Master’s Thesis Medical Anthropology and Sociology Graduate School of Social Sciences
Extending national immunization programmes: The case of varicella vaccination in the European Union
Victoria Szerényke Boehm
Amsterdam, 7th August 2020
Student ID number: 12757152 Contact: [email protected] Supervisor: Dr. Stuart Blume Second reader: Dr. Danny de Vries
Science appears calm and triumphant when it is completed; but science in the process of being done is only contradiction and torment, hope and disappointment.
- Pierre Paul Émile Roux, French physician, bacteriologist, and immunologist and developer of the first effective treatment for diphtheria1
1 as cited in Plotkin, 2009 2
Abstract
The idea that, like medicine, health policymaking should be evidence-based has gained wide popularity and support. This is also the case for immunization policies. Despite the claim that the decision to include new vaccines in national immunization programmes is rational and based on objective evidence, countries often react very differently to new vaccines. Against this background, the question arises how and why vaccines are introduced into immunization programmes. The case of varicella/chickenpox vaccination is peculiar in this respect. Even though it has been available for thirty years and a wide range of evidence is accessible and despite a trend towards harmonizing vaccination programmes in the European Union, countries reach different conclusions about the vaccine. Historical research on the introduction of vaccines suggests that in addition to evidence, politics, perceptions, as well as public and professional opinions influence immunization policymaking. Drawing from that, this thesis explores why and how vaccines are included in national immunization programmes through the case of varicella decision-making in Germany, the United Kingdom, and the Netherlands. The research is based on method triangulation consisting of qualitative interviews with Dutch healthcare professionals, online research, and document analysis.
Results from document analysis suggest that differences between countries in varicella related decision-making reflected in particular disease perceptions, the importance attached to certain considerations, the availability of evidence and its interpretation. Underlying these developments were contextual changes. In the countries studied social acceptance was not a crucial factor. I argue that it should be ascribed more importance, because a vaccination programme’s success is ultimately dependent upon its acceptance. The interviews and online data throw some light on public and professional opinions. Finally, I discuss possible influences on opinions about different vaccines, including familiarity, personal experiences, and trust.
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Preface
For the longest time I have not questioned vaccination recommendations and did not understand why some parents would refuse to vaccinate their children. It seemed so simple to me: In order to not get terrible diseases, you get some injections and on top of that you help to protect vulnerable groups as well. As I became more acquainted with the social sciences, I realised that hardly anything is simple and straightforward and especially not people’s points of view. During an inspiring class on contemporary topics in Medical Anthropology and Sociology the lecturer mentioned the reoccurrence of diseases due to declining vaccination rates and in that moment I decided that my final thesis would be about vaccination. I came across studies which showed that healthcare professionals are not always supportive of all vaccines and I was instantly captivated.
Healthcare professionals are in direct contact with parents and as trusted advisors on children’s health their work does not seldom include answering questions and soothing doubts. Consequently, they play a crucial role in the implementation of national immunization programmes and preservation of immunization rates. This makes their perceptions a significant topic worth investigating.
Chickenpox presented an interesting example to investigate vaccination perceptions because it is generally known as a harmless childhood disease, but it can have severe consequences for certain groups. The Netherlands portrayed an appealing site for research because chickenpox is currently a candidate for the national vaccination programme. A common concern with universal chickenpox immunization is the potential shift in age of infection from children to adolescents or adults due to suboptimal vaccination coverage. Such a development could lead to an increase of the disease burden. Therefore, insight into the willingness to vaccinate against chickenpox prior to its inclusion in the programme is essential.
The initial goal of this thesis was to provide insight into Dutch healthcare professionals’ perceptions on chickenpox vaccination before its introduction into the vaccination programme and thus to open up the discussion about chickenpox from their perspectives, as well as to contribute to the considerations regarding the implementation of the chickenpox vaccine in the Netherlands. The primary research questions were the following:
How do health care professionals in the Netherlands assess the need of the varicella/chickenpox vaccine in terms of risk and desirability?
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- How do healthcare professionals assess the risks associated with varicella and the vaccine?
- What is their attitude towards whether and how the varicella vaccine should be introduced into the Dutch immunization programme?
- What is their position on vaccinating certain groups only? Are there particular groups they think should be vaccinated?
The fieldwork process started in February 2020. At first it seemed feasible to stick to the original plans despite the increasing spread of the coronavirus (COVID-19), which was first identified in December 2019 in Wuhan, China. However, as the situation got worse it became clear at the beginning of March that gaining access to healthcare professionals was highly difficult and in mid-March the lockdown in the Netherlands began. In face of the rapidly changing situation it became apparent that my initial plans were not realisable. Therefore, the research focus needed to be adjusted in a way that would allow me to conduct research during a pandemic and global state of emergency. Inspired by the question why some countries introduce certain vaccines into their vaccination programmes while others do not, although all claim to base their decisions on scientific evidence, the following research question developed: How and why are vaccines added into national immunization programmes?
Since it was difficult to find research participants it was necessary to incorporate a methodological approach which does not rely on people’s availability. Consequently, document analysis became the backbone of the new research plans. In an attempt to include the social dimension of the issue at hand, interviews via videoconference and online research on social media were included as well. Since chickenpox is generally not considered to be an urgent issue, I expected interest in my research to be especially low during a global crisis. However, reactions online were quite positive and those healthcare professionals who were willing to be interviewed found it rather interesting as well.
I cannot deny that the pandemic influenced my work on a personal level as well. As a young scholar from Austria I had the privilege of growing up with the normality of open borders, freedom of travel, and not encountering crisis situations. Experiencing the rapid spread of a serious health threat, daily increasing mortality rates, and global lockdowns was simply shocking. As an international student away from home I felt vulnerable and looking back it almost seems like an understatement to say that I was worried about a variety of things. At
5 one point finishing this project and graduating seemed hardly possible. During this time the support of the university, friends, family, and particularly my supervisor put me at ease. Even though my research was not dependent on a location anymore, staying in the Netherlands made me feel closer to my project and after the initial shock proceeding seemed more manageable every day.
Most likely under normal circumstances it would have been possible to go through with the initial plans and gather more data on people’s perceptions about chickenpox vaccination. Nevertheless, in the context of the COVID-19 pandemic this research project developed in interesting ways and discussions arose which would not have otherwise. After months of work and many unexpected events it is my pleasure to present the thesis at hand.
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Acknowledgements
Behind every project stand people who influence it in many ways. I would like to take the time here to acknowledge a few of them. Without their contributions this thesis would not have been possible.
First, I would like to thank my parents and my brother for their unconditional support throughout my whole study period. When I started my bachelor’s in cultural and social anthropology back home in Vienna I was often faced with scepticism and lack of understanding for my plans, which to be fair were not very clear at that point. This changed over time and when I told you that I wanted to study medical anthropology and sociology abroad, there was not a second of hesitancy in your endorsement. I am truly grateful for everything you have done for me. You always have my back and help me grow. Without you this year would not have been possible, and I would certainly not be the person I am today.
Second, I would like to thank my supervisor Dr. Stuart Blume for all his efforts to guide me through the biggest project I have done so far. Conducting fieldwork and writing a master’s thesis is a challenge in and of itself but doing so during a global pandemic and lockdown is a different story. Thank you for your patience, input, encouragements, and guiding me into a direction that allowed me to finish my thesis under these extraordinary circumstances.
A special acknowledgement and gratitude go to the participants of this study, who took the time to talk to me and in doing so helped me graduate. It is not self-evident to participate in a master’s project, and especially not as healthcare professionals during a state of health emergency. I highly appreciate your time and effort. Of course, the same goes for the online participants who shared their thoughts and experiences with me even though I was a stranger on the internet.
I would also like to thank my boyfriend Daniel for always having an open ear for me, talking me out of uncertainties, thinking through ideas and struggles with me, and acting as proof- reader whenever I needed one.
Last, but certainly not least, a big thank you to my peers for the constant exchange of ideas and motivation. Our study sessions kept me on track and beyond that you made me feel at home in a foreign city. Without you this year would not have been as exciting.
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Table of contents
Abstract ...... 3
Preface ...... 4
Acknowledgements ...... 7
List of abbreviations ...... 10
List of Figures ...... 11
1. Introduction ...... 12
1.1 Background ...... 12
1.2 Problem statement and research questions ...... 14
2. Methodological and theoretical inspirations ...... 16
3. Research methodology ...... 22
3.1 Qualitative interviews ...... 23
3.2 Online research ...... 24
3.3 Document analysis ...... 25
3.4 Analysis of interviews and online data ...... 26
3.5 Ethical considerations ...... 27
4. Varicella: Pathology, epidemiology and development of a vaccine ...... 29
5. Varicella immunization decision-making in the EU ...... 32
5.1 Germany ...... 36
5.2 The United Kingdom ...... 40
5.3 The Netherlands ...... 45
5.4 Discussion ...... 49
6. Social acceptance of varicella vaccination: Public and professional opinions ...... 49
6.1 Chickenpox – a normal part of childhood? ...... 50
6.2 Balancing risks and preserving the national immunization programme ...... 55
6.3 Discussion ...... 59
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7. Conclusion ...... 60
8. Personal reflections and limitations ...... 68
9. References ...... 70
10. List of documents used for document analysis ...... 77
11. Annex ...... 82
11.1 Fieldwork process overview ...... 82
11.2 Coding scheme for document analysis ...... 83
11.3 Network interviews and online data themes ...... 84
11.4 Interviews and online data analysis mind map ...... 85
11.5 Linear scheme social acceptance chapter ...... 86
11.6 Post vaccine introduction discussions in Germany ...... 87
11.7 Interviewees overview...... 89
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List of abbreviations
BCG Bacillus Calmette-Guérin
ECDC European Centre for Disease Prevention and Control
EU European Union
GP General practitioner
HC Health Council
HCPs Healthcare professionals
HZ Herpes zoster
JCVI Joint Committee of Vaccinations and Immunizations
MMR Measles mumps rubella
MMRV Measles mumps rubella varicella
NHS National Health Service
NIP National immunization programme
NITAGs National Immunization Technical Advisory Groups
NPT Normalisation process theory
PHN Post-herpetic neuralgia
RKI Robert Koch Institute
STIKO Ständige Impfkommission
UK United Kingdom
USA United States of America
VENICE Vaccine European New Integrated Collaboration Effort
VZV Varicella-zoster virus
WHO World Health Organisation
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List of Figures
Figure 1. Conceptual framework for context-based evidence-based decision-making...... 20
Figure 2. Implementation of chickenpox vaccination in the EU timeline...... 35
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1. Introduction 1.1 Background
Vaccines are reckoned to be a major tool for public health success (Yaqub, Castle-Clarke, Sevdalis, & Chataway, 2014). The global vaccination narrative is shaped by victory stories of saving millions of lives every year (e.g. Jakab, 2020; Orenstein & Ahmed, 2017). Despite these stories it seems that increasingly more people are questioning the safety and/or benefits of vaccination. Lack of trust, uncertainties, sometimes inconsistencies in vaccine data, and the spread of information that contradicts biomedical data results in parents questioning or even refusing certain vaccines or whole vaccination programmes (Yaqub et al., 2014). In 2019 the World Health Organization (WHO) announced “vaccine hesitancy” as one of the ten threats to global health. The term refers to “[t]he reluctance or refusal to vaccinate despite the availability of vaccines” (WHO, 2019). This description concerns individual decision-making. Against this background it is interesting to observe that national responses towards vaccines are often diverse.
Technologies, targets, and the global perspective have become central to international health policy. It is taken for granted that new vaccines recommended by the WHO should be introduced rapidly into national immunization programmes (NIPs). The failure to do so is perceived as deviant behaviour that needs to be justified. This means that national performances are evaluated through comparison with international and global dimensions (Blume, Roalkvam & McNeill, 2013). Additionally, the erosion of public confidence in NIPs and the institutions involved confronts policymakers with challenges. Since immunization affects whole populations and particularly their most vulnerable members, it has always been subject to public scrutiny. In the face of growing scepticism, immunization policies need to be justified to new extent (Blume & Tump, 2010).
To ensure transparency and soothe public doubts the argument of rational and evidence- based decisions is highly appealing (Blume & Tump, 2010). This coincides with the general claim that like medical practice, health policy should be evidence based (Berridge & Stanton 1999; Niessen, Grijseels & Rutten, 2000). To introduce new vaccines such evidence should include especially disease burden, as well as the safety, efficacy and cost-effectiveness of the vaccine. Mathematic modelling which incorporates this evidence is used to investigate the impact of potential vaccination programmes (Salisbury, Beverley & Miller, 2002). In spite of the evidence-based narrative historical analyses of immunization policymaking point towards
12 the non-determinant character of scientific and medical data and show that this process is more complex. Immunization policymaking is driven by local, national, and international politics, ideologies, financial arguments, public demand, social acceptability, and processes of legitimization (Hagen-Berg & Blume, 2020).
Furthermore, vaccines have become to inhabit a social role. Not only are they interwoven in a complicated nexus between science and policymaking, they have also become some kind of technological fix which provides prospects of preventing and even eliminating diseases and consequently saving lives. The current case of the COVID-19 pandemic illustrates the social value of vaccines which goes beyond biomedical effectiveness. It seems the whole world is waiting for a vaccine and holding on to the idea that it will bring back normality. In this sense the vaccine becomes a symbol for global hope. COVID-19 is a particular and contextual example, however, research on previous implementations of vaccines shows that faith in vaccines is a historical and social construct (Blume, 2020).
In summary, decisions about immunization policies are embedded in national and international contexts. The globalism of today’s vaccine system resonates with a trend towards harmonisation and the political pressures to conform to international guidelines. Decision-makers face the challenge to conform to such guidelines and global interests, while dealing with public opinions.
The discourse about vaccination has become affected by notions of morality and responsibility. Parents are faced with accusations regarding their children’s best interest. Since vaccination aims to protect not only individuals, but whole populations, the argument of a collective moral obligation to contribute to herd immunity and protect those who cannot be immunized is prominent. Regarding community level it is also possible that benefits arise from financial savings as a result of vaccination and that resources could be saved (Dawson, 2011). States are perceived as having the responsibility “[t]o protect and promote individuals’ health, especially that of the most vulnerable people” (Giubilini, 2019 p. 54) and therefore ought to implement vaccination policies that ensure so. Due to these underlying notions, debates about vaccination are often charged with emotions and strong criticism, particularly of negative vaccination decisions, is not uncommon. This contributes to the challenges policymakers face.
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On the premise that evidence is not as determinant as claimed and immunization policymaking is influenced by multiple factors, the following research question arises: How and why are vaccines added into national immunization programmes? This question is the starting point for the thesis at hand and will be illustrated through the varicella vaccine in the European Union (EU) as a case study.
1.2 Problem statement and research questions
“Varicella”, also known as “chickenpox”, is caused by the varicella-zoster virus (VZV). Generally known as a childhood disease, its effects are usually not severe. The typical symptoms resemble the common cold, followed by a high temperature and a blister-like rash. Nevertheless, complications such as infections of the skin, lungs, and brain can occur. Groups most at risk for complications include pregnant women, immunocompromised individuals, infants, and adults (European Centre for Disease Prevention and Control [ECDC], 2019). Patients usually develop a lifelong immunity to the virus after recovery. However, the virus can be reactivated and result in the condition called “shingles” (herpes zoster, HZ). The symptoms of shingles usually start with pain in the area of the affected nerve, followed by a rash of blisters (ECDC, 2019).
With the development of the Oka-strain based vaccine in 1974 varicella has become a preventable disease. The first country to implement universal childhood vaccination was the United States of America (USA) in 1996. Several varicella vaccines are currently authorized in the EU. Nonetheless, the use of varicella vaccination is quite heterogeneous. While some countries recommend universal vaccination in children at national or regional level, others recommend immunization only in high-risk groups or have no recommendation at all (Carrillo- Santisteve & Lopalco, 2014; ECDC, 2015a).
The trend towards harmonising NIPs is especially strong in the EU and essentially relates to the interconnectedness of the member states, as the following argument by the Vaccine European New Integrated Collaboration Effort (VENICE) III project shows: “[t]he impact of a vaccination programme has an impact beyond political borders of a state, especially in the European context where people migrate and travel freely” (n.d.). Despite this, European countries reach different conclusions regarding the necessity of varicella immunization. From an anthropological and sociological perspective these differences make varicella an interesting
14 and relevant example to explore immunization decision-making on policy level. If, as policymakers tend to claim, immunization policymaking is based on objective criteria and evidence, why do countries come to different decisions about varicella vaccination?
This thesis explores national decision-making processes about varicella in Germany, the United Kingdom (UK), and the Netherlands. In view of aforementioned arguments regarding possible influences upon immunization policies, the following sub-questions will be discussed:
- How did the selected EU states reach their conclusions about (not) introducing the varicella vaccine? - What was the role of evidence as well as professional and public opinion in decision- making processes about (not) adding the vaccine into national immunization programmes? - What are the public’s and healthcare professionals’ perception on the varicella vaccine in terms of risk and desirability?
At the time of writing the UK is no longer part of the EU. However, the decision about varicella vaccination was reached before Brexit took place. Therefore, the UK illustrates a legitimate example for this research. Special attention will be devoted to the Netherlands because the Dutch Health Council (HC) is currently preparing its advice on varicella vaccination. A decision is expected to be made in the second half of 2020.
The elaborations in this thesis are based on methodological triangulation. Drawing upon historical research, qualitative document analysis is used to examine previous decision- making. To give insight into professional and public opinions about varicella immunization a small scale qualitative online research and semi-structured interviews with Dutch healthcare professionals (HCPs) were conducted.
The conceptual framework for evidence-based decision-making proposed by Dobrow, Goel and Upshur (2004) is used to explore the utilization of evidence in varicella related decision- making. Their “practical operational” approach allows for understanding evidence as contextual and subjective, which provides a foundation to analyse how the selected countries reached different conclusions, even though all legitimise their decision through reference to evidence. Klein’s (2000) approach to think of policies as experiments is used to shed light on varying implementation practices. The relational theory of risk, borrowed from Boholm and Corvellec (2011), is introduced to make sense of perceived risk dynamics. This approach
15 understands risk as culturally informed and allows for the examination of the interpretative nature of risk. To further analyse social desirability and acceptance beyond risk perceptions, Nichter’s (1995) distinction between “active demand” and “passive acceptance” is utilised. Implications from the normalisation process theory (NPT) (May & Finch, 2009) are used to frame social acceptance of vaccines over time.
The goal of this thesis is to contribute to the current vaccination discourse with a focus on policy decision-making. It also aims to open up the discussion about chickenpox vaccination from HCPs and the public’s perspective and thus give insight into aspects that might be relevant to consider before including the varicella vaccine in NIPs.
In the second chapter previous research in the domain of immunization policymaking and vaccination perspectives, as well as the concepts used for analysis are reviewed. The third chapter presents methodological and ethical considerations. Chapter four discusses the epidemiology of varicella and the emergence of the vaccine. Chapter five and six illustrate the heart of this thesis and consist of the presentation of the research findings. The thesis concludes with interpretations and implications drawn from this research and a discussion of its limitations.
2. Methodological and theoretical inspirations
Building upon an earlier trend towards evidence-based medicine, evidence-based approaches became prominent in health policy and health research during the 1990s and have gained wide popularity since then. One reason for this development is that these approaches provide information and tools to help with setting priorities (Niessen et al., 2000). They have become essential for the goal of increasing effectiveness and efficiency of health services in accordance with financial considerations. Underlying this notion are positivist models of science and rational models of policymaking. Advocates of the evidence-based narrative argue that properly funded and correctly positioned scientific research can and should have an influence on medicine and health policy. In this context clinical research based on the methodology of the randomised controlled trial has come to inhabit a superior position over other types of evidence and knowledge (Berridge & Stanton, 1999).
Klein (2000) explains the sentiment behind the idea of evidence-based health polices as follows:
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“The notion is as seductive as it is simple: if evidencebased medicine […] is desirable then so, by definition, is evidence-based policy […]. Just as no-one would argue that clinicians should practise medicine without regard to evidence, so it would seem an incontestable, self-evident proposition that policymakers should base their decisions on evidence. If anything, it would seem even more important for national policy-makers, as distinct from individual clinicians or local managers, to depend on the best available evidence in making their decisions since these are likely to have greater impact” (p. 65).
He then, however, goes on and explains why the concept of evidence-based policies is contestable and misguided for two reasons. First, the concept of evidence is perceived as unproblematic. Second, the notion is based on a simplistic view of the policy process because it assumes that policymaking can and should be separated from politics.
Klein is not alone in this opinion. Various scholars criticise the narrow scientific conception of evidence and point out prominent hierarchies (e.g. Dobrow et al., 2004; Miles et al., 2000) Nevertheless, the argument of evidence-based decisions is especially appealing for immunization policymakers. Among the wide range of available and often expensive vaccines, prioritisation is necessary, and a standard set of criteria based on scientific data provides a framework for such. Moreover, policymakers are faced with the challenge of legitimating their decisions towards the public, but also the international community. Especially delays in the introduction of new vaccines have become subject to criticism and need to be justified. In this regard the reference to evidence can support decisions in that it (allegedly) provides transparency of the decision-making process and soothe doubts (Blume & Tump, 2010).
Historical studies on previous introductions of vaccines show how multifaceted this process is and how factors besides evidence play a crucial role. NIPs are embedded in social, economic, and political histories, as well as linked to ideologies, and notions of identity (Holmberg, Blume & Greenough, 2017). They are further shaped by contemporary local, national, and international politics, economic arguments, as well as social demand and acceptance. Therefore, contrary to the rational evidence narrative, immunization policy decisions are most definitely not based solely on objective and measurable criteria (Hagen-Berg & Blume, 2020). In addition to that, various scholars point towards the non-determinant character of scientific and medical data.
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In this regard, Bryder’s (1999) work on the Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis is highly insightful. In her analysis she focuses on the different responses to the vaccine in Scandinavia, Britain and the USA. BCG was discovered in 1921 in France and while Scandinavia soon adopted the vaccine with enthusiasm, it was not introduced in Britain until 1950 and never used on a large scale in the USA. Bryder discusses how all three countries claimed that their policies were rooted in scientific research and how the interpretation of the same data, combined with some locally conducted research, lead to such different results. She concludes that the different approaches were driven by social policies and their underlying ideologies. Nationalism combined with scepticism towards research conducted abroad and consequent competitiveness within the scientific community, as well as central institutions and their (non) preparedness to alter their foci played a role. Essentially, the different approaches towards the vaccine seemed to mirror the welfare traditions and systems of the countries.
Blume and Tump (2010) emphasise the contextual nature of evidence and its use in policymaking. Based on document analysis of the introduction of the measles, mumps and rubella (MMR) vaccine in the Netherlands the authors make two claims. First, the significance attached to certain forms of evidence may change in the course of decision-making processes, because the decision-making context changes. Second, during the decision-making process results from international data became gradually more important than locally gathered evidence. This increasingly international orientation influenced national scientific competences.
Premised on comparative analysis of the introduction of the MMR vaccine in Denmark and the Netherlands, Hagen-Berg and Blume (2020) aim to take aforementioned arguments further. Both countries introduced the MMR vaccine in 1987, a full decade after the USA, even though they both were small welfare states with well organised NIPs. The authors suggest that this delay came about due to reasonable reflection of each country’s concerns, disease perceptions, and already adopted technological approaches. The countries’ decisions were influenced by political and ideological changes of that time, which included a growing emphasis on costs and benefits, and the growing influence of the international context. Hagen-Berg and Blume’s conclusions relate to Wiese-Posselt, Reiter, Gilsdorf, and Krause’s (2009) discussion about unifying immunisation schedules in the EU. The authors suggest that reasons for reaching different recommendations despite using the same evidence are based
18 on country specific values and goals, epidemiological situations, healthcare delivery systems, logistics of vaccine delivery, and economic situations.
Inspired by Blume and Tump (2010), this thesis incorporates the conceptual framework proposed by Dobrow et al. (2004) to make sense of the contextual nature of evidence. This framework for evidence-based decision-making focuses on “[h]ow context impacts on what constitutes evidence and how that evidence is utilised” (p. 208). Fundamental for their approach is the notion that evidence-based policy is qualitatively different from evidence- based medicine in that the decision-making context shifts from individual clinical level to population-policy level. Consequently, it becomes more uncertain, variable and complex, and because it affects larger numbers of people, explicit justification of decisions is needed. Their framework is based on what they term “the practical-operational orientation”. Contrary to the conventional normative evidence-based mindset which focuses on standardised characteristics such as reliability and validity, the practical-operational view claims that evidence is defined with respect to specific decision-making contexts and thus what constitutes evidence is inherently context based. Evidence in this sense is emergent and provisional and therefore incomplete and inconclusive. In summary, this orientation assumes that multiple factors contribute to a decision outcome and evidence is not defined by its quality, but by “[i]ts relevance applicability or generalisability to a specific context” (p. 209).
The authors differentiate between internal and external context and divide the process of evidence utilisation into three stages: introduction, interpretation, and application of evidence. The internal context refers to the environment in which a decision is made. It includes the purpose for decision-making activities, the role of participants, and the processes used to attain an outcome. The internal context can be manipulated and controlled, unlike the external one. The external context accounts for the environment in which a decision is applied. This includes disease specific, extra-jurisdictional, and political factors. Both contexts influence decision-making in different ways at the various stages. The introduction of evidence refers to the ways in which evidence is identified and the channels through which it is brought into the decision-making process. In the interpretation stage the evidence is evaluated on its quality and generalisability. Finally, in the application stage the evidence is applied to support or justify a decision. Figure 1 illustrates this framework.
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Figure 1. Conceptual framework for context-based evidence-based decision-making. Reprinted from “Evidence-based health policy: Context and utilisation”, by M. Dobrow., V. Goel. & R. Upshur, 2004, Social Science & Medicine, 58, p. 216. Copyright 2004 by Elsevier.
It is also helpful to think of policies as experiments, as Klein (2000) suggests. As aforementioned, Klein criticises the common understanding of evidence-based policies, because it is based on a misunderstanding of policy processes and an exaggerated claim about what research can deliver. He claims, however, that policy processes are indeed driven by evidence, just not the kind that the scientific community seeks to favour. If we think of policies as experiments, we can understand how they produce evidence about their feasibility and effectiveness during the implementation process. This kind of evidence is based on experience and not scientific per se, but this does not make it less legitimate for policies. While administrative channels provide evidence about the implementability of policies, the political channels provide evidence about their acceptability. This kind of evidence is determining for policies. As Klein puts it: “[i]f a policy is not implementable or acceptable, then self-evidently it is not worth pursuing - whatever research may say” (p. 65). This is especially relevant for immunization policies, because their success is ultimately dependent on people’s acceptance and can therefore not be neglected. Furthermore, due to the increasing international orientation in immunization policymaking, other countries’ experiences with certain vaccination policies have become relevant for national decision-making.
The importance of people’s opinions about vaccines is reflected in the broad spectrum of available studies. Previous research on vaccination attitudes is generally prone to focus on parents. However, research on the perception of HCPs has been conducted too. The research focus varies, while some studies focus on the perception of one specific vaccine, others provide a general assessment (e.g. Yaqub et al., 2014; Mills, Jadad, Ross & Wilson, 2005;
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Wallace et al., 2014; Eritsyan, Antonova & Tsvetkova, 2017). Some research includes qualitative methods, however, most studies that give insight into opinions about vaccination tend to be of quantitative nature.
As Eritsyan et al. (2017) point out, a qualitative approach can reveal other factors playing a role in vaccination attitudes, besides cognitive beliefs. Inspired by this, this thesis makes use of a qualitative approach.
Against common assumptions, some studies showed that reasons for vaccination attitudes do not necessarily relate to misinformation or lack of awareness. Reasons that relate to mistrust are more common than reasons due to information deficit. In this context, trust refers to trust in HCPs, but also trust in institutions through which information about vaccines is delivered (Yaqub et al. 2014). However, work that sheds light on misconceptions and lack of information has also been conducted (Hollmeyer, Hayden, Poland, & Buchholz, 2009). Another factor that influences the acceptance of vaccines are risk perceptions regarding the vaccine and the disease it aims to prevent (Lagoe & Farrar, 2015).
Research on HCPs’ vaccination attitudes and behaviours suggests that their perceptions may influence their recommendations for patients (Paterson et al., 2016). This makes their opinions an important factor to consider when introducing a new vaccine. Hence, the semi- structured interviews for this research were conducted with HCPs.
To make sense of influential aspects on people’s perceptions of vaccines Nichter’s approach and the relational theory of risk by Boholm and Corvellec are helpful. In the context of introducing new vaccines Nichter (1995) distinguishes between active demand and passive acceptance. Active demand refers to the benefits of and need for specific vaccinations, while passive acceptance implies compliance and yielding to recommendations and social pressure. Central concepts for active demand are trust and legitimacy of policymakers’ decisions, meaning that if these aspects are lacking, people tend to feel the need to reinterpret information about vaccination or seek additional sources of information. This approach is useful for exploring the dynamics of desirability of varicella vaccination. It was developed in relation to lay populations and the concept of trust has mainly been used to understand vaccine hesitancy of lay people as well. Through applying this approach to the semi-structured interviews, I aim to expand the discussion to HCPs.
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As part of the relational theory of risk Boholm and Corvellec (2011) differentiate between a risk object and an object at risk. The relation between the two is described as follows: “[r]isk emerges from situated cognition that establishes a relationship of risk between a risk object and an object at risk, so that the risk object is considered, under certain contingent circumstances and in some causal way, to threaten the valued object at risk” (p.175). This approach understands risk situations as culturally informed. It further allows for the examination of the interpretative nature of risk and sheds light on the questions of how and why something is considered a risk. This is applicable for not only understanding the perspectives of groups, but also for making sense of individual assessments. In respect to vaccination, the relational theory of risk allows for analysing different attitudes towards the relationship between the virus/disease and the vaccine, but also the relation between new vaccines and existing programmes. This is highly relevant for varicella, because of its epidemiology and reputation as mild disease.
Social acceptance is a complex and dynamic process (Wolsink, 2018). The normalisation process theory (NPT) is an attempt to explain how some practices become normalised while others do not. It is a middle-ranged action theory and the proposed model consists of three stages: implementation, embedding, and integration. The focus lies upon how actors actively work to integrate and sustain new technologies into routine (May & Finch, 2009). Since neither the research questions, nor the data address how involved actors work on normalizing vaccines, the theory cannot be applied in this sense. However, the framework is borrowed to explore gradual acceptance of vaccines over time. Although this research focuses on perceptions and not actions, it cannot be denied that a variety of actors is constantly involved in routinising and sustaining vaccination, especially policymakers and HCPs.
3. Research methodology
At the beginning of fieldwork, I conducted informal interview in order to get familiar with the field. Subsequently, data collection for this thesis was based on the following three methodological pillars: five semi-structured in-depth interviews with Dutch HCPs, online research on the social media platform Reddit, and qualitative document analysis. This combination allowed me to gather data, while not solely depending on the availability of
22 research participants and face-to-face conversations, which was fundamental for conducting feasible research during the COVID-19 outbreak2.
3.1 Qualitative interviews
Green and Thorogood (2004) define interviews as a “[p]articular kind of conversation” (p. 79), which is directed towards the researcher’s need for data. According to their elaborations on qualitative methods for health research, the informal interview resembles natural conversations in which data is gathered opportunistically, meaning that these interactions are not thoroughly structured and prepared.
Attitudes and language are not only individual but can also differ considerably among professions. Since I do not have a medical background, but aimed to work with medical professionals, it was necessary to get used to talking about my research to people who received biomedical training. Hence, an essential step at the beginning of fieldwork was familiarising myself with the field in a practical manner. In order to do so, I conducted three informal interviews with people from my personal network who study or have studied medicine in the Netherlands. These conversations provided me with valuable input on the role of vaccination in the broad spectrum of (Dutch) medical education and were highly insightful in order to further specify the target groups. Additionally, they were useful to get a sense for the visibility of the research topic for HCPs and allowed for discussing aspects which I have not thought of before. In that sense they were also a suitable preparation for the interviews that followed.
The first of the three main methodological pillars this research is built upon is the semi- structured in-depth interview. “Semi-structured” implies that the researcher sets the agenda regarding the topics that should be covered in the conversation. However, ultimately it is the interviewee’s responses that determine what kind of information is produced about the topics and the relation of their importance (Green &Thorogood, 2004). This means that even though I did have expectations based on the literature and theoretical assumptions, I tried to avoid leading the conversations into a certain direction. “In-depth” indicates that the interviewees
2 A visual overview of the fieldwork process can be found in the annex (11.1). 23 should have enough time to “develop their own accounts of the issues important to them” (Green &Thorogood, 2004, p. 80).
I conducted five semi-structured in-depth interviews with Dutch HCPs. The interviewees consisted of two general practitioners (GPs), two nurses working in child health clinics (consultatiebureaus), and one GP in the second year of training (arts in opleiding). I was able to get into contact with the interviewees through my personal network, e-mail, and snowball sampling. In preparation of these interviews I created an interview guide which was based on issues that came up during the informal conversations, literature, and the research questions. Rather than predetermining the conversations, this guide was used as a reminder for relevant issues.
The semi-structured in-depth interview was highly eligible for exploring HCPs’ opinion about varicella vaccination, because it allows space for the interviewees to answer on their own terms. Through covering the same topics or even questions, some structure for comparison is provided as well (Edwards & Holland, 2013). The interviews were documented in agreement with the respondents. Since face-to-face conversations were hardly possible during the COVID-19 pandemic, all interviews but the first (which took place before official measures were implemented) were conducted over the video conference software Zoom. As with any form of online communication, some difficulties arose from technical issues and influenced the conversations. However, ultimately there were no severe issues.
3.2 Online research
The understanding of online research in this thesis is based upon Hooley, Marriott and Wellens’ (2012) elaborations. They describe online research methods as “[a]n approach to finding out about people and the social world they inhabit, using the internet” (p. 3). The social media platform used for this part of the research was Reddit, where (mainly anonymous) users submit content in the form of links, text posts, and images. This content can then be rated and commented by other members. The posts are organized by subject into user-created communities which are called “subreddits”. As with any community, when trying to get in contact with members one should be aware of common rules and language and in this case it was no different. Having never used Reddit before, I needed to familiarise myself with the way things work and users interact with each other first (depending on the community the rules
24 and language can be quite different). Eventually, four medical communities and one Dutch community seemed to be fitting for the research.
I created posts in the chosen communities to which other users could respond through comments, to which I could respond again and so on. In these posts I introduced myself as a medical anthropology and sociology student at the University of Amsterdam who writes her master’s thesis on what people think about the chickenpox vaccine, included a brief summary of the research background (that there is a discussion on whether it makes sense to implement it in NIPs and that policies vary between EU countries) and asked what the users think about that. In the Dutch community I mentioned that chickenpox is a candidate for the Dutch immunization programme and asked what the users think about including it. In terms of privacy and transparency I ensured that I would not use anyone’s username in my thesis and invited people to ask questions about my project. Contrary to my assumption that there might be little interest in discussing chickenpox during the COVID-19 outbreak, there were several responses. The interactions occurred mainly between me and individual users directly, in- depth discussion among other users did not spark.
This course of action can best be described with what Keim-Malpass, Steeves and Kennedy (2014) term “self-identified active analysis”. In this approach the researchers identify themselves and their research interests a priori. Due to transparency and ethical considerations, self-identified active analysis seemed to be the most appropriate way to go about online research.
Initially, I planned to use online research as inspiration for the semi-structured in-depth interviews and to get insight into relevant issues regarding the primary research questions. However, after adjustment of the research focus, it proved to be a valuable and feasible method in order to explore public attitudes towards varicella vaccination during a global state of emergency when face-to-face interaction was not possible.
3.3 Document analysis
According to Bowen (2009) document analysis involves skimming (superficial examination), reading (thorough examination), and interpretation. He further points out that although documents can be a rich source of data, they should not be treated as necessarily precise, accurate, or complete recordings of events.
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Following his approach, I began with a preliminary skimming of sources. This enabled me to determine which documents are relevant for the research and need further assessment. It also provided an overview of relevant issues and arguments. To then examine the documents thoroughly, I made use of deductive and inductive coding. For this step the qualitative analysis software ATLAS.ti was used. Based on the literature I was familiar with pertinent issues that commonly arise during the implementation process of new vaccines. A network with these subjects served as visualization of potentially important categories and as initial coding scheme. I used inductive coding to identify further categories and continuously expanded the scheme while reading3. Through this combination it was possible to organise the data in accordance with the research questions without reducing them to presupposed categories. Simultaneously, I took notes and created timelines to acquire an overview of the developments in each country. The interpretation built upon the frameworks for contextualizing evidence and understanding policies as experiments.
3.4 Analysis of interviews and online data
To make sense of the data thematic analysis (Braun & Clarke, 2006) was used. The first step of the analytical process was to transcribe the recorded interviews using the software f4transkript. For this purpose, Dresing and Pehl’s (2018) elaborations on a semantic-content transcription system provided guidance. This approach enabled me to focus on the content of the conversations while also including non-verbal information to capture the interview dynamics. Due to limited time, practicalities, and considerations regarding representation I did, however, not stick entirely to the rules suggested by the authors. For example, I did not smooth out language as much as advocated. At this point I would like to highlight that transcription is essentially selective and brings with it the risk of biasing (Kowal & O’Connell 2014). Despite my endeavours to restrict my influence through careful listening and transcribing, including non-verbal elements, and reflection of the co-construction of the data, this applies to this thesis as well and the transcriptions should not be accepted uncritically as complete representation of the interviewees’ perspective and performances, but rather as means to gain insights into those.
3 The final scheme can be found in the annex (11.2). 26
To get an overview of the data the second step was to go through the transcriptions and to identify re-occurring themes. Afterwards, I used inductive coding to organise the data in detail and to allow unexpected issues to be brought to attention. Next, I used screenshots to record the online data and proceeded to code them openly as well. For the coding process ATLAS.ti was used again.
In a following step I identified themes in more detail through grouping the codes. Subsequently, I created a network with the themes to map out how they relate to each other and to visualise these connections. A mind map followed by a linear scheme helped to delve further into these connections and elaborate on the structure of the respective chapters4. Although described chronologically, the data analysis was ultimately a recursive process going back and forth between the phases. Similarly, the interpretation process consisted of going back and forth between the data, chosen literature, and theoretical concepts.
3.5 Ethical considerations
The statement on ethics by the American Anthropological Association (2012) and the ethical guidelines for student research by the Graduate School of Social Sciences, University of Amsterdam (2019/20) served as basis for ethical reflections during this research. I did not work with highly vulnerable groups. Nevertheless, the participants can be exposed to social harm, such as consequences regarding their career or social scrutiny. Therefore, the main ethical issues for this research included informed consent, anonymity, and data protection. The specific measures taken to handle these issues varied according to the used method.
For the semi-structured in-depth interviews consent was obtained in written form. In this respect, I always tried to be transparent about my intentions and openly discuss them. The interviewees received an information letter and consent form before the interview took place and during the interview I asked whether they have any questions regarding myself or the research project. The following subjects were included in the consent form:
- Information about myself and contact details - Topic and aim of my research
4 The network, mind map, and linear scheme can be found in the annex (11.3, 11.4, 11.5). 27
- Information on the possibility to withdraw from the study at all times without reason - Transparency about the methods used (recording of the interview audio, if the interviewee agrees) - Information about how long the data will be stored and how I will ensure data protection - Information on what will happen to the data (including the intention of publishing and using quotes)
In order to minimise risk, the participants, affiliations, and locations were anonymised from the time of transcription onwards and the participants have been assigned pseudonyms5. Additionally, I tried to ensure data protection to my best abilities. This included keeping the signed consent forms separate from the gathered data so that connections cannot be made easily, refraining from uploading data to online clouds or other platforms, and encryption of files and folders.
While the mentioned guidelines apply to online research as well, the practicalities of ethical decision-making regarding this part of the research were not as straight forward. Online research takes place in different dimensions than traditional research. Even though I considered the same issues as with the interviews, I had to think them through differently. In this regard the ethical recommendations by the Association of Internet researchers (2012) and a lecture on digital ethics in online ethnography by Hupli (2020) were helpful. Additionally, I had the opportunity to get direct input on uncertainties from the lecturer Aleksi Hupli.
Ultimately, I decided to obtain consent through my post on Reddit. As aforementioned, I introduced myself as a student, included information on my project, and invited people to ask me about it should they have any questions. Based on this, I considered people’s participation itself as a form of consent. I did, however, not include my name and I am aware that this is a point of criticism. I decided to do so because it is highly uncommon to reveal one’s name on Reddit and I also considered potential consequences for myself. Nonetheless, should someone be interested in my work, connections can be made, and I am of course transparent if someone asks me about it.
5 An overview of the participants can be found in the annex (11.7). 28
The issue of participants’ anonymity regarding online research is more complex. On the one hand, I did not want to expose any participants. On the other hand, Reddit users are aware that this platform is a public space where posts and comments can be accessed easily and use pseudonyms. Based on that I tried to find a middle ground. I made clear in my post that I would not quote anyone’s username. Nevertheless, due to reasons of transparency I decided to not delete the data after my thesis is finished, which means that readers can look up the online discussions. The participants deliberately wrote about their thoughts and (sometimes very personal) experiences regarding varicella vaccination and can delete their comments should they wish to do so. Deleting the posts myself would feel like disrespecting their decision to share and taking away their choice on whether their comments should stay public.
Even though the discussed issues were dealt with in certain ways, the ethical process is still ongoing. The responsibility of confidentiality and data protection does not stop with the final version of this thesis and new issues might arise even after the research project and thesis are finished.
4. Varicella: Pathology, epidemiology and development of a vaccine
The VZV is a neurotropic human virus and member of the herpesvirus family (Warren-Gash, Forbes, & Breuer, 2017). Like other herpesviruses, VZV can persist in the body as a latent infection after primary infection, in this case in the sensory nerve ganglia (CDC, 2015). VZV is endemic to all countries worldwide, with some geographic differences (Warren-Gash et al., 2017). It is highly contagious, resulting in about 96% of people who are not immune developing the disease when exposed to this virus. Since the virus is airborne, transmission occurs through mouth and nose, but infection can also be contracted through direct contact with skin lesions. If a pregnant woman has varicella, the virus can be transmitted to the baby during pregnancy and birth (ECDC, 2019).
The first infection leads to varicella, also known as chickenpox. Generally known as a childhood disease, the effects of varicella are usually not severe. Around 90% of cases affect children under the age of fifteen, the majority of whom recovers quickly (ECDC, 2019). The incubation period ranges from 10 to 21 days, with 14 to 16 being the most common. It can be prolonged in immunocompromised patients and through postexposure treatment with a varicella antibody containing product (CDC, 2015). The typical symptoms resemble the common cold,
29 followed by a high temperature and a very itchy, vesicular rash. Nevertheless, complications such as infections of the skin, lungs (pneumonia), and brain (encephalitis) can occur. Groups most at risk for complications include pregnant women, immunocompromised individuals, infants, and adults (ECDC, 2019). Affected patients are infectious from one to two days before the rash develops and until the vesicles are dry (PHE, 2019).
After recovering from varicella, patients usually develop a lifelong immunity to the virus. However, the reactivation of the virus can result in HZ, otherwise called shingles. This reactivation can be caused by weakened immune defences due to stress, illness, and medication. The most common reason for reactivation is old age (Harvard Health Publishing, 2019). HZ can occur in children and is common in immunocompromised individuals of any age. The virus can be transmitted from HZ lesions to susceptible individuals and cause chickenpox, but so far there is no confirmation that HZ can be acquired from individuals with chickenpox (PHE, 2019). The symptoms of shingles usually start with pain in the area of the affected nerve, followed by a rash of blisters. While the rash normally lasts around seven days, the pain can last longer (ECDC, 2019). As with varicella, complications in HZ can arise. These include post- herpetic neuralgia (PHN, a debilitating neuropathic pain syndrome), ophthalmic involvement, neurological complications, exacerbations of underlying cardiovascular disease causing stroke and myocardial infarction, as well as the possibility of disseminated disease. The treatment for VZV infection in immunocompetent patients is usually symptomatic (Warren-Gash et al., 2017).
While clinical descriptions of HZ infection go back to antiquity, chickenpox was characterized as a form of smallpox in the 17th century. The distinction between chickenpox and smallpox was made at the end of the 19th century. Even though varicella and HZ were investigated continuously, and there was an explosion of medical writings on both in the 18th and 19th century, their relation was not clarified until the second half of the 20th century. Simultaneously, inspired by Michiaki Takahashi's observations of a family member with severe chickenpox and fever, Takahashi and colleagues generated the first varicella vaccine in 1974 in Japan (Galetta & Gilden, 2015). The so-called vOka vaccine is a live attenuated varicella vaccine, meaning that it derived from Oka strain from wild type VZV. Initially developed to prevent severe or fatal varicella among immunocompromised children, the vaccine showed to be safe and effective, which is why it is now incorporated in NIPs in some countries. Since this vaccine is attenuated, it establishes latency like the wild type VZV and therefore has the
30 potential to reactivate and cause HZ (Warren-Gash et al., 2017). Additionally, it is contraindicated in immunocompromised individuals and during pregnancy (WHO, 2014b). In those cases, varicella immunoglobulin provides an alternative for acquiring immunity. Based on the vOka vaccine, the HZ vaccine Zostavax was developed in 1992 (Galetta & Gilden, 2015). Zostavax is live attenuated as well and more concentrated than vOka (Warren-Gash et al., 2017). A recent development in HZ prevention has been the inactivated vaccine Shingrix, which is eligible for immunocompromised people (Galetta & Gilden, 2015). Prior to vaccination VZV lead to almost universal infection. With the development of vaccines, the VZV has become the only human herpesvirus infection that can largely be prevented (Warren-Gash et al., 2017).
Several monovalent (only varicella) and combined (with MMR) vaccines are currently authorized in the EU. Even though the vaccines have shown to be safe, there are several uncertainties and concerns regarding their implementation into NIPs. Controlled clinical studies showed that monovalent and combined vaccines are highly immunogenic and efficacious in preventing varicella disease. Vaccine efficacy is higher against severe varicella than against less severe varicella. Nonetheless, breakthrough infections can arise. These are cases of wild type varicella that occur in a vaccinated person more than 42 days after vaccination following exposure to the wild-type virus. Uncertainties regarding varicella vaccination include the duration of immunity, the risk of breakthrough cases many years after vaccination, the need and optimal timing of a second dose, and long-term effects of varicella immunization further than fourteen years (ECDC, 2015a).
A common concern regarding the implementation of varicella immunization is the possibility of a shift in age of infection from children to adolescents or adults due to suboptimal vaccination coverage. A decreased exposure to VZV in the population could induce an older age distribution of the remaining cases (WHO, 2014b). Since older individuals are prone to develop a more severe course of disease, such a development would result in a higher disease burden. In this regard the WHO states that vaccination coverage that remains under 80% may “[r]esult in an increase of morbidity and mortality despite reduction in total numbers of cases” (2014b, p. 284). Additionally, uncertainties regarding how VZV vaccination influences HZ incidence exist. As aforementioned, the vOka vaccine establishes latency and reactivation can cause HZ. However, vOka is less likely to reactivate than the wild type virus (Sadaoka et al., 2016). One argument against universal vaccination is that immunity may be boosted by re-
31 exposure to the virus. If this assumption proves to be correct, low exposure to wild type VZV could potentially lead to an increase in shingles. Nonetheless, so far countries with varicella immunization programmes have not shown a shift in the age of infection or an increase in HZ incidence (Carrillo-Santisteve & Lopalco, 2014).
Further concerns include the lack of data on the incidence of varicella complications to inform cost-effectiveness models (Warren-Gash et al., 2017). Currently there is no standardized case definition for varicella at EU/EEA level. Consequently, countries use various definitions and (if existent) varicella surveillance systems. These circumstances may not only limit cost- effectiveness modelling, but also the evaluation of varicella vaccination programmes and their effects (Carrillo-Santisteve & Lopalco, 2014).
5. Varicella immunization decision-making in the EU
Efforts towards standardising immunization programmes among the member states are continuing in the EU. This trend aligns with general cooperation endeavours and collaborative goals and is linked to the sentiment that diseases do not stop at political borders. In consideration of freedom of travel and high migration rates the cross-state impact of NIPs is recognised and harmonisation of such has become desirable. Nevertheless, vaccination policies are still quite diverse, and the introduction of new vaccines is not homogeneous among member states (VENICE III, n.d.).
Both the WHO and the ECDC emphasise that the introduction of new vaccines should be an evidence-based decision. However, they also state that context specific factors need to be recognized as well. This includes local cultural values, social norms, prevailing attitudes, and preferences on vaccination. Additionally, the WHO accentuates that the systematic decision- making process should also incorporate long-term financial and other consequences of introducing the vaccine, which involves considering whether adding a new vaccine may cause burdens and thus worsen the whole programme’s performance (ECDC, 2015b; WHO, 2014a).
In the majority of industrialised countries so-called “National Immunization Technical Advisory Groups” (NITAGs) inform the decision-making about new vaccines (Duclos et al., 2012). NITAGs are expert advisory committees which are supposed to be independent and provide “[e]vidence-based recommendations to the ministry of health […], policymakers and program managers to guide policies and formulate strategies” (Blau et al, 2013, p. 2653). The role and
32 tasks of NITAGs can, however, differ considerable between countries (ECDC, 2015b) and it has been suggested that these differences could potentially explain the disparities in access to vaccinations and immunization programs across Europe (Ricciardi et al., 2015).
Varicella is one example for diverse vaccination recommendations among EU members. While some recommend universal vaccination in children at national or regional level, others recommend vaccination for high-risk groups only or have no recommendation at all (Carrillo- Santisteve & Lopalco, 2014).
Immunization programmes tend to focus on the paediatric setting. In face of demographic changes towards older populations, increased vulnerability to severe infections and complications with age, it has been argued that vaccination provides a key element for healthy aging. However, vaccinating seniors raises different issues than vaccinating children and the potential of widespread vaccination of the elderly is rarely realised (Doherty et al., 2018). Due to age-related changes of the immune system most vaccines are less efficient in the elderly. Lower effectiveness in seniors impact cost-effectiveness analyses which makes vaccination programmes for this group a less attractive intervention for healthcare providers and may also affect people’s perceptions on the benefits of vaccination (de Gomensoro, Del Giudice & Doherty, 2018). Furthermore, most countries have little experience with vaccination programmes for seniors. The most common one is influenza, and some countries include pneumococcal disease and HZ as well. Compared to vaccination rates in children, the coverage rates of seniors are considerably lower. Reasons for this include low public awareness, lack of knowledge, poor infrastructure for adult vaccination, uncertainties, inconsistent recommendations by HCPs (de Gomensoro et al., 2018; Doherty et al., 2018) but also living alone, which points towards the social dimension of this issue (Jain, van Hoek, Boccia & Thomas, 2017). Against this background varicella related immunization policymaking depicts an interesting case study, because it targets both children and seniors.
Figure 2 was created for this thesis and provides a visual overview of historical developments regarding varicella vaccination with focus on its introduction into NIPs in the EU. In the following chapters the reasons for the varying decisions in Germany, the UK, and the Netherlands will be explored in detail. Each country represents a different situation regarding varicella vaccination, which makes them relevant examples for the research question at hand.
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In Germany universal varicella vaccination was implemented in 2004, which makes it the most experienced country among EU member states (ECDC, 2015a). In addition to that, shingles vaccination is offered to seniors aged 60 or older (RKI, 2019a). In the UK varicella is not part of the childhood immunization programme. The vaccine is only offered to people who are likely to encounter persons who are vulnerable to chickenpox. The shingles vaccine, however, is included for all seniors in their 70s (NHS, n.d.). At the time of writing neither varicella nor HZ vaccination are included in the Dutch immunization programme (RIVM, 2020). Based on the analysis of relevant documents, the distinct introduction-decisions relating to paediatric varicella and senior HZ will be discussed for each country in the following chapters.
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Figure 2. Implementation of chickenpox vaccination in the EU timeline.
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5.1 Germany
Since 2001 the “German Protection against Infectious Diseases Act” (Infektionsschutzgesetz) defines the basics for vaccination. The government’s central scientific institution in the field of biomedicine is the Robert Koch Institute (RKI). It is a subordinated agency of the Federal Ministry of Health and one of the most important bodies for the safeguarding of public health. Among other things, the RKI’s tasks include the identification, surveillance and prevention of infectious diseases. Regarding vaccination, the RKI is advised by the Standing Committee on Vaccinations (Ständige Impfkommission, STIKO). The STIKO functions as NITAG in Germany and consist of twelve to eighteen unpaid members who are appointed by the Federal Ministry of Health for a period of three years. The Federal Institute for Vaccines and Biomedicines (Paul Ehrlich Institute) is responsible for licensing vaccines. The STIKO analyses the individual benefit-risk ratio, but also studies epidemiology at the population level and the effects of nationwide vaccination strategies. The STIKO’s recommendations apply nationally, but the federal states can make special arrangements for themselves. The STIKO orients its work on criteria of evidence-based medicine and their recommendations are considered medical standard (RKI, 2019b; Rechel, Richardson & McKee, 2018). For the development of vaccine recommendations, the STIKO uses a systematic approach which includes fixed criteria that need to be addressed. Those contain questions related to the pathogen, target disease, vaccine characteristics, immunization strategy, and implementation of vaccination recommendation (ECDC, 2015b). Their recommendations provide the basis for the vaccination guidelines for the Federal Joint Committee (Gemeinsamer Bundesausschuss). After the publications of new recommendations, the Federal Joint Committee has three months to decide whether they will be included in the guidelines. In case of rejection, the arguments for the decision need to be provided (Rechel et al., 2018). Vaccination is not compulsory in Germany, with the exception of measles since March 2020 (Bundesministerium für Gesundheit, 2020).
Germany was the first European country to implement universal varicella vaccination. Initially varicella vaccination was indicated for specific risk groups and their contact persons, as well as seronegative healthcare personnel and post-exposure. This changed in 2004 with the STIKO’s recommendation to implement universal varicella vaccination and a catch-up programme for those aged nine to seventeen. Varicella was argued to be the most common vaccine preventable disease in Germany and the disease burden was perceived to be high.
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Hence, the aim of universal vaccination was to reduce the high morbidity and consequently to reduce complication and hospitalisation rates, as well as potentially economic burdens. It was expected that vulnerable groups would also profit from universal vaccination due to herd immunity. The expected effects of the programme were based on mathematic modelling and data from the USA was interpreted as confirmation for the anticipated results. The vaccine was thought to be safe and efficient in inducing long-term protection. From an economic perspective it was emphasised that varicella results in a burden for the healthcare system, but also families and consequently the whole economy, since parents could not work when their children were sick. Based on national and international data, universal vaccination was expected to be a cost-effective intervention. The common arguments against universal VZV vaccination, namely potential shift in age of infection and increase in HZ incidence, were considered. However, it was argued that the experience of the USA did not confirm such developments. An increase of the average age of infection was perceived as unproblematic, provided that the absolute number of infections in these groups does not increase. Regarding the potential increase in HZ it was claimed that it was not yet possible to quantify the effects of universal vaccination on VZV epidemiology and it was further mentioned that a temporary increase in HZ would not justify denying children varicella vaccination. In this regard the varicella committee of the German Association Against Viral Disease (Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten) concluded that due to remaining uncertainties mathematic modelling on the effects of universal varicella vaccination is based on insufficient data. It was emphasised that the positive effects of a varicella programme should not be hindered by a potential temporary increase in HZ and a surveillance system to keep track of developments was recommended (RKI, 2004).
At the time of the initial recommendation two monovalent varicella vaccines were licensed in Germany. In 2006 a combined vaccine with MMR became available as well. While the monovalent vaccines were administered once, the MMRV was given twice due to the necessary second MMR shot (RKI, 2009). Based on immunogenicity data and a study conducted in the USA, the monovalent vaccines’ product information was changed in 2008 and since then included the use for a second dose. The STIKO stated that the necessity for a second shot was evident, however, it was argued that further assessments of immunological and epidemiological data was needed to make a scientific decision about the optimal timing for the second shot (RKI, 2008). The STIKO varicella working group was responsible for this
37 task and the recommendation for a second dose was given in 2009. However, the lack of data, especially regarding immunization rates and breakthrough rates, was still an issue. Furthermore, the quality of the available data on higher efficacy after two doses was criticised. The experience of the USA was again used as reference point, but it was also mentioned that the epidemiological situation in the USA was not directly applicable to Germany. The conclusion to recommend a second shot was essentially based on the consideration to adapt the varicella strategy towards the MMR strategy. The initial aims of the varicella programme could be achieved with a one-dose strategy, but the aim of the second dose was to reduce breakthrough rates, further contain virus circulation, protect vulnerable groups, and ensure acceptance of the recommendation. In terms of safety the higher risk for febrile seizures after the first dose of MMRV in comparison to the monovalent vaccines was noted and further observation recommended. The STIKO concluded with a recommendation for a second shot and timing for such, but the lack of data on optimal timing and unsatisfactory epidemiological data for Germany was pointed out once more. The need for sensitive surveillance was highlighted and recommendations for such were given. Further intense surveillance was announced as well as a re-evaluation when more data would be available (RKI, 2009).
With sight to developments in the USA and changes in the product information of MMRV vaccines the STIKO stated in 2011 that it is preferable to administer the first varicella dose separately from MMR. However, it was clarified that a second shot of MMRV does not portray a higher risk for febrile seizures and that the second dose can therefore be given through a combined vaccine (RKI, 2011). What followed was an evaluation of the programme in 2013 in which the results were interpreted as success regardless of prevailing uncertainties. Further assessments and the adjustments of recommendations at the sight of negative developments were announced (RKI, 2013). Furthermore, from 2012 to 2014 extensive mathematic modelling on the impact of varicella vaccination in Germany was conducted by the RKI and the STIKO published its comments on it in 2016 (RKI, 2016a)6.
In 2017 the STIKO considered recommending HZ vaccination with the live attenuated vaccine Zostavax which had been available in Germany since 2013. HZ was perceived as a condition that placed a large disease burden and limited quality of life. The initial goal of vaccination was the reduction of HZ illness, related complications, and long-term consequences in persons
6 A detailed discussion of these developments can be found in the annex (11.6). 38 aged fifty and older. In face of the available data the goal was specified towards reducing the frequency and severity of HZ in adults aged 70 and older. Existing immunity should be boosted with the HZ vaccine to reduce permanently the incidence of HZ and its complications, including PHN. The STIKO’s decision was negative based on the conclusion that an effective and sustainable reduction of the HZ disease burden could not be achieved with Zostavax. The contemplation was based on a systematic review of data on the efficacy, duration of protection, and safety of the vaccine and was supported by results of health economic modelling. The epidemiological benefit-risk assessment of the vaccine did not lead to a recommendation for universal vaccination due to various reasons. First, it was argued that the efficacy decreases with age and the duration of protection is limited, which is a poor performance considering the target group. Second, modelling results showed only a slight age- dependent reduction of HZ incidence with this vaccine. Third, it was stressed that HZ vaccination would not offer any added value in terms of herd immunity. Finally, it was highlighted that the live-attenuated vaccine is contraindicated in immunocompromised patients and therefore in persons who are at greatest risk of HZ and related complications. The quality of evidence on safety was considered high, but data on efficacy and effectiveness was criticised. Despite the STIKO’s criticism and negative recommendation it was suggested that an individual benefit-risk assessment may lead to different decisions in individual patients (Siedler et al., 2017).
In 2018 the STIKO recommended routine vaccination with the inactivated vaccine Shingrix to prevent HZ and PHN in persons aged 60 and older, and immunocompromised persons 50 and older. It was argued that the recommendation was made in reference to the good efficacy of Shingrix, anticipated duration of protection, and the increased risk of severe HZ and PHN with older age. Modelling suggested that administering vaccination at age 60 would have the biggest impact on preventing all HZ cases and starting from 70 showed the greatest effect on preventing PHN. The most cost-effective age was 65. 60 was chosen by the STIKO based on the premise that preventing HZ is the key prerequisite to preventing complications and late sequelae such as PHN. 60 years of age was perceived as the most favourable age to prevent both HZ and its complications. Emphasis was placed on the increased risk vulnerable groups face regarding HZ and it was claimed that evidence on Shingrix was assessed with consideration to these groups. The quality regarding efficacy in preventing HZ was classified as high, but the data on efficacy against PHN was classified as low and the quality of safety
39 evidence was estimated as moderate. The high level of protection at all ages including elderly was perceived as advantage compared to the activated vaccine Zostavax. Shingrix was evaluated as safe and effective also in the immunocompromised, but an individual risk-benefit assessment was advised. To get insight into the acceptability of the vaccine studies from other countries were referenced and to estimate acceptance in Germany flu and pneumococcal coverage data were used. It was, however, unclear whether these utilization data can be applied to HZ vaccination. Various surveillance and monitoring systems have already been implemented before the HZ programme started. Hence, it was argued that comparisons between the pre- and post-vaccination phases and effect assessments are possible. Additionally, it was announced that international data will be reviewed continuously and compared with data from Germany, which is supposed to contribute to resolve remaining questions (Siedler et al., 2019).
In 2019 an evaluation of the varicella programme was again conducted by the STIKO. The programme was perceived to be implemented well and its positive effects were highlighted. In a few fields, including social acceptance, need for action was declared and new assessments in five years were announced (RKI, 2020)7.
5.2 The United Kingdom
The UK has one over-arching vaccination programme, but the organisation of healthcare and public health services lies within the responsibilities of the local governments of the nations (England, Scotland, Wales, Northern Ireland). All the nations are advised by the Joint Committee of Vaccinations and Immunizations (JCVI), which functions as NITAG and includes members from the UK and abroad. Nevertheless, there is some autonomy and flexibility to adapt to specific local epidemiological circumstances (Rechel et al., 2018). The final decision- maker regarding the inclusion of new vaccines is the Minister of Health, who is obliged to introduce the vaccine if it is recommended by the JCVI and cost-effective. In the UK the recommendation process is not guided by a fixed list of criteria. However, a systematic approach is used whose key elements include case of need, efficacy, effectiveness, safety data, and cost-effectiveness (ECDC, 2015b). Immunization services are part of the National Health Service (NHS) in Scotland, Northern Ireland, and Wales. In 2012 the health system in England
7 A detailed discussion of this evaluation can be found in the annex (number 11.6). 40 changed and consequently national health functions (including oversight of immunization and screening) were transferred to the organisation Public Health England. While immunization responsibilities in the other three nations are integrated to varying degrees, in England it is divided among the Department of Health (=Ministry of Health), Public Health England and NHS England. Vaccination is not compulsory in the UK (Rechel et al., 2018).
In order to investigate varicella and HZ vaccination the JCVI formed a subcommittee whose function is to advise the main committee on varicella related matters. This subgroup met in December 2007, April 2008, and March 2009 to consider the potential use of available vaccines. At that time two strategies were discussed, a combined varicella and HZ programme and a HZ only programme. The epidemiological models used to inform the decision predicted that a one- or two-dose childhood programme combined with a HZ programme for elderly would result in a large reduction of varicella, given that vaccination coverage would be high (>70-80%). However, it was predicted that with a one-dose schedule for children a significant number of breakthrough cases would occur and that both strategies could lead to an increase in HZ rates for the first forty to sixty years, since immunity boosting would be reduced. It was argued that vaccinating the elderly would only improve the situation to limited extent, because the expected increase in HZ would predominantly occur in middle-aged adults too young to be targeted for vaccination. An increase in varicella infection in adulthood was also a predicted possibility. Cost-effectiveness modelling displayed that a two-dose childhood programme or a combined childhood and adult programme could be cost-effective only after eighty to a hundred years. A combined programme would be unlikely to be cost-effective before this time and likely cost-ineffective for the first thirty to fifty years. Based on these prospects neither a universal childhood nor a combined programme was recommended. Results for a HZ only programme, however, showed that universal HZ vaccination for elderly aged 70 to 79 would be cost-effective, provided that a vaccine at the cost-effective price was available. It was argued that the impact of vaccination would be the greatest in this age group. Additionally, immunizing elderly aged 60 to 69 could have been cost-effective as well but based on the vaccine evidence it was assumed that the then available vaccine Zostavax might not provide long lasting protection and a lack of knowledge regarding a second dose was highlighted. Hence, it was argued that vaccinating this group could leave them unprotected later in life when HZ is more severe. It was further declared that vaccinating older groups would not be cost-effective, because of declining effectiveness with age. Ultimately, the JCVI
41 recommended a universal HZ vaccination programme for adults aged 70 to 79 years in 2010. Note that the JCVI stated that these recommendations were based on reviewed medical, epidemiological, and economic evidence as well as safety and efficacy data. Data on the acceptability of the vaccines was not mentioned. It was further proclaimed that these recommendations would be kept under review in light of emerging epidemiological data (particularly in countries which have implemented a varicella childhood programme), duration of protection, effectiveness of a second HZ dose, and cost-effectiveness (JCVI, 2010). An additional recommendation was to consider a varicella programme in adolescents in the future, for which further modelling work was needed (JCVI Varicella Sub-Committee, 2015).
The HZ vaccination programme with Zostavax for individuals aged 70 years started in 2013. A phased catch-up programme for 70-79-year olds was implemented as well. In order to ensure vaccine supply the majority of patients was immunized in the autumn months during flu season, which only changed in 2017 (Dowden, 2018). Starting in 2018, GP practices were encouraged to offer HZ vaccination throughout the whole year (PHE, 2018b). Since the programme’s implementation declining coverage rates in all four nations were, and continue to be, a subject of concern (JCVI, 2016; JCVI, 2019b; JCVI, 2020).
The varicella subcommittee reviewed the original model on which the 2010 recommendations were based, international data on varicella programmes, as well as efficacy and safety data in 2015. Part of this review were reconsiderations regarding impact and cost-effectiveness of a universal childhood programme, strategies targeting adolescents and post-natal populations, and impact of the HZ programme. It was agreed that assessing a childhood programme would be the priority, with the option to look at an adolescent programme if this was unsuitable. The need for more epidemiological evidence in order to close certain gaps was stressed. Regarding the boosting theory it was argued that there was considerable evidence to support the existence of a boosting effect and that therefore a childhood programme would most likely increase HZ rates. However, it was still unclear how long and severe such an increase would be. Related to this, the benefits of a one-dose childhood varicella programme in comparison to two doses were discussed. The primary focus of the programme was to reduce severe varicella. A one-dose programme would be cheaper to implement and allow transmission to proceed while reducing severe cases in children. Therefore, boosting would continue and the potential increase in HZ would be reduced. Since this approach seemed promising the subcommittee requested its inclusion in the model used for informing decision-making.
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Moreover, close collaboration with international colleagues to discuss epidemiology data and vaccination programmes was planned. Insights from a previous survey on parents’ attitudes towards varicella vaccination in England were addressed as well. The study showed that there was moderate acceptance for varicella vaccination, but also highlighted the need for additional education of the public should it be introduced. The feasibility of administering a combined MMRV vaccine or a monovalent varicella vaccine were discussed. The MMRV vaccine was known to considerably increase the risk of febrile convulsion in one-year olds. However, it was argued that the varicella dose in MMRV is not the cause for this development. Furthermore, it was thought that an additional shot would not be accepted by parents and HCPs, and possible additional costs as well as an increase in the workload of the NHS were considered. Hence, MMRV was favourable and it was concluded that parental attitudes towards MMRV and its risks would need to be explored further (JCVI Varicella Sub-Committee, 2015; JCVI, 2015; JCVI Varicella Sub-Committee, 2016)
In December 2016 the subcommittee met again to follow up on these issues. The focus lay on evidence about immunity boosting, the experience of other countries using a one- and two- dose schedule and whether a one-dose programme would be cost-effective. The issue of boosting depicted strong uncertainty and it was claimed that data on this subject were difficult to interpret. It was suggested to obtain further clarity through gathering and analysing information from several sources, but that would have been resource intensive and it was argued that this might not significantly reduce uncertainties. In order to enable the committee to give advice in the short term it was therefore agreed that data collection and analysis should focus on the specific needs of cost- effectiveness modelling. The Australian experience with a one-dose programme was discussed in detail and it was concluded that it reflected the trend of other one-dose programmes globally, namely a significant reduction in the burden of varicella without interrupting transmission. This was interpreted as confirmation of previous assumptions. Two cost-effectiveness models indicated that a one-dose strategy could reduce costs but did not result in the programme being cost-effective and there were some scenarios suggesting overall loss in population health. Since the models were sensitive to uncertainty, it was concluded that they should be updated and then reviewed. Concern arose that the lowest cost option of MMRV could have negative impacts on MMR coverage and thought was given to the various implementation options of a one-dose strategy (JCVI Varicella Sub-Committee, 2016). In 2017 these considerations were discussed by the main JCVI committee. The balance
43 between avoiding an increase in HZ and managing the burden of varicella was addressed and it was agreed that a practical approach should be used to further work on boosting to ensure that a decision about varicella vaccination could be made. The need to carefully balance evidence on the benefits of vaccination against potential harm in a distinct population was highlighted (JCVI, 2017a).
Moreover, new issues regarding HZ vaccination arose in 2017 as well. First, adjustments on the eligibility criteria were made (PHE, 2018a). Second, with the prospect of the inactivated HZ vaccine Shingrix new options arose. Data on Shingrix indicated high efficacy with good duration of protection, and modelling suggested the vaccine was likely to be highly cost- effective (JCVI, 2017b). In 2018 the JCVI recommended the use of Shingrix for immunocompromised individuals who would be eligible for HZ vaccination but could not get Zostavax. It was expected that the use of Shingrix in the immunocompromised was highly likely to be at least as cost effective as Zostavax was for the immunocompetent. Additionally, modelling to inform the use of Shingrix in the wider UK programme was carried out (JCVI, 2018a).
The economic analysis showed that Shingrix would likely be more cost-effective than Zostavax, but limitations were pointed out as well. The most prominent was that there were only four years on efficacy data for Shingrix compared to eleven for Zostavax. The sub-committee pointed towards the need of further data on effectiveness and concluded that alternative vaccination strategies would be explored as well. Based on the considerations of the subcommittee the JCVI was content that Shingrix was effective and cost-effective and should therefore be considered for use in the NIP. An implementation pilot was proposed to gain insight into the acceptability of a two-dose schedule once the vaccine was available (JCVI Varicella Sub-Committee, 2018; JCVI, 2018b). However, this pilot was not further mentioned in the minute meetings available at the time of writing.
At the beginning of 2019 the subcommittee reviewed the modelling on Shingrix and concluded that the optimal age for immunization of immunocompetent individuals was 65 years and that the vaccine would be cost-effective at any age from 50 to 90 years in the immunocompromised (JCVI Varicella Sub-Committee, 2019). The JCVI recommended a two- dose schedule with Shingrix offered routinely at the age of 60 years. It was noted that the implementation of a large programme would depend on vaccine supply and that certain groups would need to be prioritised. It was further proposed that the programme should be
44 implemented in stages and that elderly aged 86 or older who had not been vaccinated with Zostavax should be considered for vaccination with Shingrix. However, since it would require more modelling, this idea was dropped. It was recommended that Shingrix should be offered to immunocompromised individuals aged 50 and over (JCVI, 2019a). At the time of writing these recommendations have not been implemented yet and considerations on varicella vaccination are still ongoing (JCVI, 2020).
5.3 The Netherlands
In the Netherlands, the Minister of Health, Welfare and Sport determines which vaccinations are included in the NIP. These decisions are based on the advice of the Health Council (Gezondheidsraad, HC), which functions as NITAG (Rechel et al., 2018). Since 2014 the HC collaborates with the National Healthcare Institute (Zorginstituut Nederland) regarding vaccination recommendations. While the HC assesses current scientific knowledge about vaccines and advises on strategies for vaccination on population level, the National Healthcare Institute advises whether the vaccine should be included in the basic health insurance package (National Healthcare Institute, n.d.). For its recommendations the HC makes use of a framework consisting of seven criteria that cover the seriousness and extent of the disease burden, effectiveness and safety, acceptability, efficiency, and priority of the vaccination (Houweling, Verweij & Ruitenberg, 2010). The execution of the NIP falls under the realm of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM), which monitors and registers the vaccinations (Rechel et al., 2018). Vaccination is not mandatory in the Netherlands (Government of the Netherlands, n.d.).
Chickenpox is so prevalent in the Netherlands that almost everyone contracts it sooner or later, but it is most common in children under the age of five. Varicella vaccination is indicated only for specific medical high-risk groups and groups with occupational risk. Currently varicella vaccination is not included in the NIP. In theory the varicella vaccine is available to patients at their own expense, but virtually hardly any use is made of it (van Lier, van der Maas & de Melker, 2020). The same goes for HZ vaccination (Health Council of the Netherlands, 2013).
In 2007 the HC introduced the seven criteria framework for the introduction of vaccines and conducted a full assessment of the existing NIP, as well as new vaccines, which also included
45 varicella and HZ vaccination. Ultimately, the HC advised against including either. It was argued that due to a lack of data an adequate assessment could not be made. Therefore, it was recommended that a reassessment should take place once additional data were available. Various uncertainties and data gaps were pointed out (Health Council of the Netherlands, 2007).
In the case of chickenpox, it was emphasised that despite its high prevalence the disease is normally not serious, and that fatality and hospital admission figures are lower in the Netherlands than in other western countries. Nonetheless it was also suggested that complication and mortality rates associated with chickenpox might have been underestimated. Consequently, at the HC’s request, data on chickenpox complications were actively collected within the Dutch Paediatric Surveillance Unit. The HC claimed that the seriousness and the extent of the disease burden were not yet satisfactory demonstrated (criterion 1) and was therefore also concerned about the public’s acceptance (criterion 4). Uncertainties regarding the influence of varicella vaccination on the incidence of shingles were mentioned. It was further concluded that chickenpox vaccination would not serve any urgent public health need (criterion 7) at that time and more data on the importance and urgency of the situation were necessary (Health Council of the Netherlands, 2007).
Part of the general recommendations in 2007 was a discussion about expanding the NIP to various age groups, such as adolescents and elderly, and not solely focusing on children. Seniors were expected to increasingly become a target group for vaccination programmes. Regarding shingles prevention different points than with chickenpox were highlighted. Contrary to chickenpox, shingles was recognised as serious condition (criterion 1) and vaccination was more desirable. Despite this, due to the overall lack of data it was argued that the other criteria for inclusion in the NIP could not yet be assessed. On top of that, the vaccine was not yet available in the Netherlands and it was claimed that incorporating it in the existing NIP would not be easy. The influenza vaccination system that was already in place for seniors was perceived as a potential model for shingles vaccination. It was concluded that vaccination against shingles was a potentially important intervention and thus that the situation should be assessed within two years (Health Council of the Netherlands, 2007).
In 2009 programmatic HZ vaccination of elderly was reviewed and the results were included in the RIVM report on developments in the NIP, which provided an overview for the diseases included in the programme and presented surveillance data of potential candidates. The then
46 available vaccine against shingles was Zostavax. The evaluation showed that the vaccine reduced the occurrence and severity of HZ. However, the efficacy was found to be suboptimal and the duration of protection uncertain. It was argued that due to this a considerable part of the disease burden caused by HZ would remain, even if the vaccine would be fully accepted. Furthermore, the cost-effectiveness ratio was estimated to be above the socially accepted threshold (Kemmeren & de Melker, 2010).
The narrative about varicella and HZ vaccination seemed to take on a different tone in a 2013 framework setting report on the individual, collective and public importance of vaccination by the HC. Amongst other things, this report discussed how potential health gains are not explored due to the underutilization of potentially useful vaccines. Chickenpox and shingles vaccines were part of the examples and referred to as “good vaccines” (p. 21). The reasons for not including them in the NIP in 2007 were illustrated, but it was also mentioned that despite those arguments the vaccines are beneficial for certain individuals and groups in society. It was also emphasised that the final judgements about these vaccines were still not in place (Health Council of the Netherlands, 2013).
In 2016 the HZ vaccine was again assessed for the inclusion in the NIP and again the advice turned out negative. According to the report, the HC’s decision was based on scientific data on disease burden, effectiveness, safety and efficiency. Although it is one of the assessment criteria, acceptability of the vaccine was not mentioned. The safety of Zostavax in healthy individuals was not doubted and adverse events perceived to be mild. However, it is a live attenuated vaccine and given that shingles is associated with a weakened immune system, it was argued that vaccination would be of no use to the very group that might otherwise most benefit from it. The vaccine was further criticised for its limited effectiveness and short-term protection. Additionally, the disease severity and burden of disease were illustrated to be low, with hospitalisation being described as uncommon and mortality from shingles as rare. It was argued that shingles is not an epidemic disease and does not spread in a way that poses a health threat to the population and social life. Hence, it was concluded that it would not be reasonable to organise and finance a vaccination programme and that vaccination with Zostavax depicted no collective relevance. Nevertheless, two committee members felt that due to the vaccine’s protection against PHN it could be regarded as essential healthcare. People’s individual choice towards HZ vaccination despite the absence of collective relevance was recognised and therefore the importance of well organised market authorisation,
47 registration of adverse effects, and public information campaigns were highlighted. In this context HCPs’ role in answering questions and the importance of including this in medical education was pointed out as well. The HC recommended further research into the use of individual vaccination care at GP practices. The report concluded with a positive outlook towards an inactivated HZ vaccine, which would be reason to re-evaluate HZ vaccination again (Health Council of the Netherlands, 2016).
The inactivated vaccine Shingrix became available in 2018. To support the advisory process the RIVM prepared an elaborate background report on HZ infection in the Netherlands, which included disease and vaccine specific data, cost-effectiveness, and national and international insights into the acceptability of HZ vaccination. In 2019 the HC issued an overall positive recommendation for immunising seniors age 60 and older against HZ with Shingrix. The HZ disease burden was illustrated to be considerable, although much lower in comparison to other diseases such as pneumococcal disease and influenza. Nevertheless, like in the 2016 assessment, it was argued that HZ does not depict a threat to public health or social life. Furthermore, it was mentioned that HZ vaccination would only provide benefits on individual level and that no herd immunity effects are to be expected. Hence, cost-effectiveness became determining for the decision. Due to the vaccine price the cost-effectiveness ratio was way beyond the accepted threshold, and the vaccine was not included in the NIP. The HC concluded that in order to achieve the targeted threshold, the vaccine price would have to drop significantly. Although it was part of the background report, social acceptance of the vaccine was not mentioned in the official statement on this decision (National Healthcare Institute & Health Council of the Netherlands, 2019).
While the discussion about HZ is on hold for now, the assessment of chickenpox vaccination is currently ongoing. Since the evaluation in 2007, national and international varicella related developments have been traced and recorded. Based on this new information, it has been claimed that the desire for varicella vaccination in the Netherlands should be reconsidered. Reportedly, experiences with varicella vaccination in other countries have provided valuable insight for this matter. Like with HZ, the RIVM issued a background report about varicella infection in the Netherlands to support the HC’s decision, which includes information on epidemiology, available vaccines, cost-effectiveness, as well as research on the local and international acceptance of varicella vaccination (van Lier et al., 2020). The HC’s decision is expected to be made in the second half of 2020.
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5.4 Discussion
All three countries reached different decisions based on varying arguments which were supposedly founded on evidence. In terms of disease severity, it is striking that varicella infection was perceived differently. Generally, shingles was perceived as a more serious disease than chickenpox. While Germany understood both as severe conditions, the Netherlands recognized the possibility of severe developments, but neither chickenpox nor shingles were depicted as serious health threat to the population. This could be related to the Dutch epidemiological situation. Based on the available documents the UK’s perception is not clear. Data on the disease burden is included in the documents, but unlike with Germany and the Netherlands those are hardly interpreted. Since both a childhood and senior programme were initially considered, I suggest that both chickenpox and shingles were perceived as at least serious enough for vaccination. However, given that considerations started in 2007 and no childhood programme has been implemented at the time of writing, chickenpox is assumedly no urgent issue.
All three states addressed common issues regarding varicella, such as effectiveness of available vaccines, higher risk of MMRV compared to a monovalent varicella vaccine, the extent of possible immunity boosting through exposure to the virus, and possible effects of a childhood programme on HZ incidence. However, the significance attached to these issues varied and the availability of evidence and the evidence itself was interpreted differently. Consequently, argumentations differed. While the UK postponed its decision on chickenpox and the Netherlands postponed its decision on both chickenpox and HZ based on the argument of lacking data and uncertainties, Germany took a more hands-on approach with the introduction of a universal childhood programme in 2004. I will return to an analysis of the significance of these differences in the conclusion.
6. Social acceptance of varicella vaccination: Public and professional opinions
To begin with, it is important to note that the interviewees, as well as the online research participants mentioned that they generally identify as vaccination advocates and distanced themselves from anti-vaccination movements and vaccine hesitancy. Furthermore, the interviewed HCPs expressed their concerns and worries about parents hesitating, or even fully refusing to vaccinate their children according to the Dutch NIP. These things are important to
49 keep in mind, because they frame the discussion and argumentations against chickenpox vaccination as not being part of an overall vaccine hesitancy/anti-vaccination mindset, but chickenpox specific.
6.1 Chickenpox – a normal part of childhood?
Chickenpox is common in the Netherlands. Compared to other countries, Dutch children contract VZV infection at a younger age, which might explain a relatively low disease burden (van Lier et al., 2013). The interviewees experiences with chickenpox reflected this overall trend. As HCPs none of them were strangers to chickenpox. Most have experienced it not only in their personal environment, but also seen typical chickenpox cases with a mild course of disease in (mostly infantile) patients. Consequently, chickenpox was perceived to be a very common and mild disease among children. Nevertheless, the possibility of severe cases and complications was recognised. Some interviewees had experiences with severe cases of varicella that lead to complications and even hospitalisation. However, it was emphasised that compared to the overall prevalence of infection, such cases are rather uncommon.
The perception of chickenpox as a mild disease which everybody gets and does not require prevention points towards it having come to be seen as part of childhood in the Netherlands. This resonated with the HCPs’ opinions about so called “chickenpox parties”, which refer to the phenomenon of deliberately infecting children with chickenpox in order to gain immunity. This is an attempt to avoid severe chickenpox later in life. Although some interviewees were not in favour of such actions, they also did not condemn parents who decide to do so. The following interview excerpt exemplifies how chickenpox is perceived to be a common experience during childhood:
VB: Because we also talked about the immunization programme and […] discussing it with parents and when changes come it might be difficult to explain them to parents. […] would you expect it to be difficult to talk about chickenpox with parents?
Natalie: Yes, I think yes. Because it's a normal disease and everybody is saying ‘Oh my child has chickenpox so I visit my sister […] so they can get it’ […]. People are not panicking about this disease, it's a normal disease. Yeah, sometimes you see problems. Three months ago I had a child who had to go to the hospital because he was very ill because, he had some skin
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diseases, an infection from the skin, so the parents were very worried because they thought oh chickenpox is not bad, but it was bad. So sometimes that happens.
VB: And what do you think about parents getting their kids together so that everybody gets the disease?
Natalie: Yeah, it's better to contact little children, when you are older it's more heavy to have chickenpox, so it's okay when they infect other children because [...] then you did it and it's okay. So, I think it's okay, that's not a problem. And when they go to the schools, I always hear parents [say] ‘Oh it's chickenpox’ and after one week every child has chickenpox, it's so infectious.
Descriptions like this do not only highlight the perceived normality of varicella infection in Dutch children, but also suggest that severe cases are perceived as exceptions. The normalisation of chickenpox becomes further apparent through the interviewees’ experiences with parents. Not only did they hardly experience parents asking about the varicella vaccine on their own accord, but they also explained that chickenpox in general is not really a topic of discussion. Dutch parents sometimes seek confirmation for the diagnosis, but usually no discussion about it emerges.
In this regard it was interesting to see that even though chickenpox is perceived to be a normal part of childhood, shingles might not necessarily be viewed as normal part of growing old. In comparison to chickenpox, shingles is perceived to be more problematic due to its symptoms and possible long-term effects. From the interviewees’ point of view, vaccination against shingles was more desirable than chickenpox vaccination. For example, James based this opinion on his experience with HZ patients as follows:
James: Well, I think as a GP I see on a regular basis people that have lot of harm after shingles, because they have a lot of pain and agony and they can't sleep and it lasts for months or even longer, so I think that's a group of patients that a lot of GPs will think, well, if you can prevent that, that's interesting. […] We would prefer that. And if you vaccinate a child […] it's a very long way. […] So it's 50 years from now, so yeah who cares. […] The question is, is this the right way to do that […]. So I think a lot of GPs will favour vaccination of seniors.
VB: I see […]. Because shingles is generally more severe than chickenpox.
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James: Well not the shingles as itself, but especially the neuropathy afterwards. So you have a varicella neuropathy with some of the patients. So I have a women now at this moment, two even, two persons. Yeah, they were everywhere, it won't work. It won't work. They have pain and they cannot sleep, and they get every medication that there is around the world but it won't help. So they are in tears and their life is a mess and well they go to the doctor but […] well, we can do nothing about it.
VB: That's quite awful.
James: Yeah. […] And they come to your office every time again […] so we are, as a matter of speaking, we are boosted on this field, because we see those people. […] We see also that we cannot help them really. So if you could prevent that, that's much more interesting for a GP. While the children, well that's rather rare. So, I saw one that was very very ill, critically, almost killed it, but that's rather […] rare. You don't see it usually. I couldn't believe it at first.
In this context it was interesting to discuss that the chickenpox vaccine became more desirable when the potential positive effects on the prevalence of shingles were considered. As Mason explained:
If you can think of a reduction in herpes zoster cases then you might consider it. What I see in chickenpox cases in children is most often quite mild, so I don't see a real reason to do a chickenpox vaccination. But if it really influences the number of severe herpes zoster cases, then I really might consider it.
Regarding the question under which circumstances vaccinating against a disease becomes necessary the severity of diseases and the possibility of severe developments, as well as their influence on the health of a community as a whole were mentioned. In this respect the interviewees compared chickenpox to diseases that are already part of the NIP. It was not surpising that chickenpox was not perceived as a priority in comparison to conditions such as poliomyelitis. Nevertheless, the comparison to the MMR vaccine is especially interesting in this regard. Mason explained the difference to me as follows:
Well, the way I look at it, measles I consider it as a more severe condition for small children, but maybe in a country like Holland where we have a proper healthcare system, economy is still quite okay, nutrition of the children is quite okay, so you can consider that the measles might also be quite a mild disease. When you look at measles in developing countries it's
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very severe […] but maybe in the western world measles also might be quite mild. But still I look at measles as a more severe condition when it's compared to chickenpox.
Perceived disease severity is without doubt an essential factor for people’s attitudes towards various vaccines. In light of the history of MMR, however, the context of such opinions might not be as straight forward. Before their inclusion in NIPs in Europe the discussion about measles and especially mumps vaccination resembled the contemporary debate about chickenpox. (Blume & Tump, 2010). Despite the similarities the interviewees perceived the MMR vaccine as essential, but not chickenpox vaccination. Considering that vaccination against measles and mumps started in the Netherlands in the 1970s, the interviewees perceptions could be linked to the vaccine’s incorporation into the healthcare system as a routine vaccine over time.
I came to this suggestion through looking at how the interviewees discussed the implementation of changes in healthcare policies in general, and the HPV vaccine as the most recent example. HPV was perceived to be a vaccine that people are still hesitant about, but the interviewees emphasised that vaccination uptake for this vaccine is on the rise and currently a lot better than at the time of implementation. While it is still not at the level where they would like it to be, they seemed optimistic about further developments. In this respect Amy mentioned the following:
It's more common [now], it's like it's always with change in a population […] at the beginning it's a discussion because, I mean change is weird, we are […] people, we like steadiness but now it's […] common and everyone [is] just like yeah it's vaccination […]. But I mean, when it's first implemented everyone needs to read about it and […] we don't have that much information yet […]. I think it will always take some years before it's […] implemented right, like it was intended at the beginning.
When asked whether it is difficult to adjust to changes in the NIP, Linda answered similarly and emphasised the need of informing patients about the necessity of a new vaccine:
I think so, it's quite difficult because we have also seen it in introducing the HPV vaccine. There was a lot of resistance in the beginning, now after some years […] the vaccination rate is getting better, because people learn to know more about the effects and the risks and they … maybe they are more willing to … well, to contribute and to join the vaccine because they are better informed during some years, I think. So it's difficult to put a new
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vaccine in the programme […] then there is alway a group of people who spreads a lot of non information or false information or makes other people scared with their stories and that's which you always have to fight against. Because it's just non information, but well, people need to get the right evidence based information of course, but that's quite a job ((laughs)).
The data gathered on Reddit points in a similar direction. Participants from countries where universal chickenpox vaccination is part of the NIP (for example the USA) mentioned that it is a common thing to do, especially in sight of HZ, and some were surprised to hear that this is not the case everywhere. Contrary to that, some people from countries where varicella is not a routine vaccine referred to its low severity again. What was striking in this regard was that quite a few participants opened up about personal experiences with severe chickenpox and/or HZ cases. In these cases, the participants emphasised that varicella infection is by no means as mild or “innocent” as often perceived. Some seemed regretful about underestimating the disease or not being informed about the possibility of vaccination for their children. It was also mentioned that seeing severe cases and possible long-lasting effects in others motivated some to vaccinate their children against varicella. This resonates with a discussion that I had with Natalie regarding the influence of experiences with diseases. She told me about a programme in Dutch TV where a paediatrician discusses vaccination with hesitant parents and invites them to join him in the hospital to personally see cases of the diseases in question. Apparently, this experience motivated these parents to change their opinions about vaccination. Chickenpox was not part of the discussion, but when I asked whether serious chickenpox cases could have similar effects on people’s perception about the disease she answered:
Yes. Yes, I think so yes, because people don't see the […] children in the hospital because they can be very ill, encephalitis and pneumonic and a lot of complications with. So when parents are seeing that, I think they will be very motivated to do it [varicella vaccination] yes.
She later went on and told me about a case where a mother lost her baby due to whooping cough, which is part of the Dutch NIP. She emphasised the impact such cases can have and related it to chickenpox as well:
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[…] and when something happens with the chickenpox something … such a heavy thing it will always change people […]. So it shocks people. Such an incidence, yes it really shocked the parents.
A couple of weeks after the interview Natalie reached out to me and told me about a conversation she had with a mother. Her daughter was admitted to the hospital because of a lung infection and got chickenpox on top of that when she was 9 months old. The chickenpox worsened her condition even more. The mother explained that she used to think of chickenpox as something children “just had to go through, not very dangerous" and that she never knew that vaccination was possible. Her daughter’s experience changed her opinion and she said she would certainly vaccinate her next child. Based on these descriptions I suggest that the experience with severe cases can disrupt the perception of a widespread disease, like chickenpox, as normal.
6.2 Balancing risks and preserving the national immunization programme
Before conducting the interviews, I expected the discussions to mainly focus on the vaccine itself, including details about efficacy, risks of adverse effects, cost effectiveness, and the various theories about universal vaccination, such as the potential shift in age of infection. While these issues were discussed, the HCPs’ views about the implementation of varicella vaccination were very much focused on something I haven’t considered as much, namely parents’ reactions to a chickenpox vaccine and its impact on the whole vaccination programme.
Overall, all the interviewees were happy with the current NIP. While possible improvements on organisational level were brought up, the vaccines included in the programme were perceived as necessary and the interviewees were very much in favour of them. In this regard, concerns about vaccine hesitancy and refusal were a re-occurring topic.
Regarding vaccination in general, two levels for assessing “harm and profit” were brought up during the interviews. First, the risks of the disease and the vaccine need to be weighed and this can vary depending on the disease. Since chickenpox is known to be not very severe, the interviewees considered whether a vaccine could actually lead to more risks, such as adverse events, than the disease itself. James mentioned for instance:
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But if you can prevent it [a disease] it's interesting to see what is the balance between, well, harm and profit. […] How big are the chances that the child gets harmed by vaccination for instance. […] Yeah, if you give a vaccination against tetanus, I don't think the child will get any harm, it's very unusual. Whooping caught was a vaccination in the past that children could be very ill, fainted, high fewer, so there was rather strong side effects. But on the other hand, the disease itself was this heavy that I think it was worthwhile. But if the side effects of vaccination against chickenpox has a chance of 0.01 percent […] that it's damaging your child, then I think what's the balance between profit and harm.
Similarly, Amy expressed:
[…] it depends on what are the symptoms that a disease will give you […]. If it's not really severe or you won't die on it or it's like really … mostly it's like five days a little bit flu and that's it […] then you don't have to vaccinate because it does have some adverse events however, because it's something you inject someone.
The interviewees recognized that implications for people’s perception of the vaccination programme as a whole also need to be considered. Generally, the interviewees mentioned that a lot of parents trust them as HCPs. For example, Natalie, who works very closely with parents, recalled that they often do not know details about vaccines and do not ask about it because they trust her. However, the interviewees also discussed that vaccinating the children can be a very emotional situation for parents, because the children’s discomfort is visible while the benefits of vaccination are not. This can induce parents to be more reluctant. The interviewees also emphasised the influence of mass media and social media on parents. They criticised the spread of information which unsettles parents and leads them to question vaccines. In light of this, the NIP was perceived as precarious.
Since chickenpox is perceived as a mild disease and highly common, the interviewees were unsure about parents’ reactions to a vaccine. They explained that parents are very sensitive to new vaccines and not seldom suspicious when there is no demand before the implementation. As James explained:
[…] sometimes people want the change. So we had a vaccination against meningitis and parents wanted this other vaccine which also made children immune to the newer meningitis forms. […] And so sometimes it's parents driven, so people want it, but when
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there comes an extra vaccination parents are sensible to it. Why is that necessary? Why is there another shot useful? Why should we do that?
Furthermore, the concern arose whether including it in the programme would make to whole programme more vulnerable, or even harm overall vaccination uptake. The following interview excerpt exemplifies this discussion:
James: […] I think it's important to focus on the main gains that you could have by vaccinating.
VB: You mean against chickenpox?
James: Yeah for instance. And I think it's important to also to check on whether it harms the total programme and in what way you could prevent that.
VB: Interesting yeah. Why would it harm the programme?
James: Well because people could say ‘Why are we vaccinating against a disease that do not kill people, that do not harm babies in that way, why should we do that’. And that makes […] the other vaccinations coming into discussion as well. […] So people can attack this programme by saying that it's not really needed. ‘Look at the chickenpox vaccine, it's not really needed, children don't die of chickenpox’ and so on. […] So they focus on one and there with this focus on one they bring the programme in […]
VB: Jeopardy?
James: Yeah, sort of jeopardy yeah. They harm the total programme this way and this is something that could happen and that's … I would be very sad about that.
VB: Yeah, right. So yeah that would also probably make your work harder then. Because people are more suspicious.
James: Yeah. Reluctant yeah, they're more afraid, or not following the rules, they are perhaps refraining from vaccination. So they are not taking their child to this bureau [child health clinic] […]. So in fact what we are doing then is harming the complete programme and in fact are harming our own children this way. Because the people who come with their child, they get vaccinated also against varicella, but if more people do not come with their child, they don't get vaccinated for the other more important diseases.
In this respect the focus was on vaccine-hesitant parents specifically, as Amy mentioned:
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I think the people who already are open to vaccination, they will accept it. Probably the people who […] don't get vaccinations […] they won't get it. And if it would be in the programme and you don't have to pay for it, probably most of the people would get it either way.
So the concern was that including universal varicella vaccination could fuel vaccine hesitancy further and lead to children missing out on all the vaccines, which would be worse than to forgo only the varicella vaccine. Additionally, emphasis was placed on the legitimacy of vaccines and the need for supporting arguments for possible discussions with parents. For instance, Mason pointed out that he is hesitant about universal chickenpox vaccination because of the risk of losing parents’ trust due to the lacking visibility (or recognition) of a problem and deficient arguments. He explained his position as follows:
Well, my most important part is to make sure to stick to vaccinations you can explain to your community, you can explain to your patients. If you don't have strong arguments to explain the vaccination programme, then you take a risk for the vaccination programme as a whole. If you put in chickenpox for all children, even for children that are not vulnerable, I think you take a risk for the vaccination programme as a whole and if your coverage for instance, let's mention it again, for diphtheria or even pertussis, then you take a risk for those vaccinations as well and the side effects might be more severe than your advances of the new chickenpox vaccination. So if you consider implementing chickenpox for all children, I think you might take a risk for that. If you […] implement the chickenpox for vulnerable children only, I think you can still explain to parents that their child is more vulnerable than other children and that's why it's a good reason to take the chickenpox vaccination.
Overall, most interviewees shared this position and preferred including the varicella vaccine for vulnerable groups only. However, it was also suggested to inform parents more about the varicella vaccine and the option to pay for it privately should they want to do so.
Due to the concern about parents’ reactions, the opinions about whether a single vaccine or MMRV would be preferable differed. On the one hand, parents’ emotions were mentioned again and how an additional shot could portray a big inhibition. On the other hand, if the varicella vaccine is combined with the MMR and parents do not perceive it as necessary, children could miss out on MMR as well.
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In addition to these considerations, the issue of how the COVID-19 pandemic might influence parents’ vaccination attitudes in general was brought up. At the time of the interviews it was too early to pinpoint into which direction the discussion might go (and this is still the case at the time of writing). Nevertheless, Linda mentioned that she and her colleagues had the impression that parents tended to be more willing to vaccinate because they were alarmed by the situation. Mason expected a boost of the NIP as well. However, both stated that this might be only temporarily, and that the introduction of a corona vaccine will spark new discussions and, as with most vaccines, new scepticism and questions.
6.3 Discussion
The comparison between the interviews and the online data points towards different narratives about varicella depending on what is common in certain countries. While in the Netherlands varicella infection is perceived as an ordinary and rather harmless part of childhood, in other countries vaccination has become routinized and is perceived as the normal thing to do. When asked about what makes a disease severe or what makes vaccination necessary, the interviewees often compared chickenpox with diseases that are already part of the Dutch NIP, such as poliomyelitis, whooping cough, measles, and tetanus. They referred to the importance of severe symptoms, including the possibilities of long-term damage, paralysis, and the chances of death. In comparison to such diseases they perceived chickenpox not to be a necessity. This is especially striking in consideration of debates about measles and mumps before their inclusion in NIPs. These implications as well as the discussions about general changes in policy and specifically the case of the HPV vaccine point towards a process of gradual acceptance of vaccines over time. At the beginning of this process people are rather unfamiliar with a new vaccine and hence doubts and uncertainties are often prevalent. This is especially the case if there is no demand for a vaccine.
Public demand is influenced by people’s opinions about diseases. Personal experiences with severe cases can alter these and therefore influence perceptions on the need for vaccination. The interviewed HCPs were not opposed to the varicella vaccine per se, but most of them emphasised that they would prefer a vaccination approach aimed at immunising vulnerable groups. They recognised the possibility of severe cases and complications, but their main concern was that universal vaccination could negatively influence overall vaccination uptake
59 in the Netherlands. This notion was based on the argument that parents are sensitive to new vaccines and concerns about vaccine hesitancy.
7. Conclusion
This study set out to answer how and why vaccines are added into NIPs based on the example of varicella in the EU and the following sub-questions:
- How did the selected EU states reach their conclusions about (not) introducing the varicella vaccine? - What was the role of evidence as well as professional and public opinion in decision making processes about (not) adding the vaccine into national immunization programmes? - What are the public’s and healthcare professionals’ perception on the varicella vaccine in terms of risk and desirability?
To answer the first two questions, I would like to discuss the comparative analysis of Germany, the UK, and the Netherlands. Much in alignment with previous research on immunization policymaking the comparison shows how countries reach completely different conclusions about a vaccine while claiming to base their decisions on evidence.
Drawing from Dobrow et al. (2004), I propose that the main differences occurred during the phases of interpretation and application of evidence. Since all three states considered similar questions, I suggest that overall similar evidence was introduced into the decision-making process. Two exceptions in this regard were local epidemiological and economic data, as well as evidence on the acceptability of the vaccines.
Bryder’s (1999) work emphasises the importance of social welfare traditions and systems but also debates how evidence is interpreted differently. While national traditions did not seem to clearly influence decisions on varicella, varying interpretations did. Hagen-Berg and Blume (2020) further discuss varying disease perceptions, evidence interpretation, and political priorities. Similar developments underlay VZV decision-making. Germany viewed both chickenpox and shingles as serious conditions. The UK seemed to perceive both as serious enough for potential vaccination, but chickenpox seemed to be no urgent issue. The Netherlands recognized the possibility of severe developments, but neither chickenpox nor
60 shingles were depicted as serious health threats to the population. This could relate to the Dutch epidemiological situation. In this regard it was striking that throughout the decision- making process the narrative on the severity of varicella infection and available vaccines seemed to adjust depending on decisions made at certain times and the agenda of documents. This could have been attempts to legitimate decisions and recommendations.
Even though all three states addressed similar issues, the availability of evidence and the evidence itself was interpreted differently and therefore its application to legitimize decisions also varied. While the UK postponed its decision on chickenpox and the Netherlands postponed its decision on both chickenpox and HZ based on the argument of lacking data and uncertainties, Germany took a more hands-on approach. Germany argued that the available data was insufficient as well, but it was nevertheless used to inform the policy. Essential for the introduction of the programme was the sentiment that a potential increase in HZ would not justify denying children chickenpox vaccination. This was clearly not the case in the other two countries, especially the UK was highly concerned with the extent of boosting and the impacts of a childhood programme on HZ incidence.
To make sense of these varying approaches I would like to highlight Klein’s (2000) suggestion to think of policies as experiments. In doing so we can understand how policies ultimately produce evidence about themselves. This was especially the case for Germany. In 2004 Germany had no other European experiences as reference for implementing universal vaccination and therefore turned to the USA. Germany combined the introduction of a programme with intense surveillance. The lack of data on immunization and breakthrough cases was a continuous issue which caused the enhancement of surveillance and in turn generated more data about the policy. With sight to this new evidence Germany re-evaluated its decisions and kept a flexible position. This flexibility was also apparent regarding the recommendation for a second chickenpox shot. The UK’s implementation of a HZ programme generated evidence as well, especially on its suboptimal acceptance. Today the experience- based evidence of Germany has become an important reference for other European countries and both the UK, and the Netherlands incorporated it in their own decision-making, albeit in different ways. All three states referred on multiple occasions to international data and specifically to the experiences of other countries with certain policies. They were mainly applied to legitimate one’s own propositions and plans. This relates to the gradual importance
61 of the international context as pointed out by Blume and Tump (2010) as well as Hagen-Berg and Blume (2020) and highlights the value of experience-based evidence for policymaking.
The instance of MMRV shows that the availability of combined vaccines can influence policies, although not necessarily in the sense that combination vaccines are automatically preferred. In Germany the availability of MMRV raised interest in a second varicella dose, but due to the higher risk of MMRV separate administration of the first shot was later recommended.
This example further indicates how interpretations of allegedly evident data depended on the interpreter. Contrary to Germany, the UK favoured MMRV over separate administration due to economic considerations and the arguments that the varicella dose is not the reason for the increased risk and that parents might not accept an additional shot. Another example for varying interpretations is Zostavax. All three countries were interested in implementing a HZ programme, although Germany and the UK seemed to be more eager than the Netherlands. Germany and the Netherlands refrained from using Zostavax and criticised its suboptimal efficacy and duration of protection. Contrary to that the UK implemented a programme with Zostavax because it was expected to be cost-effective. The limitations of the vaccine were recognized but were not interpreted as reason to omit from introducing it, instead they influenced the age group recommendations.
As Dobrow et al. (2004) suggest, the utilization of evidence is inherently contextual. In relation to this Tump and Blume (2010) discuss how contextual changes over time influenced the introduction of MMR in the Netherlands. The examples presented in this thesis show similar developments regarding internal context changes. All three countries aimed at reducing varicella related disease burden, eliminating the virus was hardly an issue. Nevertheless, the contexts in which this goal was formulated differed and changed over time, which led to new considerations and new goals. In the case of Germany, the goals were adapted with the implementation of a second shot in 2009. With these changes the issue of social acceptance was brought up, which was not mentioned in the statements on the initial 2004 recommendations. Similarly, acceptability was not discussed in the statements on refusing Zostavax but was considered later with Shingrix. This could have been attempts to legitimate policy changes and was most likely linked to unsatisfactory chickenpox coverage rates in examined birth cohorts. In terms of internal context changes the UK is particularly interesting. At the time of initial considerations, a one-dose schedule was criticised for its potential of a significant amount of breakthrough cases. As the UK continued to be worried about the impact
62 of varicella vaccination on HZ incidence a one-dose programme became more appealing for the same reason. It was clear that these uncertainties could not be resolved in the short-term but the JCVI was nevertheless expected to deliver a recommendation. In order to enable the committee to do so, the focus was shifted towards cost-effectiveness modelling. Based on the availability of data for this research it is difficult to estimate contextual changes in the Netherlands. However, initial considerations of a HZ programme in 2007 were part of an overall discussion about expanding the NIP to various age groups, which portrays an internal context change in comparison to previous years. Furthermore, the varicella narrative seemed to change depending on a document’s context and agenda.
As aforementioned, similar issues were raised by the countries, but the significance attached to them differed. Cost-effectiveness and social acceptance are two examples in this regard. Hagen-Berg and Blume (2020) argue that economic aspects became key considerations for immunization policies in the 1980s when healthcare costs rose out of control. It is evident that cost-effectiveness was determinant in the presented examples as well. Germany expected to decrease direct and indirect costs with a childhood programme. In the case of HZ costs might not have been as determining, because the implemented age was not the most cost-effective one. Compared to that, the UK initially decided to disregard a childhood or combined programme but implement a HZ only programme based on cost-effectiveness modelling in 2010. Despite the HC’s positive recommendation on Shingrix, the vaccine was not included in the Dutch NIP because it was not cost-effective. In an attempt to rationalise immunization decisions, the Netherlands claim to base their decisions on a seven criteria framework. In this regard it is striking that costs were determining for the non-inclusion of the vaccine, although HZ and Shingrix ticked all the other boxes. It appears that these criteria might not be weighted equally or that other factors play a role.
Contrary to economic considerations, public acceptance of the vaccines did not play a substantial role. The opinions of the interviewed HCPs, however, highlight the importance of people’s acceptance and trust. Germany considered acceptance after the introduction of the childhood programme with the recommendation of a second dose. Acceptability was not considered during decision-making on Zostavax, but later with Shingrix. It did not seem to be a priority, however, because no efforts were made to gather data on HZ vaccination in Germany specifically. Instead international data and utilization data on other vaccines for seniors were used as reference. The UK was not concerned with the acceptance of HZ
63 vaccination before the programme’s implementation and has been dealing with suboptimal coverage rates since its beginning. As part of the discussion on MMRV parents’ attitudes were contemplated in 2015 and it was argued that further insights were necessary, but since then it has not been a predominating issue. The Netherlands might have considered acceptance the most because it is part of their assessment framework. The criterion in question highlights the experience of inconvenience and discomfort, which mainly relates to the number of injections given. Despite its inclusion in background reports, social acceptability was clearly not a crucial matter to reach a decision about HZ vaccination, as it was not even mentioned in the HC’s statement. Whether it strongly influences the decision about a childhood programme remains to be seen.
Keeping these developments in mind I now turn to the third research question and go deeper into the issue of social acceptance. The interviews and the online data point towards different narratives about varicella depending on what is common in certain countries. In the Netherlands varicella infection is perceived as an ordinary part of childhood, but in other countries vaccination has become routinized. In comparison to vaccines included in the Dutch NIP, varicella was not perceived as necessity. This is especially striking in consideration of measles and mumps debates before their inclusion in NIPs. Both diseases resemble chickenpox in its pathology. While measles was perceived as a serious childhood disease, in the industrialised world it was no longer the health threat it once was when the vaccine was developed. Nevertheless, measles vaccination was viewed as highly desirable due to its prevalence which resulted in a considerable burden on parents and physicians. Mumps was perceived as an unpleasant, but mild disease. Similar to chickenpox, uncertainties about the duration of protection, vaccination uptake, and the concern about a shift in the age of infection were prominent (Blume & Tump, 2010). Despite these similarities the interviewees perceived MMR immunization as essential, but not chickenpox vaccination. Considering that vaccination against measles and mumps started in the Netherlands in the 1970s, these perceptions could be linked to the vaccine’s incorporation into the healthcare system as a routine vaccine over time. These implications and discussions about general changes in policy and specifically the case of the HPV vaccine point towards a process of gradual acceptance of vaccines over time. At the beginning of this process people are rather unfamiliar with a new vaccine and hence doubts and uncertainties are often prevalent. This is especially the case if there is no demand for a vaccine. Through the lens of NPT, it can be argued that involved
64 actors such as HCPs continuously work on embedding new vaccines into a country’s healthcare system. If the embedment and integration is a success, vaccination becomes a routine practice that replaces the former normality of going through a disease during childhood.
Appraisals on the necessity of vaccination seem to be strongly related to perceptions about the severity of a disease. Severe cases of chickenpox are perceived as exceptions and not as normal development. Similarly, shingles is not perceived as a normal experience during adulthood due to its more severe course of the disease. People’s perceptions on the severity of diseases can be altered by personal experiences with severe cases. In the case of varicella such experiences can disrupt the taken for granted narrative about it being a harmless part of childhood and elicit arguments for vaccination.
Perceptions about disease severity are also related to risk assessments. During the interviews two levels stood out in this regard. The comparison between diseases and vaccines and the relation between the existing NIP and the varicella vaccine. Drawing from the relational theory of risk (Boholm & Corvellec, 2011) I suggest that in vaccination discussions the child’s health is the primary object at risk, meaning that it is constructed as valuable and in need of protection. Consequently, both the vaccine and the disease present risk objects which threaten the object at risk. Hence, the focus lies on an assessment to determine which one is the less severe. For the interviewees the relationship of risk on this level seemed to be clear for diseases included in the NIP and HZ. They evidently favoured the vaccines over the diseases. However, this was not the case for varicella. Due to uncertainties and low perception of disease severity the question arose whether the vaccine might pose more risks than the disease. The online data which included participants from all over the world pointed towards different views, which underlines the sociocultural dynamics of risk perceptions.
Furthermore, the interviewees argued that parents are sensitive to new vaccines and expressed their concerns regarding vaccine hesitancy. In the absence of active parental demand, the varicella vaccine was perceived as potentially threatening to the current programme because it could make it more vulnerable for critique, fuel vaccine hesitancy, and ultimately affect overall vaccination uptake. Through such considerations the existing NIP becomes constructed as object at risk and the varicella vaccine again as risk object that poses harm. Underlying this are issues of trust and legitimacy.
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The absence of active demand (Nichter, 1995) is linked to lacking visibility and/or recognition of a problem. This enhances the need for supporting arguments for vaccination in order to legitimize the varicella vaccine towards parents. In this respect the issue arose that the interviewees did also not express strong demand for universal varicella vaccination, and some were uncertain whether they could fulfil this task. It was argued that under these circumstances introducing a vaccine that is not perceived as necessary by parents could undermine their trust in HCPs and the whole vaccination programme. In order to avoid such negative consequences, the interviewees argued for a selective vaccination approach. It was indicated that the necessity to protect high-risk groups is more apparent and therefore the HCPs felt more confident in recommending chickenpox vaccination to parents of vulnerable children.
In light of this it I would like to point out again that the presented countries were not strongly concerned with social acceptance during their decision-making. Moreover, it is important to note that what they did consider was mainly whether the vaccines themselves would be accepted. Since the UK favoured MMRV over separate administration, thought was given to potential influences on MMR uptake. However, none of the examples contemplated the interviewed HCPs’ biggest concern, namely whether the introduction of varicella vaccination could influence people’s trust in HCPs and the whole immunization system. Although the interviewees did not express this concern for HZ vaccination, I suggest that the same applies in that case as well.
In summary, the comparative analysis of Germany, the UK, and the Netherlands suggests four main differences. First, the three states perceived the severity of diseases caused by VZV differently. Second, similar issues were discussed, and similar evidence was introduced. In this regard the two main exceptions were local epidemiological and economic data as well as discussions on public acceptance. Although similar issues were raised, their importance was weighted differently. Third, the availability of evidence and evidence itself was subject to varying interpretations. Finally, based on these aspects the countries ultimately followed different approaches with Germany using a hands-on experimental approach, the Netherlands being more hesitant and the UK being in between. Underlying decision-making were contextual changes.
The analysis presented in this thesis overlaps with previous findings on immunization policymaking. The results highlight the non-determinant character of scientific and medical
66 data further. The main difference between this thesis and previous research lies in the examined time period. The studies in question investigated immunization decision-making during the 20th century. This does not make them less relevant for contemporary discussions, but they undoubtedly investigate very specific socio-political contexts which have changed. Part of this change is the even stronger orientation towards global and international goals which can easily overshadow national ones. In order to reach global health goals, the importance of harmonizing NIPs is apparent. Against that background varicella and HZ vaccination present examples where countries not only differ in their considerations and interpretations, but also in their final decisions despite the strong trend towards harmonization in the EU. Nevertheless, this study also shows that regardless of the globalism of today’s vaccine system, issues which influenced decision-making decades ago also underlie contemporary immunization policymaking.
The experiences of Germany and the UK show that the implementation of immunization policies does not stop after the introduction of a vaccine but are long and dynamic processes. Even though it might be useful to inform a decision, mathematic modelling based on gathered evidence cannot foresee all kinds of developments. Claiming to base immunization decisions upon allegedly objective assessment criteria and scientific evidence is essentially an attempt at rationalizing decisions. However, as the illustrated comparison showed, in practice the use of evidence is far from being objective and unbiased.
The success of a vaccination policy is fundamentally dependent on people’s acceptance of it. Social acceptance is not only relevant for new policies, but also for the maintenance of existing programmes. The introduction of a vaccine that is not perceived as necessary could undermine people’s trust in HCPs and the whole vaccination system and raise or enhance uncertainties. Ultimately, this can result in negative impacts on overall vaccination uptake. Drawing from the interviews and online data I suggest that opinions about vaccines are related to issues of familiarity, risk and disease perceptions, personal experiences, and trust. Such aspects are often not rational and can hardly be quantified. Certainly, this is not the kind of evidence the scientific community and policymakers favour, but that does not diminish its relevance for immunization programmes. Therefore, it should be ascribed more importance.
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8. Personal reflections and limitations
As with any research, the process of this project and its findings were impacted by a variety of aspects. My role as a student influenced my research and the way I presented myself towards different participants (even if subconsciously), as well as how they perceived me. Regarding the interviews, the way in which I got into contact with the interviewees might have influenced the way I was perceived as well. For example, it might impact the conversation depending on whether I am perceived as a family member’s colleague or there is no personal connection. Since I am not Dutch, the interviews were in English and although we all spoke English fluently, naturally it influences the conversation and ways of expression when speaking a foreign language. Moreover, some cultural differences became clear during the interviews and were discussed.
In comparison to the interviews, the online research interaction was constructed differently and aimed at a different target group. The posts in which I presented myself as a student and explained my research determined how people perceived me and whether they decided to participate. Both the interview and online data were gathered during the peak of the COVID- 19 pandemic and should therefore also be contextualised as such. Although not less insightful, due to these circumstances the amount of data gathered through these methods was moderate. More extensive research which also includes groups that this thesis does not (for example different HCPs or policymakers) could reveal further perceptions and dynamics of immunization decisions on individual and policy level.
Regarding the document analysis I would like to highlight that this part of the research was influenced by issues of accessibility. As a student I did not have access to all possible relevant documents. The decision to discuss the presented countries as well as the choice of documents was essentially a selective process guided by practicality. Language barriers played a role as well. It is possible that the varying accessibility led to slightly different pictures of the discussed decision-making processes. Albeit this does not diminish the validity of the presented data, extended access could give further insights into national immunization decision-making. At this point I would also like to express that I find it rather upsetting and problematic that some countries do not provide any accessible statements on their immunization recommendations or recordings of meetings that led to those. It is important to provide transparency for all who are interested, and especially for those who are hesitant
68 or critical about vaccination. In my view failing to do so restricts discussions and could lead to scepticism in those who are searching for information.
Before I started this research project, I was highly supportive of universal vaccination in order to diminish or even eliminate diseases of all kinds and had little understanding for refusing vaccines. However, this did not hinder me to stay open-minded all the way through the research process, which led me to question my own beliefs and ultimately impacted them. While my general view about vaccination did not change, through this project I gained better comprehension of the complexity this issue involves and no longer perceive it as straightforward or self-explanatory. Nonetheless, to minimize my influence on the presentation of the findings, I made use of inductive coding as part of the analysis, continuously reflected upon my views, and deliberated with my supervisor.
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Bryder, L. (1999). “We shall not find salvation in inoculation”: BCG vaccination in Scandinavia, Britain and the USA, 1921-1960. Social Science & Medicine, 49(9), 1157–1167. http://dx.doi.org/10.1016/S0277-9536(99)00157-4
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Bundesministerium für Gesundheit. (2020). Impfpflicht soll Kinder vor Masern schützen. Retrieved from https://www.bundesgesundheitsministerium.de/impfpflicht.html
Carrillo-Santisteve, P. & Lopalco, P.L. (2014). Varicella Vaccination: A laboured take-off. Clinical Microbiology and Infection, 20(5), 86-91. http://dx.doi.org/10.1111/1469-0691.12580
Centers for Disease Control and Prevention [CDC]. (2015). Varicella. In Hamborsky, J., Kroger, A., & Wolfe, C. (Eds.), Epidemiology and prevention of vaccine-preventable diseases (13th ed.) (pp. 353-376). Retrieved from https://www.cdc.gov/vaccines/pubs/pinkbook/chapters.html
Dawson, A. (2011). The moral case for the routine vaccination of children in developed and developing countries. Health Affairs (Project Hope), 30(6), 1029–1033. https://doi.org/10.1377/hlthaff.2011.0301 de Gomensoro, E., Del Giudice, G., & Doherty, T. (2018). Challenges in adult vaccination. Annals of Medicine, 50(3), 181–192. https://doi.org/10.1080/07853890.2017.1417632
Dobrow, M., Goel, V., & Upshur, R. (2004). Evidence-based health policy: Context and utilisation. Social Science & Medicine, 58(1), 207–217. http://dx.doi.org/10.1016/S0277-9536(03)00166-7
Doherty, T., Connolly, M., Del Giudice, G., Flamaing, J., Goronzy, J., Grubeck-Loebenstein, B … Pasquale, A. (2018). Vaccination programs for older adults in an era of demographic change. European Geriatric Medicine, 9(3), 289–300. https://doi.org/10.1007/s41999- 018-0040-8
Dowden, A. (2018). Is the UK shingles vaccination programme fit for the future? Prescriber, 29(7), 23–26. https://doi.org/10.1002/psb.1688
Dresing, T. & Pehl, T. (2018). Praxisbuch Interview, Transkription & Analyse: Anleitungen und Regelsysteme für qualitativ Forschende. Retrieved from https://www.audiotranskription.de/
Duclos, P., Ortynsky, S., Abeysinghe, N., Cakmak, N., Janusz, C., Jauregui, B., Mihigo, R., … Gacic-Dobo, M. (2012). Monitoring of progress in the establishment and strengthening of national immunization technical advisory groups. Vaccine, 30(50), 7147–7152. https://doi.org/10.1016/j.vaccine.2012.04.015
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Edwards, R. & Holland, J. (2013). What is qualitative interviewing?. http://dx.doi.org/10.5040/9781472545244
Eritsyan, K., Antonova, N., & Tsvetkova, L. (2017). Studying anti-vaccination behavior and attitudes: A systematic review of methods. Psychology in Russia: State of the Art, 10(1), 189–197. http://dx.doi.org/10.11621/pir.2017.0113
European Centre for Disease Prevention and Control [ECDC]. (2015a). ECDC Guidance: Varicella vaccination in the European Union. Retrieved from https://www.ecdc.europa.eu/en/publications-data/public-health-guidance-varicella- vaccination-european-union
European Centre for Disease Prevention and Control [ECDC]. (2015b). ECDC Technical Report: Current practices in immunization policymaking in European countries. Retrieved from https://www.ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/ Current-practices-on-immunization-policymaking-processes-Mar-2015.pdf
European Centre for Disease Prevention and Control [ECDC]. (2019). Factsheet about varicella. Retrieved from https://www.ecdc.europa.eu/en/varicella/facts
Galetta, M., & Gilden, D. (2015). Zeroing in on zoster: A tale of many disorders produced by one virus. Journal of the Neurological Sciences, 358(1-2), 38-45. http://dx.doi.org/10.1016/j.jns.2015.10.004
Giubilini, A. (2019). The Ethics of Vaccination. https://doi.org/10.1007/978-3-030-02068-2
Government of the Netherlands. (n.d). Vaccination of children. Retrieved 2020, June 30, from https://www.government.nl/topics/vaccinations/vaccination-of- children#:~:text=Vaccination%20is%20not%20compulsory.,rubella%3B%20in%20Dutc h%20BMR).
Graduate School of Social sciences, University of Amsterdam. (2019/20). Ethical Guidelines for Student Research. Retrieved from https://www.uva.nl/en/shared- content/studentensites/fmg/gsss-gedeelde-content/en/az/ethical-guidelines-for- student-research/ethical-guidelines-for-student-research.html?cb
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Harvard Health Publishing. 2019. Chickenpox (Varicella). Retrieved from https://www.health.harvard.edu/a_to_z/chickenpox-varicella-a-to-z
Hollmeyer, H., Hayden, F., Poland, G., & Buchholz, U. (2009). Influenza vaccination of health care workers in hospitals: A review of studies on attitudes and predictors. Vaccine, 27(30), 3935–3944. http://dx.doi.org/10.1016/j.vaccine.2009.03.056
Holmberg, C., Blume, S. & Greenough, P. (Eds.) (2017). The politics of vaccination: A global history. http://dx.doi.org/10.2307/j.ctt1wn0s1m
Hooley, T., Marriott, J., & Wellens, J. (2012). What is online research? Using the internet for social science research. http://dx.doi.org/10.5040/9781849665544
Houweling, H., Verweij, M. & Ruitenberg, E. (2010). Criteria for inclusion of vaccinations in public programmes. Vaccine, 28(17), 2924–2931. https://doi.org/10.1016/j.vaccine.2010.02.021
Hupli, A. (2020, April 7). Digital ethics in online ethnography: A university lecture [Video file]. Retrieved from https://www.youtube.com/watch?v=bk- 7DPljUAU&list=LLKWjoUBVw8P8I_KOOfDM2uA&index=3&t=0s
Jain, A., van Hoek, A., Boccia, D., & Thomas, S. (2017). Lower vaccine uptake amongst older individuals living alone: A systematic review and meta-analysis of social determinants of vaccine uptake. Vaccine, 35(18), 2315–2328. https://doi.org/10.1016/j.vaccine.2017.03.013
Jakab, Z. (2020). Vaccines work at all ages, everywhere [Commentary]. Retrieved from https://www.who.int/news-room/commentaries/detail/vaccines-work-at-all-ages- everywhere
Keim-Malpass, J., Steeves, R., & Kennedy, C. (2014). Internet ethnography: A review of methodological considerations for studying online illness blogs. International Journal of Nursing Studies, 51(12), 1686–1692. http://dx.doi.org/10.1016/j.ijnurstu.2014.06.003
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Kowal, S. & O’Connell, D. (2014). Transcription as a Crucial Step of Data Analysis. In U. Flick (Ed.), The SAGE Handbook of Qualitative Data Analysis (pp. 64-78). Retrieved from https://us.sagepub.com/en-us/nam
Lagoe, C., & Farrar, K. (2015). Are you willing to risk it? The relationship between risk, regret, and vaccination intent. Psychology, Health & Medicine, 20(1), 18–24. http://dx.doi.org/10.1080/13548506.2014.911923
May, C., & Finch, T. (2009). Implementing, Embedding, and Integrating Practices: An Outline of Normalization Process Theory. Sociology, 43(3), 535–554. https://doi.org/10.1177/003803850910320
Miles, A., Charlton, B., Bentley, P., Polychronis, A., Grey, J., & Price, N. (2000). New perspectives in the evidence‐based healthcare debate. Journal of Evaluation in Clinical Practice, 6(2), 77–84. http://dx.doi.org/10.1046/j.1365-2753.2000.00255.x
Mills, E., Jadad, A., Ross, C., & Wilson, K. (2005). Systematic review of qualitative studies exploring parental beliefs and attitudes toward childhood vaccination identifies common barriers to vaccination. Journal of Clinical Epidemiology, 58(11), 1081–1088. http://dx.doi.org/10.1016/j.jclinepi.2005.09.002
National Healthcare Institute. (n.d). Samenwerking advisering vaccinaties Gezondheidsraad en het Zorginstituut. Retrieved 2020, June 19, from https://www.zorginstituutnederland.nl/over-ons/programmas-en- samenwerkingsverbanden/samenwerking-advisering-vaccinaties-gezondheidsraad- en-zorginstituut
National Health Service [NHS]. (n.d.). Chickenpox vaccine FAQs. Retrieved 2020, June 16, from https://www.nhs.uk/conditions/vaccinations/chickenpox-vaccine-questions-answers/
Nichter, M. (1995). Vaccinations in the third world: A consideration of community demand. Social Science & Medicine, 41(5), 617–632. http://dx.doi.org/10.1016/0277- 9536(95)00034-5z
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Niessen, L., Grijseels, E., & Rutten, F. (2000). The evidence-based approach in health policy and health care delivery. Social Science & Medicine, 51(6), 859–869. http://dx.doi.org/10.1016/S0277-9536(00)00066-6
Orenstein, W., & Ahmed, R. (2017). Simply put: Vaccination saves lives. Proceedings of the National Academy of Sciences of the United States of America, 114(16), 4031–4033. http://dx.doi.org/10.1073/pnas.1704507114
Paterson, P., Meurice, F., Stanberry, L.R., Glismann, S., Rosenthal, S.L., & Larson, H.J. (2016). Vaccine hesitancy and healthcare providers. Vaccine, 34(52), 6700-6706. http://dx.doi.org/10.1016/j.vaccine.2016.10.042
Plotkin, S. (2009). Sang Froid in a time of trouble: Is a vaccine against HIV possible? Journal of the International AIDS Society, 12(1), 1-12. https://doi.org/10.1186/1758-2652-12-2
Public Health England [PHE]. (2019). Varicella. In Ramsay, M. (Ed.), Immunization against infectious disease (pp. 421-442). Retrieved from https://www.gov.uk/government/collections/immunization-against-infectious- disease-the-green-book#the-green-book
Rechel, B., Richardson, E. & McKee, M. (Eds.). (2018). The organization and delivery of vaccination services in the European Union [Report]. Retrieved from https://www.euro.who.int/en/publications/abstracts/the-organization-and-delivery- of-vaccination-services-in-the-european-union-2018
Ricciardi, G., Toumi, M., Weil-Olivier, C., Ruitenberg, E., Dankó, D., Duru, G., Picazo, J., … Drummond, M. (2015). Comparison of NITAG policies and working processes in selected developed countries. Vaccine, 33(1), 3–11. https://doi.org/10.1016/j.vaccine.2014.09.023
Rijksinstituut voor Volksgezondheid en Milieu [RIVM]. (2020). Protect your child against infectious diseases: National Immunization Programme [Brochure]. Retrieved from https://www.rivm.nl/documenten/bescherm-uw-kind-tegen-infectieziekten-engels-0
Robert Koch Institut [RKI]. (2016a). Mathematische Modellierung der Effekte des Varizellen- Impfprogramms in Deutschland. Retrieved from https://www.rki.de/DE/Content/Infekt/Impfen/Forschungsprojekte/abgeschlossene_ Projekte/Varizellen-Impfung/VZV_inhalt.html
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Robert Koch Institut [RKI]. (2019a). Impfkalender. Retrieved from https://www.rki.de/DE/Content/Kommissionen/STIKO/Empfehlungen/Aktuelles/Impf kalender.html?nn=2375548
Robert Koch Institute [RKI]. (2019b). The Robert Koch Institute. Retrieved from https://www.rki.de/EN/Content/Institute/institute_node.html
Sadaoka, T., Depledge, D.P., Rajbhandari, L., Venkatesan, A., Breuer, J., & Cohen, I.J. (2016). In vitro system using human neurons demonstrates that varicella-zoster vaccine virus is impaired for reactivation, but not latency. Proceedings of the National Academy of Sciences, 113(17), E2403–E2412. http://dx.doi.org/10.1073/pnas.1522575113
Salisbury, D., Beverley, P., & Miller, E. (2002). Vaccine programmes and policies. British Medical Bulletin, 62(1), 201–211. https://doi- org.proxy.uba.uva.nl:2443/10.1093/bmb/62.1.201
Vaccine European New Integrated Collaboration Effort [VENICE] III. (n.d.). [about VENICE III]. Retrieved 2020, May 19, from http://venice.cineca.org/index.html van Lier, A., Smits, G., Mollema, L., Waaijenborg, S., Berbers, G., van Der Klis, F., … de Melker, H. (2013). Varicella zoster virus infection occurs at a relatively young age in the Netherlands. Vaccine, 31(44), 5127–5133. http://dx.doi.org/10.1016/j.vaccine.2013.08.029
Wallace, A., Mantel, C., Mayers, G., Mansoor, O., Gindler, J., & Hyde, T. (2014). Experiences with provider and parental attitudes and practices regarding the administration of multiple injections during infant vaccination visits: Lessons for vaccine introduction. Vaccine, 32(41), 5301–5310. http://dx.doi.org/10.1016/j.vaccine.2014.07.076
Warren-Gash, C., Forbes, H., & Breuer, J. (2017). Varicella and herpes zoster vaccine development: Lessons learned. Expert Review of Vaccines, 16(12), 1191-1201. http://dx.doi.org/10.1080/14760584.2017.1394843
Wiese-Posselt, M., Reiter, S., Gilsdorf, A., & Krause, G. (2009). Needs and obstacles of uniform immunization schedules in the European Union. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 52(11), 1099–1104. https://doi.org/10.1007/s00103-009-0954-x
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Wolsink, M. (2018). Social acceptance revisited: Gaps, questionable trends, and an auspicious perspective. Energy Research & Social Science, 46, 287–295. https://doi.org/10.1016/j.erss.2018.07.034
World Health Organization [WHO]. (2014a). Principles and considerations for adding a vaccine to a national immunization programme: From decision to implementation and monitoring. Retrieved from https://www.who.int/immunization/programmes_systems/policies_strategies/vaccin e_intro_resources/nvi_guidelines/en/
World Health Organization [WHO]. (2014b). Varicella and herpes zoster vaccines: WHO position paper, June 2014. The Weekly Epidemiological Record (WER), 89, 265-288. Retrieved from https://www.who.int/
World Health Organization [WHO]. (2019). Ten threats to global health in 2019. Retrieved from https://www.who.int/emergencies/ten-threats-to-global-health-in-2019
Yaqub, O., Castle-Clarke, S., Sevdalis, N., & Chataway, J. (2014). Attitudes to vaccination: A critical review. Social Science & Medicine, 112, 1–11. http://dx.doi.org/10.1016/j.socscimed.2014.04.018
10. List of documents used for document analysis
Health Council of the Netherlands. (2007). The future of the National Immunization Programme: Towards a programme for all age groups [Report]. Retrieved from https://www.healthcouncil.nl/documents/advisory-reports/2007/03/07/the-future- of-the-national-immunization-programme
Health Council of the Netherlands. (2013). The individual, collective and public importance of vaccination [Report]. Retrieved from https://www.healthcouncil.nl/documents/advisory-reports/2013/10/03/the- individual-collective-and-public-importance-of-vaccination
Health Council of the Netherlands. (2016). Vaccinatie tegen gordelroos [Report]. Retrieved from https://zoek.officielebekendmakingen.nl/blg-776140.pdf
Joint Committee on Vaccination and Immunization [JCVI]. (2010). Joint Committee on Vaccination and Immunization Statement on varicella and herpes zoster vaccines
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[Statement]. Retrieved from https://webarchive.nationalarchives.gov.uk/20120907151317/http://www.dh.gov.uk /prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_1 33599.pdf
Joint Committee on Vaccination and Immunization [JCVI]. (2015). Minute of the meeting on 7 October 2015 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2016). Minute of the meeting on 05 October 2016 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2017a). Minute of the meeting on 01 February 2017 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2017b). Minute of the meeting on 04 October 2017 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2018a). Minute of the meeting on 07 February 2018 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2018b). Minute of the meeting on 06 June 2018 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2019a). Minute of the meeting held on 06 February 2019 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI]. (2019b). Minute of the meeting held on 05 June 2019 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
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Joint Committee on Vaccination and Immunization [JCVI]. (2020). Minute of the meeting held on 04 and 05 February 2020 [Meeting minutes]. Retrieved from https://app.box.com/s/iddfb4ppwkmtjusir2tc?page=1
Joint Committee on Vaccination and Immunization [JCVI] Varicella Sub-Committee. (2015). Minute of the meeting on 19 June 2015 [Meeting minutes]. Retrieved from https://app.box.com/s/vdlafy8wm4t5asq2qyfpc4dw6fzeyypf
Joint Committee on Vaccination and Immunization [JCVI] Varicella Sub-Committee. (2016). Minute of the meeting on 5 December 2016 [Meeting minutes]. Retrieved from https://app.box.com/s/vdlafy8wm4t5asq2qyfpc4dw6fzeyypf
Joint Committee on Vaccination and Immunization [JCVI] Varicella Sub-Committee. (2018). Minute of the teleconference of 23 May 2018 [Meeting minutes]. Retrieved from https://app.box.com/s/vdlafy8wm4t5asq2qyfpc4dw6fzeyypf
Joint Committee on Vaccination and Immunization [JCVI] Varicella Sub-Committee. (2019). Minute of the meeting of 16 January 2019 [Meeting minutes]. Retrieved from https://app.box.com/s/vdlafy8wm4t5asq2qyfpc4dw6fzeyypf
Kemmeren, J.M. & de Melker, H.E. (2010). The National Immunization Programme in the Netherlands: Developments in 2009 (Report no. 210021012). Retrieved from Rijksinstituut voor Volksgezondheid en Milieu website: https://www.rivm.nl/publicaties/national-immunization-programme-in-netherlands- developments-in-2009
National Healthcare Institute & Health Council of the Netherlands. (2019). Verbindende notitie Gezondheidsraad en Zorginstituut Nederland bij advies Vaccinatie tegen gordelroos [Memorandum]. Retrieved from https://www.gezondheidsraad.nl/documenten/adviezen/2019/07/15/verbindende- notitie-gezondheidsraad-en-zorginstituut-nederland-bij-advies-vaccinatie-tegen- gordelroos
Public Health England (PHE). (2018a). Herpes zoster (shingles) immunization programme 2017 to 2018: Evaluation report. Health Protection Report, 12(42), 1-17. Retrieved from https://www.gov.uk/government/publications/herpes-zoster-shingles-immunization- programme-2017-to-2018-evaluation-report
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Public Health England [PHE]. (2018b). Shingles vaccine? – all year round!. Vaccine update, 276, 1-7. Retrieved from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attac hment_data/file/699272/VU_276_April18_shingles_special.pdf
Public Health England [PHE]. (2019). Varicella. In Ramsay, M. (Ed.), Immunization against infectious disease (pp. 421-442). Retrieved from https://www.gov.uk/government/collections/immunization-against-infectious- disease-the-green-book#the-green-book
Robert Koch Institut [RKI]. (2004). Begründung der STIKO für eine allgemeine Varizellenimpfung. Epidemiologisches Bulletin 49/2004, 1-5. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Robert Koch Institut [RKI]. (2008). Mitteilung der Ständigen Impfkommission (STIKO) am RKI zur Impfung gegen Varizellen. Epidemiologisches Bulletin 41/2008, 355. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Robert Koch Institut [RKI]. (2009). Mitteilung der Ständigen Impfkommission am Robert Koch- Institut: Impfung gegen Varizellen im Kindesalter: Empfehlung einer zweiten Varizellenimpfung Empfehlung und Begründung. Epidemiologisches Bulletin 32/2009, 328-336. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Robert Koch Institut [RKI]. (2011). Mitteilung der Ständigen Impfkommission (STIKO) am Robert Koch-Institut: Zur Kombinationsimpfung gegen Masern, Mumps, Röteln und Varizellen (MMRV). Epidemiologisches Bulletin 38/2011, 352-353. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Robert Koch Institut [RKI]. (2013). Stellungnahme der Ständigen Impfkommission (STIKO): Evaluation der Varizellen-Impfempfehlung durch die STIKO. Epidemiologisches Bulletin 01/2013, 1-5. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Robert Koch Institut [RKI]. (2016b). Stellungnahme der STIKO Ergebnisse der Modellierung langfristiger epidemiologischer Auswirkungen der Varizellenimpfung in Deutschland.
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Epidemiologisches Bulletin 19/2016, 167-169. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Robert Koch Institut [RKI]. (2020). Evaluation der Varizellen-Impfempfehlung durch die STIKO. Epidemiologisches Bulletin 03/2020, 3-15. Retrieved from https://www.rki.de/DE/Content/Infekt/EpidBull/epid_bull_node.html
Siedler, A., Koch, J., Ultsch, B., Garbe E., ·von Kries, R., Ledig, T., … Hengel, H. (2017). Background paper to the decision not to recommend a standard vaccination with the live attenuated herpes zoster vaccine for the elderly in Germany: Statement of the German Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI). Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 60(10), 1162- 1179. https://doi.org/10.1007/s00103-017-2618-6
Siedler, A., Koch, J., Garbe, E., Hengel, H., von Kries, R., Ledig, T., … Überla, K. (2019). Background paper to the decision to recommend the vaccination with the inactivated herpes zoster subunit vaccine: Statement of the German Standing Committee on Vaccination (STIKO) at the Robert Koch Institute. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 62(3), 352–376. https://doi.org/10.1007/s00103-019-02882-5 van Lier, E.A., van der Maas, N.A.T. & de Melker, H.E. (2020). Varicella in the Netherlands: Background information for the Health Council (Report no. 2019-0197). Retrieved from Rijksinstituut voor Volksgezondheid en Milieu website: https://www.rivm.nl/publicaties/varicella-in-netherlands-background-information- for-health-council
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11. Annex 11.1 Fieldwork process overview
COVID
Increasing Increasing • Start of fieldwork spr
Europe Europe
February • Informal interviews eadof
• Preperation of semi-structured in-depth interviews - 2020 in 19
• Semi-structured in-depth interviews • Change of research focus
• Online research COVID March ( Netherlands • Research on documents suited for analysis
-
19 lockdown in19 the
countries)
• Semi-structured in-depth interviews literature researchOngoing • Transcription of interviews
• Online research and other April • Research on documents suited for analysis • Construction of thesis outline & start of writing process
• Semi-structured in-depth interviews • Transcription of interviews
May • Organising data of COVID Relaxation • Interview & online data analysis
t
• Writing process he
Netherlands(andother • Interview and online data analysis
• Document analysis countries) June • Interpretation of data • Writing process
-
19i measures
• Document analysis July • Interpretation of data • Writing process
• August, 7th: Deadline final thesis n August
82
11.2 Coding scheme for document analysis
11.3 Network interviews and online data themes
11.4 Interviews and online data analysis mind map
85
11.5 Linear scheme social acceptance chapter
11.6 Post vaccine introduction discussions in Germany
In 2013 the STIKO evaluated their varicella recommendations and related developments. It was argued that the data availability improved considerably since 2004 and 2009 and that the aims of the programme were generally achieved. Nevertheless, questions regarding the long- term effects of varicella vaccination remained. The biggest uncertainties were the duration of protection after two doses and the impact of varicella vaccination on HZ incidence and severity. It was claimed that in order to clarify unresolved issues data from modelling that was not yet complete and from studies that were not yet conducted were required. At that time multiple varicella surveillance systems were in place and it was suggested these should be used in combination with modelling to answer open questions. Regardless of the uncertainties the available results were interpreted as success of universal varicella vaccination during childhood with catch-up opportunities. It was emphasised that the future success of the programme largely depended on the commitment of doctors to recommend and implement varicella vaccination. The STIKO concluded that there was no need to change the recommendations, but also announced further evaluation and that recommendations will be adjusted should it be necessary due to epidemiological developments (RKI, 2013).
From 2012 to 2014 extensive mathematic modelling on the impact of varicella vaccination in Germany was conducted by the RKI. The aim was to assess the varicella programme ten years after its implementation and to estimate long-term effects. The model explored a period of a hundred years and included the experience of other countries (RKI, 2016a). Essentially it showed a reduction of overall varicella incidence and hospitalisation, but also an increase in cases during adulthood and, due to inauspicious assumptions about lethality, an increase in mortality. Under the assumption that every contact with VZV boosts immunity, HZ was shown to increase in incidence and severity, including increasing mortality rates. However, when supposed that boosting is not that strong, no increase in HZ was indicated. The cancellation of the programme would cause the rates to return to the initial situation before 2004. The STIKO published their comments on these results in 2016. That Germany was one of the few European countries to implement universal varicella vaccination was perceived as pioneer work. Although the modelling data was welcomed by the STIKO, it was noted that models always depict a simplified version of reality under ideal conditions. It was further argued that although interesting, the experience of other countries such as the USA and Australia can only be applied to Germany to limited extent due to differences in the programmes. Since the 87 available surveillance data showed only positive effects of the programme the STIKO saw no need to change the recommendations. However, it was stated that surveillance data will further be examined critically in order to be able to react, should the negative effects presented by the model occur. In this regard strategies such as expanding the programme to older age groups, including HZ vaccination, or withdrawing varicella vaccination were mentioned. Additionally, it was accented that surveillance data can be applied to the model, which allows for making statements about further developments and ensures safe strategies (RKI, 2016b).
In 2019 an evaluation of the varicella programme was again conducted by the STIKO. It was stated that the programme is implemented well and that it led to a big reduction in varicella incidence and hospitalisation. This includes direct effects on the vaccinated groups and indirect impact on non-vaccinated groups due to herd immunity. It was also highlighted that no increase in adult infection or HZ incidence was observed and that the vaccine’s good efficacy and duration of protection is proofed by studies. The maintenance and improvement of vaccination rates was declared as priority. More surveillance and data assessment were notified to gain insights into further developments. The STIKO was content with the recommendations and a new evaluation in five years was announced. Need for action was declared regarding observation of epidemiological developments and acceptance of the vaccine, surveillance in vaccinated persons, an update of the model on epidemiological developments, and examination of population immunity (RKI, 2020).
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11.7 Interviewees overview
Pseudonym Occupation Experience with vaccination and VZV
Amy GP in training (HAIO) One year of experience in a GP practice in which she did not come across a lot of chickenpox or HZ cases
Natalie Used to be a hospital nurse, Lots of experience with childhood now social nurse/youth health diseases (including chickenpox) in the nurse in a child health clinic; hospital and the child health clinic; responsible for pregnant experience with severe cases of women and children until the childhood diseases; lots of experience age of four (including with discussing vaccination with parents vaccination)
James GP with obstetrics and doctor Lots of experience with discussing at a child health clinic in which vaccination with parents; does not come he is responsible for children across a lot of chickenpox cases but those from 0 to 14 months he sees are usually mild; one experience with very severe case of chickenpox; lots of experience with HZ in the elderly
Linda Social nurse/youth health Lots of experience with discussing nurse in a child health clinic and vaccination with parents and older contact person for a lot of children; does not come across a lot of schools; responsible for chickenpox cases in her work also children aged 4 to 18 years experience with infectious diseases in Africa;
Mason GP Experience with chickenpox mostly in children and HZ in the elderly; experience mostly with influenza and pneumococcal vaccination; also experience with infectious diseases in Africa
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