This article outlines and compares current and proposed global institutional mechanisms to increase equitable access to COVID-19 vaccines, focusing on their institutional and operational complementarities and overlaps. It specifically considers the World Health Organization's (WHO’s) COVAX (COVID-19 Vaccines Global Access) model as part of the Access to COVID-19 Tools Accelerator (ACT-A) initiative, the WHO’s COVID-19 Technology Access Pool (C-TAP) initiative, the proposed TRIPS (Trade-Related Aspects of Intellectual Property Agreement) intellectual property waiver and other proposed WHO and World Trade Organization technology (...) transfer proposals. We argue that while various individual mechanisms each have their specific individual merits—and in some cases weaknesses—overall, many of these current and proposed mechanisms could be highly complementary if used together to deliver equitable global access to vaccines. Nonetheless, we also argue that there are risks posed by the proliferation of proposals in this context, including the potential to disperse stakeholder attention or to delay decisive action. Therefore, we argue that there is now a clear need for concerted global multilateral action to recognise the complementarities of specific models and to provide a pathway for collaboration in attaining global equitable access to vaccines. The institutional infrastructure or proposals to achieve this amply exist at this point in time—but much greater cooperation from industry and clear, decisive and coordinated action from states and international organisations are urgently needed. (shrink)

This article proposes the adoption of a multi-modal system for allocating vaccine doses during large transnational outbreaks of infectious diseases. The chosen allocative criteria (public health need; country-income level; qualification through funding; and, subsidiarily, a modified lottery system) are adapted from a current embodiment of allocative multi-modality outside the context of public health: the New York City Marathon.

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)

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)

This paper raises health equity concerns about the use of passports for domestic and international travel to certify COVID-19 vaccination. Part I argues that for international travel, health equity objections undercut arguments defending vaccine passports, which are based on tholding people responsible, protecting global health, safeguarding individual liberty and continuing current practice. Part II entertains a proposal for a scaled down vaccine passport for domestic use in countries where vaccines are widely and equitably available. It raises (...) health equity concerns related to racial profiling and fairness to people who are vaccine cautious. Part III sets forth a proposal for a flexible pass that certifies people who have been vaccinated, tested, previously infected or granted a conscientious objection. It sets ethical guidelines for the timing and use of flexible passes that promote equity, public health education, antidiscrimination, privacy and flexibility. (shrink)

This article discusses the triage response to the COVID-19 delta variant surge of 2021. One issue that distinguishes the delta wave from earlier surges is that by the time it became the predominant strain in the USA in July 2021, safe and effective vaccines against COVID-19 had been available for all US adults for several months. We consider whether healthcare professionals and triage committees would have been justified in prioritising patients with COVID-19 who are vaccinated above those who are unvaccinated (...) in first-order or second-order triage. Given that lack of evidence for a correlation between short-term survival and vaccination, we argue that using vaccination status during first-order triage would be inconsistent with accepted triage standards. We then turn to notions of procedural fairness, equity and desert to argue that that there is also a lack of justification for using vaccination status in second-order triage. In planning for future surges, we recommend that medical institutions base their triage decisions on principles meant to save the most lives, minimise inequity and protect the public’s trust, which for the time being would not be served by the inclusion of vaccination status. (shrink)

The manner in which limited vaccines are distributed during a pandemic is an ethical issue. The utility principle has been used to argue priority be given to certain individuals based on factors such as the epidemiology of the spread of disease and maintaining the functioning of society. The equity principle has been used to encourage fair practices that account for the economic and social costs of all decisions made. We argue that both principles are met through priority vaccination of (...) homeless individuals, as this strategy protects a medically vulnerable population while reducing the chances of transmission to others as they move through populated urban spaces. We begin by reviewing debates around ethical vaccine distribution. We then argue the homeless are a medically high-risk population who may contribute to the spread of disease through their mobility. As immunization rates are generally lower among the homeless and many do not access mainstream health care, we argue that community vaccine clinics must be used to reach these individuals. We provide support by analyzing Toronto Public Health’s operation of vaccine clinics in shelters and drop-in centres during pH1N1 and conclude that this strategy is effective for immunizing homeless individuals, bringing together the equity and utility principles. (shrink)

In the context of the global COVID-19 pandemic, the fast and equitable distribution of effective vaccines worldwide is one of the challenges faced by international institutions in charge, as global equity in vaccine supply has not yet been achieved. Our paper explains the current state of ethical research on equity in global COVID-19 vaccine allocation, focusing on the COVAX Facility established by the WHO, acting as the global vaccine distributor. The article presents a detailed analysis (...) of the first year of COVAX allocation in 2021 identifying problematic aspects of its allocation framework regarding the implementation of COVAX’s fundamental allocation principles. We argue that the COVAX Facility has developed a proper concept to deal with global vaccine allocation—but to address uncovered defaults, we introduce the ‘Prioritized Distribution of Equal Shares’ model—a both ethical and practically feasible alternative allocation framework to protect the value of human lives in both high- and low-income countries through fair and fast global vaccine distribution in health emergencies. Nonetheless, we argue that the COVAX Facility remains the main organization to provide equitable access to vaccines. Yet, the global community has to consider further aspects such as patent protection, vaccine production and the lack of power of global structures to address the inequities that have arisen. Since new wars and further crises have arisen, a shift in public global attention endangers the processing of COVID-19-related issues. That is why now more than ever extensive efforts to achieve vaccine equity are needed. (shrink)

The development of some COVID-19 vaccines by private companies like Moderna and Sanofi-GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the vaccine under (...) conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations. (shrink)

The development of some COVID-19 vaccines by private companies like Moderna and Sanofi-GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the vaccine under (...) conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations. (shrink)

The net benefit of vaccinating children is unclear, and vulnerable people worldwide should be prioritised instead, say Dominic Wilkinson, Ilora Finlay, and Andrew J Pollard. But Lisa Forsberg and Anthony Skelton argue that covid-19 vaccines have been approved for some children and that children should not be disadvantaged because of policy choices that impede global vaccination.

This study examines the procedural ethical considerations surrounding religious exemptions to Covid vaccine mandates, specifically focusing on immigrant healthcare personnel (HCP) and HCPs of color. It emphasizes communication issues with applicants by investigating exemption applications and their accompanying guidelines. While there is extensive literature on the ethical implications of religious exemptions, a notable gap remains in addressing the procedural aspects of religious exemption applications and their reviewing processes. The study scrutinized religious exemption application forms and accompanying guidelines from 32 (...) selected non-teaching and teaching hospitals for the years 2022–2023. The findings highlight significant variability in exemption application criteria and processes across institutions. Importantly, many application forms lacked comprehensive procedural information, which may result in subjective evaluations and potential misinterpretations of non-Western and non-mainstream religious beliefs, especially those of immigrant HCPs and HCPs of color. The study proposes various strategies to advocate for more equitable and transparent procedures, underlining the significance of diversity, equity, and inclusion in the religious exemption review process for vaccine mandates. (shrink)

While the unprecedented lockdown measures were at the heart of the debate in the first year of the pandemic, the focus since then has shifted to vaccination issues. The reason, of course, is that vaccines and vaccinations have become available by now. All experts agree: If mankind had failed to develop vaccines against SARS-CoV-2, the death toll would have been much higher. This issue seeks to explore what could be described as a “generational approach to vaccinations”. The question “What can (...) we do to avoid future pandemics?” is related to different aspects of the failures and successes of humanity’s vaccination strategy against SARS-CoV-2. Pathogens are among the existential risks to humanity that could potentially kill a large part of it in a very short time. For all the tragedy and horror it has brought upon the world, the Corona virus has not been lethal on such a large, all-encompassing scale. But it could serve as a wake-up call for more and better prevention in the future, put differently: as a call to build a “preventive society”. When people look back to the year 2022 from the year 2200, will they think of the absence of mandatory vaccination as a dangerous anachronism? And will the unequal global distribution of vaccines be seen as an unbearable vice of our epoch? And will “human infection studies” still be dismissed as unethical if a dangerous new virus boards human bodies? If intergenerational justice means improving the life chances and living conditions of future generations to the largest possible extent, then its link to (the avoidance) of infectious diseases is obvious. We should protect future generations from foreseeable damage if we have the power to do so. “We” is humankind in its entirety. Politically, humanity is divided into many single nations. But biologically, as members of the same species, we share the same vulnerability regardless of ethnicity. The regular reader of this journal might wonder why this issue of IGJR has a different structure. An unprecedented pandemic calls for an unprecedented reaction and therefore IGJR 1/2021 and 2/2021 are special issues that deal with this disruptive event. We have invited several health experts, politicians and scholars alike to share their perspectives in short opinion pieces (instead of regular peer-reviewed articles). And we are exploring something new: the publication of a FRFG policy paper. This policy paper starts off with a historical overview on how pandemics have afflicted humanity in the past. It separates moral from legal duties and formulates “epidemiological imperatives” – the way of thinking of a responsible and solidary individual facing the task of preventing an outbreak of epidemics in a community. With the discovery of vaccines, and their availability, the catalogue of duties is increased by one more: to get the jabs as an act of solidarity with others, including future generations. This would prevent states from being forced to take disease control measures that bring about drastic collateral damage. During the first two years of the Corona pandemic, states have imposed lockdowns. The closure of schools has put a special burden on the youngest members of society. This could have been prevented during the second and the further waves. The policy paper also calls for more government funding for prophylactic vaccine research and for the designation of vaccines as “global public goods”. The issue then moves on to a section dedicated to opinion papers by various different authors. The first paper, written by Agnes Binagwaho and Kedest Mathewos (both from University of Global Health Equity, Rwanda), focuses on the issue of health inequity, a concern which has gained more and more traction during the Covid-19 pandemic. The paper examines how vaccine distribution during the pandemic was mainly focused on the global north and how such actions might affect future generations’ perception of what is just, fair and morally correct. The second paper, by Samantha Vanderslott (University of Oxford), focuses on the right and wrongdoings connected to pandemic preparedness and response. The third paper, authored by Rajeev Sadanandan (Health Systems Transformation Platform, India), talks about the lessons that can and should be drawn from child immunisations. The fourth paper, by Adriano Mannino (LMU and Parmenides Foundation, Munich), delves into the question how future generations will assess our actions and our response to the current pandemic. The fifth and final paper, written by Jörg Tremmel (FRFG and University Tübingen), is centered around the question whether human infection studies could have been implemented during the early stages of the pandemic to minimise deaths and severe infections. The issue concludes with two reviews on recent books by Alberto Giubilini and Katie Wright. In his review of Giubilini’s The Ethics of Vaccination, Marius Kunte notes that it contains a “thought-provoking plea” for individual, collective and institutional obligations to reach high vaccination rates. Judith Kausch-Zongo concludes her review of Wright’s Gender, Migration and the Intergenerational Transfer of Human Wellbeing with a special emphasis on the book’s empirical findings, and praises it in its entirety as “undoubtedly important”. Both books serve as poignant reminders of how sustainable societies can only emerge once the challenges revolving around its most vulnerable members have been properly addressed. (shrink)

Effective vaccines for COVID‐19 are already available to humankind. In Peru, 86 million doses were administered to cover the demand for 33 million Peruvian people. Hence, vaccination has been prioritized in groups: health personnel, subjects with pre‐existing health conditions and those over 65 years of age. However, given the social problems and the public health situation in Peru, this work defends that the priority of vaccination should be focused on the population living in extreme poverty. The method used was an (...) ethical argumentation on the distribution of scarce antiSARS‐CoV2 vaccine in Peru. This argument is based on the analysis of the Peruvian population living in extreme poverty, which presents different layers of vulnerability, and that, in the face of an eventual SARS‐CoV2 infection, these would be exacerbated one after the other, through a cascade effect. This scenario would give rise to new vulnerabilities to those already existing, causing greater damage. Vaccination efforts on this key population would give them the opportunity to continue to find ways to bring food to their homes, significantly reducing the risk of contagion in their environment and mitigating the devastating effect of the local diseases to which they are already exposed. Four objections related to this argument are raised with their corresponding responses. Priority access to the vaccine would significantly reduce the humanitarian harm to people living in extreme poverty, prevailing the principles of justice and equity. (shrink)

Implementing equity principles in resource allocation is challenging. In one approach, some US states implemented race-based prioritisation of COVID-19 vaccines in response to vast racial inequities in COVID-19 outcomes, while others used place-based allocation. In a nationally representative survey of n=2067 US residents, fielded in mid-April 2021, we explored the public acceptability of race-based prioritisation compared with place-based prioritisation, by offering vaccines to harder hit zip codes before residents of other zip codes. We found that in general, a majority (...) of respondents supported the place-based approach, and a substantial proportion supported the race-based plan. Support was higher among Democrats compared with Republicans. All US residents became eligible for vaccines on 19 April 2021 but as of this writing, equitable uptake of vaccines remains urgent not only for first doses for adults but also for boosters and for children. Our findings also provide a benchmark for future pandemic planning that racial and social justice in vaccine allocation are salient considerations for the public. The findings may furthermore be of interest to policy makers designing vaccine allocation frameworks in countries with comparable health disparities across social, ethnic and racial groups, and more broadly, for those exploring ways of promoting equity in resource allocation outside of a pandemic setting. (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.

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)

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)

Although COVID-19 vaccines are free and readily available in the United States, many healthcare workers remain unvaccinated, potentially exposing their patients to a life-threatening pathogen. This paper reviews the ethical and legal factors surrounding patient requests to limit their care teams exclusively to vaccinated providers. Key factors that shape policy in this area include patient autonomy, the rights of healthcare workers, and the duties of healthcare institutions. Hospitals must also balance the rights of interested parties in the context of logistical (...) constraints, equity, and public health considerations. (shrink)

Monetary incentives to increase COVID-19 vaccinations are widely used. Even if they work, whether such payments are ethical is contested. This paper reviews ethical arguments for and against using monetary incentives that appeal to utility, liberty, civic responsibility, equity, exploitation, and autonomy. It concludes that in low-income nations and nations with meagre safety nets and income inequality, policy-makers should proceed with caution.

Equity was—and is—central in the US policy response to COVID-19, given its disproportionate impact on disadvantaged communities of colour. In an unprecedented turn, the majority of US states used place-based disadvantage indices to promote equity in vaccine allocation (eg, through larger vaccine shares for more disadvantaged areas and people of colour).We conducted a nationally representative survey experiment (n=2003) in April 2021 (before all US residents had become vaccine eligible), that examined respondents’ perceptions of the acceptability (...) of disadvantage indices relative to two ways of prioritising racial and ethnic groups more directly, and assessed the role of framing and expert anchors in shaping perceptions.A majority of respondents supported the use of disadvantage indices, and one-fifth opposed any of the three equity-promoting plans. Differences in support and opposition were identified by respondents’ political party affiliation. Providing a numerical anchor (that indicated expert recommendations and states’ actual practices in reserving a proportion of allocations for prioritised groups) led respondents to prefer a lower distribution of reserved vaccine allocations compared with the randomised condition without this anchor, and the effect of the anchor differed across the frames.Our findings support ongoing uses of disadvantage indices in vaccine allocation, and, by extension, in allocating tests, masks or treatments, especially when supply cannot meet demand. The findings can also inform US allocation frameworks in future pandemic planning, and could provide lessons on how to promote equity in clinical and public health outside of the pandemic setting. (shrink)

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts (...) of “donations” and “charity” with “vaccine equity” and the “empowerment” of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously. (shrink)

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts (...) of “donations” and “charity” with “vaccine equity” and the “empowerment” of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously. (shrink)

This paper considers the proposal to pay people to get vaccinated against the SARS-CoV-2 virus. The first section introduces arguments against the proposal, including less intrusive alternatives, unequal effects on populations and economic conditions that render payment more difficult to refuse. The second section considers arguments favouring payment, including arguments appealing to health equity, consistency, being worth the cost, respect for autonomy, good citizenship, the ends justifying the means and the threat of mutant strains. The third section spotlights long-term (...) and short-term best practices that can build trust and reduce ‘vaccine hesitancy’ better than payment. The paper concludes that people who, for a variety of reasons, are reluctant to vaccinate should be treated like adults, not children. Despite the urgency of getting shots into arms, we should set our sights on the long-term goals of strong relationships and healthy communities. (shrink)

Duty of care is the core ethical responsibility of healthcare workers. Getting the workforce vaccinated will provide safety to the public, protect the vulnerable population and provide a safe working environment. While most agree that healthcare workers should be prioritised in the vaccination programme, mandatory vaccination remains a complicated and contentious issue with political, legal and ethical dimensions. This study aims to determine the ethical considerations associated with mandatory vaccinations among healthcare workers. A total of 152 abstracts were identified of (...) which, 142 were excluded based on abstracts because they did not meet the inclusion criteria. The remaining ten articles were further evaluated with three articles that fit the inclusion criteria specifically discussing mandatory vaccination among healthcare workers and the ethical issues. Benefits, risks, effectiveness, equity and justice, autonomy, reciprocity and trust were used as a framework to discuss the ethical considerations which resonated both directly from the included papers, as well as more generally from the other literature associated with this search. There is limited literature on the topic of ethical considerations associated with COVID-19 mandatory vaccination of healthcare workers, as a systematic review identified only 3 papers. Benefits, risks, effectiveness, equity and justice, autonomy, reciprocity and trust were among the seven ethical considerations identified and discussed. (shrink)

The COVID-19 (SARS-CoV-2) pandemic dealt a severe blow to society as a whole and required countries to confront a situation that exceeded the limits of their borders. In this paper, we analyze how these countries as well as supranational organizations responded to this unprepared global emergency. We also explore what alternative models have been proposed in the wake of this crisis and propose some changes—other ways of acting—so that in future pandemics or global emergencies, we can deal with the situation (...) more effectively. (shrink)

PrécisFederally Qualified Health Centers (FQHCs) proved to be critical points of access for people of color and other underserved populations during the COVID-19 pandemic, administering 61% of their COVID-19 vaccinations to people of color, compared to the 40% rate for the overall United States’ vaccination effort. To better understand the approaches and outcomes of FQHCs in pandemic response, we conducted semi-structured interviews with FQHC health care providers and outreach workers and analyzed them using an inductive qualitative methodology.

One of the societal problems in a new influenza pandemic will be how to use the scarce medical resources that are available for prevention and treatment, and what medical, epidemiological and ethical justifications can be given for the choices that have to be made. Many things may become scarce: personal protective equipment, antiviral drugs, hospital beds, mechanical ventilation, vaccination, etc. In this paper I discuss two general ethical principles for priority setting (utility and equity) and explain how these principles (...) will often point in diverging directions. Moreover, each of these principles can be understood in different, again often competing, ways. Notwithstanding these controversies and conflicts, in the context of pandemic response there are at least some points of convergence: several policies can be justified by appeal to different ethical principles and theories. Convergence may be found with respect to a focus on saving the most lives (instead of other aggregative accounts); giving priority antiviral prophylaxis and therapy for life-saving pandemic responders; and, partly depending on epidemiology of the pandemic, to prioritise vaccination of children. Although decision-making about access to intensive care will involve choices with immediate tragic implications, the ethical complexity of these choices is relatively modest (although decisions will not be easy): there are persuasive moral reasons for giving priority to patients who are expected to benefit most within the shortest time. Finally, in the last section I tentatively argue that constraints on people’s freedom, as necessary for an effective public health approach, may support giving somewhat more weight to saving the most lives, than to concerns of equity. (shrink)

One question that has sometimes cropped up in the debate on triage and the management of scarce healthcare resources concerns patients’ merits, demerits, and responsibility with regard to their own medical condition. During the current pandemic, some have wondered, when it comes to accessing healthcare, whether patients who have refused vaccination—despite the availability of vaccines and pressure to get vaccinated from the health authorities—should be given the same priority as patients who have diligently undergone vaccination in accordance with the authorities’ (...) recommendations. The issue of patients’ merits and demerits is not new, and it did not emerge with the pandemic for the first time. In the past, the question was often posed whether terrorists have the right to receive the same treatment as their victims, with the same degree of priority, all clinical conditions being equal. Another issue that has been raised concerns patients suffering from diseases caused by unhealthy lifestyles that they have freely adopted: drinking, smoking, eating fatty foods, practising extreme sports, etc. The conclusion reached in the present article is that it is indeed possible to identify certain general rules for cases of this sort, as is shown by the literature on the topic. However, slavishly following these rules, even in exceptional cases for which it is impossible to make detailed provisions, can lead to disastrous consequences. Therefore, following Aristotle, the article seeks to take account both of the rule of justice and of equity, which is a form of “situational justice” capable of filling the gaps of general norms in the light of concrete cases. (shrink)

Objectives The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania. Methods We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program,. The respondents included teams from four clinical research centres and various collaborating partners. This paper analyses responses to (...) the question: What is Health Research for Development? Results Based on the stakeholders’ experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing. Conclusion Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country-specific context - map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision-making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development. (shrink)

The COVID-19 Vaccines Global Access Facility represents an unprecedented global collaboration facilitating the development and distribution of vaccines for COVID-19. COVAX pools and channels funds from state and non-state actors to promising vaccine candidates, and has started to distribute successful candidates to participating states. The WHO, one of the leaders of COVAX, recognised vaccine doses would initially be scarce, and therefore, prepared a two-staged allocation mechanism they considered fair. In the first stage, vaccine doses are distributed equally (...) among participating countries, while in the second stage vaccine doses will be allocated according to a country’s need. Ethicists have questioned whether this is the fairest distribution—they argue a country’s need should be taken into account from the start and correspondingly, have proposed a framework that treats individuals with equal moral concern, aims to minimise harm and gives priority to the worst-off. In this paper, we seek to explore these concerns by comparing COVAX’s allocation mechanism to a targeted allocation based on need. We consider which distribution would more likely maximise well-being and align with principles of equity. We conclude that although in theory, a targeted distribution in proportion to a country’s need would be more morally justifiable, when political realities are taken into account, an equal distribution seems more likely to avert a greater number of deaths and reduce disparities. (shrink)

Transplant centers and physicians in the United States have limited guidance on the information which they can and cannot provide to transplant candidates regarding donors of potential organs. Patients may refuse organs for a variety of reasons ranging from pernicious requests including racism to misinformation about emerging medicine as with the COVID-19 vaccine and infection. Patient autonomy, organ stewardship, and equity are often at odds in these cases, but precedent indeed exists to help address these challenges. This work (...) uses such cases to highlight the urgent need for uniform, national policy prohibiting informational requests unrelated to well-established risks. (shrink)

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair (...) disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children. (shrink)

In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one’s home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies. In Part II, I identify two types of tailored policies--activity-based and (...) group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and dining indoors. Group-based restrictions consider differences between groups with respect to risk and benefit. Examples are policies that treat children or senior citizens differently, policies that require travelers to quarantine when traveling to a new destination, and policies that treat individuals differently based on whether they have COVID-19 symptoms, have tested positive for COVID-19, have previous COVID-19 infection, or have been vaccinated against COVID-19. In Part III, I consider the public health law grounding of tailored policies in the principles of “least restrictive means” and “well-targeting.” I also examine how courts have analyzed tailored policies that have been challenged on fundamental rights or equal protection grounds. I argue that fundamental rights analyses typically favor tailored policies and that equal protection does not preclude the use of tailored policies even when imperfectly crafted. In Part IV, I consider three critiques of tailored policies, centering on the claims that they produce inequity, cause harm, or unacceptably limit liberty. I argue that we must evaluate restrictions comparatively: the question is not whether tailored policies are perfectly equitable, wholly prevent harm, or completely protect liberty, but whether they are better than untailored ones at realizing these goals in a pandemic. I also argue that evaluation must consider indirect harms and benefits as well as direct and apparent ones. (shrink)

Machine generated contents note: Preface; Introduction Angus Dawson; Part I. Concepts: 1. Resetting the parameters: public health as the foundation for public health ethics Angus Dawson; 2. Health, disease and the goal of public health Bengt Brülde; 3. Selective reproduction, eugenics and public health Stephen Wilkinson; 4. Risk and precaution Stephen John; Part II. Issues: 5. Smoking, health and ethics Richard Ashcroft; 6. Infectious disease control Marcel Verweij; 7. Population screening Ainsley Newson; 8. Vaccination ethics Angus Dawson; 9. Environment, ethics (...) and public health: the climate change dilemma Anthony Kessel and Carolyn Stephens; 10. Public health research ethics: is non-exploitation the new principle for population-based research ethics? John McMillan; 11. Equity and population health: toward a broader bioethics agenda Norman Daniels; 12. Health inequities James Wilson; Index. (shrink)

Zika virus was recognised in 2016 as an important vector-borne cause of congenital malformations and Guillain-Barré syndrome, during a major epidemic in Latin America, centred in Northeastern Brazil. The WHO and Pan American Health Organisation, with partner agencies, initiated a coordinated global response including public health intervention and urgent scientific research, as well as ethical analysis as a vital element of policy design. In this paper, we summarise the major ethical issues raised during the Zika epidemic, highlighting the PAHO ethics (...) guidance and the role of ethics in emergency responses, before turning to ethical issues that are yet to be resolved. Zika raises traditional bioethical issues related to reproduction, prenatal diagnosis of serious malformations and unjust disparities in health outcomes. But the epidemic has also highlighted important issues of growing interest in public health ethics, such as the international spread of infectious disease; the central importance of reproductive healthcare in preventing maternal and neonatal morbidity and mortality; diagnostic and reporting biases; vector control and the links between vectors, climate change, and disparities in the global burden of disease. Finally, there are controversies regarding Zika vaccine research and eventual deployment. Zika virus was a neglected disease for over 50 years before the outbreak in Brazil. As it continues to spread, public health agencies should promote gender equity and disease control efforts in Latin America, while preparing for the possibility of a global epidemic. (shrink)

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health (...) principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized. (shrink)

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health (...) principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized. (shrink)

Genetic resources are a key resource for much biomedical research. Pathogenic genetic resources are of value in the identification, surveillance, understanding, and development of vaccines, treatments, and other responses to major public threats such as pandemic influenza outbreaks. Significant attempts have been made to improve the international governance of infectious disease over the last decade, but the handling of pathogenic genetic resources remains contentious and problematic. The need to address the deficiencies in current arrangements (e.g., the World Health Organization's Pandemic (...) Influenza Preparedness Framework) is urgent because future outbreaks are likely to revert to the past situation in which developed states secured vaccine supplies for their own populations while leaving developing countries vulnerable to the pandemic. Thereby, the collaboration of developed countries with vital international systems such as the Global Influenza Surveillance and Response System is disincentivized. The current international approach to pathogenic genetic resources is based on the sovereign rights of states and access and benefit-sharing arrangements that stem from those rights. While this approach is consistent with international rules on other types of genetic resources, herein I argue that this is an inappropriate approach to pathogens on both political (serving public health goals) and ethical grounds (e.g., equity and justice). Instead I argue for a (modified) common heritage approach to pathogenic genetic resources, based on their intrinsic qualities (e.g., rapid mutation, easy transmissibility) and their value to global efforts to respond to disease outbreaks. I will further argue for de-linking access to these resources from benefit-sharing requirements; explaining that while there are strong justifications for both, their linkage (particularly for pathogenic genetic resources) is problematic and detrimental to the achievement of its intended goals (i.e., ensuring equitable benefit-sharing in return for access being granted). (shrink)

BackgroundThe COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for (...) a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.MethodsWe conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.ResultsFive main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.ConclusionsNumerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues. (shrink)

Digital COVID certificates are a novel public health policy to tackle the COVID-19 pandemic. These immunity certificates aim to incentivize vaccination and to deny international travel or access to essential spaces to those who are unable to prove that they are not infectious. In this article, we start by describing immunity certificates and highlighting their differences from vaccination certificates. Then, we focus on the ethical, legal, and social issues involved in their use, namely autonomy and consent, data protection, equity, (...) and international mobility from a global fairness perspective. The main conclusion of our analysis is that digital COVID certificates are only acceptable if they meet certain conditions: that they should not process personal data beyond what is strictly necessary for the aimed goals, that equal access to them should be guaranteed, and that they should not restrict people’s autonomy to access places where contagion is unlikely. We conclude that, if such conditions are guaranteed, digital COVID certificates could contribute to mitigating some of the most severe socioeconomic consequences of the pandemic. (shrink)

BackgroundThe coronavirus 2019 pandemic placed unprecedented pressures on healthcare services and magnified ethical dilemmas related to how resources should be allocated. These resources include, among others, personal protective equipment, personnel, life-saving equipment, and vaccines. Decision-makers have therefore sought ethical decision-making tools so that resources are distributed both swiftly and equitably. To support the development of such a decision-making tool, a systematic review of the literature on relevant ethical values and principles was undertaken. The aim of this review was to identify (...) ethical values and principles in the literature which relate to the equitable allocation of resources in response to an acute public health threat, such as a pandemic.MethodsA rapid systematic review was conducted using MEDLINE, EMBASE, Google Scholar, LitCOVID and relevant reference lists. The time period of the search was January 2000 to 6th April 2020, and the search was restricted to human studies. January 2000 was selected as a start date as the aim was to capture ethical values and principles within acute public health threat situations. No restrictions were made with regard to language. Ethical values and principles were extracted and examined thematically.ResultsA total of 1,618 articles were identified. After screening and application of eligibility criteria, 169 papers were included in the thematic synthesis. The most commonly mentioned ethical values and principles were: Equity, reciprocity, transparency, justice, duty to care, liberty, utility, stewardship, trust and proportionality. In some cases, ethical principles were conflicting, for example, Protection of the Public from Harm and Liberty.ConclusionsAllocation of resources in response to acute public health threats is challenging and must be simultaneously guided by many ethical principles and values. Ethical decision-making strategies and the prioritisation of different principles and values needs to be discussed with the public in order to prepare for future public health threats. An evidence-based tool to guide decision-makers in making difficult decisions is required. The equitable allocation of resources in response to an acute public health threat is challenging, and many ethical principles may be applied simultaneously. An evidence-based tool to support difficult decisions would be helpful to guide decision-makers. (shrink)

There is no cure or vaccine for HIV/AIDS. The only life-prolonging treatment available is antiretroviral (ARV) therapy. WHO estimates, however, that less than 5 percent of those who require treatment in developing countries currently enjoy access to these medicines. In Africa fewer than 50,000 people–less than 2 percent of the people in need–currently receive ARV therapy. These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely.The intensity of the debate concerning (...) access to life-prolonging medicines for the treatment of HIV/AIDS, and the heated rhetoric with which they are often conducted, suggest that these disagreements may be rooted in deeper disagreements of value. It is not obvious, however, what disagreements of value are at stake in this debate. By analyzing the statements of scholars, public officials, activist organizations, and private sector representatives, each of whom may endorse very different policy recommendations on access to HIV/AIDS drugs, we have identified and created a typology of the different sources of disagreement in the debate. We conclude that the central disagreements concerning access to medicines arise from competing understandings of how responsibilities for bringing remedy to hardships should be allocated to different agents and institutions. A central lesson that emerges from our analysis is that thinking about “health equity” must extend beyond the explanation and justification of goals, values, and ideals, and engage more honestly with the difficult question of how responsibilities for bringing remedy to health crises should be allocated in complex social contexts. (shrink)

This paper conducts a cost–benefit analysis of Australia’s Covid-19 lockdown strategy relative to pursuit of a mitigation strategy in March 2020. The estimated additional deaths from a mitigation strategy are 11,500 to 40,000, implying a Cost per Quality Adjusted Life Year saved by locking down of at least 11 times the generally employed figure of $100,000 for health interventions in Australia. The lockdowns do not then seem to have been justified by reference to the standard benchmark. Consideration of the information (...) available to the Australian government in March 2020 yields a similar ratio and therefore the same conclusion that lockdown was not warranted. If Australia experiences a new outbreak, and cannot contain it without resort to a nationwide lockdown, the death toll from adopting a mitigation strategy at this point would be even less than had it done so in March 2020, due to the vaccination campaign, lessons learned since March 2020, and because the period over which the virus would then inflict casualties would now be much less than the period from March 2020. This would favour a mitigation policy even more strongly than in March 2020. This approach of assessing the savings in quality adjusted life years and comparing them to a standard benchmark figure ensures that all quality adjusted life years saved by various health interventions are treated equally, which accords with the ethical principle of equity across people. (shrink)

BackgroundHuman infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs.MethodsWe conducted 6 deliberative focus groups and (...) 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials.ResultsStakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria.ConclusionsOur findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out. (shrink)

This paper argues in support of the WHO’s proposal to forego COVID-19 booster shots until 10% of people in every country are fully vaccinated. The Ethical Argument section shows that we save the most lives and ensure the least amount of suffering by allocating doses first to unvaccinated people. It also argues that there is a duty to support decent lives and to promote health equity, which establish that refraining from boosters is a requirement of justice, not charity. The (...) Replies to Objections section answers objections that appeal to pragmatism, nationalism, ownership, scientific advancement, self-interest, semantics and futility. The Conclusion section emphasizes that for now, wealthy nations should not boost vaccinated people’s immunity and should instead send doses to poorer nations where they are most urgently needed. No data was used in this study. (shrink)