Public Health Mandatory Vaccination
by
Katie Attwell
  • LAST MODIFIED: 25 August 2021
  • DOI: 10.1093/obo/9780199756797-0207

Introduction

Across the world, mass vaccination programs run by governments or third-sector organizations have saved countless lives; minimized human suffering; and maintained economic, social, and cultural functioning. Vaccination programs predominantly focus on diseases that once ravaged the infant and early childhood years. However, with significant global variation, vaccination programs also exist for adolescents, pregnant women, new parents, the elderly, and people with comorbidities as well as catch-up or booster programs for particular age groups or vaccines. Governments and organizations also run annual influenza vaccination programs for entire populations or key workers, and health-care and education workers may be subject to additional vaccination requirements. The commonality of all mass vaccination programs is that the state adopts a key role in planning, coordinating, and funding them, or implementing mechanisms to ensure vaccines’ receipt by populations. The state’s role makes mandatory vaccination a possibility. Numerous scholarship forms the evidence base for the safety, efficacy, and necessity of vaccines. However, vaccination as a practice has consistently been accompanied by a minority who doubt and refuse, either for some or all vaccines. Concern about refusal has grown in recent years. An extensive Oxford Bibliographies article, “Vaccine Hesitancy,” explains why doubt and refusal develop and persist, how scholars make sense of it, and how governments and health-care providers can address it. However, hesitancy is not the only determinant of suboptimal vaccine uptake. Vaccination programs can also fail to reach populations due to insufficient generation of demand, inefficient or inappropriate service provision, cost barriers, and access barriers. Understanding the determinants of undervaccination in any given region, country, or population group will be essential to determining what strategies, including mandatory vaccination, are appropriate. Mandatory vaccination is just one strategy among a suite of tools that governments and organizations can employ to increase uptake of vaccines by particular cohorts. Mandatory vaccination is receiving current attention due to governments in several high-income jurisdictions recently utilizing it to address parents’ vaccine hesitancy. However, as the scholarship in this article illuminates, many jurisdictions’ mandatory childhood vaccination policies predate current concerns around hesitancy. Mandates have long performed key roles in the governance of vaccination uptake, including in contexts where attention to other programmatic aspects or health promotion practices may be lacking. The author would like to acknowledge the assistance of Amy Morris in the writing of the Mandatory Vaccination of Health-Care Workers—Policies, Experiences, and Impact and the Mandatory Vaccination—Attitudinal Studies sections of this article.

General Overviews

The current global interest in mandatory vaccination starts with the urgent need to determine what mandatory means from a policy instrument and behavioral perspective, given the recent rise in adoption of such policies. Older studies, such as Lantos, et al. 2010, and more recent works, such as Walkinshaw 2011, attempt to define the field and to categorize vaccine mandates across multiple jurisdictions. Attwell, et al. 2018; MacDonald, et al. 2018; and Attwell and Navin 2019 seek to make sense of mandates’ growing adoption and enhancement. Scholars often attempt to understand the practical and ethical implications of mandates as a tool to address vaccine hesitancy or suboptimal uptake as well as to generate best practice recommendations, as seen in Omer, et al. 2019. Explanatory and contextual work in Paul and Loer 2019 and McCoy 2019 situate mandatory vaccination policies within comparative studies to demonstrate that “mandatory” and “voluntary” are not simple, binary categories, and that mandatory policies are likely to evolve from existing governance conditions, strategies, and instruments. There are several important features of mandatory policies that impact their operation and—more importantly—their power to make people vaccinate, or what Attwell and Navin 2019 call their “salience.” The authors’ conceptual and theoretical work—along with an earlier iteration in Attwell, et al. 2018 and a complementary framework developed in MacDonald, et al. 2018—draw out mandates’ key features. To talk about mandatory vaccination policies, we need to understand the populations to which they apply; the vaccines involved, the nature and extent of incentives or punishments for noncompliance; the legal or regulatory basis for the mandate; the inclusion of institutions such as schools, hospitals, or private businesses in the governance of vaccine mandates; the general conduct of enforcement; and how exemptions are structured (what type) and awarded (how easily). Different combinations of all these factors can give rise to mandatory vaccination regimes that are either extremely “hard,” “rigid,” or “restrictive” in terms of making people vaccinate, or are “soft,” “flexible,” or “permissive” in facilitating choice regarding vaccination, particularly by permitting formal refusal. Exemptions for refusers form a crucial component of US vaccination policies, as Opel, et al. 2017 elaborates. The terminology applied here labels “restrictive” mandates as those with only medical exemptions and “permissive” mandates allowing for personal belief or religious exemptions.

  • Attwell, K., and M. C. Navin. 2019. Childhood vaccination mandates: Scope, sanctions, severity, selectivity, and salience. Milbank Quarterly 97.4: 978–1014.

    DOI: 10.1111/1468-0009.12417Save Citation »Export Citation » Share Citation »

    Attwell and Navin formally analyze which features of a mandate matter to its salience, or power to make someone vaccinate. Which vaccines are included, types of punishments, their severity, frequency, and enforcement, and the structure of exemptions are systematically explained. The authors conclude that these factors mean vaccine mandates must be assessed in context and comparatively, rather than as abstract policy types.

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  • Attwell, K., M. C. Navin, P. Lopalco, C. Jestin, S. Reiter, and S. B. Omer. 2018. Recent vaccine mandates in the United States, Europe and Australia: A comparative study. Vaccine 19.36: 7377–7384.

    DOI: 10.1016/j.vaccine.2018.10.019Save Citation »Export Citation » Share Citation »

    This article takes as its starting point recent vaccine mandate developments in Australia, France, Germany, Italy, California, and the State of Washington. It describes the changes, their impetus, and constructs a continuum of coercion that considers punishments and exemptions. It considers both permissive and restrictive mandates but notes a general move toward restrictiveness. It also describes variable consequences including school exclusion, kindergarten and daycare exclusion, fines, and removal of government financial assistance.

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  • Lantos, J. D., M. A. Jackson, D. J. Opel, E. K. Marcuse, A. L. Myers, and B. L. Connelly. 2010. Controversies in vaccine mandates. Current Problems in Pediatric and Adolescent Health Care 40.3: 38–58.

    DOI: 10.1016/j.cppeds.2010.01.003Save Citation »Export Citation » Share Citation »

    This US-focused collection is a bit dated, but its strength lies in being a series of essays that considers mandates historically, and in childhood, teenage, and health-care worker populations. Not all sections are directly relevant to mandates. Inclusion of the process for adding new vaccines to a mandatory system is welcome.

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  • MacDonald, N. E., S. Harmon, E. Dube, et al. 2018. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine 36.9: 5811–5818.

    DOI: 10.1016/j.vaccine.2018.08.042Save Citation »Export Citation » Share Citation »

    This review article takes recent global developments as its starting point, and unpacks the factors comprising an approach to mandatory vaccination. The authors identify vaccine inclusion, age groups, program flexibility, and whether a vaccine injury compensation scheme is present as important factors. They offer a table with policy examples from high-, middle-, and low-income countries, and consider scenarios like pilgrims to Saudi Arabia needing meningococcal vaccine.

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  • McCoy, C. A. 2019. Adapting coercion: How three industrialized nations manufacture vaccination compliance. Journal of Health Politics, Policy and Law 44.6: 823–854.

    DOI: 10.1215/03616878-7785775Save Citation »Export Citation » Share Citation »

    This article is useful in identifying that mandatory and voluntary policies do not fall into a neat binary. McCoy attributes varying degrees of coercion in his deep, historical case studies of Britain, United States, and Australia to path-dependency and adaptive coercion in response to local resistance to vaccination programs. He considers how mandates work on both “passive” and “active” resistance.

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  • Omer, S. B., C. Betsch, and J. Leask. 2019. Mandate vaccination with care. Nature 571.7766: 469.

    DOI: 10.1038/d41586-019-02232-0Save Citation »Export Citation » Share Citation »

    This high-profile commentary draws on the authors’ global expertise in vaccination policies and programs, urging governments to approach mandates cautiously. Mandates may successfully lift rates in high income countries, but risk amplifying inequalities, especially in poorer countries. Analyzing global examples, the authors argue that optimum mandatory policy allows nonmedical exemptions but makes them difficult to access, and that mandates should join a suite of nonmandatory interventions to enhance coverage.

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  • Opel, D., J. Schwartz, S. B. Omer, et al. 2017. Achieving an optimal childhood vaccine policy. Jama Pediatrics 171.9: 893–896.

    DOI: 10.1001/jamapediatrics.2017.1868Save Citation »Export Citation » Share Citation »

    This article provides a useful overview of the historic centrality of nonmedical exemptions to childhood mandates in the United States. State-level school entry mandates are ubiquitous there, but only three states (in 2017) do not allow avenues to formally avoid them. The article then describes how the state of California and prominent medical associations are beginning to pivot away from permitting or supporting nonmedical exemptions, and considers the implications of their removal.

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  • Paul, K. T., and K. Loer. 2019. Contemporary vaccination policy in the European Union: Tensions and dilemmas. Journal of Public Health Policy.

    DOI: 10.1057/s41271-019-00163-8Save Citation »Export Citation » Share Citation »

    This perspective piece argues that recent attention on mandatory policies misses the diversity between policies and elides the “culturally contingent” local understandings of “mandatory” and “voluntary.” The authors’ Western European case studies pay attention to political principles, institutional structure, funding, guiding principles regarding vaccination, and policy instruments. They also look at the structure of the country’s National Immunization Policy and draw attention to important features such as monitoring.

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  • Walkinshaw, E. 2011. Mandatory vaccinations: The international landscape. Canadian Medical Association Journal 183.16: e1167–e1168.

    DOI: 10.1503/cmaj.109-3993Save Citation »Export Citation » Share Citation »

    Walkinshaw’s journalistic examination of the state of mandatory vaccination is dated and Canadian oriented. However, the article covers policies in a range of jurisdictions and considers the issues that they can raise. This article connects to two others in the same series, which explore the Canadian landscape and divergent viewpoints on whether mandatory vaccination policies are desirable or feasible. Marie-Claude Grégoire from the journal revisited the topic in 2019.

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Cataloguing and Counting Mandatory Vaccination Policies (Non-US)

Using a variety of categorizations and methodologies, several organizations and research teams have attempted to catalogue and count mandatory vaccination systems regionally, globally, according to network memberships, and within countries. Accordingly, resources include both traditional academic articles and databases of varying quality. As this is an evolving area, resources are partial or incomplete, yet remain crucial to understanding the global vaccine mandate landscape. Scholarly exercises in compiling an up-to-date understanding of a given country’s mandatory policy—or crude numbers worldwide, regionally, or nationally—are constantly in peril due to the ever-changing policy landscape. Attwell, et al. 2019 and Gravagna, et al. 2020 have employed multiple methods of searching and trawling; other scholars have relied on survey data, which generally imposes limitations based on countries’ memberships of particular groups, such as the regional focus in Haverkate, et al. 2012 or the reliance on shared vaccine governance mechanisms in Harmon, et al. 2020. Central to the cataloguing task—whatever the methodology—is the question of what constitutes a mandatory vaccination policy. The General Overviews section indicates that this is not necessarily a binary issue. However, each “catalogue and count” exercise employs a particular approach and definition. Of note is the question of how to categorize subnational units, since in federal or regionalist states, local jurisdictions may adopt divergent vaccination policies. A second question is whether systems with “opt-out” or personal belief exemptions should be classed as mandatory. Regionally focused studies shed light on how local political cultures and practices inform these considerations. Exemptions are not considered in Haverkate, et al. 2012 or the Sabin Vaccine Institute 2018 report, although Vaz, et al. 2020 uncovers them in three European countries, and scholars may be able to access this searchable information themselves on the Sabin Vaccine Institute’s European Immunization Policy Database. By contrast, work on the United States explored in Cataloguing and Counting Mandatory Childhood Vaccination and Exemption Policies in the United States focuses almost exclusively on the type and availability of exemptions, since school-entry mandates with exemptions are ubiquitous in that setting.

  • Attwell, K., S. Drislane, and J. Leask. 2019. Mandatory vaccination and no fault vaccine injury compensation schemes: An identification of country-level policies. Vaccine 37.1: 2843–2848.

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    At its time of publication, this article contained an up-to-date state of the global policy ecosystem. It lists countries with mandatory childhood vaccination policies, defined as government requiring vaccination based on age, or for access to a fundamental service or societal benefit. It utilizes database, literature, and Internet searches as well as World Health Organization Joint Reporting Form data and Sabin resources.

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  • Gravagna, K., A. Becker, R. Valeris-Chacin, et al. 2020. Global assessment of national mandatory vaccination policies and consequences of non-compliance. Vaccine.

    DOI: 10.1016/j.vaccine.2020.09.063Save Citation »Export Citation » Share Citation »

    This article reports the first global evaluation of mandatory policies catalogued through systematic desk research. It focuses on any subgroup and broad requirements. It excludes substate units and does not engage with exemptions, but emphasizes punishments, categorized into four types: financial, parental rights, education, and liberty. The authors include a supplementary database, a map, and several useful visuals. They find that 54 percent of 193 countries have a vaccine mandate.

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  • Harmon, S. H. E., D. E. Faour, N. E. MacDonald, et al. 2020. Immunization governance: Mandatory immunization in 28 Global NITAG Network countries. Vaccine 38.46: 7258–7267.

    DOI: 10.1016/j.vaccine.2020.09.053Save Citation »Export Citation » Share Citation »

    This article reports a 2018 survey, with binary classification of 28 Global NITAG Network countries as having mandatory vaccination, on the basis that governments require vaccination of an identified group and permit refusal only through formal opt-out. It follows the VENICE study classification in Haverkate, et al. 2012 in ignoring actual consequences. Mandatory policies are further classified based on whether they are national or provincial, and the legal instrument underpinning them.

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  • Haverkate, M., F. d’Ancona, C. Giambi, et al. 2012. Mandatory and recommended vaccination in the EU, Iceland and Norway: Results of the VENICE 2010 survey on the ways of implementing national vaccination programmes. Eurosurveillance 17.22.

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    The Vaccine European New Integrated Collaboration Effort (VENICE) study is the foundational work in categorizing and counting. It focuses on the childhood setting, defining mandatory as a requirement by law to vaccinate, irrespective of consequences. The study employs two categories: mandatory for all and mandatory for people at risk. The study uses 2010 survey data from relevant government health authorities to determine countries’ policies, with almost universal survey uptake.

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  • Sabin Vaccine Institute. European Immunization Policy Database.

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    This user-friendly and well-presented searchable database is a true gift to researchers focusing on the European region, containing links to legislation as well as summary reports compiled by researchers. However, reports are undated, and both they and the legislative links will be superseded over time, so may not be accurate unless the site indicates regular updates.

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  • Sabin Vaccine Institute. 2018. Legislative approaches to immunization across the European region. Washington, DC: Sabin Vaccine Institute.

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    This report comprehensively reviews vaccination policies in the European Region. It is underpinned by a Likert-scale survey of fifty-three countries administered to relevant national experts, qualitative analysis of legislative documents and secondary sources, and a classification of approaches including mandatory vaccination and mandatory vaccination with robust monitoring and follow-up. This report considers other parts of the vaccination policy ecosystem essential for analyzing mandates, such as coverage monitoring.

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  • Vaz, O. M., M. K. Ellingson, P. Weiss, et al. 2020. Mandatory vaccination in Europe. Pediatrics 145.2: e20190620.

    DOI: 10.1542/peds.2019-0620Save Citation »Export Citation » Share Citation »

    This article uses data from the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO) to analyze vaccination policies of twenty-nine VENICE countries. It updates Haverkate, et al. 2012 using a ECDC tool and country-based health ministry website analysis, also seeking information on nonmedical exemptions and penalties. The authors found nonmedical exemptions in three of the seven countries with mandates. They also compare monetary sanctions between countries that have them.

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Cataloguing and Counting Mandatory Childhood Vaccination and Exemption Policies in the United States

Since school entry mandates operate in every single American state, it is at the level of exemptions that the most important differences emerge. All states have medical exemption policies, but nonmedical exemptions (NMEs) offer the most variety. Design of NME policy varies between states, and in the worst-case scenario, exemption policies make it easier to receive exemptions than to vaccinate, as noted in Rota, et al. 2001. State-based distinctions between mandate exemption policies and tweaks to their operation provide a natural experiment for considering what works to boost compliance, as explored in Mandatory Childhood Vaccination Policy Implementation, Impact, and Effectiveness: Evaluating Adjusting Waiver Policies in the United States. Accordingly, exemption policies are a central focus for the US-based “catalogue and count” exercises that underpin this work. Such exercises predominantly focus on determining what kinds of nonmedical exemptions are available (religious, philosophical, or both). Scholars are also interested in deeper details such as how easy it is to get an exemption, how long it lasts once obtained, whether any actors are involved in counselling parents about the risks of exemptions, whether any other barriers are erected to limit ease of exemption access or to educate parents, and whether the state has oversight to deny applicants. Establishing these fundamental ingredients for assessing exemption policy is a cumulative work over time. Researchers use methodologies including desk research, surveys, and key informant discussions. Scholars in the United States, in works such as Blank, et al. 2013; Omer, et al. 2014; and Goldstein, et al. 2019, are also interested in cataloguing and counting changes or attempted changes to exemption policies. These exercises demonstrate the remarkable flux in exemption policies in American states. They also demonstrate the sheer scale of failed attempts to both increase and decrease the opportunity and ease of attaining nonmedical exemptions. Reform attempts appear to be driven by ideology and politicization around vaccine choice as well as the public health impetus to increase coverage rates.

  • Blank, N. R., A. L. Caplan, and C. Constable. 2013. Exempting schoolchildren from immunizations: States with few barriers had highest rates of nonmedical exemptions. Health Affairs 32.7: 1282–1290.

    DOI: 10.1377/hlthaff.2013.0239Save Citation »Export Citation » Share Citation »

    This article builds upon Rota, et al. 2001 to classify the difficulty of obtaining nonmedical exemptions within American states. Researchers used surveys and discussions with immunization program officials to assess policies. They also tracked legislative changes from 2011 to 2013 for the direction of policy movement. Helpfully, they tabulate each state classification. Twenty-one bills in fifteen states sought to broaden or narrow NMEs, with Washington, California, and Vermont successfully tightening access.

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  • Goldstein, N. D., J. S. Suder, and J. Purtle. 2019. Trends and characteristics of proposed and enacted state legislation on childhood vaccination exemption, 2011–2017. American Journal of Public Health 109.1: 102–107.

    DOI: 10.2105/AJPH.2018.304765Save Citation »Export Citation » Share Citation »

    This study builds on Omer, et al. 2014, tracking attempted changes and enlarging the scope to consider all types of exemptions. It uses and builds from data from the Association of State and Territorial Health Officials’ annual reports. The scholars also researched partisan composition of the relevant Houses. Their thematic analysis finds five primary goals of bills. Bills increased over time and some states had multiple bills.

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  • Omer, S. B., D. Peterson, E. A. Curran, A. Hinman, and W. A. Orenstein. 2014. Legislative challenges to school immunization mandates, 2009–2012. Journal of the American Medical Association 311.6: 620–621.

    DOI: 10.1001/jama.2013.282869Save Citation »Export Citation » Share Citation »

    This older article analyzes attempts to change nonmedical exemptions in American states between 2009 and 2012. The authors classify bills as arising in states with or without personal belief exemptions. They then list administrative requirements in the bills, defined as actions required beyond merely signing a form, and classify whether bills sought to expand or restrict exemptions. The majority sought expansion, but all failed. Three of five bills restricting exemptions passed.

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  • Rota, J. S., D. A. Salmon, L. E. Rodewald, R. T. Chen, B. F. Hibbs, and E. J. Gangarosa. 2001. Processes for obtaining nonmedical exemptions to state immunization laws. American Journal of Public Health 91.4: 645–648.

    DOI: 10.2105/ajph.91.4.645Save Citation »Export Citation » Share Citation »

    This foundational article establishes an important tenet of US vaccination policy: sometimes exemptions are easier to access than vaccines. Surveying health department immunization program managers in the (then) forty-eight states with religious or philosophical exemptions, the authors classify them as low, medium, or high difficulty; consider whether annual renewal is required; whether it is policy to counsel parents; and whether there is state capacity to review and deny exemptions.

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Mandatory Childhood Vaccination Policies: Deep Dives

With much of the attention on mandatory vaccination deriving from recent policy changes in high income countries, interdisciplinary work dissects the new mandates’ impetus, development, design, and potential unintended consequences. Not all articles focus on all features, but most provide useful detail of the policies and the reasons why local actors saw fit to introduce them. The articles are noteworthy in offering general critiques, lessons, and considerations for mandatory policies in other contexts. Leask and Danchin 2017 is an exemplar—while detailing the context, strengths, and unintended consequences of Australia’s 2016 “No Jab, No Pay” policy, the authors pay attention to whether the case for mandates is epidemiologically informed, and how the removal of exemptions can lead to a loss of data that explains why people are under-vaccinated. Other works, such as the analysis of France in Ward, et al. 2018 and the analysis of Italy in Crenna, et al. 2018, offer detailed analyses of local political and cultural factors, as well as vaccination policy histories. It is noteworthy that the new mandates all arose in contexts in which there were preexisting ineffective or more permissive mandates for some or all vaccines. Italy and France had long-standing mandates but just for a handful of vaccines. Australia had mandates for all recommended vaccines but allowed parents to opt out, as did California. Mello, et al. 2015, an analysis of the factors contributing to California’s policy change, provides background for making sense of the evaluative work on California explored in Removing Nonmedical Exemptions: Lessons from California. Mello 2020 revisits California five years on from the policy change and a subsequent legislative amendment to impose greater scrutiny of medical exemptions. This bloody and hard-fought coda to the 2015 policy change arose because parents who could no longer access personal belief exemptions fled to nonmedical exemptions (NMEs) instead and found a small cadre of doctors willing to provide them. Mississippi and West Virginia’s policies are not new. However, Colgrove and Lowin 2016 interrogates them as these are the only two US states to have never permitted any exemptions beyond medical. With the enhanced US interest in abolishing NMEs, deep analysis of these models is welcome. Navin and Largent 2017 drills into policies in California, Vermont, and Michigan to offer a way of considering the normative implications and public health aims of different models.

  • Colgrove, J., and A. Lowin. 2016. A tale of two states: Mississippi, West Virginia, and exemptions to compulsory school vaccination laws. Health Affairs 35.2: 348–355.

    DOI: 10.1377/hlthaff.2015.1172Save Citation »Export Citation » Share Citation »

    From 1979 to 2015, only Mississippi and West Virginia excluded NMEs from their school entry mandates. This paper engages in policy analysis to determine both the reasons and consequences. It outlines the origins of US school entry mandates and exemptions, detailing unsuccessful legislative and legal challenges to the laws in both states. It attributes policy longevity to aggregate low income and formal education, and the networks and strategies of health officials.

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  • Crenna, S., A. Osculati, and S. D. Visonà. 2018. Vaccination policy in Italy: An update. Journal of Public Health Research 7.3: 1523.

    DOI: 10.4081/jphr.2018.1523Save Citation »Export Citation » Share Citation »

    This article provides one of the most accessible overviews of Italy’s new policy and how it was reached, employing legal and social analysis. It explains how Italy’s mandate for four older vaccines was disrupted in 1999 by children being permitted to enroll in school even if unvaccinated. Government officials grew concerned about vaccine hesitancy and the Emilia-Romagna region introduced its own regional mandate.

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  • Leask, J., and M. Danchin. 2017. Imposing penalties for vaccine rejection requires strong scrutiny. Journal of Paediatrics and Child Health 53.5: 439–444.

    DOI: 10.1111/jpc.13472Save Citation »Export Citation » Share Citation »

    Australia has been at the forefront globally in making vaccination more mandatory, and Leask and Danchin explain the significance of the removal of “Conscientious Objections” that had allowed parents, until 2016, to register as vaccine refusers and still access federal government family assistance. The authors explore the reasons for and against such a change and illustrate unintended adverse consequences for families drawn from clinical experience.

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  • Mello, M. M. 2020. Narrowing vaccination exemption laws: Lessons from California and beyond. Annals of Internal Medicine 172.5: 358–359.

    DOI: 10.7326/m19-3111Save Citation »Export Citation » Share Citation »

    This article is useful for explaining SB276, the coda to California’s abolition of nonmedical exemptions. In 2019, legislators sought to address a 250 percent increase in medical exemptions by providing state oversight. Mello critiques the new law as still not requiring medical exemptions to come from the child’s regular physician, and “grandfathering” existing medical exemptions from scrutiny. She lays out further considerations for optimal medical exemption policy.

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  • Mello, M. M., D. M. Studdert, and W. E. Parmet. 2015. Shifting vaccination politics—the end of personal-belief exemptions in California. New England Journal of Medicine 373.9: 785–787.

    DOI: 10.1056/NEJMp1508701Save Citation »Export Citation » Share Citation »

    Mello and colleagues explain the 2015 California law abolishing personal belief exemptions, list the vaccines to which it applies, and outline how it will function in institutions. They attribute its passage to four key features: the “backbone” of legislators in resisting pressure from vaccine refusers, the Department of Public Health publicizing data on vast personal belief exemption increases, the Disneyland measles outbreak, and proponents framing non-vaccination as a decision that harmed others.

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  • Navin, M. C., and M. A. Largent. 2017. Improving nonmedical vaccine exemption policies: Three case studies. Public Health Ethics 10.3: 225–234.

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    This paper is written by ethicists but contains policy, political, and pragmatic analysis. The authors consider three new models: eliminationism (California with no philosophical/personal belief exemptions, or PBEs), prioritizing religion (Vermont with only religious exemptions, which the authors regard as unfair and ineffective), and inconvenience (Michigan’s newly burdensome process for attaining PBEs). They favor the latter, arguing that it can be effective and avoids the ethical hazards of the other two models.

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  • Ward, J. K., J. Colgrove, and P. Verger. 2018. Why France is making eight new vaccines mandatory. Vaccine 36.14: 1801–1803.

    DOI: 10.1016/j.vaccine.2018.02.095Save Citation »Export Citation » Share Citation »

    This article offers an accessible analysis of France’s problematic vaccination history. The roots of France’s new mandatory policy lie in historic controversies around hepatitis B and H1N1 vaccines. A citizen’s consultation process designed to restore trust in vaccines saw its steering committee embracing mandates. This was bolstered by the country’s highest court determining that parents could not be required to accept nonmandatory vaccines mixed with mandatory ones.

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Policy Implementation, Impact, and Effectiveness: Non-United States Studies of Childhood Vaccine Mandates

This section focuses on effects of mandatory childhood vaccination policies, particularly following policy changes. As elaborated in Mandatory Childhood Vaccination Policy Implementation, Impact, and Effectiveness: Evaluating Adjusting Waiver Policies in the United States, it makes sense to explore America-focused work separately. Accordingly, this section focuses on jurisdictions outside the United States. Of the work explored here, only Vaz, et al. 2020 comparatively analyzes the effects of mandatory vaccination (and policy design) across multiple countries. Greyson, et al. 2019 reviews the impact of mandates for school entry. Other studies such as Bechini, et al. 2019 focus on jurisdictions that have recently changed their policies. Evaluation of new mandatory policies in Lévy-Bruhl, et al. 2019 (France) and Signorelli, et al. 2018 (Italy) focuses predominantly on aggregated coverage data, and whether more children were vaccinated after the policy change than before it. What becomes immediately apparent is the various mechanisms by which governments measure vaccine uptake, and how these mechanisms influence researchers’ evaluation of policies’ impact. In Australia, a national register allows focus on individualized data. This can provide reasonably accurate population coverage data linked to individuals, enabling Hull, et al. 2020 to track policies’ impacts on specific children, such as those who were not previously up to date. Italian authorities keep regional percentage records, while French officials rely on less reliable calculations, including financial reimbursement data for vaccines administered to estimate national coverage. Helps, et al. 2018 uses purposive sampling and Armiento, et al. 2020 uses service-utilizing samples to measure the impact of mandatory vaccination policies on those groups most likely to be adversely impacted by them: parents who are hesitant or refuse vaccines for their children. Scholars evaluating mandatory vaccination regimes are not just interested in their effects on vaccine uptake or on key targeted populations. Adams, et al. 2015 is interested in cost effectiveness, while Vaz, et al. 2020 maps regimes to disease outbreaks. Scholars are also interested in the impact of mandates on vaccine confidence. Irrespective of actual measurements, government, scholars, and technical officials reporting policies’ effects use proxies such as uptake of vaccines by nonmandatory groups, or uptake of nonmandatory vaccines, to infer that mandates enhance vaccine confidence.

  • Adams, J., B. Bateman, F. Becker, et al. 2015. Effectiveness and acceptability of parental financial incentives and quasi-mandatory schemes for increasing uptake of vaccinations in preschool children: Systematic review, qualitative study and discrete choice experiment. Health Technology Assessment 19.94.

    DOI: 10.3310/hta19940Save Citation »Export Citation » Share Citation »

    This National Health Service–conducted systematic review of financial incentives and quasi-mandatory schemes found limited evidence of their efficacy or cost-effectiveness. Of greater ongoing interest is the qualitative study the researchers conducted with parents in England, where there are no mandates, to consider which kinds of policy might be acceptable there. The parents were much more positive about mandates—conceptualized as daycare exclusions and the like—than financial incentives.

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  • Armiento, R., M. Hoq, E. Kua, et al. 2020. Impact of Australian mandatory “No Jab, No Pay” and “No Jab, No Play” immunisation policies on immunisation services, parental attitudes to vaccination and vaccine uptake, in a tertiary paediatric hospital, the Royal Children’s Hospital, Melbourne. Vaccine 38.33: 5231–5240.

    DOI: 10.1016/j.vaccine.2020.05.094Save Citation »Export Citation » Share Citation »

    In the early years of Australia’s “No Jab” policies, researchers at Victoria’s Royal Children’s Hospital surveyed parents at their immunization clinics. Twelve percent were motivated to attend by the policies, 19 percent were vaccine hesitant, and only half the latter planned to vaccinate. Their children were less likely to be fully vaccinated seven months later than at baseline; the researchers concluded that the policies were not changing behavior in hesitant parents.

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  • Bechini, A., S. Boccalini, A. Ninci, et al. 2019. Childhood vaccination coverage in Europe: Impact of different public health policies. Expert Review of Vaccines 18.7: 693–701.

    DOI: 10.1080/14760584.2019.1639502Save Citation »Export Citation » Share Citation »

    The premise of this non-systematic review article is to assess the impact of public health policies on childhood vaccine uptake. It reviews vaccine coverage by antigen and analyzes the (positive) impact of mandatory policies in Italy and France. It describes, but does not evaluate, changing German policies, starting with mandatory declination for kindergarten entry (2015) and the tightening to include fines for noncompliant parents (2017).

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  • d’Ancona, F., C. d’Amario, F. Maraglino, G. Rezza, and S. Iannazzo. 2019. The law on compulsory vaccination in Italy: An update 2 years after the introduction. Eurosurveillance 24.26: 1900371.

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    Two years out from Italy’s new mandate, government and technical officials reflect on changes to coverage data and policy impacts. Vaccine coverage for mandatory and voluntary vaccines has continued to rise. A run on catch-up vaccination and certification impacted routine services and prompted authorities to permit affected children to enroll in educational services. The article describes other implementation challenges around catch-ups and penalties. Public information campaigns may have enhanced coverage.

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  • Greyson, D., C. Vriesema-Magnuson, and J. Bettinger. 2019. Impact of school vaccination mandates on pediatric vaccination coverage: A systematic review. Canadian Medical Association Journal 7.3: 524–536.

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    This review employs narrative analysis of twenty papers studying the implementation of school entry mandates (including record checks), picking up several studies conducted when new vaccines were added to existing mandates. Eighteen are from the United States, and a variety of methods are used. Many found increased vaccine rates, but the scholars note bias including co-interventions, ecological fallacy, and non-representativeness. Included mandates are broader than the definitions employed in this Oxford Bibliographies article.

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  • Helps, C., J. Leask, and L. Barclay. 2018. “It just forces hardship”: Impacts of government financial penalties on non-vaccinating parents. Journal of Public Health Policy 39.2: 156–169.

    DOI: 10.1057/s41271-017-0116-6Save Citation »Export Citation » Share Citation »

    This article reports qualitative data collected in Byron Shire, New South Wales, known for its historic low vaccination coverage. Thirty-one interview transcripts with vaccine-rejecting parents were analyzed. The authors report families seeking to manage the loss of financial assistance by adjusting their lives. Parents criticized the policy and determined to stand their ground against it even if it meant moving. Seven parents reported unregistered childcare providers taking unvaccinated children.

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  • Hull, B. P., F. H. Beard, A. J. Hendry, A. Dey, and K. Macartney. 2020. “No Jab, No Pay”: Catch-up vaccination activity during its first two years. Medical Journal of Australia 213.8: 364–369.

    DOI: 10.5694/mja2.50780Save Citation »Export Citation » Share Citation »

    This article reports that Australia is close to reaching the 95 percentile for vaccination coverage for one- and five-year-olds. A component of the federal “No Jab, No Pay” policy extended vaccine records and requirements from age seven to twenty, making catch-up vaccination activity a key area to evaluate. The article reports the policy prompting higher levels of catch-up vaccinations for measles, mumps, and rubella (MMR), with the greatest impact in lower socioeconomic areas.

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  • Lévy-Bruhl, D., L. Fonteneau, S. Vaux, et al. 2019. Assessment of the impact of the extension of vaccination mandates on vaccine coverage after 1 year, France, 2019. Eurosurveillance 24.26: 1900301.

    DOI: 10.2807/1560-7917.ES.2019.24.26.1900301Save Citation »Export Citation » Share Citation »

    France’s new mandate applies only to children born in or after 2018, and this study finds that more of them are vaccinated than previously—dramatically so for some vaccines. The researchers also analyzed coverage rates for children too old for the new mandates, and human papillomavirus (HPV) vaccination, concluding that rising coverage here reflects rising vaccine confidence due to the mandate and associated positive publicity for vaccination.

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  • Signorelli, C., A. Odone, P. Cella, and S. Iannazzo. 2018. Childhood vaccine coverage in Italy after the new law on mandatory immunization. Annali di Igiene: Medicina Preventiva e di Comunità 30.4 Suppl. 1: 1–10.

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    This article reports vaccination rates in Italy from 2000 to 2017, taking in the first months of the new mandate. It reports national and regional rises in coverage since the new law, and across a range of vaccines, including nonmandatory ones.

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  • Vaz, O. M., M. K. Ellingson, P. Weiss, et al. 2020. Mandatory vaccination in Europe. Pediatrics 145.2: e20190620.

    DOI: 10.1542/peds.2019-0620Save Citation »Export Citation » Share Citation »

    This article uses data from the European Centre for Disease Prevention and Control and the World Health Organization (WHO) to analyze whether the twenty-nine VENICE countries demonstrate a relationship between mandates, measles, and pertussis vaccine coverage, and outbreaks of these diseases. Mandatory vaccination and larger fines are associated with higher vaccine coverage. Where the mandate precludes nonmedical exemptions, measles outbreaks are lower. Where non-compliers are fined, there are fewer incidences of both diseases.

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Mandatory Childhood Vaccination Policy Implementation, Impact, and Effectiveness: Evaluating Adjusting Waiver Policies in the United States

The United States of America is a laboratory for vaccination policies. Blessed with a large natural experiment (policies are set at state level), a history of high-caliber research, and a seemingly strong translational current from research to policy, American research is a powerful exercise in determining “what works” when comparing state policies, and “what happens” when a state changes its policy. While comparative mandatory policy research globally grapples with a variety of models (General Overviews), the ubiquitous model in all American states is that students must demonstrate proof of vaccination according to a state-decreed schedule in order to enroll in school. Greyson, et al. 2019 finds that when new vaccines are added to these schedules, their uptake increases. There are state-specific variations in how often families need to provide vaccination proof. Wider variation comes at the level of exemptions, which can be medical or nonmedical. Nonmedical exemptions (NMEs) further divide into religious and philosophical/personal belief exemptions (PBE)—some states have both while others have only one. The variation continues with ease or difficulty in obtaining NMEs. Omer, et al. 2012 and Blank, et al. 2013 note local variations including whether states require parent letters or standard forms, from which locations parents can obtain forms, whether forms must be notarized, and whether parents must employ special wording. Navin, et al. 2020 and Omer, et al. 2018 elaborate additional attempts to make accessing PBEs more burdensome: requiring parental education (Michigan) and requiring counseling from a medical practitioner (Washington). What have we learned from this long experiment? First, Omer, et al. 2008 shows that NME policies matter to disease outbreaks within states, and Bradford and Mandich 2015 explores the comparative likelihood of outbreaks occurring between states. Second, Omer, et al. 2012 and Blank, et al. 2013 demonstrate that easy access to NMEs means more NMEs. Third, Omer, et al. 2018 finds that tweaks to make NMEs less accessible have successfully increased vaccine coverage rates in Washington, with Buttenheim, et al. 2018 finding the same in California. Fourth, Stadlin, et al. 2012 finds that medical exemptions are important, particularly when states remove or make it more challenging to access other exemptions. However, work in Navin, et al. 2020 finds that reorientation to medical exemptions is not necessarily a pattern. Fifth, Jones, et al. 2018 finds that clustering of all types of non-vaccinated children matters and may not be addressed by policies that make accessing exemptions more burdensome.

  • Blank, N. R., A. L. Caplan, and C. Constable. 2013. Exempting schoolchildren from immunizations: States with few barriers had highest rates of nonmedical exemptions. Health Affairs 32.7: 1282–1290.

    DOI: 10.1377/hlthaff.2013.0239Save Citation »Export Citation » Share Citation »

    This article explores the relationship between the difficulty of obtaining nonmedical exemptions and the numbers of such exemptions. Researchers used surveys and discussions with immunization program officials to assess policies, which they then cross-referenced with Centers for Disease Control data on NMEs by state. States with simpler procedures had more than double the number of exemptions as those with complex procedures.

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  • Bradford, W. D., and A. Mandich. 2015. Some state vaccination laws contribute to greater exemption rates and disease outbreaks in the United States. Health Affairs 34.8: 1383–1390.

    DOI: 10.1377/hlthaff.2014.1428Save Citation »Export Citation » Share Citation »

    Researchers used the State Vaccination Requirements and Exemption Law Database to ascertain variables determining a policy’s effectiveness, tested with regression analyses. They used all types of mandate exemptions as the dependent variable, aware that parents move to different types of exemptions (“substitute behavior”) as avenues close. Health department approval requirements had a significant association with lowering exemption rates, as did physician signatures and criminal or civil punishments for noncompliance.

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  • Buttenheim, A. M., M. Jones, C. McKown, D. Salmon, and S. B. Omer. 2018. Conditional admission, religious exemption type, and nonmedical vaccine exemptions in California before and after a state policy change. Vaccine 36.26: 3789–3793.

    DOI: 10.1016/j.vaccine.2018.05.050Save Citation »Export Citation » Share Citation »

    California followed the Washington model and would only permit NMEs after health-care provider consultation following a law passed in 2012 and implemented in 2014. Using California Department of Public Health data, scholars analyzed PBE prevalence and immunization status from 2012–2013 to 2015–2016 and employed an interrupted time series. The statewide exemption rate fell 25 percent over this time.

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  • Greyson, D., C. Vriesema-Magnuson, and J. Bettinger. 2019. Impact of school vaccination mandates on pediatric vaccination coverage: A systematic review. Canadian Medical Association Journal 7.3: 524–536.

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    Eighteen of the papers picked up in this review are from the United States. The review tended not to pick up the exemption changes catalogued in this Oxford Bibliographies article, but rather a different set of studies conducted when new vaccines were added to existing mandates in states that were not tweaking their exemption policies. Many reported increased vaccine rates, but the scholars note bias including co-interventions, ecological fallacy, and non-representativeness.

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  • Jones, M., A. M. Buttenheim, D. Salmon, and S. B. Omer. 2018. Mandatory health care provider counseling for parents led to a decline in vaccine exemptions in California. Health Affairs 37.9: 1494–1502.

    DOI: 10.1377/hlthaff.2018.0437Save Citation »Export Citation » Share Citation »

    Authors of the previous study led by Buttenheim subject the California health-care provider counseling policy to longer scrutiny, going back to 2001 to measure impact. Prevalence and clustering of PBEs had risen until 2013–2014, and then declined modestly. Clustering was less impacted by the policy change, and students enrolled on conditional admissions also continued to cluster.

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  • Navin, M. C., M. A. Largent, and A. M. McCright. 2020. Efficient burdens decrease nonmedical exemption rates: A cross-county comparison of Michigan’s vaccination waiver education efforts. Preventative Medicine Reports 17:101049.

    DOI: 10.1016/j.pmedr.2020.101049Save Citation »Export Citation » Share Citation »

    Michigan has sought to make NMEs more difficult to attain. Since 2014, parents must attend a state-run education session. The scholars report variable reductions in NME rates after the policy change, explicable by some local health districts already having the requirement in place. Variation in session organization and their relative burdensomeness did not affect NME rates. The researchers conclude that the mere presence of the educational burden effected change.

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  • Omer, S. B., K. Allen, D. H. Chang, et al. 2018. Exemptions from mandatory immunization after legally mandated parental counseling. Pediatrics 141.1: e20172364.

    DOI: 10.1542/peds.2017-2364Save Citation »Export Citation » Share Citation »

    Washington sought to make NMEs more difficult to maintain, requiring parental counseling by a licensed health-care provider from 2011. This study explored the new policy’s effect in 2013–2014, finding a 40 percent drop and increases in almost all vaccines, plus a decline in geographic clustering of exemption holders.

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  • Omer, S. B., K. S. Enger, L. H. Moulton, N. A. Halsey, S. Stokley, and D. A. Salmon. 2008. Geographic clustering of nonmedical exemptions to school immunization requirements and associations with geographic clustering of pertussis. American Journal of Epidemiology 168.12: 1389–1396.

    DOI: 10.1093/aje/kwn263Save Citation »Export Citation » Share Citation »

    This study, conducted in Michigan, is frequently cited for the claim that “clustering” of NMEs for America’s school entry vaccine mandates maps to outbreaks of disease. Researchers found an overlap between areas of high nonmedical exemptions and reported pertussis cases. They use their finding to alert state officials that monitoring of state-level exemption rates to school entry mandates should also pay attention to local variations.

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  • Omer, S. B., J. Richards, M. A. B. Ward, and R. A. Bednarczyk. 2012. Vaccination policies and rates of exemption from immunization, 2005–2011. New England Journal of Medicine 367.12: 1170–1171.

    DOI: 10.1056/NEJMc1209037Save Citation »Export Citation » Share Citation »

    This article builds on Rota, et al. 2001 (see Cataloguing and Counting Mandatory Childhood Vaccination and Exemption Policies in the United States) to assess rates of exemptions over time in states with easy, medium, or difficult exemption policies, and philosophical, religious or both. NMEs increase across the board during the study period, with rates 2.54 times as high in states permitting philosophical exemptions compared to those permitting only religious exemptions.

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  • Stadlin, S., R. A. Bednarczyk, and S. B. Omer. 2012. Medical exemptions to school immunization requirements in the United States—association of state policies with medical exemption rates (2004–2011). Journal of Infectious Diseases 206.7: 989–992.

    DOI: 10.1093/infdis/jis436Save Citation »Export Citation » Share Citation »

    All US states allow medical exemptions, but the ease of obtaining them and their extent varies. The researchers used state health department websites to categorize ease by quantifying administrative criteria (physician statement, form, health department approval, physician’s status, annual approval, and form notarization) and length. Higher exemption rates occurred in states with easy or medium criteria. Access to permanent exemptions also correlated with more of them being in place.

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Removing Nonmedical Exemptions: Lessons from California

The abundance of work on the United States exemption policy tweaking (see Mandatory Childhood Vaccination Policy Implementation, Impact, and Effectiveness: Evaluating Adjusting Waiver Policies in the United States) demonstrates the keen interest that researchers and policymakers have in experimenting with design to try and increase vaccination compliance. These impulses are checked by the high politicization of vaccine policy efforts from civil society to reduce compulsions on parents and make exemptions easier to access. The California experiment has received considerable scholarly attention because it has been the first state to remove nonmedical exemptions entirely as a response to parental vaccine refusal. Following this policy change, scholars have tracked the impact of the policy change, with key findings summarized in this section. Delamater, et al. 2019 finds that when philosophical/personal belief exemptions (PBEs) are removed, vaccination levels increase, but not all children will immediately become vaccinated, and a “replacement effect” can see families fleeing to other categories that allow them to remain unvaccinated, including medical exemptions, as shown in Delamater, et al. 2017 and Mohanty, et al. 2018. Mohanty, et al. 2019 considers policy implementation and problems that emerge through vague language.

  • Delamater, P. L., T. F. Leslie, and Y. Yang. 2017. Change in medical exemptions from immunization in California after elimination of personal belief exemptions. Journal of the American Medical Association 318.9: 863–864.

    DOI: 10.1001/jama.2017.9242Save Citation »Export Citation » Share Citation »

    Medical exemptions were largely stable in California for twenty years, even as PBEs were rising. When the latter were abolished, medical exemptions (MEs) increased from 0.17 percent to 0.51 percent in the first year, but with considerable local variation, and counties with higher PBE use showing the biggest increases in MEs. MEs, however, may have been underused when PBEs were available.

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  • Delamater, P. L., S. C. Pingali, A. M. Buttenheim, D. A. Salmon, N. P. Klein, and S. B. Omer. 2019. Elimination of nonmedical immunization exemptions in California and school-entry vaccine status. Pediatrics 143.6.

    DOI: 10.1542/peds.2018-3301Save Citation »Export Citation » Share Citation »

    This study explores whether children enrolling in kindergarten after California’s policy change were fully vaccinated. Some of the meaningful decrease in the first year was because fewer students were enrolled “conditionally” the basis of later providing paperwork. The number of medical exemptions and exempt independent study or homeschoolers grew. In the second year, fully vaccinated numbers increased. Geographic areas with many refusers continued to contain unvaccinated children.

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  • Mohanty, S., A. M. Buttenheim, C. M. Joyce, A. C. Howa, D. Salmon, and S. B. Omer. 2018. Experiences with medical exemptions after a change in vaccine exemption policy in California. Pediatrics 142.5: e20181051.

    DOI: 10.1542/peds.2018-1051Save Citation »Export Citation » Share Citation »

    The authors report a 250 percent increase in MEs over two years and investigate implementation experience through qualitative analysis of interviews with forty county health officers and immunization staff. Staff describe different tracking processes for filed medical exemptions to look for patterns, and a lawsuit about tracking that had a chilling effect. Participants were concerned about the burdens and some physician behavior, including granting inappropriate MEs.

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  • Mohanty, S., A. M. Buttenheim, C. M. Joyce, A. C. Howa, D. Salmon, and S. B. Omer. 2019. California’s Senate Bill 277: Local health jurisdictions’ experiences with the elimination of nonmedical vaccine exemptions. American Journal of Public Health 109.1: 96–101.

    DOI: 10.2105/AJPH.2018.304768Save Citation »Export Citation » Share Citation »

    Reporting on the same data set as Mohanty, et al. 2018, the scholars consider implementation, including vagueness of the legislative and regulatory language and the issue of no oversight for medical exemptions. The researchers argue for more specific language in policies and centralized review of exemptions.

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Mandatory Vaccination of Health-Care Workers—Policies, Experiences, and Impact

Other than children, the cohort primarily subjected to mandatory vaccination is health-care workers (HCWs). Policies can require HCWs to demonstrate vaccination or immunity to diseases such as measles, as explored in Maltezou, et al. 2019b or hepatitis B, as explored in de Schryver, et al. 2020. HCWs may also require regular vaccinations for influenza. The mandate can lie with government or with the individual’s employer—either way, the latter will likely play a key role in enforcing it. Mandating vaccines for HCWs appears to be driven by their essential workforce role, their capacity to spread disease (including to very ill patients), and suboptimal vaccine uptake for reasons including but not limited to hesitancy, with crises such as the H1N1 pandemic a driver. Maltezou and colleagues note that consequences for noncompliance with government mandates generally include fines, worksite changes, and employment status, including termination (Maltezou, et al. 2019a), although strengths vary. Hospital-based mandates commonly cover vaccinations not covered by government mandates. Many articles discussing hospital-based influenza vaccination mandates are US based. US governments have not imposed HCW influenza mandates, notes Seale 2018, but Babcock and colleagues demonstrate how employers have claimed the regulatory space. Unlike government mandates, hospital-based mandates are restricted by only being able to apply pressure to vaccinate in the workplace. Babcock, et al. 2010 notes that hospital mandates generally include formal exemptions on medical or religious objection grounds, and that harder mandates respond to noncompliance with termination of employment, although this is preceded by warnings. Hospital mandates are also explored in Esolen and Kilheeney 2013; Benin, et al. 2018; and Vensel 2018. However, softer hospital mandates restrict worksite access, as discussed in Seale 2018 and Jenkin, et al. 2019, or visually distinguish the unvaccinated with masks—Benin, et al. 2018 notes that this can include those who receive exemptions. Hospital-based mandates are limited uniquely in that enforcing hard consequences (i.e. termination of employment or restriction of shifts) can attract legal challenges or union disputes, as explored in Vensel 2018. While government legislation can be challenged by organized activists through the legal system or protests, hospitals have no legislative power and may lack the resources required for a legal battle. This may inform the decision of some hospitals to focus on softer policies, or to favor research/education over punishing noncompliance. Babcock, et al. 2010 and Esolen and Kilheeney 2013 review the efficacy of HCW vaccine mandates, finding that they are highly effective in boosting the vaccination rates of staff.

  • Babcock, H. M., N. Gemeinhart, M. Jones, W. C. Dunagan, and K. F. Woeltje. 2010. Mandatory influenza vaccination of health care workers: Translating policy to practice. Clinical Infectious Diseases 50.4: 459–464.

    DOI: 10.1086/650752Save Citation »Export Citation » Share Citation »

    After previously introducing a formal declination policy, a large mid-Western US health-care organization made influenza vaccination a condition of employment in 2008, with those lacking a medical or religious exemption terminated in early 2009. The article outlines the programmatic execution of this policy and its high efficacy in terms of coverage rates, describing assessment of exemptions and numbers of exemptions and noncompliant personnel.

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  • Benin, A. L., G. Lockwood, T. Creatore, D. Donovan, M. Predmore, and S. MacArthur. 2018. Improving mandatory vaccination against influenza: Minimizing anxiety of employees to maximize health of patients. American Journal of Medical Quality 33.4: 372–382.

    DOI: 10.1177/1062860617748738Save Citation »Export Citation » Share Citation »

    The authors suggest theirs is the first known study to qualitatively evaluate employee experience of a mandate that their study sites, a children’s hospital in Connecticut, implemented for influenza in 2011. They describe the policy and consider the motivation of employees to comply, as well as attitudes and experiences. They also describe how study findings were fed back into improving the system.

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  • de Schryver, A., T. Lambaerts, N. Lammertyn, G. François, S. Bulterys, and L. Godderis. 2020. European survey of hepatitis B vaccination policies for healthcare workers: An updated overview. Vaccine 38.11: 2466–2472.

    DOI: 10.1016/j.vaccine.2020.02.003Save Citation »Export Citation » Share Citation »

    Using survey data, the researchers dive deep into hepatitis B vaccination mandates in this comparative study, considering types of HCW, existence of mandates, and consequences, finding that countries with lower GDPs have more mandates.

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  • Esolen, L. M., and K. L. Kilheeney. 2013. A mandatory campaign to vaccinate health care workers against pertussis. American Journal of Infection Control 41.8: 740–742.

    DOI: 10.1016/j.ajic.2012.10.012Save Citation »Export Citation » Share Citation »

    This brief report describes a time-limited intervention in two hospitals in the United States to require tetanus, diphtheria, acellular pertussis (Tdap) vaccination or evidence, supported by free and easy distribution. Medical, ethical, and religious exemptions were available but assessed. Noncompliant personnel could eventually be terminated. With low compliance prior to the mandate, the article reports a large rise in vaccination rates and also reports exemptions/terminations, as well as the cost of the program.

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  • Jenkin, D. C., H. Mahgoub, K. F. Morales, P. Lambach, and J. S. Nguyen-Van-Tam. 2019. A rapid evidence appraisal of influenza vaccination in health workers: An important policy in an area of imperfect evidence. Vaccine: X 2:100036.

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    This rapid review engages with several other reviews, some of which conclude that mandates followed by “soft” mandates (masks, opt-outs, formal declination) are the most effective single strategies in increasing influenza vaccination uptake in HCWs.

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  • Maltezou, H. C., E. Botelho-Nevers, A. B. Brantsæter, et al. 2019a. Vaccination of healthcare personnel in Europe: Update to current policies. Vaccine 37.52: 7576–7584.

    DOI: 10.1016/j.vaccine.2019.09.061Save Citation »Export Citation » Share Citation »

    The researchers update an earlier study to study HCW vaccination policy in thirty-six European studies. They lay out recommendations and requirements by disease and then, in helpful tables, by country. They drill into specific consequences, for example, the ability to be hired, relocation of worksite, termination, individual fines, and facility fines, with variations across jurisdictions and diseases. The authors note increasing comprehensiveness of policies since their earlier 2011 survey.

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  • Maltezou, H. C., K. Theodoridou, C. Ledda, V. Rapisarda, and M. Theodoridou. 2019b. Vaccination of healthcare workers: Is mandatory vaccination needed? Expert Review of Vaccines 18.1: 5–13.

    DOI: 10.1080/14760584.2019.1552141Save Citation »Export Citation » Share Citation »

    This recent non-systematic review (2010–2018) covers published information on mandatory HCW vaccination policies. It notes such policies in place in a few countries and for specific diseases with varying success, but much higher implementation at hospital level in the United States. It tracks the history of US influenza mandates and even includes its own annotated bibliography! State-of-the-art resource.

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  • Pitts, S., N. M. Maruthur, K. R. Millar, T. M. Perl, and J. Segal. 2014. A systematic review of mandatory influenza vaccination in healthcare personnel. American Journal of Preventive Medicine 47.3: 330–340.

    DOI: 10.1016/j.amepre.2014.05.035Save Citation »Export Citation » Share Citation »

    This review looks at twelve studies of mandatory influenza vaccination in hospitals. It discusses the proportion of objections, the number of terminations/resignations, and how mandates were put into place with the presence of unions. Mandates increase uptake but gaps regarding further impact are noted.

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  • Seale, H. 2018. Don’t forget healthcare workers are required to have other mandatory immunizations, so why isn’t the influenza vaccination included? Expert Review of Respiratory Medicine 12.10: 805–807.

    DOI: 10.1080/17476348.2018.1512410Save Citation »Export Citation » Share Citation »

    This well-referenced editorial sets the global scene for understanding seasonal influenza vaccine mandates within a context of other voluntary uptake policies, and other vaccine mandates for HCWs. It briefly reviews the ethical and efficacy literature, as well as noting gaps in existing studies (e.g., minimal focus on absenteeism and patient outcomes).

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  • Vensel, M. 2018. Flu vaccine programs for providers: Making it legal, effective, and mandatory. Patient Safety Monitor Journal 19.9: 7–9.

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    This US focused journalistic article extensively quotes Terri Rebmann on HCW mandates, who clarifies that mandates set the tone rather than requiring every single worker to be vaccinated. The article describes (but does not cite) scenarios in which unions and government legal authorities have intervened in institutional mandatory policies. Rebmann outlines the “must-haves” for effective and fair policies, including that they be written and permit exemptions.

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Mandatory Vaccination—Attitudinal Studies

Work has been conducted in a range of settings to determine the attitudes of specific populations to vaccine mandates, but Gualano, et al. 2019 notes that there has been little consolidation. Mandates may already exist in the study jurisdiction or setting, or exist elsewhere and be under consideration locally, or researchers may simply be speculating about policy options. The populations to be potentially mandated include health-care workers (HCWs) and children, and studies explore attitudes of HCWs, parents, or whole populations. Mandates may be conceptualized in general terms, or may include considerations of exemptions, consequences, and enforcement. Work in this area, both qualitative and quantitative, has been conducted in health-care settings (e.g., nursing homes, hospitals, medical schools) to identify the attitudes of students and employees toward vaccination mandates. Studies have been conducted in a variety of facilities at different stages of implementing policy; the studies Moretti, et al. 2020 and Stead, et al. 2019 are conducted in settings with no mandate, while Benin, et al. 2018 evaluates responses to a current policy. HCW support of a vaccine mandate has a strong relationship with how informed HCWs are about the particular vaccine and its benefits. This specific knowledge is important, as in other cases some HCWs may report conflicting attitudes—acknowledging that high vaccination rates benefit employees and patients and that mandates increase vaccination rates, but resisting mandates (or vaccines as a whole) on the basis of personal or ethical beliefs. Moretti, et al. 2020 finds that the most frequently recurring sentiments in favor of vaccination are that vaccination is beneficial to patients, and that mandatory vaccination policies are effective in increasing vaccination rates. By contrast, the most frequently recurring concerns are that mandatory vaccination violates the personal liberty of HCWs and their capability to make personal health decisions, a lack of confidence in vaccine effectiveness, and feeling inadequately informed of vaccines (e.g., risks, side effects, etc.), findings also explored in Gualano, et al. 2019 and Benin, et al. 2018. Beyond the hospital setting, attitudinal studies in Smith, et al. 2019 and Mathieu, et al. 2019 seek to measure population attitudes toward mandates in the childhood setting. Vrdelja, et al. 2020 seeks to determine what childhood vaccine acceptance would look like if existing mandates were removed. Betsch and Böhm 2015 and Meier, et al. 2019 experimentally determine the impact of mandates on vaccination behavior.

  • Benin, A. L., G. Lockwood, T. Creatore, D. Donovan, M. Predmore, and S. MacArthur. 2018. Improving mandatory vaccination against influenza: Minimizing anxiety of employees to maximize health of patients. American Journal of Medical Quality 33.4: 372–382.

    DOI: 10.1177/1062860617748738Save Citation »Export Citation » Share Citation »

    Evaluating and seeking to improve an existing mandatory policy in a US hospital setting, researchers qualitatively interviewed twenty-one hospitals’ staffs regarding impact. They described problems including the visible marker of a different badge for non-recipients, deciding to wean a baby due to fears of the vaccine affecting her, and perceptions of defensiveness. Opponents disliked the mask alternative. Mandate supporters saw mandates as consistent with their work and responsibilities.

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  • Betsch, C., and R. Böhm. 2015. Detrimental effects of introducing partial compulsory vaccination: Experimental evidence. European Journal of Public Health 26.3: 378–381.

    DOI: 10.1093/eurpub/ckv154Save Citation »Export Citation » Share Citation »

    This article reports a gamified experiment on German university students to determine whether compulsory or voluntary vaccination would make them more likely to vaccinate against a disease, considering their vaccination attitude and whether they reacted against compulsory vaccination. The authors found that for individuals negatively disposed to vaccination, partial compulsory vaccination would detrimentally impact uptake of other vaccines.

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  • de Perio, M. A., X. Yue, A. S. Laney, S. M. Greby, and C. L. Black. 2018. Agreement with employer influenza vaccination requirements among us healthcare personnel during the 2016–2017 season. Infection Control & Hospital Epidemiology 39.8: 1019–1020.

    DOI: 10.1017/ice.2018.111Save Citation »Export Citation » Share Citation »

    This representative panel study of HCWs across a range of settings in the United States found that 73 percent supported a requirement for flu vaccination; the statement participants were asked to agree with did not engage with consequences or exemptions.

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  • Gualano, M. R., E. Olivero, G. Voglino, et al. 2019. Knowledge, attitudes and beliefs towards compulsory vaccination: A systematic review. Human Vaccines & Immunotherapeutics 15.4: 918–931.

    DOI: 10.1080/21645515.2018.1564437Save Citation »Export Citation » Share Citation »

    This review was conducted to provide greater knowledge about attitudinal studies regarding mandatory vaccination, not limited to any specific setting. Consequently, it covers both childhood and HCW mandates, and contexts in which mandates exist, are being considered, or in which the field is being reviewed. The review does not specifically engage with types of consequence or exemption. Twenty-two studies focus on vaccination in general, while nine focus on human papillomavirus (HPV).

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  • Mathieu, P., A. Gautier, J. Raude, et al. 2019. Population perception of mandatory childhood vaccination programme before its implementation, France, 2017. Eurosurveillance 24.25.

    DOI: 10.2807/1560-7917.ES.2019.24.25.1900053Save Citation »Export Citation » Share Citation »

    Scholars from France’s technical and research institutions surveyed an existing panel to ascertain views on the country’s new but not-yet-implemented extended childhood vaccine mandate in late 2017; 64.5 percent agreed with the new policy, and 68.7 percent saw it as necessary, but a third considered it unsafe for children and more than half considered it authoritarian. A larger number—81.7 percent—supported vaccination in general.

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  • Meier, N. W., R. Böhm, L. Korn, and C. Betsch. 2019. Individual preferences for voluntary vs. mandatory vaccination policies: An experimental analysis. European Journal of Public Health 30.1: 50–55.

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    The German research team reports more gamified experimental research to explore preferences for mandatory or voluntary vaccination, considering personal characteristics and what others’ vaccination behavior might be. Players preferred voluntary vaccination, especially over time as they played the game, but turned toward mandatory vaccination when rates of vaccination dropped.

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  • Moretti, F., D. Visentin, E. Bovolenta, et al. 2020. Attitudes of nursing home staff towards influenza vaccination: Opinions and factors influencing hesitancy. International Journal of Environmental Research and Public Health 17.6: 1851.

    DOI: 10.3390/ijerph17061851Save Citation »Export Citation » Share Citation »

    This study in northern Italy had a low response rate that the researchers attributed to distrust and fear that it was part of a strategy to mandate the flu vaccine. Very low numbers of respondents supported a mandate.

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  • Smith, D. T., K. Attwell, and U. Evers. 2019. Majority acceptance of vaccination and mandates across the political spectrum in Australia. Politics 40.2.

    DOI: 10.1177/0263395719859457Save Citation »Export Citation » Share Citation »

    This attitudinal study of population attitudes toward Australia’s newly implemented mandatory childhood vaccination policy contains a useful literature review reporting findings of similar studies in Australia, the United States, and the United Kingdom, many of which are conducted by survey companies or ongoing panels rather than academic researchers, and so may not be easily accessible through database searches.

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  • Stead, M., N. Critchlow, D. Eadie, F. Sullivan, K. Gravenhorst, and F. Dobbie. 2019. Mandatory policies for influenza vaccination: Views of managers and healthcare workers in England. Vaccine 37.1: 69–75.

    DOI: 10.1016/j.vaccine.2018.11.033Save Citation »Export Citation » Share Citation »

    This study was undertaken to explore UK HCWs’ views of three mandatory models: mandatory declination forms; mask and patient-minimization; and mandates with religious and personal belief exemptions. The article includes a useful outline of these strategies and a helpful engagement with existing literature.

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  • Vrdelja, M., V. Učakara, and A. Kraigher. 2020. From mandatory to voluntary vaccination: Intention to vaccinate in the case of policy changes. Public Health 180:57–63.

    DOI: 10.1016/j.puhe.2019.10.026Save Citation »Export Citation » Share Citation »

    Vaccination in Slovenia is mandatory for some childhood vaccines, for which coverage rates are above 90 percent. Noncompliant parents are fined. Coverage rates for nonmandatory vaccines are much lower. This cross-sectional study of mothers studied their intention to vaccinate if there was no mandate. Just over half would vaccinate, and less than a quarter were undecided. The authors conclude that the mandate performs an important function in keeping people vaccinating.

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Ethical and Pragmatic Arguments for and against Mandatory Vaccination

Mandatory vaccination may be applied to various population cohorts, but the most common are children and health-care workers (HCWs). A series of analyses and debates have occurred within and beyond the bioethical literature regarding the ethics of mandating vaccination for specific population groups. This literature also engages with the pragmatic implications of adding, removing, or tightening mandates (Opel and Diekema 2012). Given the ubiquitous US model of mandates plus exemptions, considerable attention is placed on philosophical or personal belief exemptions (PBEs) and religious exemptions to school entry mandates (Navin 2016, Pierik 2017) in terms of their legitimacy as categories, as well as optimal ways of organizing and executing them from a normative perspective. Texts on the ethics of vaccination that treat conscientious objections to vaccination as abstract practices rather than in the context of mandates are not included. Rather, texts in this section focus specifically or substantially on the ethics of mandatory policies; many also engage in pragmatic considerations. Readers are introduced to the key ideas at play (Pierik 2018), including liberty (Lantos, et al. 2012; Navin and Largent 2017 cited under [Mandatory Childhood Vaccination Policies: Deep Dives]), fairness (Giubilini 2019), and the Least Restrictive Alternative model’s notion that states should pursue the minimal amount of coercion necessary to achieve a goal (Giubilini 2019, Navin and Attwell 2019). Free-riding, collective action problems and the concept of the collective or public goods are also explored (Navin 2016; Pierik 2017; Lantos, et al. 2012). That vaccine mandates might pertain only to some vaccines (Pierik 2017) or differ structurally in other key ways (Navin and Attwell 2019) are important to the ethical arguments for or against mandates.

  • Brennan, J. 2018. A libertarian case for mandatory vaccination. Journal of Medical Ethics 44.1: 37–43.

    DOI: 10.1136/medethics-2016-103486Save Citation »Export Citation » Share Citation »

    Brennan argues that even libertarian positions can entertain mandates—the position need not rest on paternalism. He employs the clean hands principle and argues for its consistency with libertarianism: it is wrong to participate in activities that impose an unjust risk of harm.

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  • Flanigan, J. 2014. A defense of compulsory vaccination. HEC Forum 26.1: 5–25.

    DOI: 10.1007/s10730-013-9221-5Save Citation »Export Citation » Share Citation »

    If vaccine refusal puts others at risk, argues Flanigan, then the right to refuse should be prohibited. The focus should be on those at risk, not on those who do not want to vaccinate. Flanigan explores the various forms mandates can justifiably take, including exclusion from public services, employment restrictions, fines, and civil liabilities.

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  • Giubilini, A. 2019. The ethics of vaccination. Cham, Switzerland: Palgrave Pivot.

    DOI: 10.1007/978-3-030-02068-2Save Citation »Export Citation » Share Citation »

    This short, open-access book dedicates one chapter to vaccination policies, including mandates, and its final chapter advocates for compulsory vaccination. Giubilini constructs an intervention ladder that includes all mandate models and how restrictive they are. He then engages with other scholars’ arguments and advocates that vaccination policies ought to aim for universal coverage, which is underpinned by fairness: the ethical distribution of the burdens entailed in attaining herd immunity.

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  • Lantos, J. D., M. A. Jackson, and C. J. Harrison. 2012. Why we should eliminate personal belief exemptions to vaccine mandates. Journal of Health Politics, Policy and Law 37.1: 131–140.

    DOI: 10.1215/03616878-1496038Save Citation »Export Citation » Share Citation »

    This article unpacks arguments for and against mandates. Anti-mandate positions may be based on religious objection, libertarianism (limitation of state power), and the desire for individual’s autonomy. Pro-mandate positions start from the assumption that vaccines save lives and address the collective action problem. The authors argue for mandating vaccines based on consideration of specific disease risks and for eliminating personal belief exemptions to spread the risks and burdens.

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  • Navin, M. 2016. Values and vaccine refusal: Hard questions in ethics, epistemology, and health care. New York: Routledge.

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    Following a chapter on the morality of vaccination, Navin dedicates one chapter of this book to coercive vaccination, and the final chapter to considering exemptions. He explores informed consent and parents’ rights, paternalism, harm prevention, fairness, and herd immunity as a public good. He considers exemptions from both ethical and pragmatic perspectives and raises several problems with privileging religious exemptions.

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  • Navin, M. C., and K. Attwell. 2019. Vaccine mandates, value pluralism, and policy diversity. Bioethics 33.9: 1042–1049.

    DOI: 10.1111/bioe.12645Save Citation »Export Citation » Share Citation »

    The authors work through the value arguments commonly raised in discussions of vaccine mandates: utilitarianism, libertarianism, and single-value analogies to justify state coercion. They argue that all considerations need to be conducted in the light of mandates differing in the vaccines required, the treatment of refusers, and enforcement and exemption procedures. Particular values arise when these are homed in on, which the authors illustrate with examples.

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  • Opel, D. J., and D. S. Diekema. 2012. Finding the proper balance between freedom and justice: Why we should not eliminate personal belief exemptions to vaccine mandates. Journal of Health Politics, Policy and Law 37.1: 141–147.

    DOI: 10.1215/03616878-1496047Save Citation »Export Citation » Share Citation »

    The authors dispute the arguments raised in Lantos, et al. 2012, not on ethical but pragmatic grounds. With low population trust in vaccines and belief in celebrity views, they argue it is not wise to ramp up coercion and interference with parental choice because these will further erode trust. Better to make it harder to obtain PBEs—the authors outline some suggestions, now rather dated but salient because they have since been implemented in several states.

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  • Pierik, R. 2017. On religious and secular exemptions: A case study of childhood vaccination waivers. Ethnicities 17.2: 220–241.

    DOI: 10.1177/1468796817692629Save Citation »Export Citation » Share Citation »

    Pierik considers the legitimacy of mandatory vaccination just for measles, justifying mandates for maintaining herd immunity. With high coverage rates required and some individuals unable to be vaccinated, exemption numbers must be kept low and free riding should be excluded. Religious and secular distinctions should be abolished. Proxies for distributing exemptions are offered in the form of education sessions, “polluter pays”–style taxes, and lotteries—but each comes with problems.

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  • Pierik, R. 2018. Mandatory vaccination: An unqualified defence. Journal of Applied Philosophy 35.2: 381–398.

    DOI: 10.1111/japp.12215Save Citation »Export Citation » Share Citation »

    Pierik considers whether the state or parents should decide for children when parents’ disagreements with vaccinating are not objectively founded. He also explores the need to protect the vulnerable in communities, considering that unvaccinated children can be not only victims but also vectors. Both examinations inform his arguments for mandates, which he then considers according to a proportionality test.

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  • van Delden, J. J. M., R. Ashcroft, A. Dawson, G. Marckmann, R. Upshur, and M. Verweij. 2008. The ethics of mandatory vaccination against influenza for health care workers. Vaccine 26.44: 5562–5566.

    DOI: 10.1016/j.vaccine.2008.08.002Save Citation »Export Citation » Share Citation »

    Vaccinating health-care workers against influenza protects their vulnerable patients and keeps staff well and working, with benefits for patient care. However, with suboptimal uptake, mandatory vaccination might be desirable or justifiable. This article works through efficacy and cost-effectiveness and whether voluntary strategies have been exhausted. It explains mandates as limiting the ability to work, rather than vaccinating individuals against their will. Arguments on both sides, and exemptions, are considered.

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