Vaccines

COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that COVID-19 vaccination (...) provides to children, the potential for rare risks to outweigh these benefits and undermine vaccine confidence, and substantial evidence that COVID-19 vaccination confers adequate protection to risk groups, such as older adults, without the need to vaccinate healthy children. We conclude that child COVID-19 vaccination in wealthy communities before adults in poor communities worldwide is ethically unacceptable and consider how policy deliberations might evolve in light of future developments. (shrink)

COVID-19 vaccination of children has begun in a number of countries with provisional regulatory approval and public support. This article provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we present three of the strongest arguments that might justify COVID-19 vaccination of children: (a) an argument from paternalism, (b) an argument from indirect protection and altruism, and (c) an argument from global eradication. We offer a series of objections to each of these arguments to show that none of (...) them is currently tenable. Given the minimal direct benefit of COVID-19 vaccination for healthy children, the potential for rare risks to outweigh these benefits and to undermine vaccine confidence, the substantial evidence that COVID-19 vaccination confers adequate protection to risk groups whether or not healthy children are vaccinated and that current vaccines do not provide sterilizing immunity, and given that eradication of the virus is neither feasible nor a high priority for global health, we argue that routine COVID-19 vaccination of healthy children is currently ethically unjustified. Since mandates for children have already been implemented in some places (e.g., California) and may be considered elsewhere, we also present two additional arguments explicitly against making COVID-19 vaccination mandatory for children. (shrink)

Coronavirus vaccines have made their debut. Now, allocation practices have stepped into the spotlight. Following Centers for Disease Control and Prevention guidelines, states and healthcare institutions initially prioritised healthcare personnel and elderly residents of congregant facilities; other groups at elevated risk for severe complications are now becoming eligible through locally administered programmes. The question remains, however: who else should be prioritised for immunisation? Here, we call attention to individuals institutionalised with severe mental illnesses and/or developmental or intellectual disabilities—a group highly (...) susceptible to the damages of COVID-19, recent research shows, and critical to consider for priority vaccination. The language describing both federal-level and state-level intentions for this population remains largely vague, despite the population’s diversity across age, diagnosis, functional status and living arrangement. Such absence of specificity, in turn, leaves room for confusion and even neglect of various subgroups. We review data stressing this group’s vulnerability, as well as select state plans for priority vaccination, highlighting the importance of clarity when describing intentions to vaccinate, or even generally care for, diverse populations composed of distinct subgroups in need. (shrink)

In the years around 1900 one of the most significant practical consequences of new styles of bacteriological thought and practice was the development of preventive vaccines and therapeutic sera. Historical scholarship has highlighted how approaches rooted in the laboratory methods of Robert Koch, Louis Pasteur and their collaborators were transformed in local contexts and applied in diverse ways to enable more effective disease identification, prevention and treatment. Amongst these, the anti-anthrax serum developed by the Italian physician Achille Sclavo has received (...) little to no attention from historians. This article positions Sclavo's serum as a neglected but significant presence in British microbiology, which achieved widespread uptake amidst a wave of optimism, despite prolonged uncertainty about its mechanism of action and dosage. After being introduced to Britain in 1904 by the enterprising first medical inspector of factories Thomas Morison Legge, within a matter of months the serum became regarded by medical practitioners as an effective treatment of cutaneous anthrax, though access to ‘fresh’ serum and the necessary speedy diagnosis remained problematic. Like the disease anthrax itself, discussion of ‘Sclavo's serum’ was out of all proportion to the relatively low number of cases, reflecting a deep-seated fascination with the wider possibilities afforded by effective serum therapy. (shrink)

The prospect of vaccinating children and young people (CYP) against COVID raises questions that apply more widely to vaccination in children. When can CYP consent, on their own, for vaccination? What should happen if children and their parents disagree about the desirability of a vaccine? When, if ever, should vaccination proceed despite a child’s dissent or apparent refusal? A range of ethical dilemmas may arise. (Box 1) In this article, we will address general ethical issues relating to consent for vaccination, (...) highlighting their relevance to COVID. We will not address the wider ethical questions of whether or when children should be vaccinated against COVID. (shrink)

In bioethics vaccine refusal is often discussed as an instance of free riding on the herd immunity of an infectious disease. However, the social science of vaccine refusal suggests that the reasoning behind refusal to vaccinate more often stems from previous negative experiences in healthcare practice as well as deeply felt distrust of healthcare institutions. Moreover, vaccine refusal often acts like an exit mechanism. Whilst free riding is often met with sanctions, exit, according to Albert Hirschman’s theory of exit and (...) voice is most efficiently met by addressing concerns and increasing the quality and number of feedback channels. If the legitimate grievances responsible for vaccine refusal are not heard or addressed by healthcare policy, further polarization of attitudes to vaccines is likely to ensue. Thus, there is a need in the bioethics of vaccine refusal to understand the diverse ethical questions of this inflammable issue in addition to those of individual responsibility to vaccinate. (shrink)

Healthcare workers in Pakistan are still fighting at the frontline to control the spread of severe acute respiratory syndrome coronavirus-2 and have been identified as the earliest beneficiaries for COVID-19 vaccination by the health authorities of the country. Besides, the high vaccination rates of frontline healthcare workers are essential to overcome the ongoing pandemic and reduce the vaccines hesitancy among the general population. The current research employed the theory of planned behavior to investigate the COVID-19 vaccination behavior among FHWs in (...) Pakistan as well as the predictors of such behavior. Following the epidemic control and prevention policies, a sample of 680 FHWs were accessed to fill in the questionnaire evaluating the components of the TPB. Moreover, the potential role of anticipated regret and perceived susceptibility on COVID-19 vaccination behavior was also assessed. The partial least square structural equation modeling results revealed that the TPB components, as well as the AR, have positive associations with the COVID-19 vaccination behavior. The results further confirmed that PS positively affects the anticipated regret, attitude, and subjective norm to vaccinate against SARS-CoV-2. The perceived susceptibility also has a positive association with COVID-19 vaccination behavior through the mediation of anticipated regret, ATT, and SN. Our findings highlighted the importance of COVID-19 vaccination among healthcare workers, which can be applied to reduce vaccine hesitancy among the general public. (shrink)

Proponents of vaccine mandates typically claim that everyone who can be vaccinated has a moral or ethical obligation to do so for the sake of those who cannot be vaccinated, or in the interest of public health. I evaluate several previously undertheorised premises implicit to the ‘obligation to vaccinate’ type of arguments and show that the general conclusion is false: there is neither a moral obligation to vaccinate nor a sound ethical basis to mandate vaccination under any circumstances, even for (...) hypothetical vaccines that are medically risk-free. Agent autonomy with respect to self-constitution has absolute normative priority over reduction or elimination of the associated risks to life. In practical terms, mandatory vaccination amounts to discrimination against healthy, innate biological characteristics, which goes against the established ethical norms and is also defeasible a priori. (shrink)

To understand how different types of cues in vaccine education messages affect attitude toward campaign messages and vaccination intention, this study examined the impact of the presence of social norm appeals and the presence of fear appeals in coronavirus disease 2019 vaccine campaign posters on perceived communication quality and vaccination intention. A 2 × 2 × 3 within-subject factorial design experiment was conducted in China. Findings demonstrated that the presence of fear appeals in COVID-19 vaccine campaign posters elicited lower levels (...) of perceived communication quality and vaccination intention than those without fear appeals. The interactive effect of fear appeals and social norm appeals was also found to be significant. Specifically, positive-framed messages with group cues and fear appeal messages with individual cues elicited higher perceived information quality and stronger vaccination intention than other types of messages. Understanding how these cues function jointly in COVID-19 vaccine campaign messages will help public health practitioners create more effective intervention strategies. (shrink)

There have been calls for mandatory vaccination legislation to be introduced into the UK in order to tackle the national and international rise of vaccine-preventable disease. While some countries have had some success associated with mandatory vaccination programmes, the Royal College of Paediatrics and Child Health insist this is not a suitable option for the UK, a country which has seen historical opposition to vaccine mandates. There is a lack of comprehensive data to demonstrate a direct link between mandatory vaccination (...) legislation and increased uptake. While there are examples whereby there has been an improvement, some studies suggest that comparable results can be obtained by strongly recommending vaccinations instead. The RCPCH insist that healthcare workers are ideally placed to engage and inform parents to make every interaction a ‘vaccine opportunity’. This paper calls for a principled, rational approach to interpretations of autonomy which underpin parental informed consent. MacLean’s concept of mutual persuasion could be a vehicle to ensuring parents are suitably informed of both the material risks associated with vaccine choices and to consider the rationality of their decisions, while ultimately upholding parental autonomy. It is argued that this, alongside infrastructural improvement, could create a more sustainable, long-term improvement in childhood vaccination rates in the UK than mandatory vaccination. (shrink)

When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds—often reflecting staffing shortages—but also therapies and intensive treatments. Safe, highly effective COVID-19 vaccines have been free and widely available since mid-2021, yet many Americans remain unvaccinated by choice. Should their decision to forgo vaccination be considered when allocating scarce resources? Some have suggested it should, while others disagree. We offer a (...) framework for evaluating when it is ethical and briefly discuss its legality in American law. (shrink)

By 20 October 2021, the U.S. Food and Drug Administration (FDA) had amended its Emergency Use Authorizations for immunocompetent adults who previously received the Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccines. For the 2-dose Pfizer-BioNTech and Moderna vaccines, the FDA permitted a single booster dose for adults aged 65 years or older and adults aged 18 to 64 years at high-risk for severe COVID-19 or at high risk for occupational or institutional COVID-19 exposure. For the single-dose Johnson & Johnson (...) vaccine, the FDA permitted a single booster dose for all adults aged 18 or older. These eligibility schemes were endorsed by the Centers for Disease Control and Prevention shortly after FDA approval. (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)

In ‘Against vaccine nationalism’, Nicole Hassoun misrepresents our argument, distorts our position and ignores crucial distinctions we present in our article, ‘Love thy neighbor? Allocating vaccines in a world of competing obligations’. She has created a strawman that does not resemble our position. In this reply, we address two features of ‘Against vaccine nationalism’. First, we address a phantom premise. Hassoun misattributes to us a thesis, according to which citizen-directed duties are stronger than noncitizen-directed duties. This thesis is a figment (...) of her imagination, not a fragment of our argument. Second, we address a shape-shifting ism. Ambiguity attaches to ‘vaccine nationalism,’ ambiguity that Hassoun exploits despite our distinguishing various meanings of the phrase. As a result, the type of vaccine nationalism she argues against is not the type we defend. (shrink)

Given the negative consequences of the ongoing COVID-19 pandemic on public health, his study aimed at investigating: the differences between adults with and without chronic illness in buying behavior, vaccination intention, pandemic worry, and the health belief model components; the HBM components as mediators of the relationship between pandemic worry and vaccination intention. The sample consisted of 864 adults, of which 20.5% reported having a chronic illness. Associations between pandemic worry, vaccination intention, and HBM were ascertained using correlation and mediation (...) analyses. Individuals with chronic illness reported a higher level of pandemic worry, higher levels of perceived threat, greater benefits from vaccination, had lower self-efficacy and bought more medicine and sanitary/hygienic products. No significant differences were observed regarding vaccination intention, barriers against vaccination, and changes in food buying behavior. We found that the relationship between pandemic worry and vaccination intention was partially mediated by the perceived threat of disease and the benefits of vaccination. Pandemic worry predicted vaccination intention directly but also through the contribution of the perceived threat of disease and the benefits of vaccination. These findings suggest that presenting evidence of COVID-19 vaccine efficacy and the benefits of having the vaccine will encourage the population to follow vaccination recommendations. (shrink)

This paper addresses the just distribution of vaccines against the SARS-CoV-2 virus and sets forth an ethical framework that prioritises frontline and essential workers, people at high risk of severe disease or death, and people at high risk of infection. Section I makes the case that vaccine distribution should occur at a global level in order to accelerate development and fair, efficient vaccine allocation. Section II puts forth ethical values to guide vaccine distribution including helping people with the greatest need, (...) reducing health disparity, saving the most lives and promoting narrow social utility. It also responds to objections which claim that earlier years have more value than later years. Section III puts forth a practical ethical framework to aid decision-makers and compares it with alternatives. (shrink)

The devastating impact of the COVID‐19 (coronavirus disease 2019) pandemic is prompting renewed scrutiny of practices that heighten the risk of infectious disease. One such practice is refusing available vaccines known to be effective at preventing dangerous communicable diseases. For reasons of preventing individual harm, avoiding complicity in collective harm, and fairness, there is a growing consensus among ethicists that individuals have a duty to get vaccinated. I argue that these same grounds establish an analogous duty to avoid buying and (...) eating most meat sold today, based solely on a concern for human welfare. Meat consumption is a leading driver of infectious disease. Wildlife sales at wet markets, bushmeat hunting, and concentrated animal feeding operations (CAFOs) are all exceptionally risky activities that facilitate disease spread and impose immense harms on human populations. If there is a moral duty to vaccinate, we also should recognize a moral duty to avoid most meat. The paper concludes by considering the implications of this duty for policy. (shrink)

Steven Soderbergh’s Contagion positions the vaccine as the end point of the arc of ​pandemic, marking both the containment of an elusive virus and ​the resumption of a life not fundamentally different from ​before the disease outbreak. ​The film reinforces the ​assumption that a pandemic will awaken ​all of us to the urgency of vaccination​, persuading us to put aside our reservations and anxieties ​and the idea that compliance is the inevitable outcome of quarantine. This article explores how pro-vaccination cultural (...) products ​such as Contagion might in fact undermine public health efforts by promoting a false narrative, which simplifies the kind of vaccination campaign necessary for herd immunity to develop. An ethic of sacrifice and selflessness drives the public health messaging of the film but leaves intact certain individualistic tropes and plague narrative scapegoating tendencies, while the framing of the vaccine as “gift” takes it out of the realm of medical science altogether. (shrink)

Preventive vaccination is one of the greatest successes of modern medicine. The SARS-CoV-2 epidemic, during which vaccination is the main method of prevention against death and severe disease, gave rise to a resurgence of anti-vaccine movements. The aim of this study was to analyse the attitudes of students towards vaccination and the COVID-19 pandemic. The statistical analysis was performed with the use of the following data-mining methods: correspondence analysis and basket analysis. The obtained results show that students of medicine are (...) characterized with the highest level of knowledge. Students of other medical faculties, on the other hand, have a significantly less uniform views, as do students of non-medical faculties. (shrink)

We propose 4 equity-advancing operational improvements to eligibility and sign-up processes at mass vaccination sites: (1) preregistration using existing information, (2) eligibility rules that recognize the greater burden of COVID-19 in underserved neighborhoods, (3) appointment assignment that prioritizes those with disadvantage, and (4) socioculturally informed outreach to lottery selectees.

America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. How can the allocation of scarce treatments for COVID-19 and similar public health threats fairly and legally respond to these racial disparities? Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that this prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who (...) have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. I argue that, to pass muster under current law, policymaking in this area must recognize a crucial distinction: prioritizing minority communities, such as hard-hit neighborhoods, without regard to individual race is typically legal, but prioritizing individuals on the basis of their racial identity faces is likely not. I also explain how prioritization on the basis of Native American status is allowable and legally distinct from prioritization on the basis of individual race. -/- In Part II, I provide a brief overview of current and proposed COVID-19 treatments and identify documented or likely scarcities and disparities in access. In Part III, I argue that randomly allocating scarce medical interventions, as some propose, will not effectively address disparities: it both permits unnecessary deaths and concentrates those deaths among people who are more exposed to infection. In Part IV, I explain why using individual-level racial classifications in allocation is precluded by current Supreme Court precedent. Addressing disparities will require focusing on factors other than race, or potentially considering race at an aggregate rather than individual level. I also argue that policies prioritizing members of Native American tribes can succeed legally even where policies based on race would not. In Part V, I examine two complementary strategies to narrow racial disparities. One would prioritize individuals who live in disadvantaged geographic areas or work in hard-hit occupations, potentially alongside race-sensitive aggregate metrics like neighborhood segregation. These approaches, like the policies school districts adopted after the Supreme Court rejected individualized racial classifications in education, would narrow disparities without classifying individuals by race. The other strategy would address the starkly disparate racial impact of deaths early in life by limiting the use of age-based exclusions from vaccine or treatment access that explicitly deprioritize the prevention of early deaths and so disparately exclude minorities, and by considering policies that prioritize the prevention of early deaths. (shrink)

We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines should be evaluated.

We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.

While public health organizations can detect disease spread, few can monitor and respond to real-time misinformation. Misinformation risks the public’s health, the credibility of institutions, and the safety of experts and front-line workers. Big Data, and specifically publicly available media data, can play a significant role in understanding and responding to misinformation. The Public Good Projects uses supervised machine learning to aggregate and code millions of conversations relating to vaccines and the COVID-19 pandemic broadly, in real-time. Public health researchers supervise (...) this process daily, and provide insights to practitioners across a range of disciplines. Through this work, we have gleaned three lessons to address misinformation. Sources of vaccine misinformation are known; there is a need to operationalize learnings and engage the pro-vaccination majority in debunking vaccine-related misinformation. Existing systems can identify and track threats against health experts and institutions, which have been subject to unprecedented harassment. This supports their safety and helps prevent the further erosion of trust in public institutions. Responses to misinformation should draw from cross-sector crisis management best practices and address coordination gaps. Real-time monitoring and addressing misinformation should be a core function of public health, and public health should be a core use case for data scientists developing monitoring tools. The tools to accomplish these tasks are available; it remains up to us to prioritize them. (shrink)

This paper examines the case of Ebola, ça Suffit trial which was conducted in Guinea during Ebola Virus Disease outbreak in 2015. I demonstrate that various non-epistemic considerations may legitimately influence the criteria for evaluating the efficacy and effectiveness of a candidate vaccine. Such non-epistemic considerations, which are social, ethical, and pragmatic, can be better placed and addressed in scientific research by appealing to non-epistemic values. I consider two significant features any newly developed vaccine should possess; the duration of immunity (...) the vaccine provides; and safety with respect to the side effects of the vaccine. Then, I argue that social and ethical values are relevant and desirable in setting the parameters for evaluating these two features of vaccines. The parameters that are employed for setting up the criteria for assessing the features might have far-reaching implications on the well-being of society in general, and the health conditions of several thousand people in particular. The reason is that these features can play a decisive role during the evaluation of the efficacy and effectiveness of the vaccine. I conclude by showing why it is necessary to reject the concept of epistemic priority, at least when scientists engage in policy-oriented research. (shrink)

In a recent article, Ethan Bradley and Mark Navin (2021) argue that vaccine refusal is not akin to free riding. Here, I defend one connection between vaccine refusal and free riding and suggest that, when viewed in conjunction with their other arguments, this might constitute a reason to mandate Covid-19 vaccination.

When considering the persuasive characteristics and prospective influences of Darwin‐skeptic mass media, uncertainties remain about how to reciprocally promote evolutionary theory to skeptical audiences. This study aims to improve evolution advocacy by translating some of the most successful methods of science endorsement to Evolution Wars contexts. In particular, strategies used to address vaccine hesitancies and enhance immunization uptake policies are reinterpreted for those seeking to improve pro‐evolution communications to religious publics. What results are three recommendation categories described as General Guiding (...) Principles, Proximate Interventions, and Auxiliary Interventions. (shrink)

Efficiently communicating information on vaccination is crucial to maintaining a high level of immunization coverage, but it implies finding the right content for the right audience. Provaccination individuals, who represent the majority of the population, and who have been neglected in the literature, could play an important role relaying provaccination messages through informal discussions, if only these messages are (a) found plausible, (b) remembered, and (c) shared. We conducted 7 experiments on 2,761 provaccination online participants (United States and United Kingdom), (...) testing whether the valence of a statement (positive or negative) and its rhetorical orientation (pro- or antivaccine) affected these 3 steps. Participants deemed more plausible, were more willing to transmit (and actually transmitted more), but did not remember positively framed statements better. Provaccination rhetorical orientation had little or no effect. Overall, the framing effects observed were dramatic: one framing made participants very eager to transmit a statement, while another made them reluctant to transmit it at all. The framing effects also influenced vaccination attitudes, with participants exposed to positively framed statements reporting more positive attitudes toward vaccination. Since messages have to be framed one way or the other, the framing effects demonstrated here should be considered when designing public health messages. (shrink)

Vaccination complacency occurs when perceived risks of vaccine-preventable diseases are sufficiently low so that vaccination is no longer perceived as a necessary precaution. Disease outbreaks can once again increase perceptions of risk, thereby decrease vaccine complacency, and in turn decrease vaccine hesitancy. It is not well understood, however, how change in perceived risk translates into change in vaccine hesitancy. -/- We advance the concept of vaccine propensity, which relates a change in willingness to vaccinate with a change in perceived risk (...) of infection—holding fixed other considerations such as vaccine confidence and convenience. (shrink)

As we face this unprecedented epidemic, researchers are racing to develop a cure and find ways to prevent more infections in the future. Yet, with so much uncertainty about the future of this virus, the current absence of an effective therapy,[i] and limited research on natural immunity to the disease through direct exposure,[ii] it seems the only certainty is that a vaccine could be a solution. Several laboratories across a multitude of countries have begun to develop a vaccine[iii] for SARS-CoV-2 (...) with anticipated public arrival as early as late 2020. However, a vaccine is not effective at the population level if only a few decide to receive it. Herd immunity is the phenomenon that occurs when a sufficient proportion of a population is immune to a virus. This decreases the amount and/or duration of pathogen shedding, thereby reducing the spread of a pathogen to susceptible individuals.[iv] Herd immunity is obtained most easily and safely through widespread vaccination, and it is essential to protecting the most vulnerable. This includes individuals of lower socioeconomic status who are more likely to have high-risk comorbidities, the immunocompromised, the elderly, and those with disabilities. The question then arises: should we consider mandating compulsory vaccinations for SARS-CoV-2? Is this the only way to ensure the virus does not return? The prospect of compulsory vaccinations has an arduous history in the United States dating back to the 1905 court case Jacobson v. Massachusetts when, in the face of the smallpox epidemic, Henning Jacobson refused vaccination, arguing that the law requiring all adults vaccinate or pay a fine was an infringement on his autonomy and “an assault on his person”[v].[vi] In the modern era, the conversation has largely shifted its focus toward childhood vaccinations. A combination of poorly conducted research,[vii] sensational media coverage, safety concerns, desire for additional education, and philosophical opinions about “natural” immunity have all been cited as reasons that people refuse to vaccinate.[viii] As a result, many parents have claimed exemptions to vaccinations, and consequently, outbreaks of preventable diseases such as measles have struck several communities across the country.[ix] Now, this is not to say that these fears are entirely unwarranted. Although most adverse reactions to vaccinations are quite mild, there are some known, extremely rare potential side effects to some common childhood vaccinations.[x] These, however, are frequently mitigated through proper medical screening and exemption. Furthermore, rigorous research on the efficacy and safety of the SARS-CoV-2 vaccine prior to FDA approval will help to prevent our most vulnerable populations from experiencing adverse effects. Government control over vaccine research and use of the National Vaccine Injury Compensation Program [xi] can ensure potential adverse outcomes are limited and properly addressed. Furthermore, educational resources and proper use of the media can help establish trust in concerned populations. The greater philosophical discussion of the value of personal autonomy in the U.S., however, is much more complicated. The case for autonomy may be summarized as the right to choose for oneself. Culturally and constitutionally, it is considered to be a fundamental right in the U.S., and Supreme Court Cases have ruled in favor of autonomy and the right to bodily integrity time and time again, as demonstrated in Roe v. Wade [xii] and Griswold v. Connecticut.[xiii] There is a basic philosophy of autonomy: any person with capacity and competence has the right to choose what they deem to be in their own best interests, and a right to protect their body from unwanted intrusion or harm. A competent patient cannot be forced to undergo surgery, nor can they be held against their will in the emergency room, nor forced to receive a blood transfusion if they are a Jehovah’s Witness. There is, however, a second part to this philosophy: an autonomous decision may not pose significant risk or harm to another person. Consequently, the case for personal autonomy and bodily integrity in the context of highly infectious diseases is weak. Unlike many other personal medical decisions, refusing to vaccinate is not a decision that affects the patient independently. Instead, it poses a threat to any community member who is unable to vaccinate for legitimate medical purposes. Moreover, I argue that a mandatory vaccination program does not significantly inhibit the autonomy of any normally healthy person, but rather it acts to protect those who are not already in good health. A compulsory vaccination program would serve as a viable public health effort to protect the most vulnerable groups. In the case of COVID-19, this includes those who are immunocompromised, diabetic, elderly, obese, or with chronic heart or lung disease.[xiv] Vaccination should therefore be considered a moral responsibility of the healthy. In essence, the argument for autonomy simply does not carry enough significance when weighed against community-level beneficence. This novel coronavirus also raises an entirely new dilemma not often faced with other infectious diseases – scarcity of resources. For those who become extremely ill, treating this disease requires invasive, expensive, and scarce medical resources. Many of the patients admitted to the hospital are placed on ventilators and their healthcare providers require copious amounts of personal protective equipment. As many states reach their projected peak of new cases, many hospitals continue to teeter on the edge of maximum capacity. Hospital ethics committees face the real possibility of deciding to withdraw or withhold care to preserve resources for those with a higher chance of survival.[xv] This has raised alarms for disability rights groups,[xvi] as should a purely utilitarian approach be applied to resource allocation, people with many cognitive and physical disabilities may be denied treatment despite the fact that it violates the American with Disabilities Act.[xvii] As we look toward the future of this pandemic, it is unclear if hospitals will face another spike of cases come autumn that will, once again, stretch resources and place many lives at risk. I argue that we have a moral duty to do what we can to prevent this ethical quandary from occurring as part of an effort to protect those with high-risk comorbidities and disabilities. These individuals deserve equal moral value under the utilitarian practices that guide triage decisions. This is most easily realized through a compulsory vaccination program for SARS-CoV-2. There is a caveat, however. Should a mandatory vaccination program be implemented, cost should not represent a limitation. This virus already disproportionately affects those of lower socioeconomic status.[xviii] Populations already at increased risk of contracting the virus should not be denied access to the vaccine due to cost. If vaccination becomes mandatory, these populations should not incur the burden of cost. For such a system to be considered just, the U.S. government must be willing to cover the cost of SARS-CoV-2 vaccination for everyone. We cannot be certain what the next several months will look like. This novel coronavirus may fade over the summer, or it may return in the fall, and we may experience another spike in cases. Nevertheless, in the absence of effective therapeutic measures, and assuming a vaccine becomes available, the risk of repeating our current situation is too high and we must consider mandatory vaccination as a real possibility. Personal liberty does not give one the right to endanger another person, and people have an individual right to be protected from others who may place them in danger. Even a culture that prides itself on individual choice and personal liberty should be willing to see the crucial need for such measures. It is thought that younger generations are unwilling to trust vaccines because they have not experienced outbreaks such as smallpox or polio, and therefore do not believe vaccines are an effective or necessary tool in preventing disease. Perhaps this pandemic will be the experience that motivates them to reconsider and reappreciate the role of vaccination in our lives. With that in mind, we can begin to ask again, is the ongoing pandemic the catalyst we needed for compulsory vaccinations to enter the forefront of health policy discourse? [i] “Therapeutic Options for COVID-19 Patients.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, March 21, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html. [ii] Apoorva Mandavilli. “Can You Become Immune to the Coronavirus?” The New York Times, March 25, 2020. https://www.nytimes.com/2020/03/25/health/coronavirus-immunity-antibodies.html?auth=link-dismiss-goo gle1tap. [iii] Jeff Craven. “COVID-19 Vaccine Tracker.” Regulatory Affairs Professionals Society. Regulatory Focus, April 10, 2020. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker. [iv] FE Andre, R Booy, HL Bock, J Clemens, SK Datta, TJ John, BW Lee, et al. “Vaccination greatly reduces disease, disability, death, and inequity worldwide.” Bulletin of the World Health Organization 86, no. 2 : 81-160. [v] DA Salmon, SP Teret, CR MacIntyre, D Salisbury, MA Burgess, and NA Halsey. “Compulsory vaccination and conscientious or philosophical exemptions: past, present, and future.” Lancet 367, no. 9508 : 436-42. [vi] Wendy K Mariner, George J Annas, and Leonard H Glantz. “Jacobson v Massachusetts: It's Not Your Great-Great-Grandfather's Public Health Law.” American Journal of Public Health 95, no. 4 : 581–90. https://doi.org/10.2105/AJPH.2004.055160. [vii] AJ Wakefield, SH Murch, A Anthony, J Linnell, DM Casson, M Malik, M Berelowitz, et al. “RETRACTED: Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis, and Pervasive Developmental Disorder in Children.” The Lancet 351, no. 9103 : 637–41. https://doi.org/10.1016/s0140-673611096-0. [viii] Chephra McKee and Kristin Bohannon. “Exploring the Reasons Behind Parental Refusal of Vaccines” The Journal of Pediatric Pharmacology and Therapeutics 21, no. 2, : 104-109 [ix] “Measles Cases and Outbreaks.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, April 6, 2020. https://www.cdc.gov/measles/cases-outbreaks.html. [x] “Vaccines: Vac-Gen/Side Effects.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, April 2, 2020. https://www.cdc.gov/vaccines/vac-gen/side-effects.htm. [xi] “National Vaccine Injury Compensation Program.” Official web site of the U.S. Health Resources & Services Administration, January 7, 2020. https://www.hrsa.gov/vaccine-compensation/index.html. [xii] Roe v. Wade, 410 U.S. 113 [xiii] Griswold v. Connecticut, 381 U.S. 479 [xiv] Shikha Garg, Lindsay Kim, Michael Whitaker, Alissa O’Halloran, Charisse Cummings, Rachel Holstein, Mila Prill, et al. “Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 – COVID-NET, 14 States, March 1-30, 2020” MMWR Morb Mortal Wkly Rep 69,. https://dx.doi.org/10.15585/mmwr.mm6915e3 [xv] Mike Baker, and Sheri Fink. “At the Top of the Covid-19 Curve, How Do Hospitals Decide Who Gets Treatment?” The New York Times, March 31, 2020. https://www.nytimes.com/2020/03/31/us/coronavirus-covid-triage-rationing-ventilators.html. [xvi] “Protect Rights of People with Disabilities During COVID-19.” Human Rights Watch, March 26, 2020. https://www.hrw.org/news/2020/03/26/protect-rights-people-disabilities-during-covid-19. [xvii] Amy Osteen. “Preventing Discrimination in the Treatment of COVID-19 Patients: The Illegality of Medical Rationing on the Basis of Disability.” Disability Rights Education & Defense Fund, April 2, 2020. https://dredf.org/the-illegality-of-medical-rationing-on-the-basis-of-disability/. [xviii] Max Fisher, and Emma Bubola. “As Coronavirus Deepens Inequality, Inequality Worsens Its Spread.” The New York Times, March 15, 2020. (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)

Some societies tolerate or encourage high levels of chickenpox infection among children to reduce rates of shingles among older adults. This tradeoff is unethical. The varicella zoster virus (VZV) causes both chickenpox and shingles. After people recover from chickenpox, VZV remains in their nerve cells. If their immune systems become unable to suppress the virus, they develop shingles. According to the Exogenous Boosting Hypothesis (EBH), a person’s ability to keep VZV suppressed can be ‘boosted’ through exposure to active chickenpox infections. (...) We argue that even if this hypothesis were true, immunization policies that discourage routine childhood varicella vaccination in order to prevent shingles for other people are unethical. Such policies harm children and treat them as mere means for the benefit of others, and are inconsistent with how parents should treat their children and physicians should treat their patients. These policies also seem incompatible with institutional transparency. (shrink)

Vaccine refusal forces us to confront tensions between many values, including scientific expertise, parental rights, children’s best interests, social responsibility, public trust, and community health. Recent outbreaks of vaccine-preventable and emerging infectious diseases have amplified these issues. The prospect of a coronavirus disease 2019 vaccine signals even more friction on the horizon. In this contentious sociopolitical landscape, it is therefore more important than ever for clinicians to identify ethically justified responses to vaccine refusal.

Initial vaccine allocations for the coronavirus disease 2019 (COVID-19) will be limited. It is crucial to assess the ethical values associated with different methods of allocation, as well as important scientific and practical questions. This Viewpoint identifies three ethical values, benefiting people and limiting harm; prioritizing disadvantaged populations; and equal concern for all. It then explains why these values support prioritizing three groups: health care workers; other essential workers and people in high-transmission settings; and people with medical vulnerabilities associated with (...) poorer COVID-19 outcomes. In contrast, two other groups, people over 65 without medical vulnerabilities and participants in clinical research, present more complex ethical questions. This prioritization also encompasses valuing direct benefits to vaccinated individuals, indirect benefits to individuals protected from spread of infection, and indirect health and socioeconomic benefits to those protected from harm as health system and societal functioning improve. Vaccine allocation that recognizes important ethical values and avoids arbitrariness, waste, and corruption can ensure that the distribution of a COVID-19 vaccine is both fair and perceived as fair. (shrink)

Society is facing uncertainty on a multitude of domains and levels: usually, reasoning and decisions about political, economic, or health issues must be made under uncertainty. Among various approaches to probability, this chapter presents the coherence approach to probability as a method for uncertainty management. The authors explain the role of uncertainty in the context of important societal issues like legal reasoning and vaccination hesitancy. Finally, the chapter presents selected psychological factors which impact probabilistic representation and reasoning and discusses what (...) society can and cannot learn from the coherence approach from theoretical and practical perspectives. (shrink)

Photo by CDC on Unsplash INTRODUCTION Safe and effective vaccines are yet to be developed and distributed for the treatment of the virus that causes COVID-19. “Vaccine trials are notoriously lengthy, with optimistic estimates of 12 to 18 months to vaccine rollout.”[1] Safe and effective vaccine development within the shortest possible time requires adopting a medical research strategy like human challenge trials. A few weeks ago, experts in the fields of bioethics, philosophy, medicine, computer sciences - some of whom are (...) Nobel Laureates - and some prominent businessmen sent a signed letter to Dr. Francis Collins, the Director of the National Institutes of Health, calling on the government to embark on human challenge trials to accelerate the development and distribution of a COVID-19 vaccine. According to the 125 signatories to the letter, human challenge trials are indispensable during the COVID-19 pandemic as successful development of vaccines through this method would help improve human health and well-being, and save countries from a looming social and economic meltdown.[2] Human challenge trials involve fewer participants, are not restrained by the rate of natural infections, and can be completed in much less time than conventional vaccine trials.[3] There is a potential projection that if vaccines are not developed quickly, the global poverty index may increase from 600 million pre-pandemic to one billion before the end of 2020.[4] Some bioethicists argue that government and medical scientists should adhere strictly to the best ethical standard to ensure that research volunteers are not exploited in any way despite the severity of the pandemic.[5] The 125 experts that signed the letter to the NIH recognize the need to mitigate any possible ethical issue of exploitation that might arise if the government endorses human challenge trials. Though the letter fails to highlight and address the ethical issue of possible incentivization of the human challenge trials, I argue that advertised incentives as a recruitment strategy undermine the the benefit of recruiting individuals to participate out of altruism. Given the high poverty index rate, the government and medical scientists could, in effect, be taking advantage of the vulnerability of those who are socially and economically impoverished, treating them as mere means to some scientific end. ANALYSIS Human Challenge Trials: Mitigating Possible Exploitation Challenge trials involve a deliberate exposure of healthy research participants to pathogens to study how people contract the disease and how resistance can be attained in order to develop a vaccine. These trials have proven useful in the past for the advancement of scientific knowledge through the development of vaccines for cholera, malaria, and smallpox. Some bioethicists caution about the reliance on human challenge trials to address the COVID-19 pandemic. Shah et al. contend that “given the stakes of exposing volunteers to potentially fatal risks, it would be a mistake to rush the implementation of challenge trials without adequately considering what it will take for them to make a difference.”[6] Their concern stems from the fact that little is known about COVID-19 and there is no standard treatment. The experts highlighted four basic criteria to ensure that human challenge trials meet high ethical standards. The criteria are that only young, healthy participants should be enrolled; the highest quality medical care should be provided for participants; the ethical and scientific review must be of the highest standard; and the autonomy of participants must be respected. These principles are aimed at mitigating ethical challenges that had arisen in the past, especially, the issue of lack of consent and the risk of exposure of research participants to harm. Additionally, this paper explores compensation as an incentive to participate. I. Age of Permissible Participation The experts noted that potential participants should be healthy youths who are within the age range of 20 and 29 because they are less likely to die of the virus when exposed. Some bioethicists and scientists agree with this requirement. Verity et al., for instance, argue that the fatality ratio of people within that age range is.0778–.398.[7] According to some reports, healthy persons of 19 years and under may be less likely to suffer adverse events like hospitalization or death when they are infected with COVID-19. However, those in the age range of 20 to 44 years seem to be at higher risks for hospitalization, ICU admission, or death.[8] So, there is no guarantee that the participants in that age range will be free from any adverse events when they are exposed to the virus. To be valid, researchers will have to address the problem of applying the results to the elderly population. If the participants are all 29 and under, a vaccine may produce either better, stronger antibodies or weaker and fewer antibodies in them than in the elderly. Transparency about research limitations is crucial. III. Protection of Participants from Harm The experts suggested that participants should be provided with the highest quality medical care and also be monitored frequently to mitigate any possible harm that may arise due to their exposure to the virus. Nir Eyal et al. note that “any volunteers in whom infection was confirmed should receive excellent care for COVID-19, including priority for any scarce life-saving resources, in state-of-the-art facilities.”[9] It is not clear how proper resource distribution would be made between challenge trials and other medical emergencies. Many hospitals in the US and other parts of the world with high incidents of COVID-19 are overwhelmed by an increasing number of patients in ICUs and other inpatient units with COVID-19. There are scarcities of medical care facilities and resources as hospitals and ICUs are under intense pressure due to the surge.[10] It is reasonable to use resources for challenge trials but in some areas, there are not available resources. It is also important to ensure that adequate provisions, both in terms of health facilities and manpower are made available for the care of patients already in precarious situations whether due to COVID-19 or other diseases like cancer. An increase in the number of fatalities has occured when there were fewer resources to cater to the health and well-being of critically ill patients with COVID-19 and other chronic ailments.[11] Prioritizing the health and well-being of volunteers for challenge trials over those of critically ill COVID-19 patients is morally problematic. To resolve this moral dilemma, the challenge trials must take place where there are ample hospital beds, critical care doctors, and where a surge in COVID-19 cases is not expected. Some states within the US and some countries have flattened their curve, are past the overwhelming volume of hospital stays, and have state-of-the-art medical facilities. The trials should take place where other patients’ care will not have to be compromised and where the research participants will have access to care. III. Standard of ethics boards The experts also suggested that ethical and scientific review must be of the highest standard. Beyond the usual FDA and IRB review process, they suggested a robust public discussion and an additional independent ethics and science taskforce.[12] However, it is unclear how this will pan out. Also, the letter did not explain whether consensus-based ethical decision making would be adopted to resolve conflicting moral issues that may arise during the review process. The challenge with a consensus-based ethical decision is that members may agree with it without recourse to whether such decision is morally appropriate. Members may agree because they want to act in solidarity with the proposer of the decision or because they have a special stake in the outcome. To avoid decisions that do not comport with proper ethics, a decision-making procedure with accountability is required. IV. Respect for participants’ autonomy The experts emphasized that the autonomy of participants must be respected. Although voluntary informed consent is necessary as it tends to protect the rights of research participants to accept risks, participants may make irrational decisions.[13] Individuals who are incompetent to make decisions like children should be excluded. Researchers should provide a tool to ensure that potential participants understand the risks of participation. “The wish of informed volunteers to participate in the trial ought to be given substantial weight.”[14] There is an ethical concern about enrolling volunteers who may want to participate in the challenge trials due to some motivations other than altruism. Some may have a psychological misconception of risk or desire to take on risk; others are motivated by compensation. Researchers should assess autonomy to be certain that participants understand risks and have freely decided to participate. V. Ethical Concern about Advertised Financial Incentives The success of clinical research depends on the availability of participants. According to the Council for International Organizations of Medical Sciences ethical guidelines, financial or material incentives are essential aspects of clinical research.[15] Incentives induce individuals to get involved in something inherently good. The inherent goodness of clinical research is that it is scientifically and socially valuable as long as there is a sound research design.[16] The compensation is made to attract participants who are altruistic and who believe in the research goals or who have certain qualities the researchers need. According to Dickert and Grady, incentives are like wages because although research participation does not require much expertise, it, however, requires “time, effort, and the endurance of undesirable or uncomfortable procedures.”[17] As unskilled labour, researchers and their sponsors are ethically required to pay participants incentives “on a scale commensurate with that of other unskilled but essential jobs.”[18] Some see compensation as coercive undermining the voluntary aspect of informed consent.[19] Some bioethicists, however, contend that the use of incentive as a recruitment strategy is morally problematic because it seems to reduce research participation to a kind of commercialized venture where services are paid for. Many research participants are desperately looking for ways to address their economic needs. Employing incentives as a recruitment strategy targets vulnerable, and economically impoverished groups. Financial incentivization in clinical research is morally problematic because it is used to "attract the poor and socially disadvantaged, while those who profit most from the outcome of these studies are the better-off members of society."[20] Researchers should not approach vulnerable groups that may be incentivized by desperation and more tempted to ignore the risks. There is significant debate over whether compensation for clinical trial participation is ethical. Compensation can be appropriate if it is not coercively high. To ensure enough participants and that low-income people have the opportunity to participate, the challenge trials should compensate to cover their living expenses or any lost income but should not offer additional payments that could be coercive. CONCLUSION The COVID-19 pandemic has worsened the global poverty. Adopting an expedient research procedure like human challenge trials which would accelerate vaccine development for COVID-19 is morally imperative. Volunteers who participate in the challenge trials should be motivated to advance human health and well-being rather than driven by their economic needs. It is morally necessary to eliminate the possibility of motivations based on financial desperation, or a distorted understanding of the risks. Researchers must use fair methods to attract those able to digest the scientific risks and societal benefits while avoiding taking advantage of marginalized groups. [1] Weinberg, Justin, “Philosophers, Epidemiologists & Others Call for Human Challenge Trials for COVID-19 Vaccine,” Daily Nous, July 16, 2020, https://dailynous.com/2020/07/16/philosophers-epidemiologists-others-call-human-challenge-trials-cov id-19-vaccine/. [2] Open Letter, “Challenge Trials for COVID-19,” 1 Day Sooner, July 2020, https://1daysooner.org/openletter. [3] Ferguson, Kyle and Caplan, Art, “Accepting the Challenge: COVID Vaccine Challenge Trials Can Be Ethically Justified,” The Hasting Centre, June 29, 2020, https://www.thehastingscenter.org/accepting-the-challenge-covid-vaccine-challenge-trials-can-be-ethi cally-justified/. [4]Business Standard, “Study says global poverty may surge to over 1 billion, warns Asian nations,”, June 12, 2020, https://www.business-standard.com/article/pti-stories/study-warns-of-poverty-surge-to-over-1-billion -due-to-virus-120061200112_1.html. [5] Mateus, Benjamin, “Human challenge trials are being pushed to develop a vaccine against the coronavirus,” World Socialist Web Site, May 5, 2020, https://www.wsws.org/en/articles/2020/05/05/vacc-m05.html. [6] Shah, Seema K. et al., "Before Deliberately Infecting People with Coronavirus, Be Sure It’s Worth It," The New York Times, June 2, 2020, https://www.nytimes.com/2020/06/02/opinion/coronavirus-vaccine-challenge-trials.html?action=click&mo dule=Opinion&pgtype=Homepage. [7] Verity, Robert et al., “Estimates of the severity of coronavirus disease 2019: a model-based analysis,” The Lancet: Infection Diseases, Vol 20, : 669-677, https://doi.org/10.1016/ S1473-309930243-7, 673. [8] Radcliffe, Shawn, “Nearly 40% of Those Hospitalized for COVID-19 Are Under 55,” Health Line, March 19, 2020, https://www.healthline.com/health-news/covid-19-isnt-just-dangerous-for-older-adults. [9] Eyal, Nir et al., “Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure," The Journal of Infectious Diseases, Vol. 221, : 1753. [10] Phua, Jason et al., "Intensive care management of coronavirus disease 2019 : challenges and recommendations," The Lancet: Respiratory Medicine, Vol 8, : 506-17. https://doi.org/10.1016/S2213-260030161-2; Aziz, Shadman et al., "Managing ICU surge during the COVID-19 crisis: rapid guidelines," Intensive Care Medicine. Vol. 46, No. 7, : 1303-1325, doi:10.1007/s00134-020-06092-5. [11] Leclerc, Thomas et al., "Prioritisation of ICU treatments for critically ill patients in a COVID-19 pandemic with scarce resources," Anaesthesia, Critical Care Pain Medicine, Vol. 39, No. 3, : 334, DOI: 10.1016/j.accpm.2020.05.008. [12] Open Letter, “Challenge Trials for COVID-19.” [13] Dawson, Liza et al., “Severe Acute Respiratory Syndrome Coronavirus 2 Human Challenge Trials: Too Risky, Too Soon,” The Journal of Infectious Diseases, Vol. 222, : 514–6, DOI: 10.1093/infdis/jiaa314. [14] Open Letter, “Challenge Trials for COVID-19.” For more on ethical guidelines on human challenge trials, cf. World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011; Expert Committee on Biological Standardization. Human Challenge Trials for Vaccine Development: regulatory considerations. Geneva: World Health Organization, 2016. [15] CIOMS-WHO, International Ethical Guidelines for Health-related Research Involving Humans, 4th. Geneva, 2016. [16] Grant, Ruth W. and Sugarman, Jeremy, "Ethics in Human Subjects Research: Do Incentives Matter?," Journal of Medicine and Philosophy, Vol. 29, No. 6, : 726. [17] Dickert, Neal, Grady, Christine, “What’s the Price of a Research Subject? Approaches to Payment for Research Participation,” The New England Journal of Medicine, Vol. 341 No. 3, : 199. [18] Dickert and Grady, What’s the Price of a Research Subject?,” 200. [19] Malmqvist, Erik, “Paid to Endure: Paid Research Participation, Passivity, and the Goods of Work,” The American Journal of Bioethics, Vol. 19, No. 9 : 11. [20] Faden, Ruth R. et al., A History and Theory of Informed Consent, 354. Kaewkungwal et al. also argued raised concerned about the ethical permissibility of targeting the economically impoverished population for human challenge trials. For more on this view, cf. Kaewkungwal, Jaranit et al. 2019. “Conducting human challenge studies in LMICs: A survey of researchers and ethics committee members in Thailand.” Plos One, 14: e0223619.https://doi.org/10.1371/journal.pone.0223619. (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)

Scientific knowledge is the most solid and robust kind of knowledge that humans have because of its inherent self-correcting character. Nevertheless, anti-evolutionists, climate denialists, and anti-vaxxers, among others, question some of the best-established scientific findings, making claims unsupported by empirical evidence. A common aspect of these claims is reference to the uncertainties of science concerning evolution, climate change, vaccination, and so on. This is inaccurate: whereas the broad picture is clear, there will always exist uncertainties about the details of the (...) respective phenomena. This book shows that uncertainty is an inherent feature of science that does not devalue it. In contrast, uncertainty advances science because it motivates further research. This is the first book on this topic that draws on philosophy of science to explain what uncertainty in science is and how it makes science advance. It contrasts evolution, climate change, and vaccination, where the uncertainties are exaggerated, and genetic testing and forensic science, where the uncertainties are usually overlooked. The goal is to discuss the scientific, psychological, and philosophical aspects of uncertainty in order to explain what it really is, what kinds of problems it actually poses, and why in the end it makes science advance. Contrary to public representations of scientific findings and conclusions that produce an intuitive but distorted view of science as certain, people need to understand and learn to live with uncertainty in science. This book is intended for anyone who wants to get a clear view of the nature of science. (shrink)

Health care systems can positively influence our personal decision-making and health-related behavior only if we trust them. I propose a conceptual analysis of the trust relation between the public and a healthcare system, drawing from healthcare studies and philosophical proposals. In my account, the trust relation is based on an epistemic component, epistemic authority, and on a value component, the benevolence of the healthcare system. I argue that it is also modified by the vulnerability of the public on healthcare matters, (...) and by the system’s credibility. I apply my proposed analysis of public trust in health care systems to the phenomenon of vaccine hesitancy, a tendency to question vaccine policies, and to seek alternative vaccine schedules or to refuse vaccination. Understanding the role of trust and its components can be key to understanding the phenomenon. (shrink)

There can be little doubt about the ethical imperative to ensure adequate vaccination uptake against certain infectious diseases. In the face of vaccine refusal, health authorities and providers instinctively appeal to coercive approaches or increased education as methods to ensure adequate vaccine uptake. Recently, some have argued that public fear around Ebola should be used as an opportunity for such approaches, should an Ebola vaccine become available. In this article, the author describes the difficulties associated with coercion and education when (...) addressing vaccine opposition. Both coercion and education can cause opposite effects than intended in certain circumstances. The correct area of focus is to address the breakdown in trust within clinical relationships. The author presents suggestions for an approach towards vaccine refusal that may be more promising. (shrink)

Public health law courses typically focus a good deal of attention on two related topics: the duty of government agencies to control the spread of communicable diseases and their use of the police power to do so. While governments sometimes take forceful actions in responding to disease outbreaks, they can also act to prevent their occurrence. Indeed, one of the great triumphs of public health in the 20th century was the development of vaccines and their widespread use, which seemed on (...) course to relegate many formerly crippling or deadly diseases to the history books. Particular success occurred with vaccinations against childhood diseases such as polio, smallpox, and measles, outbreaks of which once routinely closed schoolrooms, playgrounds, and community swimming pools. By the last quarter of the century, completion of an elaborate schedule of immunizations was not merely the standard in pediatric practice but an official requirement for school enrollment. As a result, the range of communicable diseases that had once terrified parents had become threats to be feared only in memory. (shrink)

Used appropriately, reliance on science distinguishes public health from policymaking driven more by theory and opinion and enhances trust in public health interventions. Evidence-based vaccine policymaking aims to control communicable disease by urging decision makers to base policies on the best available evidence rather than politics or personal views. The results of this approach, such as smallpox eradication, have been dramatic. Historically, mandatory childhood vaccination has been perhaps the most successful evidence-based tool in combating many epidemics. Philosophically, vaccination mandates correspond (...) to the legal system’s dual role in codifying what society deems undesirable behavior and declaring beneficial social norms and values consistent with understandings of the social contract. Despite their effectiveness and philosophical grounding, vaccination mandates present serious legal and ethical questions. Public health policymakers have a continuing responsibility to rely on evidence not only as a basis for generating policy, but also for evaluating and improving elements of its legal design. (shrink)

Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent (...) chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice. (shrink)

In these twelve papers notable ethicists use the resources of ethical theory to illuminate important theoretical and practical topics, including the nature of public health, notions of community, population bioethics, the legitimate role of law, the use of cost-effectiveness as a methodology, vaccinations, and the nature of infectious disease.

In the first decades of the twentieth century, a heterogeneous assortment of groups and individuals articulated scientific, political, and philosophical objections to vaccination. They engaged in an ongoing battle for public opinion with medical and scientific elites, who responded with their own counterpropaganda. These ideological struggles reflected fear that scientific advances were being put to coercive uses and that institutions of the state and civil society were increasingly expanding into previously private realms of decision making, especially child rearing. This essay (...) analyzes the motivations and tactics of antivaccination activists and situates their actions within the scientific and social climate of the Progressive Era and the 1920s. Their actions reveal how citizens of varied ideological persuasions, activists and nonactivists alike, viewed scientific knowledge during a period of swift and unsettling change, when the application of biologic products seemed to hold peril as well as promise. (shrink)