INVESTIGATION OF VACCINATION COVERAGE IN CHILDREN …
Transcript of 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
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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.
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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.
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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
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LIST OF FIGURES
Figure 1.1: Outline of the dissertation ........................................................................... 5
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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
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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
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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.
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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
Chapter 1: Introduction
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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).
Chapter 1: Introduction
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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
Chapter 1: Introduction
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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
Chapter 1: Introduction
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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?
Chapter 1: Introduction
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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
Chapter 1: Introduction
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
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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.
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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
Chapter 2: Literature Review
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
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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
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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
Chapter 2: Literature Review
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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12
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).
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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
Chapter 2: Literature Review
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).
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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).
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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).
Chapter 2: Literature Review
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).
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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
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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-
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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).
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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.
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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).
Chapter 2: Literature Review
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
Chapter 2: Literature Review
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.
Chapter 3: Methodology
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
Chapter 3: Methodology
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
Chapter 3: Methodology
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
Chapter 3: Methodology
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.
Chapter 3: Methodology
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.
Chapter 3: Methodology
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.
Chapter 4: Results and Discussion
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
Chapter 4: Results and Discussion
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,
Sefako Makgatho Health Sciences University
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,
Sefako Makgatho Health Sciences University
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
Chapter 4: Results and Discussion
41
Cell: +27 83 636 3931
Email: [email protected]
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
Email: [email protected]
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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).
Chapter 4: Results and Discussion
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
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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.
Chapter 4: Results and Discussion
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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rubella surveillance review, South Africa, 2017. Available at:
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surveillance-review-South-Africa-2017.pdf [Accessed 13 December 2018].
5. National Institute for Communicable Diseases (NICD). 2017. Vaccine-preventable
diseases: Diphtheria outbreak in the Western Cape Province. Available at:
http://www.nicd.ac.za/index.php/update-diphtheria-confirmed-in-the-western-cape/
[Accessed 13 December 2018].
6. World Health Organization (WHO). 2018. WHO/UNICEF review of national
immunization coverage, 1980-2017. Available at:
http://www.who.int/immunization/monitoring_surveillance/data/zaf.pdf [Accessed 13
December 2018].
7. National Department of Health (NDoH), Statistics South Africa (StatsSA), South
African Medical Research Council (SAMRC) and ICF. 2017. South Africa
Demographic and Health Survey 2016. Key Indicator Report. Available at:
http://www.statssa.gov.za/publications/Report%2003-00-09/Report%2003-00-
092016.pdf [Accessed 13 December 2018].
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
immunization coverage. South African Medical Journal, 98(1): 41-45.
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.
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13. Ramraj T, Chirinda W. 2016. Immunisation. In Massyn N, Peer N, English R,
Padarath A, Barron P, Day C, editors. District Health Barometer 2015/16. Durban:
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alth%20Barometer%202015_16.pdf [Accessed 13 December 2018].
14. Wiysonge C, Ngcobo N, Jeena P et al. 2012. Advances in childhood immunization in
South Africa: where to now? Programme managers’ views and evidence from
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15. Ngcobo NJ, Kamupira MG. 2017. The status of vaccine availability and associated
factors in Tshwane government clinics. South African Medical Journal, 107(6): 535-
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16. Bamford L. 2015. Immunisation. In Massyn N, Peer N, Padarath A, Barron P, Day C.
District Health Barometer 2014/15. Durban: Health Systems Trust; October 2015.
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20. Monticelli F. 2007. Immunisation. In Barron P, Day C, Monticelli F, editors. District
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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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23. World Health Organization (WHO). 2015. Vaccination coverage cluster surveys:
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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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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:
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Campaign_-Lesley-Bamford_NDoH.pdf [Accessed 25 April 2019].
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.
Chapter 5: Limitations, Recommendations and Conclusions
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
Chapter 5: Limitations, Recommendations and Conclusions
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.
Chapter 5: Limitations, Recommendations and Conclusions
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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b (Hib) vaccine introduction in South Africa. Bulletin of the World Health Organization 2006;
84(10): 811-818. Available at: http://www.who.int/bulletin/volumes/84/10/06-030361.pdf
[Accessed 12 December 2018].
World Health Organization (WHO). 2006c. Standards for maternal and neonatal care:
Integrated management of pregnancy and childbirth (IMPAC). Department of Making
Pregnancy Safer (MPS), WHO. Available at:
http://archives.who.int/making_pregnancy_safer/publications/Standards1.5N.pdf [Accessed
12 December 2018].
World Health Organization (WHO). 2004. WHO position paper: BCG vaccine. Weekly
Epidemiological Record, 79(4), pp. 27-38.
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.
References
75
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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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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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
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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
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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]
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.
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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
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83
associated publications. Queries with regard to privacy may be directed to
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.
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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
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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.
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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.
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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:
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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).
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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)'.