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)

Volume 20, Issue 9, September 2020, Page 68-70.

Should people get vaccinated for the sake of others? What could ground—and limit—the normative claim that people ought to do so? In this paper, we propose a reasons-based consequentialist account of vaccination for the benefit of others. We outline eight harm-based and probabilistic factors that, we argue, give people moral reasons to get vaccinated. Instead of understanding other-directed vaccination in terms of binary moral duties (i.e., where people either have or do not have a moral duty to get (...) vaccinated), we develop a scalar approach according to which people can have stronger or weaker moral reasons to get vaccinated in view of the moral good of vaccination. One advantage of our approach is that it can capture why a person might have strong moral reasons to get vaccinated with Vaccine A, but only weak moral reasons to get vaccinated with Vaccine B. We discuss theoretical strengths of our approach and provide a case study of vaccination against COVID-19 to demonstrate its practical significance. (shrink)

The potential for vaccines to prevent the spread of infectious diseases is crucial for vaccination policy and ethics. In this paper, I discuss recent evidence that the current COVID-19 vaccines have only a modest and short-lived effect on reducing SARS-CoV-2 transmission and argue that this has at least four important ethical implications. First, getting vaccinated against COVID-19 should be seen primarily as a self-protective choice for individuals. Second, moral condemnation of unvaccinated people for causing direct harm to others (...) is unjustified. Third, the case for a harm-based moral obligation to get vaccinated against COVID-19 is weak. Finally, and perhaps most significantly, coercive COVID-19 vaccination policies (e.g., measures that exclude unvaccinated people from society) cannot be directly justified by the harm principle. (shrink)

Can Covid-19 vaccines be used off-label? Should they be? These were questions on the minds of parents, pediatricians, and the media when the FDA fully approved the Pfizer-BioNTech Covid-19 vaccine for people aged 16 and up. Yet the American Academy of Pediatrics cautioned against pediatric off-label use of the vaccine, and the CDC Covid-19 Vaccine Provider Agreement appears to prohibit it. After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and (...) considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of a blanket prohibition on off-label pediatric Covid-19 vaccination, as it limits clinician ability to provide care they may determine to be clinically and ethically appropriate. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests. (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)

This open access book discusses individual, collective, and institutional responsibilities with regard to vaccination from the perspective of philosophy and public health ethics. It addresses the issue of what it means for a collective to be morally responsible for the realisation of herd immunity and what the implications of collective responsibility are for individual and institutional responsibilities. The first chapter introduces some key concepts in the vaccination debate, such as ‘herd immunity’, ‘public goods’, and ‘vaccine refusal’; and (...) explains why failure to vaccinate raises certain ethical issues. The second chapter analyses, from a philosophical perspective, the relationship between individual, collective, and institutional responsibilities with regard to the realisation of herd immunity. The third chapter is about the principle of least restrictive alternative in public health ethics and its implications for vaccination policies. Finally, the fourth chapter presents an ethical argument for unqualified compulsory vaccination, i.e. for compulsory vaccination that does not allow for any conscientious objection. The book will appeal to philosophers interested in public health ethics and the general public interested in the philosophical underpinning of different arguments about our moral obligations with regard to vaccination. (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)

This dissertation explores the idea and ethics of vaccination for the sake of others. It conceptually distinguishes four different kinds of vaccination—self-protective, paternalistic, altruistic, and indirect—based on who receives the primary benefits of vaccination and who ultimately makes the vaccination decision. It describes the results of focus group studies that were conducted to investigate what people who might get vaccinated altruistically think of this idea. It also applies the different kinds of vaccination to ethical (...) issues surrounding COVID-19, such as lockdown measures, routine or mandatory vaccination of healthy children, and the ethical justification of restrictive measures for unvaccinated people. A more general philosophical account of vaccination ethics is ultimately developed, which is based not on moral duties, but on the moral reasons that people may have to get vaccinated for the sake of others. It is argued that such reasons may be stronger or weaker, depending on various factors related to the vaccines in question and the specific epidemiological circumstances. (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.

The urgent drive for vaccine development in the midst of the current COVID-19 pandemic has prompted public and private organisations to invest heavily in research and development of a COVID-19 vaccine. Organisations globally have affirmed the commitment of fair global access, but the means by which a successful vaccine can be mass produced and equitably distributed remains notably unanswered. Barriers for low-income countries include the inability to afford vaccines as well as inadequate resources to vaccinate, barriers that are exacerbated during (...) a pandemic. Fair distribution of a pandemic vaccine is unlikely without a solid ethical framework for allocation. This piece analyses four allocation paradigms: ability to develop or purchase; reciprocity; ability to implement; and distributive justice, and synthesises their ethical considerations to develop an allocation model to fit the COVID-19 pandemic. (shrink)

Health care institutions have paid increasing attention to preventing nosocomial transmission of influenza through vaccination of health care personnel. While multifaceted voluntary interventions have increased vaccination rates, proponents of mandatory programs contend the rates remain unacceptably low. Conventional bioethical analyses of mandatory programs are inadequate; they fail to account for the obligations of nonprofessional personnel or to justify the weights assigned to different ethical principles. Using an ethics framework for public health permits a fuller analysis. The framework's (...) focus on fairness accentuates the potential differences between the risk of transmitting infection and employment status, and the need to equitably evaluate exemptions. The framework's emphasis on balancing benefits and burdens highlights the need to justify a specific goal and questions the need to exclude all nonmedical exemptions. While mandatory vaccination programs are justifiable, greater attention should be paid to their implementation. (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)

When the HPV vaccine was released over a decade ago, there was intense opposition to mandating the vaccine, including among bioethics and legal scholars. Some of the original concerns are now obsolete, while other objections continue to present an obstacle to mandating the vaccine. This essay responds to earlier critiques of mandatory HPV vaccination and offers a series of arguments in support of a vaccine mandate. The first section briefly addresses initial concerns that are no longer relevant. The second (...) section makes the ethical case for mandating HPV vaccination, based on three principles: 1) the best interests of children, 2) solidarity, and 3) health equity. The final section addresses concerns related to implementation of the vaccine, including the validity of linking vaccination to school entry. The essay concludes that we have a moral imperative to protect children from the leading cause of cervical cancer, and that mandating HPV vaccination is the best way to ensure that children of all backgrounds receive the vaccine before they have been exposed to the virus. (shrink)

Brussen, Kerri Anne Ethically compromised vaccines are vaccines where the virus used in the manufacture of the vaccine has been cultured in a cell line developed from tissue grown from an aborted foetus. In Australia, an ethically compromised vaccine is the only vaccine available for Chicken pox (varicella), shingles (zoster), Hepatitis A, and Rubella (which is part of the MMR - measles, mumps, rubella - vaccine). The poliovirus vaccine component of Quadracel, available in Western Australia, is ethically compromised. However, the (...) poliovirus component of Infanrix-IPV is not ethically compromised and is used in all other Australian States and Territories. The rabies vaccine, Rabipur, is not ethically compromised and is the preferred option to Merieux Inactivated Rabies Vaccine (MIRV) which is an ethically compromised vaccine. This article lists the ethically compromised vaccines available in the various Australian States and Territories, and explains why they are ethically compromised. It also explains when and why vaccination should still be accepted even when the only available vaccine is ethically compromised. (shrink)

In recent years, more and more religious communities have been refusing to vaccinate their children, and in so doing are allowing diseases to spread. These communities justify resistance to vaccination on various religious grounds and make common cause with nonreligious communities who oppose vaccination for their own reasons. Today this situation is reflected primarily in the spread of measles, and vaccine hesitancy was identified by the World Health Organization as 1 of the top 10 global health threats of (...) 2019. The present article presents the religious and ethical arguments for the obligation within Jewish tradition to vaccinate all children. Apart from the obligation on parents to vaccinate their own children, it includes the ethical arguments based on Judaism that call for parents to become organized and force schools to refuse to accept children who have not been vaccinated and demand vaccination of those who have not been inoculated. (shrink)

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)

The COVID-19 pandemic will likely recede only through development and distribution of an effective vaccine. Although there are many unknowns surrounding COVID-19 vaccine development, vaccine demand will likely outstrip early supply, making prospective planning for vaccine allocation critical for ensuring the ethical distribution of COVID-19 vaccines. Here, we propose three central goals for COVID-19 vaccination campaigns: to reduce morbidity and mortality, to minimise additional economic and societal burdens related to the pandemic and to narrow unjust health inequalities. We evaluate (...) five prioritisation approaches, assess their likely impact on advancing the three goals of vaccine allocation and identify open scientific questions that may alter their outcomes. We argue that no single prioritisation approach will advance all three goals. Instead, we propose a multipronged approach that considers the risk of serious COVID-19 illness, instrumental value and the risk of transmission, and is guided by future research on COVID-19-specific clinical and vaccine characteristics. While we focus this assessment on the USA, our analysis can inform allocation in other contexts. (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)

Purpose The COVID-19 pandemic broke out at the end of 2019, and throughout 2020 there were intensive international efforts to find a vaccine for the disease, which had already led to the deaths of some five million people. In December 2020, several pharmaceutical companies announced that they had succeeded in producing an effective vaccine, and after approval by the various regulatory bodies, countries started to vaccinate their citizens. With the start of the global campaign to vaccinate the world’s population against (...) COVID-19, debates over the prioritization of different sections of the population began around the world, but the prison population has generally been absent from these discussions. Approach and Findings This article presents the approach of Jewish ethics regarding this issue, that is, that there is a religious and a moral obligation to heal the other and to take care of his or her medical well-being and that this holds true even for a prisoner who has committed a serious crime. Hence, prisoners should be vaccinated according to the same priorities that govern the administration of the vaccine among the general public. Originality The originality of the article is in a comprehensive and comparative reference between general ethics and Jewish ethics on a subject that has not yet received the proper attention. (shrink)

Hofmann and Holm’s recent survey on issues of research misconduct with PhD graduates culminated with a notable conclusion by the authors: ‘ Scientific misconduct seems to be an environmental issue as much as a matter of personal integrity’. Here, we re-emphasise the usefulness of an education-based countermeasure against toxic research environments or cultures that promote unethical practices amongst the younger researchers. We posit that an adequately conducted course in research ethics and integrity, with a good dose of case studies (...) and analyses, can function in a manner that is metaphorically akin to vaccination. The training would cultivate the ability to analyse and build confidence in young researchers in making decisions with sound moral reasoning as well as in speaking up or arguing against pressure and coercions into unacceptable behaviour. A sufficiently large number of young researchers exposed to research ethics trainings would essentially provide a research community some degree of lasting herd immunity at its broadest base. Beyond passive immunity, a crop of research ethics-savvy young researchers could also play active and influential roles as role models for others at their level and perhaps even help correct the wayward attitudes of some senior researchers and initiate prompt action from institutional policy makers in a bottom-up manner. (shrink)

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered “developing” countries. Safeguarding the rights and welfare of individuals participating as (...) research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process. (shrink)

Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, (...) it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines. (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)

Health care institutions have paid increasing attention to preventing nosocomial transmission of influenza through vaccination of health care personnel. While multifaceted voluntary interventions have increased vaccination rates, proponents of mandatory programs contend the rates remain unacceptably low. Conventional bioethical analyses of mandatory programs are inadequate; they fail to account for the obligations of nonprofessional personnel or to justify the weights assigned to different ethical principles. Using an ethics framework for public health permits a fuller analysis. The framework's (...) focus on fairness accentuates the potential differences between the risk of transmitting infection and employment status, and the need to equitably evaluate exemptions. The framework's emphasis on balancing benefits and burdens highlights the need to justify a specific goal and questions the need to exclude all nonmedical exemptions. While mandatory vaccination programs are justifiable, greater attention should be paid to their implementation. (shrink)

There are three broad ethical issues related to handling public health emergencies. They are the three R's - rationing, restrictions and responsibilities. Recently, a severe shortage of annual influenza vaccine in the US, combined with the threat of pandemic flu, has provided an opportunity for policy makers to think about rationing in very concrete terms. Some lessons from annual flu vaccination likely will apply to pandemic vaccine distribution, but many preparatory decisions must be based on very rough estimates. What (...) ethical principles should guide rationing decisions, what data should inform these decisions, how to revise decisions as new data emerge, and how to implement rationing decisions on the ground are all important considerations. In addition, ethicists might be able to help policy makers think through the importance of international cooperation in surmounting global rationing dilemmas and to accept the inevitable responsibilities of government in making and implementing rationing decisions. (shrink)

Human papillomavirus (HPV) infection is the world’s most common sexually transmitted infection. It is a prerequisite for cervical cancer, the second most common cause of death in cancer among women worldwide, and is also believed to cause other anogenital and head and neck cancers. Vaccines that protect against the most common cancer-causing HPV types have recently become available, and different countries have taken different approaches to implementing vaccination. This paper examines the ethics of alternative HPV vaccination strategies. (...) It devotes particular attention to the major arguments for and against one strategy: voluntary, publicly funded vaccination for all adolescent boys and girls. This approach seems attractive because it would protect more people against cervical cancer and other HPV-related cancers than less inclusive alternatives, without the sacrifice of autonomy that a comparably broad compulsory programme would require. Also, the herd immunity that it would likely generate would protect those who remain unvaccinated, a major advantage from a justice perspective. However, there is a possibility that a HPV vaccination programme targeting all adolescents of both sexes is not considered sufficiently cost-effective. Also, it might pose more difficulties for achieving informed consent than comparable vaccination programmes against other diseases. Ultimately, society’s choice of HPV vaccination strategy requires careful consideration not only of the values at stake but also of available and emerging scientific evidence. (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)

Vaccines are responsible for many global public health successes, such as the eradication of smallpox and significant reductions in other serious infections like diphtheria, pertussis, tetanus, polio and measles. However, mass vaccination has also been the subject of various ethical controversies for decades. Several factors need to be considered before any vaccine is deployed at national programme like the potential burden of disease in the country or region, the duration of the protection conferred, herd immunity in addition to individual (...) protection, vaccine-related risks, financing and the logistical feasibility of the large-scale vaccination. Moreover, several ethical dilemmas revolve around authority and mandates for vaccination, informed consent, benefits vs. risks, and disparities in access to vaccination. This review paper aims to elaborate the ethical issues involved in mass vaccination programme and present some additional challenges in the context of a resource-poor settings of public health in Bangladesh. (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)

Techniques from behavioral economics—nudges—may help physicians increase pediatric vaccine compliance, but critics have objected that nudges can undermine autonomy. Since autonomy is a centrally important value in healthcare decision-making contexts, it counts against pediatric vaccination nudges if they undermine parental autonomy. Advocates for healthcare nudges have resisted the charge that nudges undermine autonomy, and the recent bioethics literature illustrates the current intractability of this debate. This article rejects a principle to which parties on both sides of this debate sometimes (...) seem committed: that nudges are morally permissible only if they are consistent with autonomy. Instead, I argue that, at least in the case of pediatric vaccination, some autonomy-undermining nudges may be morally justified. This is because parental autonomy in pediatric decision-making is not as morally valuable as the autonomy of adult patients, and because the interests of both the vaccinated child and other members of the community can sometimes be weighty enough to justify autonomy-infringing pediatric vaccination nudges. This article concludes with a set of worries about the effect of pediatric vaccination nudges on parent-physician relationships, and it calls on the American Academy of Pediatrics to draw on scientific and bioethics research to develop guidelines for the use of nudges in pediatric practice and, in particular, for the use of pediatric vaccination nudges. (shrink)

The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries (...) without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. (shrink)

Proper conduct of an AIDS vaccine trial in Africa must be informed not only by the epidemiology and biology of HIV infection in African settings, but also by the ethical norms and cultural constraints prevailing in African settings.

Vaccination policy is an ethically challenging domain of public policy. It is a matter of collective importance that reaches into the most private sphere of citizens and unavoidably conflicts with individual-based ethics. Policy makers need to walk a tight rope in order to complement utilitarian public health values with individual autonomy rights, protection of privacy, non-discrimination and protection of the worst-off. Whether vaccination is voluntary or compulsory, universal or targeted, every option faces complex ethical hurdles because of (...) the interdependence of humans in infectious disease matters. In this article, we explore the following three policy questions. (i) Ethically, which policy measures should be addressed when vaccination coverage is insufficient in a population? Information campaigns, legal compulsion, or the use of financial incentives can all be effective, but also controversial policy options. (ii) Is it ethical to target vaccination programs at certain risk-groups? If such measures are necessary, we argue that policymakers will often have to decide which is more important to uphold: non-discrimination or the protection of privacy. And (iii), what is the ethical significance of adverse herd immunity effects? Some vaccination programs will improve average population health, but will at the same time increase the risk of severe morbidity and mortality for individuals in the worst-off groups of society. (shrink)

Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific questions are raised (...) about the difficulties of informed consent in different cultural settings and whether there is any role for community involvement. Discussants debate whether drug and vaccine trials not approved in an industrialised country are ever defensible if performed in a third-world setting. Potential conflicting priorities between investigators are discussed and ideas regarding conflict resolution are offered. (shrink)

In the paper ‘COVID-19 vaccine boosters for young adults: a risk–benefit assessment and ethical analysis of mandate policies at universities,’ Bardosh _et al_ argued that college mandates of the COVID-19 booster vaccine are unethical. The authors came to this conclusion by performing three different sets of comparisons of benefits versus risks using referenced data and argued that the harm outweighs the risk in all three cases. In this response article, we argue that the authors frame their arguments by comparing values (...) that are not scientifically or reasonably comparable and that the authors used values that represent grossly different risk profiles and grouped them into a set of figures to create an illusion of fair comparisons. We argue that absent the falsely skewed portrayals of a higher level of risk over benefit in their misrepresented figures, the five ethical arguments they presented completely fall apart. (shrink)

In many countries, the COVID‐19 pandemic varied starkly between different racial and ethnic groups. Before vaccines were approved, some considered assigning priority access to worse‐hit racial groups. That debate can inform rationing in future pandemics and in some of the many areas outside COVID‐19 that admit of racial health disparities. However, concerns were raised that “race‐responsive” prioritizations would be ruled unlawful for allegedly constituting wrongful discrimination. This legal argument relies on an understanding of discrimination law as demanding color‐blindness. We argue (...) that a, color‐blind understanding of discrimination would be hostile only to one of two rationales for prioritizing the relevant racial minorities in settings of racial health disparities. We also propose a method for incorporating appropriate race‐responsive concerns that is in many ways ethically and legally superior to ones suggested thus far. That method turns artificial intelligence, thanks precisely to its artificial and “black box” nature (features that underlie recent concerns about artificial intelligence's discriminatory potential), into an instrument of social justice. (shrink)

COVID-19 vaccine uptake among healthcare workers (HCWs) remains of significant public health concern due to the ongoing COVID-19 pandemic. As a result, many healthcare institutions are considering or have implemented COVID-19 vaccine mandates for HCWs. We assess defenses of COVID-19 vaccine mandates for HCWs from both public health and professional ethics perspectives. We consider public health values, professional obligations of HCWs, and the institutional failures in healthcare throughout the COVID-19 pandemic which have impacted the lived experiences of HCWs. We (...) argue that, despite the compelling urgency of maximizing COVID-19 vaccine uptake among HCWs, the ethical case for COVID-19 vaccine mandates for HCWs in the United States is complex, and, under current circumstances, inconclusive. Nevertheless, we recognize that COVID-19 vaccine mandates for HCWs have already been and will continue to be implemented across many healthcare institutions. Given such context, we provide suggestions for implementing COVID-19 vaccine mandates for HCWs. (shrink)

Although the COVID-19 pandemic is a serious public health and economic emergency, and although effective vaccines are the best weapon we have against it, there are groups and individuals who oppose certain kinds of vaccines because of personal moral or religious reasons. The most widely discussed case has been that of certain religious groups that oppose research on COVID-19 vaccines that use cell lines linked to abortions and that object to receiving those vaccine because of their moral opposition to abortion. (...) However, moral opposition to COVID-19 vaccine research can be based on other considerations, both secular and religious. We argue that religious or personal moral objections to vaccine research are unethical and irresponsible, and in an important sense often irrational. They are unethical because of the risk of causing serious harm to other people for no valid reason; irresponsible because they run counter to individual and collective responsibilities to contribute to important public health goals; and in the case of certain kinds of religious opposition, they might be irrational because they are internally inconsistent. All in all, our argument translates into the rather uncontroversial claim that we should prioritize people’s lives over religious freedom in vaccine research and vaccination roll out. (shrink)

Vaccination, meaning induction of immunity through controlled exposure to antigens, has been mainly used as a prophylactic measure, but more recently as a therapeutic measure. As far as ethical dilemmas from therapeutic vaccines resemble those occurring for conventional treatment clinical trials, this chapter will focus only on prophylactic vaccines. Analogously, some of the ethical aspects of pre-exposure prophylaxis through medication or passive immunity are shared with prophylactic vaccines. This chapter will discuss the implications of having most vaccine trials not (...) conducted in combination with health care, the compensation of vaccine study participants, the preventive misconception, the need to keep participant commitment in vaccine studies, post-trial access in vaccine trials, controlled human infection models, studies in special populations, and vaccine community-based studies. (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)

Trial participation in the proposed HIV Vaccine Trials in South Africa is discussed in the context of the ethical tension that exists between international ethical research standards and local standards of care and cultural norms in the Third World. The important concepts of informed consent, risk-benefit ratio and fair treatment of trial participants are interpreted differently in traditional, rural African communities, where a moderate form of communitarianism referred to as "Ubuntu" or "communalism" is still prevalent. Research is an altruistic endeavor (...) that benefits communities and societies as a result of risks taken by individuals. Universal ethical guidelines that are highly individualistic and fail to emphasize communalism may represent serious problems for the sort of research needed in Africa today. (shrink)

This article starts with a case outlining ethical challenges encountered in participatory action research (PAR) on vaccine hesitancy in rural India during Covid-19. Community researchers were recruited by a not-for-profit organisation, with the aim of both discovering the reasons for vaccine hesitancy and encouraging take-up. This raised issues about the roles and responsibilities of local researchers in their own communities, where they might be blamed for adverse reactions to vaccination. They and their mentor struggled with balancing societal protection against (...) individual rights to make choices. These themes are explored in two commentaries discussing the difficulties in balancing ethics in public health (prioritising societal benefits), social research (protecting participants from harm and respecting their rights not to be involved) and participatory research practices (maximising democratic participation and decision-making). As discussed in the first commentary, often these cohere, but tensions can arise. The second commentary also raises the issue of epistemic justice, questioning the extent to which the villagers could have a say in the design, implementation and interpretation of the research, and the dangers of not hearing the voices and arguments of people who reject vaccination. The case and commentaries highlight the complexities of PAR and additional challenges in a public health context. (shrink)

Evaluation of the potential of a cocaine vaccine requires a detailed understanding of the intended and unintended social consequences of its use. Prospective technology assessment is always difficult, but in the case of treatment and prevention of cocaine addiction we need to understand not only the neuroscience and pharmacology of cocaine addiction, but also social attitudes to drug use and addiction, the social context of drug use, and the factors which make drug use a rational strategy for an addict and (...) make treatment seeking or relapse more or less likely. By considering different scenarios related to differing levels of effectiveness of the vaccine, the authors argue that vaccination will be at best a useful adjunct to existing methods of treatment, rather than a substitute for them. (shrink)

Volume 31, Issue 1, December 2020, Page 13-28.