A call from justice to support the people in Gaza

Using Madison Powers and Ruth Faden's definition of ‘well‐being,’ the authors argue that Israel, the international community and public health practitioners have a justice‐based obligation to assist the Palestinian people in the Occupied Palestinian Territories. Focusing on Palestinians in Gaza, the authors first outline a normative framework of justice, as articulated by Powers and Faden. Following Powers and Faden's assumption that empirical assessments of justice can be made using the six dimensions of well‐being, the authors next present current data on the living conditions in Gaza and describe how these conditions prevent residents from achieving sufficient levels of well‐being. Using these indicators to demonstrate that Palestinians living in Gaza suffer deficiencies in these dimensions of well‐being, the authors present a strong argument from justice to assist the residents of Gaza. The medical, public health, and bioethics community cannot sit idle while injustice continues.     

Bioethics and practical justice in the post‐COVID‐19 era

The ethical concept of justice, as it relates to the development and deployment of innovative health technologies, commands the fair and equitable distribution of burdens and benefits. In bioethics, specific guidance on practical strategies for achieving what this concept of justice demands are somewhat elusive. Drawing on issues of justice arising or likely to arise in the context of the search for a vaccine or cure for COVID‐19, this paper argues for a focus on the concept of “practical justice” in post‐pandemic bioethics work. To illustrate the value and promise of this concept, the paper reflects on an approach to achieving practical justice in health biotechnology research that is grounded in a commitment to offer technical assistance to developing and under‐resourced nations.     

Responsibility amid the social determinants of health

It is natural to think that there is a tight connection between whether someone is responsible for some outcome and whether it is appropriate to hold her accountable for that outcome. And this natural thought naturally extends to health: if someone is responsible for her health, then, all else being equal, she is accountable for it. Given this, some have thought that responsibility for health has an important role to play in distributing the benefits and burdens of healthcare. But there is a reason for caution. That health is influenced by social, economic, and environmental factors is a matter of consensus. And some have argued that in light of these social determinants of health, individuals are not typically responsible for their health, rendering inappropriate policies that employ a responsibility‐for‐health criterion. This debate implicates a number of overlapping concepts and questions that are often difficult to pull apart. And I worry that those who maintain that social determinants undermine responsibility for health have latched on to the wrong target. The social determinants of health are relevant to such policies, but, I argue, not by globally undermining responsibility. Rather, social determinants are sometimes responsibility‐undermining, sometimes responsibility‐preserving, and often relevant to whether we should hold individuals accountable for their health regardless of their responsibility. This calls for a more nuanced appraisal of the ways in which the social determinants of health are relevant to such policies. And here I attempt to provide one.     

Utilitarianism and the pandemic

There are no egalitarians in a pandemic. The scale of the challenge for health systems and public policy means that there is an ineluctable need to prioritize the needs of the many. It is impossible to treat all citizens equally, and a failure to carefully consider the consequences of actions could lead to massive preventable loss of life. In a pandemic there is a strong ethical need to consider how to do most good overall. Utilitarianism is an influential moral theory that states that the right action is the action that is expected to produce the greatest good. It offers clear operationalizable principles. In this paper we provide a summary of how utilitarianism could inform two challenging questions that have been important in the early phase of the pandemic: (a) Triage: which patients should receive access to a ventilator if there is overwhelming demand outstripping supply? (b) Lockdown: how should countries decide when to implement stringent social restrictions, balancing preventing deaths from COVID-19 with causing deaths and reductions in well-being from other causes? Our aim is not to argue that utilitarianism is the only relevant ethical theory, or in favour of a purely utilitarian approach. However, clearly considering which options will do the most good overall will help societies identify and consider the necessary cost of other values. Societies may choose either to embrace or not to embrace the utilitarian course, but with a clear understanding of the values involved and the price they are willing to pay.     

Medical crowdfunding and the virtuous donor

Patients and families are increasingly turning to crowdfunding to help them cover the cost of medical care. The ethics of crowdfunding has garnered some attention in the bioethical literature. In this paper I examine an ethical aspect of medical crowdfunding (MCF) that has received limited attention: the role of donors. I defend a virtue ethical approach to analyzing the role of donors in MCF. Vicious donation, where donors do not exercise the relevant virtues, can compound some of the ethical risks associated with MCF, as seen in the several recent, high‐profile cases. My primary contention in this paper is that encouraging donors to think about how donating to a particular campaign would measure against the virtues I outline could help to discourage acts of ethically problematic donation to MCF campaigns.     

Family size and vaccination among older individuals: The case of COVID-19 vaccine

While vaccination is generally considered efficient in protecting against transmissible diseases, the compliance is not complete in many countries. In this study, we investigate how an individual-specific factor – family size – affects the probability of getting vaccinated against COVID-19. To answer this research question, we focus on individuals above 50 years of age, who are at a higher risk of developing severe symptoms. The analysis uses the Survey of Health, Ageing and Retirement in Europe Corona wave, conducted in the summer of 2021. To identify the effect of family size on vaccination, we exploit an exogenous variation in the probability of having more than two children, due to the sex composition of two firstborns. We document that a larger family size increases the probability of receiving the COVID-19 vaccine among older individuals. This impact is economically and statistically significant. We propose several potential mechanisms behind this result and document that family size can be related to the higher probability of being exposed to the disease. This effect can be by knowing someone who tested positive for COVID-19 or had symptoms similar to it, and by network size and frequency of contact with children, before the outbreak of COVID-19.     

An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior

The Brazilian Federal Senate created a Parliamentary Inquiry Commission (CPI) to investigate the Bolsonaro government's irregularities in the management of the COVID-19 pandemic. One of the cases that drew attention was the research conducted by Prevent Senior, a private health insurance company, on the early treatment of COVID-19. The article analyzes the scientific validity of the research and the ethical problems related to its implementation. It is based on analysis of Prevent Senior's report of the clinical study, the Brazilian and USA clinical trial registries, the Senate's CPI report, and on the information reported by the media. This case of scientific fraud and political-ideological bias exemplifies how Prevent Senior, using a questionable protocol to enhance its reputation and gain government support, was instrumental in building the “early treatment” narrative for COVID-19, and shows how it served as a basis for a government public policy that promoted the use of ineffective drugs.     

SARS-CoV-2: Targeted managements and vaccine development

Infection with the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) results in diverse outcomes. The symptoms appear to be more severe in males older than 65 and people with underlying health conditions; approximately one in five individuals could be at risk worldwide. The virus’s sequence was rapidly established days after the first cases were reported and identified an RNA virus from the Coronaviridae family closely related to a Betacoronavirus virus found in bats in China. SARS-CoV-2 is the seventh coronavirus known to infect humans, and with the severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS), the only ones to cause severe diseases. Lessons from these two previous outbreaks guided the identification of critical therapeutic targets such as the spike viral proteins promoting the virus’s cellular entry through the angiotensin-converting enzyme 2 (ACE2) receptor expressed on the surface of multiple types of eukaryotic cells. Although several therapeutic agents are currently evaluated, none seems to provide a clear path for a cure. Also, various types of vaccines are developed in record time to address the urgency of efficient SARS-CoV-2 prevention. Currently, 58 vaccines are evaluated in clinical trials, including 11 in phase III, and 3 of them reported efficacy above 90 %. The results so far from the clinical trials suggest the availability of multiple effective vaccines within months.     

Recommendations on COVID-19 triage: international comparison and ethical analysis

On March 11, 2020 the World Health Organization classified COVID-19, caused by Sars-CoV-2, as a pandemic. Although not much was known about the new virus, the first outbreaks in China and Italy showed that potentially a large number of people worldwide could fall critically ill in a short period of time. A shortage of ventilators and intensive care resources was expected in many countries, leading to concerns about restrictions of medical care and preventable deaths. In order to be prepared for this challenging situation, national triage guidance has been developed or adapted from former influenza pandemic guidelines in an increasing number of countries over the past few months. In this article, we provide a comparative analysis of triage recommendations from selected national and international professional societies, including Australia/New Zealand, Belgium, Canada, Germany, Great Britain, Italy, Pakistan, South Africa, Switzerland, the United States, and the International Society of Critical Care Medicine. We describe areas of consensus, including the importance of prognosis, patient will, transparency of the decision-making process, and psychosocial support for staff, as well as the role of justice and benefit maximization as core principles. We then probe areas of disagreement, such as the role of survival versus outcome, long-term versus short-term prognosis, the use of age and comorbidities as triage criteria, priority groups and potential tiebreakers such as ‘lottery’ or ‘first come, first served’. Having explored a number of tensions in current guidance, we conclude with a suggestion for framework conditions that are clear, consistent and implementable. This analysis is intended to advance the ongoing debate regarding the fair allocation of limited resources and may be relevant for future policy-making.     

Association of disease severity and death outcome with vaccination status of admitted COVID-19 patients in delta period of SARS-COV-2 in mixed variety of vaccine background

To understand the effectual role of COVID-19 vaccination, we must analyze its effectiveness in dampening the disease severity and death outcome in patients who acquire infection and require hospitalization. The goal of this study was to see if there was an association between disease progression in admitted COVID-19 patients and their prior vaccination exposure. A prospective cohort study based on 1640 admitted COVID-19 patients were carried between June 2021 and October 2021. Depending on vaccination exposure they were divided into vaccinated (exposed) and unvaccinated (unexposed) groups, excluding partially vaccinated patients. Disease severity was assessed at admission on severity index scale. Disease progression to mortality or need of mechanical ventilation and survival were taken as outcome. Absolute difference with 95%CI and Risk Ratio were calculated using cross tabulation, Chi square test and multivariable logistic regression analysis. Among 1514 total analyzed cohort (median age, 53 years [IQR, 17,106]; 43.7% from 46 to 65 years of age group, 56.2% males,33.4% with no comorbid factor for disease progression) 369(24.4%) were vaccinated breakthrough cases and 1145(75.6%) were unvaccinated controls. 556(36.7%) progressed to death or mechanical ventilation, 958(63.3%) patients survived and were discharged home. Disease progression to death or mechanical ventilation was significantly associated with decreased likelihood of vaccination (24.9% among vaccinated breakthrough vs 40.5% unvaccinated controls, [Absolute difference ?15.6% 95%CI (?10.2% to ?20.6%); RR 0.615 95%CI (0.509, 0.744); p <.001]). This association was stronger for old age population and for increase time span between second dose of vaccine and onset of symptoms. There was no statistically significant difference among different types of vaccination and occurrence of outcome when compared to unvaccinated controls (RR 0.607(0.482, 0.763); 0.673(0.339, 1.33) and 0.623(0.441, 0.881) for Inactivated virus vaccine, mRNA and Adenovirus vector-based vaccine respectively. The patients who were fully vaccinated against SARS-COV-2 die or shift to mechanical ventilation less frequently than unvaccinated COVID-19 admitted patients.     

Antiphospholipid antibodies and risk of post-COVID-19 vaccination thrombophilia: The straw that breaks the camel's back?

Antiphospholipid antibodies (aPLs), present in 1–5 % of healthy individuals, are associated with the risk of antiphospholipid syndrome (APS), which is the most common form of acquired thrombophilia. APLs may appear following infections or vaccinations and have been reported in patients with COronaVIrus Disease-2019 (COVID-19). However, their association with COVID-19 vaccination is unclear. Notably, a few cases of thrombocytopenia and thrombotic events resembling APS have been reported to develop in recipients of either adenoviral vector- or mRNA-based COVID-19 vaccines.The aim of this review is therefore to speculate on the plausible role of aPLs in the pathogenesis of these rare adverse events.Adenoviral vector-based vaccines can bind platelets and induce their destruction in the reticuloendothelial organs. Liposomal mRNA-based vaccines may instead favour activation of coagulation factors and confer a pro-thrombotic phenotype to endothelial cells and platelets. Furthermore, both formulations may trigger a type I interferon response associated with the generation of aPLs. In turn, aPLs may lead to aberrant activation of the immune response with participation of innate immune cells, cytokines and the complement cascade. NETosis, monocyte recruitment and cytokine release may further support endothelial dysfunction and promote platelet aggregation. These considerations suggest that aPLs may represent a risk factor for thrombotic events following COVID-19 vaccination, and deserve further investigations.     

Absence of antibody responses to SARS-CoV-2 N protein in COVID-19 vaccine breakthrough cases

Understanding the risk factors for breakthrough coronavirus disease 2019 (COVID-19) (BC19) is critical to inform policy. Herein, we assessed Delta (Lineage B.1.617.2) variant-specific effectiveness of the BNT162b2 (Pfizer) vaccine and characterized Delta-driven BC19 cases (fully vaccinated individuals who get infected) with known-time-since-vaccination. In this longitudinal prospective study (January 21–October 30, 2021), 90 naïve and 15 convalescent individuals were enrolled at the initiation of vaccination. Samples from 27 unvaccinated individuals with previous laboratory-confirmed COVID-19 diagnosis were collected at a single time point. Longitudinal serology profile (antibodies against severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] S and N proteins) and live-virus-based neutralization capacities were assessed while controlling for age. Sex, age, history of reactions to the COVID-19 vaccine, and viral neutralization capacities were identified as significant risk factors for breakthrough COVID-19. At 8 months postvaccination, male sex, individuals ⩾65 years of age, and individuals who experienced noticeable side effects with the COVID-19 vaccine were at 5.47 (p-value = 0.0102), 4.33 (p-value = 0.0236), and 4.95 (p-value = 0.0159) fold greater risk of BC19 as compared to their peers, respectively. Importantly, every five-fold increase in viral neutralization capacities (by live-virus-based assays) was significantly associated with ~4-fold reduction in the risk occurrence of breakthrough COVID-19 (p-value = 0.045). Vaccine boosting remarkably increased these viral neutralization capacities by 16.22-fold (p- value = 0.0005), supporting the importance of the BNT162b2 booster in efforts to control the incursion of future variants into the population at large. Strikingly, BC19 cases exhibited a delayed/absent antibody response to the N protein, suggesting limited exposure to the virus. Since antibodies against N protein are widely used to evaluate the extent of virus spread in communities, our finding has important implications on the utility of existing serological diagnostic and surveillance for COVID-19.     

Immunogenicity,effectiveness and safety of COVID-19 vaccine in older adults living in nursing homes: A real-life study

IntroductionBNT162b2 (BioNTech and Pfizer) is a nucleoside-modified mRNA vaccine that provides protection against SARS-CoV-2 infection and is generally well tolerated. However, data about its efficacy, immunogenicity and safety in people of old age or with underlying chronic conditions are scarce.PurposeTo describe BNT162b2 (BioNTech and Pfizer) COVID-19 vaccine immunogenicity, effectiveness and reactogenicity after complete vaccination (two doses), and immunogenicity and reactogenicity after one booster, in elders residing in nursing homes (NH) and healthy NH workers in real-life conditions.MethodsObservational, ambispective, multicenter study. Older adults and health workers were recruited from three nursing homes of a private hospital corporation located in three Spanish cities. The primary vaccination was carried out between January and March 2021. The follow-up was 13 months. Humoral immunity, adverse events, SARS-CoV-2 infections, hospitalizations and deaths were evaluated. Cellular immunity was assessed in a participant subset.ResultsA total of 181 residents (mean age 84.1 years; 89.9% females, Charlson index ≥2: 45%) and 148 members of staff (mean age 45.2 years; 70.2% females) were surveyed (n:329). After primary vaccination of 327 participants, vaccine response in both groups was similar; ≈70% of participants, regardless of the group, had an antibody titer above the cut-off considered currently protective (260 BAU/ml). This proportion increased significantly to ≈ 98% after the booster (p < 0.0001 in both groups). Immunogenicity was largely determined by a prior history of COVID-19 infection. Twenty residents and 3 workers were tested for cellular immunity. There was evidence of cellular immunity after primary vaccination and after booster. During the study, one resident was hospitalized for SARS-CoV-2. No SARS-CoV-2-related deaths were reported and most adverse events were mild.ConclusionsOur results suggest that the BNT162b2 mRNA COVID-19 vaccine is immunogenic, effective and safe in elderly NH residents with underlying chronic conditions.     

Responsibility and the limits of patient choice

Patients are generally assumed to have the right to choices about treatment, including the right to refuse treatment, which is constrained by considerations of cost-effectiveness. Independently, many people support the idea that patients who are responsible for their ill health should incur penalties that non-responsible patients do not face. Surprisingly, these two areas have not received much joint attention. This paper considers whether restricting the scope of responsibility to pre-treatment decisions can be justified, or whether a demand to hold people responsible for 'usual suspect' choices such as smoking or failure to exercise commits us to also holding people responsible for their treatment choices. I argue that there is no good reason to support this restriction: those who advocate responsibility for (some) pre-treatment choices should also advocate responsibility for (some) treatment choices. However, I also note that, as with pre-treatment choices, patients may sometimes have reason to choose in ways that do not optimize their health. As such, I also consider a process, based on the idea of public reasons, for deciding which treatment choices patients cannot legitimately be held responsible for, along with a method for considering proposed changes to this category.     

Disparities in COVID-19 mortality by county racial composition and the role of spring social distancing measures

Available COVID-19 data shows higher shares of cases and deaths occur among Black Americans, but reporting of data by race is poor. This paper investigates disparities in county-level mortality rates across counties with higher and lower than national average Black population shares using nonlinear regression decomposition and estimates potential differential impact of social distancing measures. I find counties with Black population shares above the national share have mortality rates 2 to 3 times higher than in other counties. Observable differences in living conditions, health, and work characteristics reduce the disparity to approximately 1.25 to 1.65 overall, and explain 100% of the disparity at 21 days after the first case. Though higher rates of comorbidities in counties with higher Black population shares are an important predictor, living situation factors like single parenthood and population density are just as important. Higher rates of co-residence with grandchildren explain 11% of the 21 day disparity but do not appear important by 42 days, suggesting families may have been better able to protect vulnerable family members later in the epidemic. To analyze differential effects of social distancing measures use two approaches. First, I exploit the timing of interventions relative to the first case among counties that began their epidemic at the same time. Second, I use event study analysis to analyze within-county changes in mortality. Findings for social distancing measures are not always consistent across approaches. Overall, I find no evidence that school closures were less effective in counties with larger Black population shares, and some estimates suggest closures may have disproportionately helped more diverse counties and counties with high rates of grandparent and grandchild co-residence. Conversely, stay at home orders are less clearly associated with mortality in any counties, reaching peak unemployment did not reduce mortality in any models, and some estimates indicate reaching peak unemployment before the first case was associated with higher mortality rates, especially in more diverse counties.     

On the morality of vaccination tourism

Vaccination tourism (whereby citizens of one nation travel to a different, usually more developed nation to receive a vaccine unavailable or with little availability at home) during the COVID pandemic raises a host of moral issues and is usually met with criticism. From the perspective of the society of origin, the criticism is that those who use their socio-economic privileges to go abroad and receive the vaccine ahead of other citizens instead of ‘making the line’ act objectionably because in doing so they use their purchasing power to obtain a benefit that should not be distributed like any other product in the market. From the perspective of the society of destination, the criticism is that citizens and residents should receive the vaccines first; after all, their government purchased vaccines (with their taxes) to immunize the local population. The paper calls into question both objections to vaccination tourism. There might be other reasons to oppose it, but this pair of objections cannot ground a moral criticism of the practice.     

Structure-guided T cell vaccine design for SARS-CoV-2 variants and sarbecoviruses

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Rawlsian Justice and Palliative Care

Palliative care serves both as an integrated part of treatment and as a last effort to care for those we cannot cure. The extent to which palliative care should be provided and our reasons for doing so have been curiously overlooked in the debate about distributive justice in health and healthcare. We argue that one prominent approach, the Rawlsian approach developed by Norman Daniels, is unable to provide such reasons and such care. This is because of a central feature in Daniels' account, namely that care should be provided to restore people's opportunities. Daniels' view is both unable to provide pain relief to those who need it as a supplement to treatment and, without justice‐based reasons to provide palliative care to those whose opportunities cannot be restored. We conclude that this makes Daniels' framework much less attractive.     

Justifying the risks of COVID-19 challenge trials: The analogy with organ donation

In the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID vaccine, so it is important to evaluate their merit. One common way of doing so is to make an analogy to other social practices that are relevantly similar and which we currently sanction. We submit that non-directed live organ donation (NDLOD) is a promising analogy. After arguing that the risks to volunteers for each activity appear similar, we explore potential disanalogies that would undermine the comparison. We note that there are differences in both the kind and certainty of benefit secured by NDLOD compared to challenge trials. We conclude these differences are insufficient to make NDLOD permissible and challenge trials impermissible. Ultimately, if we think the risks associated with NDLOD are ethically permissible, then we should think the same of the risks associated with COVID challenge trials.     

Stopping the COVID-19 pandemic in dental offices: A review of SARS-CoV-2 transmission and cross-infection prevention

Due to the essential role of dentists in stopping the COVID-19 pandemic, the purpose of this review is to help dentists to detect any weaknesses in their disinfection and cross-contamination prevention protocols, and to triage dental treatments to meet the needs of patients during the pandemic. We used PRISMA to identify peer-reviewed publications which supplemented guidance from the center for disease control about infection control and guidelines for dentists. Dentists must triage dental treatments to meet the needs of patients during the pandemic. The ongoing pandemic has changed the practice of dentistry forever, the changes make it more cumbersome, time-consuming, and costly due to the possible pathways of transmission and mitigation steps needed to prevent the spread of COVID-19. Dental chairside rapid tests for SARS-CoV-2 are urgently needed. Until then, dentists need to screen patients for COVID-19 even though 75% of people with COVID-19 have no symptoms. Despite the widespread anxiety and fear of the devastating health effects of COVID-19, only 61% of dentists have implemented a change to their treatment protocols. As an urgent matter of public health, all dentists must identify the additional steps they can take to prevent the spread of COVID-19. The most effective steps to stop the pandemic in dental offices are to; vaccinate all dentists, staff, and patients; triage dental treatments for patients, separate vulnerable patients, separate COVID-19 patients, prevent cross-contamination, disinfect areas touched by patients, maintain social distancing, and change personal protective equipment between patients.