Background: While employers are increasingly considering and implementing COVID-19 vaccination requirements, little is known about the reasons offered by employees seeking religious exemptions.Methods: We conducted a mixed methods analysis of all the requests for religious exemptions submitted during the initial implementation of a COVID-19 vaccination requirement at a single academic medical center in the United States.Results: Five hundred sixty-five (3.4%) employees requested religious exemptions. At least 305 (54.0%) requesters had job titles suggesting that they had direct patient (...) contact. Four hundred ninety-nine (88.3%) of requesters self-identified as Christian, of whom 120 (21.2%) identified as Roman Catholic. Requesters offered 0 to 8 (mean 2.7) categories of reasons for their request. The most frequently stated reasons pertained to the use of fetal cell lines in vaccine development and manufacturing (382, 67.6%), interest in maintaining purity (221, 39.1%), or belief in divine healing (172, 30.4%). Some requesters also volunteered evidence of the sincerity of their beliefs including examples of their religious practices (116, 20.5%), other practices (66, 11.7%), and emotional states (32, 5.7%). One hundred fifty-two applications (26.9%) contained text copied without attribution, primarily from sample religious exemption request letters available on the Internet.Conclusions: Most requesters focused on the use of fetal cell lines in the development or manufacturing of the vaccines as the justification for their request. The development of vaccines that are not reliant on fetal cell lines may increase vaccination rates. Understanding reasons for religious exemption requests may inform vaccine education and vaccination policies. (shrink)

The United States may justifiably exclude unvaccinated aliens, perhaps even under the assumption of Open Borders, according to which people should generally be permitted to settle in countries of their choosing. Furthermore, there are good reasons to endorse the Centers for Disease Control and Prevention’s (CDC’s) current vaccination-related exclusion criteria, which were last revised in 2009. I frame my discussion around CDC’s 2008 decision to permit immigrant girls and women to be excluded if they were not vaccinated against human (...) papillomavirus (HPV)—a decision that was quickly reversed and that led to the 2009 revisions to CDC’s vaccination-related immigrant exclusion criteria. (shrink)

Vaccine hesitancy is a growing threat to public health. The reasons are complex but linked inextricably to a lack of trust in vaccines, expertise and traditional sources of authority. Efforts to increase immunization uptake in children in many countries that have seen a fall in vaccination rates are two-fold: addressing hesitancy by improving healthcare professional-parent exchange and information provision in the clinic; and, secondly, public health strategies that can override parental concerns and values with coercive measures such as mandatory (...) and presumptive vaccination. It is argued that such conflicting, parallel approaches seriously risk undermining trust that is crucial for sustaining herd immunity. Although public health strategies can be ethically justified in limiting freedoms, a parent-centered approach seldom acknowledges how it is impacted by contemporaneous coercive measures. In addition, the clinical encounter is not well suited to helping parents consider the public dimensions of vaccination, despite these being important for trust formation and informed decision-making. Efforts to address vaccine hesitancy require more consistent engagement of parental and citizen views. Along with evidence-based information, debates need to be informed by ethical support that equips parents and professionals to respond to the private and public dimensions of vaccination in a more even-handed, transparent manner. Efforts to address vaccine hesitancy need to avoid simple reliance on either parental values or coercive public policies. To do this effectively requires increasing citizen engagement on vaccination to help inform a parent-centered approach and legitimize public policy measures. In addition, cultivating a more ethically consistent strategy means moving beyond the current silos of health ethics - clinical and public health ethics. (shrink)

In principle, mandatory vaccination in employment could be justified in certain circumstances. These include: the availability of safe and effective vaccination; if alternative, less coercive strategies did not work; and, the costs to the individual were proportionate. However, in COVID-19, the long term safety of vaccines is yet to be established. Vaccines should be made available by employers, and voluntary vaccination encouraged.

Vaccine hesitancy has been a major cause for concern throughout the COVID-19 pandemic. The World Health Organization have previously addressed vaccine hesitancy via the ‘3C model’ (Convenience, Complacency, and Confidence). Recent scholarship has added two more ‘Cs’ (Context and Communication) to formulate a ‘5C model’ that is more equipped to adapt to the uncertainties of the pandemic. This paper focuses on the four ‘Cs’ that explicitly concerns trust (Complacency, Confidence, Context, and Communication) and phenomenologically distinguishes confidence from trust. Experts view (...) vaccines in terms of confidence, where the prospect of an undesirable outcome is extremely rare. Hence, not vaccinating and compromising herd immunity is seen to be unreasonable. Hesitant individuals contest the expert perspective and view vaccines in terms of trust, where the prospect of disappointment is likely. From this perspective, to vaccinate is to take a risk, and it is within reason to have the freedom to choose otherwise. This paper focuses on the hesitant perspective to identify the two social indicators of trust in vaccines most prominently shown during the COVID-19 pandemic in the Global North: (i) the expert reaction to hesitant concerns and (ii) the loss of freedom in relation to vaccine requirements. (shrink)

We argue that, from the point of view public health ethics, vaccination is significantly analogous to seat belt use in motor vehicles and that coercive vaccination policies are ethically justified for the same reasons why coercive seat belt laws are ethically justified. We start by taking seriously the small risk of vaccines’ side effects and the fact that such risks might need to be coercively imposed on individuals. If millions of individuals are vaccinated, even a very small risk (...) of serious side effects implies that, statistically, at some point side effects will occur. Imposing such risks raises issues about individual freedom to decide what risks to take on oneself or on one’s children and about attribution of responsibility in case of adverse side effects. Seat belt requirements raise many of the same ethical issues as vaccination requirements, and seat belt laws initially encountered some opposition from the public that is very similar to some of the current opposition to vaccine mandates. The analogy suggests that the risks of vaccines do not constitute strong enough reasons against coercive vaccination policies and that the same reasons that justify compulsory seat belt use—a measure now widely accepted and endorsed—also justify coercive vaccination policies. (shrink)

This Article examines whether policies—sometimes termed “vaccine mandates” or “vaccine requirements”— that consider vaccination status as a condition of employment, receipt of goods and services, or educational or other activity for participation are legally permitted, and whether such policies may even sometimes be legally required. It does so with particular reference to COVID-19 vaccines. -/- Part I explains the legality of private actors, such as employers or private universities, considering vaccination status, and concludes that such consideration is (...) almost always legally permissible unless foreclosed by specific state legislation. Part II examines the consideration of vaccination status by state or federal policy. It concludes that such consideration is similarly allowed at the state level unless expressly foreclosed, and is allowed at the federal level if appropriately supported by federal regulatory authority. Part III examines what may be a future front in these debates: whether policies considering vaccination status may be required rather than merely permitted, just as some courts have found that mask requirements may be federally required in certain circumstances. (shrink)

As a medical ethicist, I want to explain why college vaccination requirements decidedly do not violate the core principles of medical ethics which include avoiding or lessening harms, promoting benefits, respecting people and their informed and free choices, and promoting justice and fairness. In particular, vaccine requirements do not violate the respect-related requirement to not selfishly “use” and abuse others as “means” for someone else’s benefit. Since false claims on important issues often have dire consequences, it’s important (...) to explain why medical ethics supports vaccinating college students. (shrink)

Vaccine refusal harms and risks harming innocent bystanders. People are not entitled to harm innocents or to impose deadly risks on others, so in these cases there is nothing to be said for the right to refuse vaccination. Compulsory vaccination is therefore justified because non-vaccination can rightly be prohibited, just as other kinds of harmful and risky conduct are rightly prohibited. I develop an analogy to random gunfire to illustrate this point. Vaccine refusal, I argue, is morally (...) similar to firing a weapon into the air and endangering innocent bystanders. By re-framing vaccine refusal as harmful and reckless conduct my aim is to shift the focus of the vaccine debate from non-vaccinators’ religious and refusal rights to everyone else’s rights against being infected with contagious illnesses. Religious freedom and rights of informed consent do not entitle non-vaccinators to harm innocent bystanders, and so coercive vaccination requirements are permissible for the sake of the potential victims of the anti-vaccine movement. (shrink)

Context In response to outbreaks of vaccine‐preventable disease and increasing rates of vaccine refusal, some political communities have recently implemented coercive childhood immunization programs, or they have made existing childhood immunization programs more coercive. Many other political communities possess coercive vaccination policies, and others are considering developing them. Scholars and policymakers generally refer to coercive immunization policies as “vaccine mandates.” However, mandatory vaccination is not a unitary concept. Rather, coercive childhood immunization policies are complex, context‐specific instruments. Their legally (...) and morally significant features often differ, and they are imposed by political communities in varying circumstances and upon diverse populations. Methods In this paper, we introduce a taxonomy for classifying real‐world and theoretical mandatory childhood vaccination policies, according to their scope (which vaccines to require), sanctions and severity (which kind of penalty to impose on vaccine refusers, and how much of that penalty to impose), and selectivity (how to enforce or exempt people from vaccine mandates). Findings A full understanding of the operation of a vaccine mandate policy (real or potential) requires attention to the separate components of that policy. However, we can synthesize information about a policy's scope, sanctions, severity, and selectivity to identify a further attribute—salience —which identifies the magnitude of the burdens the state imposes on those who are not vaccinated. Conclusion Our taxonomy provides a framework for forensic examination of current and potential mandatory vaccination policies, by focusing attention on those features of vaccine mandates that are most relevant for comparative judgments. (shrink)

ABSTRACT Legislation recently adopted by the United States Congress provides producers of pandemic vaccines with near‐total immunity from civil lawsuits without making individuals injured by those vaccines eligible for compensation through the Vaccine Injury Compensation Program. The unusual decision not to provide an alternative mechanism for compensation is indicative of a broader problem of inconsistency in the American approach to vaccine‐injury compensation policy. Compensation policies have tended to reflect political pressures and economic considerations more than any cognizable set of principles. (...) This article identifies a set of ethical principles bearing on the circumstances in which vaccine injuries should be compensated, both inside and outside public health emergencies. A series of possible bases for compensation rules, some grounded in utilitarianism and some nonconsequentialist, are discussed and evaluated. Principles of fairness and reasonableness are found to constitute the strongest bases. An ethically defensible compensation policy grounded in these principles would make a compensation fund available to all individuals with severe injuries and to individuals with less‐severe injuries whenever the vaccination was required by law or professional duty. (shrink)

BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons (...) due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites. (shrink)

Parents in the US and other societies are increasingly refusing to vaccinate their children, even though popular anti-vaccine myths – e.g. ‘vaccines cause autism’ – have been debunked. This book explains the epistemic and moral failures that lead some parents to refuse to vaccinate their children. First, some parents have good reasons not to defer to the expertise of physicians, and to rely instead upon their own judgments about how to care for their children. Unfortunately, epistemic self-reliance systematically distorts beliefs (...) in areas of inquiry in which expertise is required. Second, vaccine refusers and mainstream medical authorities are often committed to different values surrounding health and safety. For example, while vaccine advocates stress that vaccines have low rates of serious complications, vaccine refusers often resist vaccination because it is ‘unnatural’ and because they view vaccine-preventable diseases as a ‘natural’ part of childhood. Finally, parents who refuse vaccines rightly resist the utilitarian moral arguments – ‘for the greater good’ – that vaccine advocates sometimes make. Unfortunately, vaccine refusers also sometimes embrace a pernicious hyper-individualism that sanctions free-riding on herd immunity and that cultivates indifference to the interpersonal and social harms that unvaccinated persons may cause. (shrink)

Employment-based vaccine mandates have worse consequences for existing than prospective employees. Prospective employees are not yet dependent on a particular employment arrangement, so they are better positioned to respond to such mandates. Yet despite this asymmetry in consequences, Smith argues that if vaccine mandates are justified for prospective employees, they are similarly justified for existing employees. This paper responds to Smith’s argument. First, Smith holds that bona fide occupational requirements are actions that are necessary for the safe and effective (...) completion of one’s job. As such, they apply to existing and prospective employees alike. However, I argue that the existence of effective alternative interventions precludes vaccination from being considered a bona fide occupational requirement under current circumstances. Second, Smith holds that if a requirement is justified for prospective employees, it is justified for existing employees, despite the asymmetry in consequences. However, I argue that since vaccination is not a bona fide requirement, the asymmetry in the harms of mandates experienced by prospective versus existing employees entails an asymmetry in the justification required to mandate vaccination for each group. As such, vaccination can be considered a requirement for prospective employees while not being required for existing employees. (shrink)

Legislation recently adopted by the United States Congress provides producers of pandemic vaccines with near‐total immunity from civil lawsuits without making individuals injured by those vaccines eligible for compensation through the Vaccine Injury Compensation Program. The unusual decision not to provide an alternative mechanism for compensation is indicative of a broader problem of inconsistency in the American approach to vaccine‐injury compensation policy. Compensation policies have tended to reflect political pressures and economic considerations more than any cognizable set of principles. This (...) article identifies a set of ethical principles bearing on the circumstances in which vaccine injuries should be compensated, both inside and outside public health emergencies. A series of possible bases for compensation rules, some grounded in utilitarianism and some nonconsequentialist, are discussed and evaluated. Principles of fairness and reasonableness are found to constitute the strongest bases. An ethically defensible compensation policy grounded in these principles would make a compensation fund available to all individuals with severe injuries and to individuals with less‐severe injuries whenever the vaccination was required by law or professional duty. (shrink)

Experimental vaccines are being developed for the treatment of ‘unhealthy lifestyles’ and associated chronic illnesses. Policymakers and other stakeholders will have to deal with the ethical issues that this innovation path raises: are there morally justified reasons to integrate these innovative biotechnologies in future health policies? Should public money be invested in further research? Focusing on the case of an experimental nicotine vaccine, this article explores the ethical aspects of ‘lifestyle vaccines’ for public health. Based on findings from a qualitative (...) study into a vaccine for smoking cessation, the article articulates possible value conflicts related to nicotine vaccination as an intervention in tobacco control. The ‘vaccinization’ of lifestyle disease piggybacks on the achievements of classic vaccines. Contrary to expectations of simplicity and success, quitting smoking with a vaccine requires a complex supportive network. Social justice and public trust may become important ethical challenges when deciding whether to use further public funds for research or whether to implement these innovative vaccines in the future. (shrink)

What does vaccine justice require at the domestic and global levels? In this essay, using the COVID-19 pandemic as a backdrop, we argue that deliberative-democratic participation is needed to answer this question. To be effective on the ground, abstract principles of vaccine justice need to be further specified through policy. Any vaccination strategy needs to find ways to prioritize conflicting moral claims to vaccine allocation, clarify the grounds on which low-risk people are being asked to vaccinate, and reach a (...) balance between special duties toward countrymen and universal duties toward foreigners. Reasonable moral disagreement on these questions is bound to exist in any community. But such disagreement threatens to undermine vaccine justice insofar as the chosen vaccination strategy (and its proposed specification of vaccine justice) lacks public justification. Inclusive democratic deliberation about vaccine justice is a good mechanism for tackling such moral disagreement. By allowing residents and citizens to participate in the specification of abstract principles of vaccine justice, and their translation into policy, democratic deliberation can enhance the legitimacy of any vaccination strategy and boost compliance with it. (shrink)

Addressing vaccination hesitancy is a major challenge in the fight against infectious disease. Vaccine hesitancy has given rise to recent outbreaks of vaccine preventable diseases (e.g., measles) in developed countries. In developed regions, particularly Europe and North America non-structural barriers to vaccination such as risk perceptions and philosophical beliefs seem to play a crucial role in vaccination uptake (Larson et al. 2014), and also contribute to current vaccine hesitancy with regard to COVID-19. To combat these developments, understanding (...) psychological factors in vaccination hesitancy is increasingly important. A better understanding of these psychological factors in turn points to communication strategies that can reduce vaccine hesitancy. These strategies depend upon individuals’ possession of capacities that are required for morally responsible agency (“responsibility-level capacities”), and in particular the capacities to recognize and respond to reasons. Strategic communication concerning vaccines can improve the exercise of individuals’ responsibility-level capacities as they pertain to risk perception and outcome expectancies. We begin by introducing cutting-edge work from the philosophical literature on agency and responsibility, with a special focus on the responsibility-level capacities at work in the practical context of deciding whether to vaccinate. We then summarize lessons drawn from a variety of studies in psychology and behavioural economics on how individuals reason, decide, and behave in these practical contexts. These lessons help illuminate the extent to which individuals exercise responsibility-level capacities in such contexts while also pointing to strategies that can improve the exercise of those capacities. (shrink)

Recent arguments over whether certain public health interventions should be mandatory raise questions about what counts as a "mandate." A mandate is not the same as a mere recommendation or the standard of practice. At minimum, a mandate should require an active opt-out and there should be some penalty for refusing to abide by it. Over-loose use of the term "mandate" and the easing of opt-out provisions could eventually pose a risk to the gains that truly mandatory public health interventions, (...) such as childhood vaccines, have provided over the last 50 years. Already, confusion about what counts as a mandate, and about what criteria should be used to determine when a public health intervention should be implemented as a mandate, has led to some inappropriate public policy decisions. For instance, by any reasonable criteria, the yearly influenza vaccine should be mandatory for health care workers. To enforce this mandate, those who refuse vaccination should be required to sign a waiver, and patients - especially those at high risk from flu - should be informed when they receive care from unvaccinated practitioners. (shrink)

This article argues that the Supreme Court should not require a religious exemption from vaccine mandates. For children, who cannot yet make autonomous religious decision, religious exemptions would allow parents to make a choice that puts the child at risk and makes the shared environment of the school unsafe — risking other people’s children. For adults, there are still good reasons not to require a religious exemption, since vaccines mandates are adopted for public health reasons, not to target religion, are (...) an area where free riding is a real risk, no religion actually prohibits vaccinating under a mandate, and policing religious exemptions is very difficult. (shrink)

Vaccination involves priming the immune system with an antigenic agent that mimics a virus or bacterium, which results in immunity against the “real” microorganism. Collective vaccination policies have played an important role in the control of infectious disease worldwide. They can serve the utilitarian aim to protect public health – hence welfare – and also promote fairness: making essential vaccines accessible to all members of the public. Yet as more and more vaccines are developed, societies face the question (...) of how far to go in expanding public programs. Decisions about adopting new vaccines in the program will require combining scientific evidence about the disease and the vaccine, with value judgments about, for example, the extent to which a disease poses a threat to public health. It makes sense to promote transparency of such deliberations because one cannot expect that citizens simply accept every government vaccination policy. (shrink)

COVID-19 vaccine requirements have generated significant debate. Here, we argue that, on the evidence available, such policies should have recognised proof of natural immunity as a sufficient basis for exemption to vaccination requirements. We begin by distinguishing our argument from two implausible claims about natural immunity: natural immunity is superior to ‘artificial’ vaccine-induced immunity simply because it is ‘natural’ and it is better to acquire immunity through natural infection than via vaccination. We then briefly survey the (...) evidence base for the comparison between naturally acquired immunity and vaccine-induced immunity. While we clearly cannot settle the scientific debates on this point, we suggest that we lack clear and convincing scientific evidence that vaccine-induced immunity has a significantly higher protective effect than natural immunity. Since vaccine requirements represent a substantial infringement of individual liberty, as well as imposing other significant costs, they can only be justified if they are necessary for achieving a proportionate public health benefit. Without compelling evidence for the superiority of vaccine-induced immunity, it cannot be deemed necessary to require vaccination for those with natural immunity. Subjecting them to vaccine mandates is therefore not justified. We conclude by defending the standard of proof that this argument from necessity invokes, and address other pragmatic and practical considerations that may speak against natural immunity exemptions. There are no data in this work. (shrink)

Vaccine refusal occurs for a variety of reasons. In this article we examine vaccine refusals that are made on conscientious grounds; that is, for religious, moral, or philosophical reasons. We focus on two questions: first, whether people should be entitled to conscientiously object to vaccination against contagious diseases ; second, if so, to what constraints or requirements should conscientious objection to vaccination be subject. To address these questions, we consider an analogy between CO to vaccination and (...) CO to military service. We argue that conscientious objectors to vaccination should make an appropriate contribution to society in lieu of being vaccinated. The contribution to be made will depend on the severity of the relevant disease, its morbidity, and also the likelihood that vaccine refusal will lead to harm. In particular, the contribution required will depend on whether the rate of CO in a given population threatens herd immunity to the disease in question: for severe or highly contagious diseases, if the population rate of CO becomes high enough to threaten herd immunity, the requirements for CO could become so onerous that CO, though in principle permissible, would be de facto impermissible. (shrink)

The rapid development and roll-out of COVID-19 vaccines has been a surprising success of the pandemic and has likely saved hundreds of thousands of lives. Although most people were eager to receive a vaccine, many jurisdictions introduced mandates to ensure rapid uptake in the population, especially among key workers including healthcare workers. In some instances, individuals who can prove they have recovered from COVID-19 have been exempt from vaccine mandates, but in other cases such exemptions have not been made. Pugh (...) et al argue that such exemptions for those already immune ought to be included in COVID-19 vaccine mandates.1 They review the evidence on infection-induced and vaccine-induced immunity and show that that there is not evidence that vaccines offer better protection against severe COVID-19 or of SARS-CoV-2 infection. They argue that to treat people differently based on the source of their COVID-19 immunity is wrongful discrimination, with this discrimination bringing harms in the form of unjust restriction of liberty and negative consequences such as lost employment. I agree with Pugh et al ’s view that, given the available evidence, infection-induced immunity to SARS-CoV-2 ought to be treated as equivalent to vaccine-induced immunity for the purposes of most COVID-19 vaccine mandates. However, their article highlights the need for clarity in the rationale for mandates. This clarity is necessary to be able to identify when exemptions are appropriate. It may be the case that in some instances infection-induced immunity ought not to be grounds for exemption. Pugh et al ’s argument also suggests that collection of data on infection-induced immunity may be a requirement for ethical vaccine mandates. To be confident in such exemptions, we need evidence that infection-induced immunity is comparable to vaccine-induced immunity in the …. (shrink)

Discussion about whether adolescents ought to be able to consent for their own vaccines long predates the COVID-19 pandemic. Providers have been counseling self-identified vaccine skeptics for year...

The purpose of the paper is to use analytical method and optimization tool to suggest a vaccination program intensity for a basic SIR epidemic model with limited resources for vaccination. We show that there are two different scenarios for optimal vaccination strategies, and obtain analytical solutions for the optimal control problem that minimizes the total cost of disease under the assumption of daily vaccine supply being limited. These solutions and their corresponding optimal control policies are derived explicitly (...) in terms of initial conditions, model parameters and resources for vaccination. With sufficient resources, the optimal control strategy is the normal Bang–Bang control. However, with limited resources, the optimal control strategy requires to switch to time-variant vaccination. (shrink)

Vaccination is a highly effective public health strategy that provides protection to both individuals and communities from a range of infectious diseases. Governments monitor vaccination rates carefully, as widespread use of a vaccine within a population is required to extend protection to the general population through “herd immunity,” which is important for protecting infants who are not yet fully vaccinated and others who are unable to undergo vaccination for medical or other reasons. Australia is unique in employing (...) financial incentives to increase vaccination uptake, mainly in the form of various childcare payments and tax benefits linked to timely, age-appropriate vaccination. Despite relatively high compliance with the childhood vaccination schedule, however, the Australian government has determined that rates should be higher and has recently introduced policy that includes removing certain tax and childcare benefits for non-vaccinators and formally disallowing conscientious objection to vaccination. In addition, it has raised the possibility of banning unvaccinated children from childcare centres. This article examines the impact of coercive approaches to childhood vaccination and raises the question of the ethical justification of health policy initiatives based on coercion. We consider the current evidence regarding childhood vaccination in Australia, the small but real risks associated with vaccination, the ethical requirement for consent for medical procedures, and the potential social harms of targeting non-vaccinators. We conclude that the evidence does not support a move to an increasingly mandatory approach that could only be delivered through paternalistic, coercive clinical practices. (shrink)

In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as (...) economic destruction. It proposes proceeding in three phases: the first addresses premature death, the second long-term health issues and economic harms, and the third aims to contain viral transmission fully and restore pre-pandemic activity. -/- To those who may deem an ethical framework irrelevant because of the belief that many countries will pursue "vaccine nationalism," we argue such a framework still has broad relevance. Reasonable national partiality would permit countries to focus on vaccine distribution within their borders up until the rate of transmission is below 1, at which point there would not be sufficient vaccine-preventable harm to justify retaining a vaccine. When a government reaches the limit of national partiality, it should release vaccines for other countries. -/- We also argue against two other recent proposals. Distributing a vaccine proportional to a country's population mistakenly assumes that equality requires treating differently situated countries identically. Prioritizing countries according to the number of front-line health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country may exacerbate disadvantage and end up giving the vaccine in large part to wealthy nations. (shrink)

We ask whether it is reasonable to delay or refuse to take COVID-19 vaccines that have been shown in clinical trials to be safe and effective against infectious diseases. We consider two kinds of vaccine hesitancy. The first is geared to scientifically informed open questions about vaccines. We argue that in cases where the data is not representative of relevant groups, such as pregnant women and ethnic minorities, hesitancy can be reasonable on epistemic grounds. However, we argue that hesitancy is (...) not reasonable if a vaccine has passed well-conducted clinical trials. The second kind of hesitancy is to do with beliefs about the institutions offering a successfully trialled vaccine and the justifiability of cooperating with those institutions. For example, in the UK, distrust of the UK Government or the National Health Service is identified as a factor in the vaccine hesitancy of minority ethnic populations. We ask whether this sort of hesitation is reasonable given normative requirements of fair co-operation, both with those institutions and the wider population. We suggest that the answer is not straightforward. Sometimes the hesitation is unreasonable but understandable. -/- . (shrink)

All of the 50 states of the United States have laws governing childhood vaccinations; 48 allow for religious exemptions, while 19 also offer exemptions based on some sort of personal philosophy. Recent disease outbreaks have caused these states to reconsider philosophical exemptions. However, we cannot, consistent with the U.S. Constitution, give preference to religion by creating religious exemptions only. The Constitution requires states to put religious and nonreligious claims on equal footing. Given the ubiquity of nonreligious objections to vaccination, (...) I conclude that the best response is to remove all exemptions, as two states have already done. But removing exemptions should not end our concern for children. Removing exemptions only bars children from public schools; it still leaves them unvaccinated, a danger to others, and reliant on whatever nonpublic schooling is available. If public school attendance is not enough of an incentive for vaccine reluctant parents, perhaps we should look into stronger measures. (shrink)

Background Policy decisions about childhood vaccination require consideration of multiple, sometimes conflicting, public health and ethical imperatives. Examples of these decisions are whether vaccination should be mandatory and, if so, whether to allow for non-medical exemptions. In this article we argue that these policy decisions go beyond typical public health mandates and therefore require democratic input.Methods We report on the design, implementation, and results of a deliberative public forum convened over four days in Ontario, Canada, on the topic (...) of childhood vaccination.Results 25 participants completed all four days of deliberation and collectively developed 20 policy recommendations on issues relating to mandatory vaccinations and exemptions, communication about vaccines and vaccination, and AEFI (adverse events following immunization) compensation and reporting. Notable recommendations include unanimous support for mandatory childhood vaccination in Ontario, the need for broad educational communication about vaccination, and the development of a no-fault compensation scheme for AEFIs. There was persistent disagreement among deliberants about the form of exemptions from vaccination (conscience, religious beliefs) that should be permissible, as well as appropriate consequences if parents do not vaccinate their children.Conclusions We conclude that conducting deliberative democratic processes on topics that are polarizing and controversial is viable and should be further developed and implemented to support democratically legitimate and trustworthy policy about childhood vaccination. (shrink)

The rapid development of vaccines against COVID‐19 represents a huge achievement, and offers hope of ending the global pandemic. At least three COVID‐19 vaccines have been approved or are about to be approved for distribution in many countries. However, with very limited initial availability, only a minority of the population will be able to receive vaccines this winter. Urgent decisions will have to be made about who should receive priority for access. Current policy in the UK appears to take the (...) view that those who are most vulnerable to COVID‐19 should get the vaccine first. While this is intuitively attractive, we argue that there are other possible values and criteria that need to be considered. These include both intrinsic and instrumental values. The former are numbers of lives saved, years of life saved, quality of the lives saved, quality‐adjusted life‐years (QALYs), and possibly others including age. Instrumental values include protecting healthcare systems and other broader societal interests, which might require prioritizing key worker status and having dependants. The challenge from an ethical point of view is to strike the right balance among these values. It also depends on effectiveness of different vaccines on different population groups and on modelling around cost‐effectiveness of different strategies. It is a mistake to simply assume that prioritizing the most vulnerable is the best strategy. Although that could end up being the best approach, whether it is or not requires careful ethical and empirical analysis. (shrink)

ArgumentThis essay places some therapeutic vaccines, including particularly the diphtheria antitoxin, into their larger historical context of the late nineteenth century. As industrially produced drugs, these vaccines ought to be seen in connection with the structural changes in medicine and pharmacology at the time. Given the spread of industrial culture and technology into the field of medicine and pharmacology, therapeutic vaccines can be understood as boundary objects that required and facilitated communication between industrialists, medical researchers, public health officials, and clinicians. (...) It was in particular in relation to evaluation and testing for efficacy in animal models that these medicines became a model for twentieth-century medicine. In addition, these medicines came into being as a parallel invention in two very distinct local cultures of research: the Institut Pasteur in Paris and the Institut für Infektionskrankheiten in Berlin. While their local cultural origins were plainly visible, the medicines played an important role in the alignment of the methods and objects that took place in bacteriology research in France and Germany in the 1890s. This article assesses the two locally specific regimes for control in France and in Imperial Germany. In France the Institut Pasteur, building on earlier successful vaccines, enjoyed freedom from scrutinizing control. The tight and elaborate system of control that evolved in Imperial Germany is portrayed as being reliant on experiences that were drawn from the dramatic events that surrounded the launching of a first example of so-called “bacteriological medicine,” tuberculin, in 1890. (shrink)

Although a safe, effective, and licensed coronavirus vaccine does not yet exist, there is already controversy over how it ought to be allocated. Justice is clearly at stake, but it is unclear what justice requires in the international distribution of a scarce vaccine during a pandemic. Many are condemning ‘vaccine nationalism’ as an obstacle to equitable global distribution. We argue that limited national partiality in allocating vaccines will be a component of justice rather than an obstacle to it. For there (...) are role-based and community-embedded responsibilities to take care of one’s own, which constitute legitimate moral reasons for some identity-related prioritisation. Furthermore, a good form of vaccine nationalism prioritises one’s own without denying or ignoring duties derived from a principle of equal worth, according to which all persons, regardless of citizenship or identity, equally deserve vaccine-induced protection from COVID-19. Rather than dismissing nationalism as a tragic obstacle, it is necessary to acknowledge that a limited form of it is valuable and expresses moral commitments. Only then can one understand our world of competing obligations, a world where cosmopolitan duties of benevolence sometimes conflict with special obligations of community membership. Once these competing obligations are recognised as such, we can begin the work of designing sound ethical frameworks for achieving justice in the global distribution of a coronavirus vaccine and developing practical strategies for avoiding, mitigating or resolving conflicts of duty. (shrink)

Vaccine scarcity and availability distinguish two central ethics questions raised by the Covid-19 pandemic. First, in situations of scarcity, which groups of persons should receive priority? Second, in situations where safe and effective vaccines are available, what circumstances and reasons can support mandatory vaccination? Regarding the first question, normative approaches converge in prioritizing most-vulnerable groups. Though there is room for prudential judgement regarding which groups are most vulnerable, the human dignity principle is most relevant for prioritization consideration of both (...) medical and non-medical issues. The second question concerning mandates is distinct from considerations about persons’ individual moral duty to receive vaccines judged reasonably safe and critical for individual and public health. While there is consensus regarding the potential normative support for mandated vaccination, the paternalistic government intervention of vaccine mandates requires a high bar of demonstrated vaccine safety and public health risk. We discuss stronger and weaker forms of paternalism to deal with the Covid-19 pandemic from an “integrative” approach that integrates leading normative approaches. We argue against a population-wide compulsory vaccination and support prudential measures to 1) protect vulnerable groups; 2) focus upon incentivizing vaccine participation; 3) maintain maximum-possible individual freedoms, and 4) allow schools, organizations, and enterprises to implement vaccine requirements in local contexts. (shrink)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least (...) 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

Mass vaccination has been a successful public health strategy for many contagious diseases. The immunity of the vaccinated also protects others who cannot be safely or effectively vaccinated—including infants and the immunosuppressed. When vaccination rates fall, diseases like measles can rapidly resurge in a population. Those who cannot be vaccinated for medical reasons are at the highest risk of severe disease and death. They thus may bear the burden of others' freedom to opt out of vaccination. It (...) is often asked whether it is legitimate for states to adopt and enforce mandatory universal vaccination. Yet this neglects a related question: are those who opt out, where it is permitted, morally responsible when others are harmed or die as a result of their decision? In this article, we argue that individuals who opt out of vaccination are morally responsible for resultant harms to others. Using measles as our main example, we demonstrate the ways in which opting out of vaccination can result in a significant risk of harm and death to others, especially infants and the immunosuppressed. We argue that imposing these risks without good justification is blameworthy and examine ways of reaching a coherent understanding of individual moral responsibility for harms in the context of the collective action required for disease transmission. Finally, we consider several objections to this view, provide counterarguments and suggest morally permissible alternatives to mandatory universal vaccination including controlled infection, self-imposed social isolation and financial penalties for refusal to vaccinate. (shrink)

In November 2006, Merck pharmaceuticals started a massive advertising and lobbying campaign aimed at promoting Gardasil, a vaccine that prevents cervical cancer from two of the thirty strains of the human papillomavirus that can cause cervical cancer. Their advertising campaign, titled "One Less," touted the benefits of the vaccine through a series of commercials in which female actors stated that they wanted to be "one less woman who will battle cervical cancer. One less". A few months later, the governor of (...) Texas issued an executive order directing the Health and Human Services Commission to adopt rules that would require all eleven- and twelve-year-old girls to have been given the vaccine. (shrink)

Many parents are hesitant about, or face motivational barriers to, vaccinating their children. In this paper, we propose a type of vaccination policy that could be implemented either in addition to coercive vaccination or as an alternative to it in order to increase paediatric vaccination uptake in a non-coercive way. We propose the use of vaccination nudges that exploit the very same decision biases that often undermine vaccination uptake. In particular, we propose a policy under (...) which children would be vaccinated at school or day-care by default, without requiring parental authorization, but with parents retaining the right to opt their children out of vaccination. We show that such a policy is likely to be effective, at least in cases in which non-vaccination is due to practical obstacles, rather than to strong beliefs about vaccines, ethically acceptable and less controversial than some alternatives because it is not coercive and affects individual autonomy only in a morally unproblematic way, and likely to receive support from the UK public, on the basis of original empirical research we have conducted on the lay public. (shrink)

With evidence of vaccine hesitancy in several jurisdictions, the option of making COVID-19 vaccination mandatory requires consideration. In this paper I argue that it would be ethical to make the COVID-19 vaccination mandatory for older people who are at highest risk of severe disease, but if this were to occur, and while there is limited knowledge of the disease and vaccines, there are not likely to be sufficient grounds to mandate vaccination for those at lower risk. Mandating (...) vaccination for those at high risk of severe disease is justified on the basis of the harm principle, as there is evidence that this would remove the grave public health threat of COVID-19. The risk–benefit profile of vaccination is also more clearly in the interests of those at highest risk, so mandatory vaccination entails a less severe cost to them. Therefore, a selective mandate would create fairness in the distribution of risks. The level of coercion imposed by a mandate would need to be proportionate, and it is likely that multiple approaches will be needed to increase vaccine uptake. However, a selective mandate for COVID-19 vaccines is likely to be an ethical choice and should be considered by policy-makers. (shrink)

In several countries, governments have implemented so-called ‘COVID passport’ schemes, which restrict access to venues such as bars or sports events to those who are vaccinated against COVID-19 and/or exempt vaccinated individuals from public health measures such as curfews or quarantine requirements. These schemes have been the subject of a heated debate. Concerns about inequality have played an important role in the opposition to such schemes. This article highlights that determining how COVID passports affect equality requires a much more (...) nuanced analysis than is typically assumed. I identify a range of broadly egalitarian considerations that could be affected by the introduction of COVID passport schemes. While these schemes could undermine certain aspects of equality, I argue that they could also be used to promote equality. The magnitude and severity of these different effects, both promoting and undermining equality, depend on how precisely these schemes are framed and the local context in which they are implemented. (shrink)

Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent (...) requirements, child protection laws, and processes for the ethical and regulatory approval of research. Summary This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance. (shrink)

This article will focus on the ethical issues of vaccine mandates and stake claim to the relatively extreme position that outright requirements for people to receive the vaccine are ethically correct at both the governmental and institutional levels. One novel strategy employed here will be to argue that deontological considerations pertaining to consent rights cut as much in favor of mandating vaccines as against them. The presumption seems to be that arguments from consent speak semi-definitively against forcing people to (...) inject something into their bodies, and so any argument in favor of mandates must produce different and overriding logical and ethical considerations. Our central claim will be that the same logic that might seem to prohibit vaccine mandates as violations of consent actually supports such mandates when viewed from the perspective of the potential bystander who might otherwise be exposed to COVID-19. (shrink)

We argue that individuals who have access to vaccines and for whom vaccination is not medically contraindicated have a moral obligation to contribute to the realisation of herd immunity by being vaccinated. Contrary to what some have claimed, we argue that this individual moral obligation exists in spite of the fact that each individual vaccination does not significantly affect vaccination coverage rates and therefore does not significantly contribute to herd immunity. Establishing the existence of a moral obligation (...) to be vaccinated despite the negligible contribution each vaccination can make to the realisation of herd immunity is important because such moral obligation would strengthen the justification for coercive vaccination policies. We show that two types of arguments—namely a utilitarian argument based on Parfit’s Principle of Group Beneficence and a contractualist argument—can ground an individual moral obligation to be vaccinated, in spite of the imperceptible contribution that any single vaccination makes to vaccine coverage rates. We add a further argument for a moral obligation to be vaccinated that does not require embracing problematic comprehensive moral theories such as utilitarianism or contractualism. The argument is based on a “duty of easy rescue” applied to collectives, which grounds a collective moral obligation to realise herd immunity, and on a principle of fairness in the distribution of the burdens that must be borne to realise herd immunity. (shrink)

Introduction: There is currently no binding, internationally accepted and successful approach to ensure global equitable access to healthcare during a pandemic. The aim of this ethical analysis is to bring into the discussion a legally regulated vaccine allocation as a possible strategy for equitable global access to vaccines. We focus our analysis on COVAX (COVID-19 Vaccines Global Access) and an existing EU regulation that, after adjustment, could promote global vaccine allocation. -/- Methods: The main documents discussing the two strategies are (...) examined with a qualitative content analysis. The ethical values reasonableness, openness and transparency, inclusiveness, responsiveness and accountability serve as categories for our ethical analysis. -/- Results: We observed that the decision-making processes in a legal solution to expand access to vaccines would be more transparent than in COVAX initiative, would be more inclusive, especially of nation states, and the values responsiveness and accountability could be easily incorporated in the development of a new regulation. -/- Discussion: A legal strategy that offers incentives to the pharmaceutical industry in return for global distribution of vaccines according to the Fair Priority Model is an innovative way to achieve global and equitable access to vaccines. However, in the long term, achieving the Sustainable Development Goals will require from all nations to work in solidarity to find durable solutions for global vaccine research and development. Interim solutions, such as our proposed legal strategy for equitable access to vaccines, and efforts to find long-term solutions must be advanced in parallel. (shrink)

While all states in the United States require certain vaccinations for school attendance, all but three allow for religious exemptions to receiving such vaccinations, and 18 allow for exemptions on the basis of other deeply held personal beliefs. The rights of parents to raise children as they see fit may conflict with the duty of the government and society to protect the welfare of children. In the U.S., these conflicts have not been settled in a uniform and consistent manner. We (...) apply a test that provides a concrete and formal rubric to evaluate such conflicts. For some vaccinations, based on the individual medical characteristics of the disease and the risks of being unvaccinated, the test would suggest that permitting conscientious exemptions is ethical. However, for vaccinations protecting against other diseases that are more severe or easily transmitted, the test would suggest that the federal government may ethically impose laws that deny such exemptions. (shrink)

We thank Leo Lam and Taylor Nichols for their response1 to our paper ‘COVID-19 vaccine boosters for young adults: a risk–benefit assessment and ethical analysis of mandate policies at universities’.2 In our paper, we demonstrate that the risk–benefit calculus to mandate boosters for young adults aged 18–29 is a net risk intervention. The authors assert that we have made three inappropriate comparisons of benefits versus risks of the mRNA vaccine booster dose in this age group. We provide our response to (...) each below. We erred on the side of overestimating benefits of the booster dose against severe COVID-19 in this age group and still found net harms to outweigh net benefits. The conclusion of our paper holds, and university booster mandates for young people were—and remain—unethical. For the first comparison, we weighed predicted hospitalisations prevented by one booster dose of BNT162b2 with vaccine-associated SAEs from the manufacturer’s randomised trial (3/5055).3 We found that the rate of expected SAEs would outweigh the benefits of the booster against hospitalisation by at least 18-fold. Lam and Nichols suggest that this was an inappropriate comparison, as not all SAEs result in hospitalisation. However, the definition of SAE as used in the trial included death, hospitalisation, disability, permanent damage, life-threatening event or condition, which required medical or surgical intervention to prevent a serious outcome.4 While all comparisons include some degree of incommensurability, comparing these SAEs with hospitalisations prevented by the booster is more reasonable than Lam and Nichols’ suggestion of comparing SAEs to infections prevented. The COVID-19 infection hospitalisation risk in this age group was <0.5% (or <1/200)5 even prior to widespread immunity, thus comparing SAEs to infection risk is entirely inappropriate. Furthermore, a booster dose will only offer transient (if any) protection against infection6 and cumulative infection rates …. (shrink)

ABSTRACT Because of the nature of preventive vaccination programs, the viability of these public health interventions is particularly susceptible to public perceptions. This is because vaccination relies on a concept of ‘herd immunity’, achievement of which requires rational public behavior that can only be obtained through full and accurate communication about risks and benefits. This paper describes how irrational behavior that threatens the effectiveness of vaccination programs – both in crisis and non‐crisis situations – can be tied (...) to public perceptions created by media portrayals of health risks. I concentrate on childhood vaccination as an exemplar of ‘non‐crisis’ preventive vaccination, and on the recent flu vaccine shortage as a ‘crisis’ situation. The paper concludes with an examination of the steps necessary to resolve these threats through better public communication. (shrink)

We discuss the relationship between expertise, expert authority, and trust in the case of vaccine research and policy, with a particular focus on COVID-19 vaccines. We argue that expert authority is not merely an epistemic notion, but entails being trusted by the relevant public and is valuable if it is accompanied by expert trustworthiness. Trustworthiness requires, among other things, being transparent, acknowledging uncertainty and expert disagreement (e.g., around vaccines’ effectiveness and safety), being willing to revise views in response to new (...) evidence, and being clear about the values that underpin expert recommendations. We explore how failure to acknowledge expert disagreement and uncertainty can undermine trust in vaccination and public health experts, using expert recommendations around COVID-19 vaccines as a case study. (shrink)

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing (...) the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm. (shrink)