-face interviews

with the participants. The first questionnaire was a structured questionnaire whereby

demographic data and immunisation status of the child with details on vaccination dates

were recorded (see Appendix 1A). The information was obtained from the child’s RtHC. A

cellular phone camera was used to capture a photograph of the child’s RtHC and the

photograph was sent directly to the study supervisor via electronic mail. This was to allow

real-time supervision. The time, date and global positioning system (GPS) co-ordinates were

available in the properties of the photograph. Data were not captured on personal identifiers

of either the caregiver or the child. Where the name of a child appeared on the RtHC, this

was covered before taking the photograph.

A semi-structured questionnaire was thereafter administered ONLY to caregivers of children

who were partially- or non-vaccinated (see Appendix 1B). To ensure that potentially

important information about partial- or non-vaccination was not missed or categorised

incorrectly, these interviews with caregivers were recorded using a cellular phone or a digital

voice recorder. After obtaining permission to make an audio recording of this second

interview, the participants were asked one open-ended question at the beginning of the

interview, i.e. “I can see from the RtHC that the child is not fully immunised; can you

please explain why the child is not fully immunised?” to determine the reasons for

partial- or non-vaccination. Categories with possible response options appear on the

questionnaire for the purpose of the data collector ONLY. These options were NOT shown to

participants to prevent any response bias. The data collector listened to the participant’s

response and ticked the appropriate option on the questionnaire. Any reason given by the

caregiver that did not appear on the questionnaire, was audio recorded and written verbatim

on the questionnaire in the provided space. Based on the caregiver’s response, he/she was

prompted to elaborate further to obtain further details for non-vaccination. Examples of

possible prompts included “Did they tell you when the vaccines will be available?”, “Were

you told to come back?”, “Why did you not go back?”, “Where did you hear that?”, “Please

explain”, “What is the reason for not …?”. Again, the answer was audio recorded and written

down verbatim and the appropriate category on the questionnaire was ticked


35

3.6 DATA ENTRY AND ANALYSIS

Raw data from the cluster forms were captured on Microsoft Excel (Microsoft Office 2013).

The data were then compared with the photographs of the RtHCs captured in the field. After

validating the data with the photographs, they were cleaned, coded and then imported to Epi

InfoTM 7 (Centers for Disease Control and Prevention, USA) for further analysis. Descriptive

statistical analyses were conducted. These included calculations of the mean age, median

age and age range; the proportion of boys and girls included in the study; the FIC

percentage; the coverage of the different vaccines and vaccine series, and drop-out rates;

and frequencies of reasons why children are not vaccinated.

FIC was estimated as the proportion of children who have been fully vaccinated against the

10 diseases covered by EPI-SA, which includes a birth dose of BCG vaccine; 2 doses of

OPV at 0 and 6 weeks; 3 doses of pentavalent and HepB vaccines or hexavalent vaccine at

6, 10 and 14 weeks; 2 doses of RV at 6 and 14 weeks; 3 doses of PCV at 6, 14 weeks and a

booster dose at 9 months; and 1 dose of measles vaccine at 6 months.

3.7 RELIABILITY AND VALIDITY

The questionnaires that were used in the study were adapted from the WHO protocol (WHO,

2015a). These questionnaires have been validated and they are widely used for collection of

data. A MPH graduate who was experienced with the methodology accompanied the data

collectors on the first day of data collection in order to ensure that the data collectors

became familiar with the process and materials used in the study and to assess, advise and

ensure that the data collection process was done in a correct manner as per the WHO

protocol (WHO, 2015a).

The validity and reliability of the data were also ensured by the fact that photographs of the

RtHC were taken during data collection to verify data on immunisation coverage collected

during the interview. Similarly, interviews were recorded to ensure that accurate information

was captured on the data collection sheets. Furthermore, only children for whom an RtHC

was produced, were included in the study.

All data were entered by the researcher and were cross-checked by the second masters

student who had assisted with data collection, to ensure the reliability of data entry.

Corrections were made where there were discrepancies.


36

3.8 ETHICAL CONSIDERATIONS

The protocol was reviewed by the School of Pharmacy Research Committee and thereafter

by the Sefako Makgatho Health Sciences University Research Ethics Committee

(SMUREC). The study commenced after SMUREC granted ethical clearance to conduct the

study (Appendix 2). Permission to conduct the study was obtained from the Chief Director,

Tshwane Research Committee (Appendix 3). All participants were requested to provide

informed verbal consent prior to participation in the study. Where the second interview was

needed (i.e. where missed vaccinations were seen on the RtHC), participants were

requested for permission to make an audio recording of the interview.

All documentation relating to the study was secured and participants’ confidentiality was

ensured by not recording participants’ names or any identifying markers on any of the data

collection instruments. Instead a unique study identification was assigned to each participant

(see Appendix 1A). All data were and will be kept in a safe place and only the researcher

and the supervisors will have access to the data. Participants were free to withdraw from the

study at any time.

3.9 SUMMARY

This chapter described the methodology used for this study. This was a two phased

descriptive study. The first phase was a quantitative survey whereby a researcher-

administered questionnaire was used for recording the demographic data and immunisation

status of the child with details on vaccination obtained from the child’s RtHC. A photograph

of the child’s RtHC was captured and the time, date and GPS co-ordinates were available in

the properties of the photograph.

The second phase of the study took the form of a qualitative survey where a semi-structured

questionnaire containing an open-ended question, with follow-up questions or prompts was

used for children who were not fully immunised. Interviews were recorded onto a digital

voice recorder or a cellular phone. Responses were either ticked on the questionnaire or

transcribed verbatim.

Raw data from the cluster forms were captured on Microsoft Excel and then compared with

the photographs of the RtHCs captured in the field. After validating the data with the

photographs, they were cleaned, coded and then imported to Epi InfoTM 7 for descriptive

statistical analyses.


37

Ethical clearance for the study was obtained from the SMUREC prior to the commencement

of the study. Permission to conduct the study in Tshwane Region 5 was obtained from the

Tshwane Research Committee. All participants were requested to provide informed verbal

consent prior to participation in the study. Participants were free to withdraw from the study

at any time

The results of the data collected in this study, are presented and discussed in Chapter 4, in

the form of a manuscript for publication in an accredited journal.

Chapter 4: Results and Discussion

38

RESULTS AND DISCUSSION

4.1 INTRODUCTION

As a requirement for the MPharm degree, the results of the study are presented and

discussed in this chapter in manuscript format. The manuscript will be submitted to the

South African Medical Journal (SAMJ) for publication under the title ‘Modifiable health facility

obstacles result in missed vaccination opportunities for 12-23 month-olds in Tshwane

Region 5 in Gauteng Province’. The manuscript is presented in the format required by the

journal according to the author’s guidelines. The author guidelines appear in Appendix 4

and can be accessed electronically at:

http://www.samj.org.za/index.php/samj/about/submissions#authorGuidelines.

A draft letter to the editor appears in Section 4.2 of this chapter, followed by the manuscript

in Section 4.3.

4.2 LETTER TO THE EDITOR

The letter to the editor of the SAMJ, which will accompany the manuscript, appears on the

next page.

http://www.samj.org.za/index.php/samj/about/submissions#authorGuidelines


39

Dr Bridget Farham

Deputy Editor: South African Medical Journal

Private Bag x 1

Pinelands

Cape Town

Dear Dr Farham

RE: SUBMISSION OF MANUSCRIPT: Modifiable health facility obstacles result in missed

vaccination opportunities for 12-23 month-olds in Tshwane Region 5 in Gauteng Province.

Please consider the abovementioned manuscript for publication in the South African Medical Journal

(SAMJ). The authors (DN Montwedi, JC Meyer, VV Nkwinika and RJ Burnett) have consented to

publication in your journal, and the article has not been published in or submitted to any other journal.

For several years Tshwane District has been reporting very high fully immunised under one year-old

immunisation coverage (FIC), at times exceeding 100%. However, Tshwane District recently

experienced a measles outbreak, which was attributed to suboptimal vaccination coverage. This study

was conducted in 2017 in Tshwane Region 5, where no surveys have been conducted to validate

official administrative FIC data before and after the incorporation of Metsweding into Tshwane

District in 2011.

We believe that the results of the study will help by giving insight into immunisation coverage and

reasons for non-immunisation in Region 5 of Tshwane. Results can also be used to identify gaps at

sub-district and health facility level. SAMJ is the journal of choice for publishing this manuscript

because it is open-access and widely read by South Africans working in the field of public health.

Yours faithfully,

_______________________ Mr DN Montwedi

01 May 2019

Telephone: +27 12 521 4567 Email: [email protected]

www.smu.ac.za

School of Pharmacy Molotlegi Street, Ga-Rankuwa Pretoria, Gauteng PO Box 218, Medunsa, 0204


40

4.3 MANUSCRIPT FOR PUBLICATION

The manuscript, which will be submitted to the SAMJ for consideration of publication, is

included in this section.

Modifiable health facility obstacles result in missed vaccination opportunities for 12-23

month-olds in Tshwane Region 5 in Gauteng Province

DN Montwedi,1 BPharm; JC Meyer,1,2 BPharm, MSc, PhD; VV Nkwinika, 2,3 BSc (Hons); RJ

Burnett,2,3 MPH, PhD

__________________________________________________________

1Department of Public Health Pharmacy and Management, Sefako Makgatho Health Sciences

University, Pretoria, South Africa.

2South African Vaccination and Immunisation Centre, Sefako Makgatho Health Sciences

University, Pretoria, South Africa.

3Department of Virology, Sefako Makgatho Health Sciences University, Pretoria, South

Africa.

Running head:

Immunisation coverage of 12-23 month-olds in Tshwane Region 5

Word counts:

Abstract only: 388

Body text: 3 648

Mr Diedericks Nkuke Montwedi (Corresponding author), BPharm, Academic intern and part-

time lecturer, Division of Public Health and Pharmacy Management, School of Pharmacy,


P.O. Box 218, Medunsa, 0204.

Cell: +27 22 5232 656

Email: [email protected]

Prof Johanna Catharina Meyer, BPharm, MSc (Med), PhD (Pharmacy), Associate Professor,

Division of Public Health and Pharmacy Management, School of Pharmacy,


P.O. Box 218, Medunsa, 0204.

Tel: +27 12 521 4567

Cell: +27 83 629 0678

Email: [email protected]; [email protected]

Prof Rosemary Joyce Burnett,

Head: South African Vaccination and Immunisation Centre

Department of Virology, Sefako Makgatho Health Sciences University

PO Box 173, Medunsa, 0204.

Tel: +27 12 521 3880

mailto:[email protected]



tel:+27%2012%20521%203880


41

Cell: +27 83 636 3931


Ms Versatile Vaster Nkwinika,

South African Vaccination and Immunisation Centre Health Programme Co-ordinator

Department of Virology, Sefako Makgatho Health Sciences University

PO Box 173, Medunsa, 0204.

Tel: +27 12 521 3880

Cell: +27 64 683 4220


tel:+27%2083%20636%203931


tel:+27%2012%20521%203880

tel:+27%2083%20636%203931



42

Abstract

Introduction: Although the annual South African official administrative fully immunised

under one year-old immunisation coverage (FIC) figures are high, failure to vaccinate has

been identified as a cause of recent vaccine-preventable disease outbreaks.

Objectives: This study investigated individual vaccine coverage, FIC, drop-out rates and

reasons for missed vaccinations, in children aged 12–23 months in Region 5 of Tshwane,

Gauteng Province.

Methods: A household survey was conducted based on the World Health Organization’s

(WHO) Vaccination Coverage Cluster Surveys: Reference manual. Consenting caregivers of

children aged 12-23 months with available Road to Health Cards (RtHCs), were surveyed.

RtHCs were checked for missing vaccinations, and reasons given by caregivers for missed

vaccinations were recorded. Cellular telephone photographs of RtHCs were e-mailed to the

supervisor. Data captured using Microsoft Excel 2013 were imported to Epi InfoTM7 for

descriptive statistical analysis.

Results: Of the 8060 houses visited, 327 had eligible children. Of these, 84.4% (276/327)

caregivers consented to participate in the study. Gated communities and houses enclosed by

security fencing were inaccessible. Vaccination coverage ranged from 98.9% (273/276) for

birth vaccines to 87.3% (241/276) for the nine month vaccine. 76.4% (94/123) of the missed

vaccines was from 14 weeks to 9 months. The FIC was 78.3% (216/276), with all other

children being partially vaccinated. The overall drop-out rate was 21.1%. Nine of the 59

partially-immunised children had subsequent doses of vaccinations recorded in their RtHCs

in the absence of having received a prior dose, and these missed vaccinations were never

caught up at subsequent visits. Over a third (39.0% [48/123]) of missed vaccines was by six

children. In total, 123 vaccinations were missed by 59 children, with reasons related to health

facility obstacles being the largest contributor (34.1% [42/123]), and followed by lack of

information (26.8% [33/123]).

Conclusion: The 78.3% FIC is just below the 80% district-level target set by the WHO. The

majority of reasons for missed vaccinations are due to modifiable healthcare facility

obstacles. While a low prevalence of vaccine hesitancy was found, the study did not include

caregivers living in security complexes / gated communities, who are more likely to have

internet access and higher rates of vaccine hesitancy. The FIC can be improved through (a)

providing programmes aimed at empowering vaccinators with more information about

immunisation and vaccines including ensuring availability of vaccines and make caregivers

aware of missed doses; and (b) extending clinic hours to include early evenings and

weekends.

Keywords: Road to Health Card; fully immunised under one year-old coverage; reasons for

missed vaccinations.


43

Introduction

Immunisation is one of the most powerful and cost-effective public health interventions to

prevent and control vaccine-preventable diseases (VPDs).[1] However, vaccines provide long-

term protection only when all the required doses are received.[2] Although the national annual

South African Expanded Programme on Immunisation (EPI-SA) official administrative fully

immunised under one year-old immunisation coverage (FIC) figures for the past 5 years are

relatively high,[3] they do not reach the 90% target set by the World Health Organization

(WHO)[1] and South Africa is still experiencing outbreaks of VPDs.[4,5] Also, the WHO and

United Nations Children’s Fund Estimates of National Immunization Coverage (WUENIC)

have been substantially lower than the official South African administrative coverage figures

for more than a decade.[6] In addition, the 2016 South African Demographic and Health

Survey reported an FIC of only 53%,[7] and there have been reports of sub-optimal FIC in

some areas of South Africa.[8,9,10,11,12] The current FIC definition for South Africa is the

proportion of children who have received a birth dose of Bacille Calmette-Guérin vaccine

(BCG); 2 doses of oral poliovirus vaccine (OPV) at 0 and 6 weeks; 3 doses of hexavalent

vaccine (DTaP-IPV-Hib-HepB [Diphtheria, tetanus, acellular pertussis, inactivated

poliovirus, Haemophilus influenzae type b, hepatitis B]) at 6, 10 and 14 weeks; 2 doses of

rotavirus vaccine (RV) at 6 and 14 weeks; 3 doses of pneumococcal conjugate vaccine (PCV)

at 6, 14 weeks and a booster dose at 9 months; and 1 dose of measles-containing vaccine

(MCV) at 6 months.[3,13]

There are a number of reasons or explanations suggested for low immunisation coverage in

South Africa. In a study on the key challenges experienced by EPI-SA, programme managers

reported insufficient knowledge of healthcare workers on vaccines and immunisation; parents

refusing vaccination because of anti-vaccination rumours; insufficient financial and human

resources at the facilities; and vaccine stock-outs, as some of the problems that they

encounter.[14] In support of some of these findings, vaccine shortages have been reported by a

number of surveys,[9,12,15] and vaccine hesitancy was found to be the cause of the 2017

measles outbreaks in Gauteng and KwaZulu-Natal.[4] In addition, lack of information (e.g.

caregiver unaware of missed immunisations);[8,9] facility obstacles (e.g. inconvenient time of

immunisation);[8] personal obstacles (e.g. the distance to the clinic being too far)[8] and lack of

motivation[8,12] were also reported by South African household surveys.

From 2010 to 2016, Gauteng Province reported FICs exceeding 100%[13] which suggests poor

data quality. Similarly, from 2010 to 2016, Tshwane district reported FICs above 90%.[13,16]

The bulk of Tshwane Region 5 is made up of the former Metsweding district, which was

incorporated into Tshwane district in 2011.[17] Metsweding’s FIC was 54% and 66% in

2004/05[18] and 2005/06[19], respectively. The Metsweding FIC enjoyed a vast improvement

since the National Department of Health (NDoH) made corrections to the population

estimates of children aged 12-23 months in 2005/06.[20] Remarkably, from 2006/07 until

2010/11, Metsweding district only failed to reach the 80% FIC district target in 2009/10.[21]

There are no community-based survey data validating the FIC in Metsweding district prior to

2011, nor in Tshwane Region 5 after the incorporation of Metsweding in 2011. This study

aimed to investigate immunisation coverage and reasons for non-vaccination of children

between the ages of 12-23 months from Tshwane Region 5, Gauteng Province.

Methods

Tshwane Region 5 is approximately 1 555 km² comprised of informal settlements, farms,

security estates, urban and rural areas.[17], with an estimated total population of 49 397.[22]

This descriptive household survey was adapted from the WHO’s vaccination coverage cluster


44

surveys Reference manual (WHO protocol).[23] The study population was caregivers of

children aged 12–23 months, who had spent the night prior to the survey in Tshwane Region

5 and were in possession of the child’s Road to Health Card (RtHC).

The sample size was obtained from the WHO protocol.[23] Assuming 50% FIC, with a desired

precision of ±5% (90% power) at 95% confidence and a design effect of 2 for 30 clusters, 26

eligible participants per cluster were to be sampled, thus giving a target of 780 participants.

Region 5 was divided into 30 clusters (~400-520 houses per cluster) based on the number of

households per residential area.[22] Adjacent areas with fewer households were combined to

form one cluster. Farms and security estates were not surveyed, because of anticipated

difficulty in gaining access.[10] The 30 clusters were made up of either existing extensions or

blocks bordered by roads (Table 1).

A map showing all Tshwane Region 5 households was obtained from the Town Planning

Department, City of Tshwane (CoT). The first household visited in each cluster was

randomly selected from the map using Research Randomiser Software® for clusters with

house numbers on the map. For informal settlements, the first house from the main road was

chosen as a starting point. Thereafter households from the right side were visited until the

target (26 successful cases in each cluster) was reached or all the households were visited. If

there was no-one home, the house was revisited the following day or weekend if the

neighbours reported that there was an eligible child in the house.

Two researcher-administered questionnaires, adapted from the WHO protocol[23] were used

to conduct interviews with the participants. There were two data collection teams each led by

a postgraduate student who was fluent in English and Setswana. The aim and objectives of

the study were explained to the caregivers and data collection commenced only after verbal

consent to participate was given. Participants were free to withdraw from the study at any

time.

The first questionnaire dealt with demographic data and immunisation status of the child. The

immunisation dates were obtained from the child’s RtHC. In addition, a cellular phone

camera was used to capture photographs of the children’s RtHCs and the photographs were

immediately sent to the study supervisor via electronic mail to allow real-time supervision.

The time, date and global positioning system co-ordinates were available in the properties of

the photograph.

A second questionnaire was administered only to caregivers of children who were not fully

immunised. The interviews were recorded to ensure that the responses were correctly

captured. One team used a cellular phone; the other team used a digital voice recorder. The

participants were asked to give reasons for partial- or non-vaccination. Their responses were

also captured in writing.

Data were collected daily for 30 days as per WHO protocol[23] starting from 02/07/2017 up to

and including 31/07/2017. Raw data from the cluster forms were captured on Microsoft Excel

(Microsoft Office 2013). The data were then compared with the photographs of the RtHCs

captured in the field. After validating the data with the photographs, they were cleaned, coded

and imported to Epi InfoTM 7 (Centers for Disease Control and Prevention, USA) for

descriptive statistical analysis.


45

The protocol was approved by the Sefako Makgatho Health Sciences University Research

Ethics Committee (SMUREC/P/69/2017:PG), and permission to conduct the study was

granted by the Tshwane Research Committee (NHRD NO: GP_2017RP13_814).


46

Table 1: Distribution of sample within 30 clusters in Tshwane Region 5

Site Cluster

Houses provided

by CoT

Accessible

houses

Houses

visited

Nobody

home

No child aged

12-23 months

Aged 12-23

months; no RtHC Eligible

Aged 12-23 months;

RtHC; No consent Successful

Onverwacht 1 428 336 336 6 312 2 16 1 15

Refilwe 2* 446 490 490 25 433 5 27 1 26

3 502 310 310 22 267 3 18 2 16

4 510 395 395 32 347 4 12 0 12

5* 497 497 369 75 259 7 28 2 26

6 492 355 355 45 283 0 27 2 25

7 482 306 306 6 282 1 17 2 15

8 460 298 298 23 252 6 17 2 15

9 489 337 337 5 316 5 11 1 10

10 467 394 394 17 346 3 28 4 24

11 428 221 221 17 188 3 13 1 12

12 456 156 156 11 135 4 6 0 6

13† 410 0

Cullinan 14 402 380 380 87 289 0 4 4 0

15 427 286 286 52 232 0 2 0 2

16 412 304 304 8 290 2 4 1 3

17‡ 386 0

Rayton 18 453 307 307 11 289 5 2 1 1

19 432 262 262 42 208 0 12 0 12

20 442 148 148 19 126 1 2 2 0

21 433 324 324 82 225 2 15 14 1

22 424 263 263 21 239 1 2 2 0

23‡ 426 0

Kameeldrift 24 502 363 363 99 242 3 19 5 14

25 522 450 450 109 318 5 18 1 17

26† 503 0

27† 490 0

28‡ 506 0

Baviaanspoort and

Roodeplaat

29 452 739 739 159 560 3 17 2 15

Derdepoort and

Roodeplaat

30 514 267 267 55 200 2 10 1 9

Total 13 793 8 188 8060 1028 6638 67 327 51 276 *Stopped surveying after target was reached (n = 26) †Clusters that could not be surveyed because they were made up of vacant / undeveloped numbered stands, which were only discovered during data collection ‡Clusters that could not be surveyed because they were made up of gated communities, which were only discovered during data collection


47

Results

The number of households provided by the CoT included vacant / undeveloped numbered

stands, which was discovered only during data collection. Hence there were only 24 clusters

instead of 30 (Table 1).

Of the houses visited, someone was found at home in 87.2% (7032/8060). Of these houses,

94.4% (6638/7032) did not have a child aged 12-23 months. A child aged 12-23 months old

had spent the previous night in 5.6% (394/7032) of these houses. Of these, an RtHC was

available for 83.0% (327/394). Of caregivers with RtHCs, 15.6% (51/327) refused to

participate. Of the missing RtHCs, 71.6% (48/67) were left at the crèche; 16.4% (11/67) were

left at home as the family was on vacation; and 11.9% (8/67) were lost. Of the caregivers of

eligible children, 84.4% (276/327) consented to participate in the study (Table 1).

The majority of children were Black (96.0% [265/276]) and female (56.5% [156/276]). Ages

ranged from 12.03 to 23.97 months, with a mean of 17.73 months, and a median of 17.75

months. Of the caregivers, 50.4% (139/276) were single; 25.0% (69/276) were co-habiting;

24.3% (67/276) were married; and 0.4% (1/276) were divorced. Also, 14.9% (41/276) had

tertiary education; 43.1% (119/276) completed secondary school; 38.8% (107/276)

completed primary school; 0.7% (2/276) had not completed primary school; and 1.8%

(5/276) had no education. Parents constituted 94.9% (262/276) of the caregivers; 4.3%

(12/276) were grandparents; 0.4% (1/276) was a sibling; and 0.4% (1/276) did not specify

any relationship.

The FIC was 78.6% (217/276), while 21.4 % (59/276) were partially immunised, i.e. having

missed at least one vaccine as per EPI-SA schedule. These 59 children had missed 123

vaccinations, with 39.0% (48/123) being missed by 6 children (Table 2).

Table 2: Frequency distribution of vaccines received and missed (n=276)

Number of

vaccines received

Number (%) of

children

Total vaccines

received Total missed

2 1 (0.4%) 2 13

5 1 (0.4%) 5 10

8 1 (0.4%) 8 7

9 3 (1.1%) 27 18

12 4 (1.4%) 48 12

13 14 (5.1%) 182 28

14 35 (12.7%) 490 35

15* 217 (78.6%) 3 255 0

Total 276 (100.0%) 4 017 123 *For FIC each child must receive a total of 15 vaccines

The coverage of individual vaccines is shown in Table 3. There were 9 children who missed

vaccinations because a subsequent dose of a vaccine was recorded on the RtHC when the

previous dose had not been administered, and these missed vaccinations were never caught

up at subsequent visits (Table 4). Table 5 shows the combinations of vaccinations received,

and the drop-out rates. The overall drop-out rate was 21.1% (58/275) (Table 5). Of the missed

vaccines, 76.4% (94/123) occurred from 14 weeks to 9 months.


48

Of the children who were not fully vaccinated, the majority of reasons given for the missed

vaccinations were related to health facility obstacles (34.1% [42/123]), followed by lack of

information (26.8% [33/123]), followed by personal obstacles (23.6% [29/123]), and lack of

motivation (15.4% [19/123]).

Table 3: The coverage of individual vaccines

Vaccine % 95% Confidence interval

OPV0 99.6 (98.0 – 99.9)

BCG 99.3 (97.4 – 99.9)

RV 1 99.3 (97.4 - 99.9)

Penta1 99.3 (97.4 - 99.9)

PCV1 98.9 (96.9 - 99.8)

Penta2 98.9 (96.9 - 99.8)

HepB1 98.6 (96.3 - 99.6)

HepB2 98.2 (96.3 - 99.6)

PCV2 97.5 (94.8 – 99.0)

RV 2 97.1 (94.4 - 98.7)

OPV1 97.1 (94.4 - 98.7)

HepB3 96.0 (93.0 – 98.0)

Penta3 95.7 (92.1 - 97.5)

Meas1 92.8 (89.0 - 95.5)

PCV3 87.3 (82.8 - 91.0)

Table 4: Subsequent dose recorded in the absence of a prior dose

Vaccine dose recorded

Age when

received Next vaccination opportunity missed*

RV2 without RV1 30.3 weeks The child would have been too old

Penta3 without Penta2 18.6 weeks Received PCV3 at 14.8 months

HepB2 without HepB1 14.3 weeks Received 2nd dose (recorded as HepB3) at 18.3 weeks;

received PCV3 at 8.4 months

HepB2 without HepB1 23.7 weeks Received 2nd dose (recorded as HepB3) at 19.7 weeks;

received PCV3 at 9 months

HepB3 without HepB2 18.6 weeks Received PCV3 at 14.8 months

HepB3 without HepB2 15.1 weeks Received PCV3 at 9 months

PCV2 without PCV1 15.0 weeks Received 2nd dose (recorded as PCV3) at 9 months

PCV2 without PCV1 13.0 weeks Received 2nd dose (recorded as PCV3) at 9.5 months

PCV3 without PCV2 9.7 months No vaccinations after this date

*The MCV given at 6 months of age in South Africa cannot be administered together with other vaccines, thus this visit

does not count as a missed vaccination opportunity for these vaccines.


49

Table 5: Frequencies of vaccination combinations and drop-out rates

Interval Vaccine combinations n (%) % Drop-out*

Birth OPV0 275 (99.6)

OPV0+BCG 273 (98.9) 0.7

6 weeks

OPV0+BCG+RV1 272 (98.6) 0.4

OPV0+BGC+RV1+Penta1 271 (98.2) 0.4

OPV0+BCG+RV1+Penta1+PCV1 269 (97.5) 0.7

OPV0+BCG+RV1+Penta1+PCV1+HepB1 267 (96.7) 0.7

OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1 262 (94.9) 1.9

10 weeks OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2 261 (94.6) 0.4

OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2 260 (94.2) 0.4

14 weeks

OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2+PCV2 256 (92.8) 1.5

OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2+PCV2+RV2 254 (92.0) 0.8

OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2+PCV2+RV2+HepB3 249 (90.2) 2.0

OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2+PCV2+RV2+HepB3+Penta3 248 (89.9) 0.4

6 months OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2+PCV2+RV2+HepB3+Penta3+MCV1 235 (85.1) 5.2

9 months OPV0+BCG+RV1+Penta1+PCV1+HepB1+OPV1+Penta2+HepB2+PCV2+RV2+HepB3+Penta3+MCV1+

PCV3

217 (78.6) 7.7

*The drop-out rate was calculated using the number of children who received the previous vaccine series in the schedule as the denominator. It is the percentage of children who

received the previous vaccination combination, who did not receive the next vaccination in the series.


50

Discussion

This study is the first household immunisation coverage survey to be conducted in Tshwane

Region 5 since the incorporation of Metsweding into the Tshwane district in 2011. The FIC

of 78.6% found in this study is very similar to the official FIC of 80.9% for Tshwane in

2016/2017.[3] While the FIC is just below the WHO district target of 80%,[1] it is far below

the NDoH national target of 92%.[3] Failure to achieve adequate immunisation coverage is a

major cause of outbreaks of VPDs.[4,5,9,11]

Individual vaccine coverage ranged from 99.6% (OPV0) to 87.3% (PCV3). The FIC is lower

than the coverage for the last vaccine in the schedule (i.e. PCV3). This indicates that there

may have been missed vaccination opportunities if the missed vaccines were available in the

clinic at the time of receiving PCV3, since PCV can be administered simultaneously with all

other vaccines except for MCV1. This also illustrates that using PCV3 coverage as a

surrogate marker for FIC is not advisable.

Nine of the 59 children who were not fully immunised had subsequent doses of vaccinations

recorded in their RtHCs in the absence of having received a prior dose. This shows that

vaccinators had administered vaccines only according to the age of the child when presenting

at the clinic, instead of also checking the RtHCs for missed vaccinations. Seven of these

children could have benefitted from catch-up vaccinations since they were still eligible for

these vaccines at a subsequent visit to the clinic for vaccination. These missed vaccination

opportunities would have been avoided if vaccinators were thoroughly checking the RtHCs,

as previously suggested by other studies conducted in South Africa.[8,9,12]

Some South African studies have reported that vaccination drop-out rates increase as children

grow older.[8,9,10,24] Tshwane Region 5 is not an exception as 76.4% of the missed

vaccinations occurred when the children were 14 weeks to nine months old. The overall drop-

out rate was 21.1%, with 5.2% and 7.7% drop-out rates at 6 and 9 months, in contrast to the

0.4% drop-out rate between vaccines scheduled at birth and 6 weeks of age (Table 5). A

study conducted in Ga-Rankuwa suggested that caregivers might not see the need to take

older children to the clinic, especially if the child is growing well.[11] However, in this study,

the caregiver being too busy and the inconvenient time of vaccination were cited as reasons

for non-vaccination with these later vaccines.

Inconvenient time of vaccination, accounting for 13% of missed vaccinations in this study,

falls under the category of facility obstacles, which at 34.1% was the most commonly

reported category of reasons for non-vaccination in this study. Inconvenient and restricted

immunisation times combined with long waiting times, were named as some of the reasons

given for non-vaccination of children in studies conducted in OR Tambo District (Eastern

Cape Province)[9] and Cape Town (Western Cape Province).[8]

The turnout to a 2017 vaccination catch-up campaign organised by Master of Pharmacy

students from the Public Health Pharmacy and Management Division of the School of

Pharmacy at Sefako Makgatho Health Sciences University, also shows that caregivers are

willing to have their children vaccinated. The campaign reached 1 081 children of whom

84.5% (914/1081) were vaccinated.[25] The success of the campaign, which took place on

Saturdays at shopping centres and taxi ranks, is an indication of the benefits of adjusting

vaccination times to include weekends.


51

A more prevalent facility obstacle identified in this study, was vaccine unavailability at the

healthcare facilities. These shortages were responsible for 16.2% of missed vaccinations,

affecting 16.7% of partially vaccinated children. A similar problem was reported by a study

conducted at Doctor George Mukhari Academic Hospital, where 62.3% of missed

vaccinations were due to vaccine unavailability.[12] Also, 56% of missed vaccinations were

caused by vaccine unavailability in a study conducted in OR Tambo district, Eastern Cape

Province.[9] In the current study, six vaccines were missed because a caregiver stopped taking

the child to the clinic for vaccination after being told on several occasions that the vaccines

were not available.

Caregivers’ lack of information, accounting for 26.8%, was another category of reasons

reported for non-vaccination in this study. These points to the importance of verbal

communication between vaccinators and caregivers to avoid vaccinations being missed

because caregivers were not aware that the child did not receive certain vaccines, the need for

further immunisations and the next date of immunisation. Caregivers not being aware the

child did not receive certain vaccines, accounting for 14.6% of missed vaccinations, was the

main reason reported under this category. In a study conducted in OR Tambo District

(Eastern Cape Province), 16% of the caregivers reported that they were not informed that the

child did not receive certain vaccines during scheduled immunisation visit.[9]

Studies conducted in Cape Town (Western Cape Province)[8] and OR Tambo District (Eastern

Cape Province).[9] also reported that caregivers were often unaware of the need for

immunisations. Similarly, 8.9% of caregivers in this study also reported being unaware of the

need for further immunisations as another reason for non-vaccination.

Other reasons for non-vaccination due to lack of information were that some caregivers were

unaware that they could take children to any clinic.[9] This was also a limitation to the study

because there were 11 caregivers who did not participate in the study as they had left the

RtHCs at home since they were on vacation. Also, unknown location of healthcare facility,

led to 3.3% of vaccines being missed in this study. As a result, 27 children could have been

vaccinated if the vaccinators had verbally communicated with the caregivers instead of only

recording in the RtHCs.

Of the 23.6% personal obstacles reported for non-vaccination in this study, 79.3% (23/29)

was due to the caregiver being too busy. While lack of motivation accounted for 15.4%

(19/123) of the reasons for non-vaccinations. In a study conducted in Cape Town (Western

Cape Province), 22.8% of caregivers reported being unable to attend the clinic.[8]

The majority of caregivers in this study were willing to vaccinate their children, with only

one caregiver having no faith in vaccination hence the child only received birth vaccines.

Also, another caregiver stopped taking the child for vaccinations after 10 weeks because she

had lost faith in the healthcare system.

While only 0.4% (1/276) of the caregivers showed vaccine hesitancy , the survey did not

include gated communities/security complexes, where caregivers may have higher rates of

internet access, which may result in higher rates of vaccine hesitancy and lower FIC rates.[26]

This is a major limitation of the study, and since the majority of people living in gated

communities are likely to use the private sector for vaccination services, as a result their

children’s coverage is not included in the official coverage figures. This might explain why


52

the results of the survey (78.3%) are close to the 80.9% 2016/17 FIC in Tshwane District,[3]

since these do not include private sector figures.

Furthermore, there were 245 households which could not be entered, despite there being

someone in the house, because (i) the gates were locked; (ii) there was no response from the

occupant; (iii) there were guard dogs in the yard. This further limits the interpretation of the

results of the study.

Another major limitation of the study was that the sample size of 780 was not reached.

However, it is important to note that the entire Region 5 had been divided into 30 clusters,

and the 6 clusters that could not be surveyed consisted of vacant / undeveloped numbered

stands and security villages / gated communities. Thus of the 13 794 household listed by

CoT, only 12 878 existed, while a further 1 846 were within gated communities, leaving 8

188 theoretically accessible households. Of these, 8 060 (98.4%) were visited during the

survey. Also, assuming 50% FIC, with a desired precision of ±10% (80% power) at 95%

confidence and a design effect of 2 for 30 clusters, only 7 eligible participants from each

cluster were needed to give a sample size of 210 participants. Thus despite this limitation, the

study is powered at greater than 80%, thus satisfying the statistical power requirement for a

sub-district survey.[23]

One of the reasons why no one was found in 1 028 houses, might be that some people were

on vacation, as this study was conducted during the school holidays. Of the 67 caregivers

who did not participate in the study despite there being a 12-23 month-old in the household,

88.1% (59/67) was because the RtHCs were currently not in their possession, while 11.9%

(8/67) had lost the RtHCs. This was also a concern in studies conducted in Cape Town

(Western Cape Province)[8] and OR Tambo District (Eastern Cape Province).[9] Both studies

reported that children without RtHCs were less likely to have been immunised and thus

having an impact on immunisation coverage, as clinic nurses require them for vaccinations to

be given.

On 8 March 2019, the NDoH launched a digital Road to Health Booklet (RtHB), a

Smartphone application which was developed by Jembi Health Systems. The application can

be downloaded for free onto android smartphones from the Google Play Store and it is

similar to the paper version of the RtHB,[28,29] which was launched in November 2017 by

NDoH.[30] In this study, 67 caregivers could have benefitted from this application as they

were excluded from the study because they did not have RtHCs with them.

In this study, 51 caregivers were not interested in participating in the study despite there

being a 12-23 month-old in the household. One of the reasons cited was that they were too

busy. Similarly, several caregivers refused to participate in a study conducted in Cape Town

(Western Cape Province) due to time constraints.[8] While others did not give reasons for non-

participation as also reported in a study conducted in Gauteng Province.[10] Caregivers were

also willing to participate in the study if a well-known person in the community accompanied

the data collectors,[10] even though the caregivers were not previously informed about the

impending survey.

The following recommendations for the improvement of FIC are directed to all the EPI-SA

stakeholders. These include healthcare workers, managers at various levels in the healthcare

system, health policy makers and researchers.


53

Providing programmes aimed at empowering vaccinators with more information about

immunisation and vaccines, including how to avoid missed vaccination opportunities and

making caregivers aware of any vaccines that were not administered. Also on how to

avoid or decrease vaccine stock-outs.

Educating the community on the importance of immunisation and always keeping the

RtHC with the child especially for overnight visits.

Facility managers to advocate for the extending of clinic hours to include early evenings

and at least one weekend per month. Also to offer immunisations daily and not only on

dedicated days.

Upgrading the MomConnect service to include immunisation visits in the short

messaging service (SMS) in order to remind caregivers about the date for next visit.

MomConnect is an interactive NDoH initiative whereby pregnant women are registered

on a database to receive weekly SMS messages regarding their pregnancy and until the

baby turns one year. MomConnect participants can also send free SMS messages to ask

questions.[27]

Conducting online surveys to reach caregivers in gated communities.

Conclusions

The 78.3% FIC is below the international district target of 80% set by the WHO, and can be

improved by addressing and taking into account the reasons for non-vaccinations especially

modifiable healthcare facility obstacles. These include extending operating hours of

healthcare facilities, offering vaccinations daily, training on stock control to avoid

unavailability of vaccines, making caregivers aware about missed doses and the return date

and updating MomConnect services to include details about immunisation visits as part of

SMS messages. The availability of the digital RtHB will help ensure that the caregivers

always have RtHBs with them.

While a low prevalence of vaccine hesitancy was found, the study did not include caregivers

living in security complexes / gated communities, who may be more affluent and educated;

and are more likely to have higher rates of vaccine hesitancy. Online surveys are

recommended to reach these caregivers.

More household surveys are required to provide insight into reasons for non-vaccination and

help validate official administrative immunisation coverage data collected at healthcare

facilities.

Acknowledgements: S Mahori, RN Montwedi and RT Motha for data collection, and T

Ndlovu for data collection training.

Conflict of interest: None.

Author contributions: JCM and RJB conceptualised the study. DNM developed the

protocol, under the supervision of JCM and RJB. DNM led one of the data collection teams,

captured the data and wrote the first draft of the manuscript. RJB and JCM conducted training

of data collectors and supervision of field work. VVN lead one of the data collection teams,

and validated the data capturing. RJB performed the statistical analysis. All others

contributed to the interpretation of the data and critically reviewed the manuscript.


54

Funding sources:

The National Research Foundation of South Africa

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3. Aung Y, Dlamini RN. 2017. Immunisation. In Massyn N, Padarath A, Peer N, Day C.

District Health Barometer 2016/17. Durban, SA: Health Systems Trust; 2017.

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alth%20Barometer%202016-2017.pdf [Accessed November 2018].

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surveillance-review-South-Africa-2017.pdf [Accessed 13 December 2018].

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[Accessed 13 December 2018].

6. World Health Organization (WHO). 2018. WHO/UNICEF review of national

immunization coverage, 1980-2017. Available at:

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December 2018].

7. National Department of Health (NDoH), Statistics South Africa (StatsSA), South

African Medical Research Council (SAMRC) and ICF. 2017. South Africa

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8. Corrigall J, Coetzee D, Cameron N. 2008. Is the Western Cape at risk of an outbreak

of preventable childhood diseases? Lessons from an evaluation of routine

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9. le Roux K, Akin-Olugbade O, Katzen LS et al. 2017. Immunisation coverage in the

rural Eastern Cape – are we getting the basics of primary care right? Results from a

longitudinal prospective cohort study. South African Medical Journal, 107(1): 52-55.

10. Fonn S, Sartorius B, Levin J, Likibi M. 2003. Immunisation coverage estimates by

cluster sampling survey of children (aged 12–23 months) in Gauteng province, 2003:

Southern African Journal of Epidemiology and Infection, 21(4): 164 – 169.

11. Wright SCD, Maja TMM, Furaha, S.A, 2011. The impact of mothers' knowledge on

the immunisation of children younger than five in Ga-Rankuwa, South Africa. Africa

Journal of Nursing and Midwifery, 13(2): 29-42.

12. Burnett RJ, Mmoledi G, Ngcobo NJ, Dochez C, Seheri LM, Mphahlele MJ. 2018.

Impact of vaccine stock-outs on infant vaccination coverage: a hospital-based survey

from South Africa. International Health, 10(5): 376-381.

http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/


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http://www.nicd.ac.za/wp-content/uploads/2018/09/Annual-measles-and-rubella-surveillance-review-South-Africa-2017.pdf

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13. Ramraj T, Chirinda W. 2016. Immunisation. In Massyn N, Peer N, English R,

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alth%20Barometer%202015_16.pdf [Accessed 13 December 2018].

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December 2018].

18. Barron P, Day C, Loveday M, Monticelli F, editors. 2005. The District Health

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2005/06. Durban: Health Systems Trust; December 2006. Available at:

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20. Monticelli F. 2007. Immunisation. In Barron P, Day C, Monticelli F, editors. District

Health Barometer 2006/07. Durban: Health Systems Trust; 2007. Available at:

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.pdf [Accessed 13 December 2018].

21. Jassat W. 2012. Immunisation. In Day C, Barron P, Massyn N, Padarath A, English R,

editors. District Health Barometer 2010/11. Durban: Health Systems Trust; 2012.

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-11lowres.pdf [Accessed 13 December 2018].

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http://www.statssa.gov.za/?page_id=1021&id=city-of-tshwane-municipality


23. World Health Organization (WHO). 2015. Vaccination coverage cluster surveys:

Reference manual. Available at:

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uster_survey_with_annexes.pdf?ua=1. [Accessed 13 December 2018].

24. Fadnes L, Jackson D, Engebretsen I et al. 2011. Vaccination coverage and timeliness

in three South African areas: a prospective study. BioMed Central Public Health, 11:

404-414.

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http://www.tshwane.gov.za/sites/regions/Pages/Region-5.aspx

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25. Meyer H and Moila T. 2018. Vaccination Catch-up Campaign: Multidisciplinary

teams led by public health pharmacists. South African Pharmacy Journal, 85(1): 16-

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26. Burnett R, Von Gogh L, Moloi M, François G. 2015. A profile of anti-vaccination

lobbying on the South African internet, 2011 - 2013. South African Medical Journal,

105(11): 922-926.

27. National Department of Health (NDoH). 2014. MomConnect. Available at:

http://www.kznhealth.gov.za/Momconnect/Booklet.pdf [Accessed 14 December

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28. National Department of Health (NDoH). 2019. Launch of the Digital Road to Health

Booklet. Available at: https://www.jembi.org/road-health-mobile-app/ [Accessed 16

April 2019].

29. Slemming W and Bamford L. 2018. The new Road to Health Booklet demands a

paradigm shift. South African Journal on Child Health, 12(3): 86-87

30. National Department of Health (NDoH). 2017. Under 5 Side-by-Side Campaign:

available at: https://za.usembassy.gov/wp-content/uploads/sites/19/1.-Side-by-Side-

Campaign_-Lesley-Bamford_NDoH.pdf [Accessed 25 April 2019].

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https://za.usembassy.gov/wp-content/uploads/sites/19/1.-Side-by-Side-Campaign_-Lesley-Bamford_NDoH.pdf

Chapter 5: Limitations, Recommendations and Conclusions

57

LIMITATIONS, RECOMMENDATIONS AND CONCLUSIONS

5.1 INTRODUCTION

Limitations encountered during the study are presented in Section 5.2 of this chapter.

Section 5.3 and Section 5.4 presents the recommendations based on the study results and

conclusions according to the study objectives, respectively.

5.2 LIMITATIONS OF THE STUDY

The number of households in Region 5

The number of households provided by the CoT included vacant / undeveloped stands. This

affected the number of clusters visited because the allocation of clusters was based on the

number of households. In the end, only 24 clusters were surveyed instead of the required

30.

However, it is important to note that the entire Region 5 had been divided into 30 clusters,

and the 6 clusters that could not be surveyed consisted of vacant / undeveloped stands and

security villages / gated communities.

Other clusters also had several security villages or gated communities where the survey

could not be conducted.

Access to households

There were 245 households which could not be entered, even when there was someone in

the house because (i) the gates were locked; (ii) there was no response from the occupant;

(iii) there were guard dogs in the yard

Households with no-one at home

There were 1028 houses where no-one was at home. This might be because the study was

conducted during the school holidays, and as a result some people might have been on

vacation as reported by some neighbours.


58

Caregivers not having the child’s RtHC with them

In this study, 67 caregivers did not participate despite there being a 12-23 month-old in the

household because (i) the RtHCs were either at the crèche or school and they will only

receive them when the schools re-open; (ii) the RtHCs were lost; and (iii) the RtHCs were

left at home as they were visiting.

Refusal to participate in the study

In total, 51 caregivers refused to participate in the study despite there being a 12-23 month-

old in the household. Some of the reasons they gave included (i) the fear of being reported

to the health authorities; (ii) the fear of their children being stolen; (iii) not being informed by

community leaders about the survey; (iv) no media reports about the survey; and (v) being

too busy.

Verification of information

There were some instances where shortage of vaccines in the local clinic could not be

verified as there was no indication of vaccine unavailability in the RtHC.

5.3 RECOMMENDATIONS

The following recommendations for the improvement of FIC are directed to all the

stakeholders in the EPI-SA i.e. HCWs, managers at various levels in the healthcare system,

health policy makers and the community for consideration:

Providing programmes aimed at empowering vaccinators with more information about

immunisation and vaccines; how to avoid missed opportunities and the importance of

professional conduct and a good non-judgmental attitude.

Educating the community on the importance of immunisation and always keeping the

RtHC with the child especially for overnight visits

Facility managers to advocate for the extending of clinic hours to include early evenings

and at least one weekend per month. Also to offer immunisations daily and not only on

dedicated days.

Upgrading the MomConnect service to include immunisation visits in the short

messaging service (SMS) in order to remind caregivers about the date for next visit.

MomConnect is an interactive NDoH initiative whereby pregnant women are registered

on a database to receive weekly SMS messages regarding their pregnancy and until the


59

baby turns one year. MomConnect participants can also send free SMS messages to

ask questions.

Conducting online surveys to reach caregivers in gated communities.

Ensuring availability of vaccines and making caregivers aware of missed doses and the

return date.

Extending clinic hours to include early evenings and at least one Saturday per month.

Offering immunisations daily and not only on dedicated days.

Upgrade the MomConnect service to include immunisation visits in the short messaging

service (SMS).

5.4 CONCLUSIONS

The 78.3% FIC is below the international district target of 80% set by the WHO, and can be

improved by addressing and taking into account the reasons for non-vaccinations especially

the modifiable healthcare facility obstacles. These include extending operating hours of

healthcare facilities, offering vaccinations daily, training on stock control to avoid

unavailability of vaccines, making caregivers aware about missed doses and the return date

and updating MomConnect service to include messages about immunisation visits in the

SMS. Communication with the caregivers needs to be reinforced as there were 26

caregivers who did not bring children to the clinic because of lack of information (i.e. being

unaware of the need to return for another dose and unaware that the child was not

immunised). The availability of the digital RtHB will also help ensure that the caregivers

always have RtHBs with them.

South Africa’s experience with the measles outbreak in 2003 - 2005, 2009 – 2010 and 2017

does not only demonstrate the compelling need to have our children vaccinated and to

maintain high immunisation coverage levels. It also points to the drop in social responsibility

in providing herd immunity for those children who experience vaccine failures or cannot be

vaccinated because: (I) of medical reasons; (II) they are too young to receive vaccination.

While a low prevalence of vaccine hesitancy was found, the study did not include caregivers

living in security complexes / gated communities, who may be more affluent and educated;

and are more likely to have higher rates of vaccine hesitancy. Online surveys are

recommended to reach these caregivers.


60

More household surveys are required to provide insight into reasons for non-vaccination and

help validate official administrative immunisation coverage data collected at healthcare

facilities.

The results of community-level surveys throughout South Africa can help strengthen the

WHO/UNICEF call for a large national survey.

References

61

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Albertyn C, Van Der Plas H, Hardie D, Candy S, Tomoka T, LeePan EB, Heckmann JM.

2011. Issues in public health: silent casualties from the measles outbreak in South Africa.

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Amponsah-Dacosta E, Lebelo RL, Rakgole JN, Burnett RJ, Selabe SG, Mphahlele MJ.

2014. Evidence for a change in the epidemiology of hepatitis B virus infection after nearly

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http://polioeradication.org/polio-today/polio-now/this-week/

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APPENDICES

Appendix 1A: Participant questionnaire Demographic information

Date: Participant’s number: Cluster number: Area:

Time: Marital status of the caregiver

Married

Race

African

Date of birth: Widowed Coloured

Gender Female Divorced White

Male Live with partner

Indian or Asian

Caregiver relationship with child

Parent Single Other

Grandparent Basic literacy of primary caregiver

No education

Sibling Primary school not completed

Other (specify)

Primary school completed

Secondary school completed

Age of the primary caregiver: Tertiary Education Received vaccinations

Mark with (x) at the corresponding answer

Immunisation coverage Received

Age Vaccine Date given Yes No Yes No Yes No

At birth BCG

OPV(0)

6 weeks

OPV(1)

RV(1)

DTaP-IPV/Hib(1)

Hep B(1)

PCV(1)

10 weeks DTaP-IPV/Hib(2)

Hep B(2)

14 weeks

RV(2)

DTaP-IPV/Hib(3)

Hep B(3)

PCV(2)

6 months Measles vaccine (1)

9 months PCV(3)

Immunisation status

Not immunised Partially immunised Fully immunised

Name of the interviewer Signature

Please proceed to appendix 2b if the child is not fully immunised.

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76

Appendix 1B: Participant questionnaire for partially- or non-immunised children

Date: Time: Cluster number: Participant’s number:

Reasons for partial or non-vaccination

If any vaccination has not been given, ask the participants to give the most important reason why the child did not receive all the vaccinations in the series. This is an open-ended questionnaire. Wait until the respondent answers in his/her own words. Do NOT read the list of possible answers. Prompt the participant until the real reasons are given.

Ask only one question: “I can see from the RtHC that the child is not fully immunised, can you please explain why the child is not fully immunised?”

Mark with (x) at the closest answer given

Lack of information

Unaware of the need to immunise

Unaware of the need to return for another dose

Fear of side effects

Wrong ideas about contraindications

Place and/or time of immunisation unknown

Other reasons

Lack of motivation

Postponed until another time

Cultural reasons

Religious reasons

Rumours about vaccinations

No faith in vaccinations

Other reasons

Obstacles

Time of immunisation inconvenient

Vaccine not available

Being told to return another time

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77

Mother too busy

Family problems including illness of the mother

Child ill – went to the health facility but not given

Child ill – did not go to the health facility

Long waiting time at the health facility

Other reasons

Additional information

Note: If it is felt that categorisation of possible responses may risk missing potentially important information from the respondents, the interviewer can simply write down verbatim the reply given by participant.

The survey supervisors and coordinator will later review all responses and decide on appropriate categories for presentation of the analysis.

Name of the interviewer

Signature

THANK YOU FOR YOUR PARTICIPATION

Appendices

78

Appendix 2: SMUREC clearance certificate

Appendices

79

Appendix 3: City of Tshwane clearance certificate

Appendices

80

Appendix 4: SAMJ Author Guidelines

Author Guidelines

The SAMJ has launched a new submission and tracking system. Authors will be required to

register a profile on the Editorial Manager platform in order to submit a manuscript.

To submit a manuscript, please proceed to the SAMJ Editorial Manager website:

www.editorialmanager.com/samj

To access and submit an article already in production, please see the guidelines here.

Author Guidelines

Please view the Author Tutorial for guidance on how to submit on Editorial Manager.

Please take the time to familiarise yourself with the policies and processes below. If you still

have any questions, please do not hesitate to ask our editorial staff (tel.: +27 (0)21 532

1281, email: [email protected]).

SAMJ Policies

Type of articles considered by the SAMJ

The SAMJ will no longer limit the articles accepted to those that have ‘general medical

content’, but is intending to capture the spectrum of medical and health sciences, grouped

by relevance to the country’s burdens of disease. This content will include research in the

social sciences and economics that is relevant to the medical issues around our burden of disease. Please see ‘A new vision for the SAMJ – and a call for papers’ for a full discussion of the new

directions for the SAMJ.

We accept the following types of articles:

Research

Reviews

Clinical trials

Editorials

In Practice (Previously Forum incl. Case Reports)

Correspondence

Obituaries

Book reviews

Ad hoc supplements e.g. guidelines, conference/congress abstracts, Festschrifts*

The following articles are by invitation only:

Guest editorial

Continuing Medical Education (CME)

*Contact [email protected] for information on submitting ad hoc/commissioned

supplements, including guidelines, conference/congress abstracts, Festschrifts, etc.

Publication Fees

All articles published in the South African Medical Journal are open access and freely

available online upon publication. This is made possible by applying a business model to

offset the costs of peer review management, copyediting, design and

production, by charging a publication fee of R5 250 (ex vat) for each research article

published. The charge applies only to Research articles submitted after 1 March 2017. The

http://www.editorialmanager.com/samj

http://www.samj.org.za/_sub/SAMJ%20Production%20Steps.pdf

https://www.editorialmanager.com/nci/accounts/author_tutorial.pdf

http://www.samj.org.za/index.php/samj/article/view/10817/7262

http://www.samj.org.za/index.php/samj/about/submissions#Research

http://www.samj.org.za/index.php/samj/about/submissions#Review_articles

http://www.samj.org.za/index.php/samj/about/submissions#Clinical_Trials

http://www.samj.org.za/index.php/samj/about/submissions#Editorials

http://www.samj.org.za/index.php/samj/about/submissions#In_Practice

http://www.samj.org.za/index.php/samj/about/submissions#Correspondence

http://www.samj.org.za/index.php/samj/about/submissions#Obituaries

http://www.samj.org.za/index.php/samj/about/submissions#Book_reviews

http://www.samj.org.za/index.php/samj/about/submissions#Sponsored_supplements

Appendices

81

publication fee is standard and does not vary based on length, colour, figures, or other

elements.

When submitting a Research article to the SAMJ, the submitting author must agree to pay

the publication fee should the article be accepted for publication. The publicaiton fee is

payable when your manuscript is editorially accepted and before production commences for

publication. The submitting author will be notified that payment is due and given details on

the available methods of payment. Prompt payment is advised; the article will not enter into

production until payment is received.

Queries can be directed to [email protected].

Please refer to the section on ‘Sponsored Supplements’ regarding the publication of

supplements, where a charge is applicable. Queries can be directed to [email protected]

or [email protected]

Authorship

Named authors must consent to publication. Authorship should be based on: (i) substantial

contribution to conceptualisation, design, analysis and interpretation of data; (ii) drafting or

critical revision of important scientific content; or (iii) approval of the version to be

published. These conditions must all be met (uniform requirements for manuscripts

submitted to biomedical journals; refer to www.icmje.org)

If authors’ names are added or deleted after submission of an article, or the order of the

names is changed, all authors must agree to this in writing.

Please note that co-authors will be requested to verify their contribution upon submission.

Non-verification may lead to delays in the processing of submissions.

Author contributions should be listed/described in the manuscript.

Conflicts of interest

Conflicts of interest can derive from any kind of relationship or association that may

influence authors’ or reviewers’ opinions about the subject matter of a paper. The existence

of a conflict – whether actual, perceived or potential – does not preclude publication of an

article. However, we aim to ensure that, in such cases, readers have all the information they

need to enable them to make an informed assessment about a publication’s message and

conclusions. We require that both authors and reviewers declare all sources of support for

their research, any personal or financial relationships (including honoraria, speaking fees,

gifts received, etc) with relevant individuals or organisations connected to the topic of the

paper, and any association with a product or subject that may constitute a real, perceived or

potential conflict of interest. If you are unsure whether a specific relationship constitutes a

conflict, please contact the editorial team for advice. If a conflict remains undisclosed and is

later brought to the attention of the editorial team, it will be considered a serious issue

prompting an investigation with the possibility of retraction.

Research ethics committee approval

Authors must provide evidence of Research Ethics Committee approval of the research where

relevant. Ensure the correct, full ethics committee name and reference number is included in the manuscript.



http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

Appendices

82

If the study was carried out using data from provincial healthcare facilities, or required active

data collection through facility visits or staff interviews, approval should be sought from the

relevant provincial authorities. For South African authors, please refer to the guidelines for submission to the National Health Research Database. Research involving human subjects must be

conducted according to the principles outlined in the Declaration of Helsinki. Please refer to the National Department of Health’s guideline on Ethics in Health research: principles, processes and structuresto ensure that the appropriate requirements for conducting research have been met,

and that the HPCSA’s General Ethical Guidelines for Health Researchershave been adhered to.

Protection of rights to privacy

Patient

Information that would enable identification of individual patients should not be published in

written descriptions, photographs, and pedigrees unless the information is essential for

scientific purposes and the patient (or parent or guardian) has given informed written

consent for publication and distribution. We further recommend that the published article is

disseminated not only to the involved researchers but also to the patients/participants from

whom the data was drawn. Refer to Protection of Research Participants. The signed consent form

should be submitted with the manuscript to enable verification by the editorial team.

Other individuals

Any individual who is identifiable in an image must provide written agreement that the image

may be used in that context in the SAMJ.

Copyright notice

Copyright remains in the Author’s name. The work is licensed under a Creative Commons

Attribution - Noncommercial Works License. Authors are required to complete and sign

an Author Agreement form that outlines Author and Publisher rights and terms of

publication. The Author Agreement form should be uploaded along with other submissions

files and any submission will be considered incomplete without it.

Material submitted for publication in the SAMJ is accepted provided it has not been published

or submitted for publication elsewhere. Please inform the editorial team if the main findings

of your paper have been presented at a conference and published in abstract form, to avoid

copyright infringement. The SAMJ does not hold itself responsible for statements made by

the authors.

Previously published images

If an image/figure has been previously published, permission to reproduce or alter it must be

obtained by the authors from the original publisher and the figure legend must give full

credit to the original source. This credit should be accompanied by a letter indicating that

permission to reproduce the image has been granted to the author/s. This letter should be

uploaded as a supplementary file during submission.

Privacy statement

The SAMJ is committed to protecting the privacy of its website and submission system users.

The names, personal particulars and email addresses entered in the website or submission

system will not be made available to third parties without the user’s permission or due process. By registering to use the website or submission system, users consent to receive

communication from the SAMJ or its publisher HMPG on matters relating to the journal or

http://nhrd.hst.org.za/Home/Index

http://www.mrc.ac.za/ethics/DOHEthics.pdf

http://www.mrc.ac.za/ethics/DOHEthics.pdf

http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_6_gen_ethical_guidelines_for_researchers.pdf

http://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html

http://www.samj.org.za/_sub/Image%20Release%20Form.pdf

https://creativecommons.org/licenses/by-nc/4.0/

https://creativecommons.org/licenses/by-nc/4.0/

http://www.samj.org.za/_sub/Author%20Agreement%20Form.pdf

http://www.samj.org.za/_sub/Author%20Agreement%20Form.pdf

Appendices

83

associated publications. Queries with regard to privacy may be directed to

[email protected].

Ethnic/race classification

Use of racial or ethnicity classifications in research is fraught with problems. If you choose to

use a research design that involves classification of participants based on race or ethnicity,

or discuss issues with reference to such classifications, please ensure that you include a

detailed rationale for doing so, ensure that the categories you describe are carefully defined,

and that socioeconomic, cultural and lifestyle variables that may underlie perceived racial

disparities are appropriately controlled for. Please also clearly specify whether race or

ethnicity is classified as reported by the patient (self-identifying) or as perceived by the

investigators. Please note that is not appropriate to use self-reported or investigator-

assigned racial or ethnic categories for genetic studies.

Continuing Professional Development (CPD)

SAMJ is an HPCSA-accredited service provider of CPD materials. Principal authors can earn

up to 15 CPD continuing education units (CEUs) for publishing an article; co-authors are

eligible to earn up to 5 CEUs; and reviewers of articles can earn 3 CEUs. Each

month, SAMJ also publishes a CPD-accredited questionnaire relating to the academic content

of the journal. Successful completion of the questionnaire with a pass rate of 70% will earn

the reader 3 CEUs. Administration of our CPD programme is managed by Medical Practice

Consulting. To complete questionnaires and obtain certificates, please visit MRP Consulting

Manuscript preparation

Preparing an article for anonymous review

To ensure a fair and unbiased review process, all submissions are to include an anonymised

version of the manuscript. The exceptions to this are Correspondence, Book reviews and

Obituary submissions.

Submitting a manuscript that needs additional blinding can slow down your review process,

so please be sure to follow these simple guidelines as much as possible:

An anonymous version should not contain any author, affiliation or particular institutional

details that will enable identification.

Please remove title page, acknowledgements, contact details, funding grants to a named

person, and any running headers of author names.

Mask self-citations by referring to your own work in third person.

General article format/layout

Accepted manuscripts that are not in the correct format specified in these guidelines will be

returned to the author(s) for correction, which will delay publication.

General:

Manuscripts must be written in UK English.

https://www.mpconsulting.co.za/

Appendices

84

The manuscript must be in Microsoft Word format. Text must be single-spaced, in 12-

point Times New Roman font, and contain no unnecessary formatting (such as text in

boxes).

Please make your article concise, even if it is below the word limit.

Qualifications, full affiliation (department, school/faculty, institution, city, country) and

contact details of ALL authors must be provided in the manuscript and in the online

submission process.

Abbreviations should be spelt out when first used and thereafter used consistently, e.g.

'intravenous (IV)' or 'Department of Health (DoH)'.

Include sections on Acknowledgements, Conflict of Interest, Author Contributions and

Funding sources. If none is applicable, please state ‘none’.

Scientific measurements must be expressed in SI units except: blood pressure (mmHg)

and haemoglobin (g/dL).

Litres is denoted with an uppercase L e.g. 'mL' for millilitres).

Units should be preceded by a space (except for % and ºC), e.g. '40 kg' and '20 cm' but

'50%' and '19ºC'.

Please be sure to insert proper symbols e.g. µ not u for micro, a not a for alpha, b not B

for beta, etc.

Numbers should be written as grouped per thousand-units, i.e. 4 000, 22 160.

Quotes should be placed in single quotation marks: i.e. The respondent stated: '...'

Round brackets (parentheses) should be used, as opposed to square brackets, which are

reserved for denoting concentrations or insertions in direct quotes.

If you wish material to be in a box, simply indicate this in the text. You may use the

table format –this is the only exception. Please DO NOT use fill, format lines and so on.

SAMJ is a generalist medical journal, therefore for articles covering genetics, it is the

responsibility of authors to apply the following:

- Please ensure that all genes are in italics, and proteins/enzymes/hormones are not.

- Ensure that all genes are presented in the correct case e.g. TP53 not Tp53.

**NB: Copyeditors cannot be expected to pick up and correct errors wrt the above, although

they will raise queries where concerned.

- Define all genes, proteins and related shorthand terms at first mention, e.g. ‘188del11’ can

be glossed as ‘an 11 bp deletion at nucleotide 188.’

- Use the latest approved gene or protein symbol as appropriate:

Human Gene Mapping Workshop (HGMW): genetic notations and symbols

HUGO Gene Nomenclature Committee: approved gene symbols and nomenclature

OMIM: Online Mendelian Inheritance in Man (MIM) nomenclature and instructions

Bennet et al. Standardized human pedigree nomenclature: Update and assessment of

the recommendations of the National Society of Genetic Counselors. J Genet Counsel

2008;17:424-433: standard human pedigree nomenclature.

Preparation notes by article type

Research

Guideline word limit: 4 000 words

Research articles describe the background, methods, results and conclusions of an original

research study. The article should contain the following sections: introduction, methods,

results, discussion and conclusion, and should include a structured abstract (see below). The

introduction should be concise – no more than three paragraphs – on the background to the

research question, and must include references to other relevant published studies that

clearly lay out the rationale for conducting the study. Some common reasons for conducting

a study are: to fill a gap in the literature, a logical extension of previous work, or to answer

an important clinical question. If other papers related to the same study have been published

Appendices

85

previously, please make sure to refer to them specifically. Describe the study methods in as

much detail as possible so that others would be able to replicate the study should they need

to. Results should describe the study sample as well as the findings from the study itself, but

all interpretation of findings must be kept in the discussion section, which should consider

primary outcomes first before any secondary or tertiary findings or post-hoc analyses. The

conclusion should briefly summarise the main message of the paper and provide

recommendations for further study.

Select figures and tables for your paper carefully and sparingly. Use only those figures that

provided added value to the paper, over and above what is written in the text.

Do not replicate data in tables and in text .

Structured abstract

This should be 250-400 words, with the following recommended headings:

o Background: why the study is being done and how it relates to other published work.

o Objectives: what the study intends to find out

o Methods: must include study design, number of participants, description of the

intervention, primary and secondary outcomes, any specific analyses that were done on

the data.

o Results: first sentence must be brief population and sample description; outline the

results according to the methods described. Primary outcomes must be described first,

even if they are not the most significant findings of the study.

o Conclusion: must be supported by the data, include recommendations for further

study/actions.

Please ensure that the structured abstract is complete, accurate and clear and has been

approved by all authors.

Do not include any references in the abstracts.

Here is an example of a good abstract.

Main article

All articles are to include the following main sections: Introduction/Background, Methods,

Results, Discussion, Conclusions.

The following are additional heading or section options that may appear within these:

Objectives (within Introduction/Background): a clear statement of the main aim of the

study and the major hypothesis tested or research question posed

Design (within Methods): including factors such as prospective, randomisation, blinding,

placebo control, case control, crossover, criterion standards for diagnostic tests, etc.

Setting (within Methods): level of care, e.g. primary, secondary, number of participating

centres.

Participants (instead of patients or subjects; within Methods): numbers entering and

completing the study, sex, age and any other biological, behavioural, social or cultural

factors (e.g. smoking status, socioeconomic group, educational attainment, co-existing

disease indicators, etc)that may have an impact on the study results. Clearly define how

participants were enrolled, and describe selection and exclusion criteria.

Interventions (within Methods): what, how, when and for how long. Typically for

randomised controlled trials, crossover trials, and before and after studies.

Main outcome measures (within Methods): those as planned in the protocol, and those

ultimately measured. Explain differences, if any.

http://www.samj.org.za/index.php/samj/article/view/9932

Appendices

86

Results

Start with description of the population and sample. Include key characteristics of

comparison groups.

Main results with (for quantitative studies) 95% confidence intervals and, where

appropriate, the exact level of statistical significance and the number need to treat/harm.

Whenever possible, state absolute rather than relative risks.

Do not replicate data in tables and in text.

If presenting mean and standard deviations, specify this clearly. Our house style is to

present this as follows:

E.g.: The mean (SD) birth weight was 2 500 (1 210) g. Do not use the ± symbol for

mean (SD).

Leave interpretation to the Discussion section. The Results section should just report the

findings as per the Methods section.

Discussion

Please ensure that the discussion is concise and follows this overall structure – sub-headings

are not needed:

Statement of principal findings

Strengths and weaknesses of the study

Contribution to the body of knowledge

Strengths and weaknesses in relation to other studies

The meaning of the study – e.g. what this study means to clinicians and policymakers

Unanswered questions and recommendations for future research

Conclusions

This may be the only section readers look at, therefore write it carefully. Include primary

conclusions and their implications, suggesting areas for further research if appropriate. Do

not go beyond the data in the article.

Guidelines

Guidelines should always be discussed with the Editor prior to submission.

Because of the intensive review process required to ensure Guidelines are independent,

evidence-based and free from commercial bias, they are usually published as a supplement

to the SAMJ, the costs of which must be covered by sponsorship, advertising or payment by

the guideline authors/association. We will provide a quote based on the expected length of

the guideline and whether it is to appear online only, or in print, which must be accepted by

the body putting the guidelines together before submitting the work to the SAMJ.

The Editor reserves the right to determine the scheduling of supplements. Understandably, a

delay in publication must be anticipated dependent upon editorial workflow.

All guidelines should include a clear, transparent statement about all sources of funding and

an explicit, clear statement of conflicts of interest of any of the participants in the guidelines

about industry funding for lectures, research, conference participation etc.

All guidelines should be structured according to Agree II.

Please access this website before putting the guidelines together, download the Agree 11

instrument and use this to put the guidelines together.

All submitted guidelines will be sent to the local Agree II appraisal committee for review and

must be endorsed by an appropriate body prior to consideration and all conflicts of interest

expressed.

http://www.agreetrust.org/agree-ii

Appendices

87

A structured abstract not exceeding 400 words (recommended sub-headings: Background,

Recommendations, Conclusion) is required. Sections and sub-sections must be numbered

consecutively (e.g. 1. Introduction; 1.1 Definitions; 2.etc.) and summarised in a Table of

Contents.

Illustrations/photos/scans

If illustrations submitted have been published elsewhere, the author(s) should provide

consent to republication obtained from the copyright holder.

Figures must be numbered in Arabic numerals and referred to in the text e.g. '(Fig. 1)'.

Each figure must have a caption/legend: Fig. 1. Description (any abbreviations in full).

All images must be of high enough resolution/quality for print.

All illustrations (graphs, diagrams, charts, etc.) must be in PDF or jpeg form.

Ensure all graph axes are labelled appropriately, with a heading/description and units (as

necessary) indicated. Do not include decimal places if not necessary e.g. 0; 1.0; 2.0;

3.0; 4.0 etc.

Scans/photos showing a specific feature e.g. Intermediate magnification micrograph of a

low malignant potential (LMP) mucinous ovarian tumour. (H&E stain). –include an arrow

to show the tumour.

Each image must be attached individually as a 'supplementary file' upon submission (not

solely embedded in the accompanying manuscript) and named Fig. 1, Fig. 2, etc.

Tables

Tables should be constructed carefully and simply for intelligible data representation.

Unnecessarily complicated tables are strongly discouraged.

Large tables will generally not be accepted for publication in their entirety. Please

consider shortening and using the text to highlight specific important sections, or offer a

large table as an addendum to the publication, but available in full on request from the

author

Embed/include each table in the manuscript Word file - do not provide separately as

supplementary files.

Number each table in Arabic numerals (Table 1, Table 2, etc.) and refer to consecutively

in the text.

Tables must be cell-based (i.e. not constructed with text boxes or tabs) and editable.

Ensure each table has a concise title and column headings, and include units where

necessary.

Footnotes must be indicated with consecutive use of the following symbols: * † ‡ § ¶ ||

then ** †† ‡‡ etc.

Do not: Use [Enter] within a row to make ‘new rows’:

Rather:

Each row of data must have its own proper row:

Do not: use separate columns for n and %:

Rather:

Combine into one column, n (%):

Do not: have overlapping categories, e.g.:

Rather:

Use <> symbols or numbers that don’t overlap:

Appendices

88

References

NB: Only complete, correctly formatted reference lists in Vancouver style will be

accepted. Reference lists must be generated manually and not with the use of reference

manager software. Endnotes must not be used.

Authors must verify references from original sources.

Citations should be inserted in the text as superscript numbers between square brackets,

e.g. These regulations are endorsed by the World Health Organization,[2] and others.[3,4-6]

All references should be listed at the end of the article in numerical order of appearance

in the Vancouver style (not alphabetical order).

Approved abbreviations of journal titles must be used; see the List of Journals in Index Medicus.

Names and initials of all authors should be given; if there are more than six authors, the

first three names should be given followed by et al.

Volume and issue numbers should be given.

First and last page, in full, should be given e.g.: 1215-1217 not 1215-17.

Wherever possible, references must be accompanied by a digital object identifier (DOI) link). Authors are encouraged to use the DOI lookup service offered by CrossRef:

o On the Crossref homepage, paste the article title into the ‘Metadata search’ box.

o Look for the correct, matching article in the list of results.

o Click Actions > Cite

o Alongside 'url =' copy the URL between { }.

o Provide as follows, e.g.: https://doi.org/10.7196/07294.937.98x

Some examples:

Journal references: Price NC, Jacobs NN, Roberts DA, et al. Importance of asking about

glaucoma. Stat Med 1998;289(1):350-355. http://dx.doi.org/10.1000/hgjr.182

Book references: Jeffcoate N. Principles of Gynaecology. 4th ed. London: Butterworth,

1975:96-101.

Chapter/section in a book: Weinstein L, Swartz MN. Pathogenic Properties of Invading

Microorganisms. In: Sodeman WA, Sodeman WA, eds. Pathologic Physiology:

Mechanisms of Disease. Philadelphia: WB Saunders, 1974:457-472.

Internet references: World Health Organization. The World Health Report 2002 -

Reducing Risks, Promoting Healthy Life. Geneva: WHO, 2002.

http://www.who.int/whr/2002 (accessed 16 January 2010).

Legal references

• Government Gazettes:

National Department of Health, South Africa. National Policy for Health Act, 1990 (Act No.

116 of 1990). Free primary health care services. Government Gazette No. 17507:1514.

1996.

In this example, 17507 is the Gazette Number. This is followed by :1514 - this is the notice

number in this Gazette.

• Provincial Gazettes:

Gauteng Province, South Africa; Department of Agriculture, Conservation, Environment and

Land Affairs. Publication of the Gauteng health care waste management draft regulations.

Gauteng Provincial Gazette No. 373:3003, 2003.

• Acts:

South Africa. National Health Act No. 61 of 2003.

• Regulations to an Act:

South Africa. National Health Act of 2003. Regulations: Rendering of clinical forensic medicine services. Government Gazette No. 35099, 2012. (Published under Government

Notice R176).

http://www2.bg.am.poznan.pl/czasopisma/medicus.php?lang=eng

http://www2.bg.am.poznan.pl/czasopisma/medicus.php?lang=eng

http://www.crossref.org/

http://dx.doi.org/10.7196/07294.937.98x

Appendices

89

• Bills:

South Africa. Traditional Health Practitioners Bill, No. B66B-2003, 2006.

• Green/white papers:

South Africa. Department of Health Green Paper: National Health Insurance in South Africa.

2011.

• Case law:

Rex v Jopp and Another 1949 (4) SA 11 (N)

Rex v Jopp and Another: Name of the parties concerned

1949: Date of decision (or when the case was heard)

(4): Volume number

SA: SA Law Reports

11: Page or section number

(N): In this case Natal - where the case was heard. Similarly, (C) woud indicate Cape, (G)

Gauteng, and so on.

NOTE: no . after the v

Other references (e.g. reports) should follow the same format: Author(s). Title. Publisher

place: Publisher name, year; pages.

Cited manuscripts that have been accepted but not yet published can be included as

references followed by '(in press)'.

Unpublished observations and personal communications in the text must not appear in

the reference list. The full name of the source person must be provided for personal

communications e.g. '...(Prof. Michael Jones, personal communication)'.

investigation of vaccination coverage in children …

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