WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Immunity certification for COVID-19: ethical considerations.

Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights.

Les restrictions imposées dans le cadre de la lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) ont eu de lourdes conséquences économiques, sociales et sanitaires. Certains pays ont envisagé la mise en place d'une stratégie visant à alléger ces restrictions pour les individus guéris en leur octroyant un document communément appelé «passeport d'immunité¼. Ce document atteste qu'ils ont développé une immunité protectrice contre le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2), le virus à l'origine de la COVID-19. L'Organisation mondiale de la Santé a déconseillé l'usage du certificat d'immunité pour l'instant, car l'incertitude demeure quant à l'existence réelle d'une immunité à long terme pour ceux qui se sont remis de la COVID-19. En outre, la fiabilité des tests sérologiques censés déterminer si l'individu est immunisé n'est pas avérée. Un tel certificat ne peut être instauré que si les seuils scientifiques en matière d'immunité sont respectés, qu'ils soient fondés sur les anticorps ou sur d'autres critères. Néanmoins, même si le certificat d'immunité est désormais bien accepté par la science, il s'accompagne de nombreuses questions d'ordre éthique en ce qui concerne la limitation des libertés individuelles et la mise en œuvre. Dans le présent document, nous examinons les principales considérations à prendre en compte pour garantir l'acceptabilité éthique du certificat d'immunité visant à lever les mesures de restriction pour certaines personnes durant la pandémie de COVID-19. Cette acceptabilité éthique dépend non seulement de son degré de conformité à des critères scientifiques stricts, mais aussi de son usage, des objectifs politiques ainsi que des mesures mises en place pour atténuer les préjudices potentiels et éviter d'imposer une charge disproportionnée sur les individus dépourvus de certificat, ou de bafouer les droits et libertés de tout un chacun.

Las medidas restrictivas impuestas a causa de la pandemia de la enfermedad coronavirus de 2019 (COVID-19) han tenido graves efectos sociales, económicos y sanitarios. Algunos países han considerado la posibilidad de utilizar la certificación de inmunidad como estrategia para flexibilizar dichas medidas para las personas que se han recuperado de la infección mediante la expedición a dichas personas de un documento, comúnmente denominado pasaporte de inmunidad. Este documento certifica que han desarrollado inmunidad protectora contra el coronavirus-2 del síndrome respiratorio agudo severo (SARS-CoV-2), el virus que causa la COVID-19. La Organización Mundial de la Salud ha desaconsejado la aplicación de la certificación de la inmunidad en la actualidad debido a la incertidumbre sobre si existe realmente una inmunidad a largo plazo para quienes se han recuperado de la COVID-19 y a las preocupaciones sobre la fiabilidad del método de prueba serológica propuesto para determinar la inmunidad. La certificación de la inmunidad solo puede considerarse si se cumplen los umbrales científicos para asegurar la inmunidad, ya sea que se basen en anticuerpos o en otros criterios. Sin embargo, incluso si la certificación de la inmunidad llegara a estar bien respaldada por la ciencia, tiene muchas cuestiones éticas en cuanto a las diferentes restricciones de las libertades individuales y su proceso de aplicación. Examinamos las principales consideraciones sobre la aceptabilidad ética de la certificación de la inmunidad para eximir a los individuos de las medidas restrictivas durante la pandemia de la COVID-19. Además de necesitar cumplir criterios científicos sólidos, la aceptabilidad ética de la certificación de inmunidad depende de sus usos y objetivos de política y de las medidas que se apliquen para reducir los posibles daños y evitar que se impongan cargas desproporcionadas a las personas que no cuenten con dicha certificación y se violen las libertades y derechos individuales.

Top five ethical lessons of COVID-19 that the world must learn.

As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned.

Ethical Considerations for Restrictive and Physical Distancing Measures in Brazil During COVID-19: Facilitators and Barriers.

COVID-19 was recognized as a pandemic on March 11, 2020. Nine days later in Brazil, community transmission was deemed ongoing, and following what was already being put in place in various affected countries, restrictive and physical distancing measures that varied in severity across the different states were adopted. Adherence to restrictive and physical distancing measures depends on the general acceptance of public health measures as well as communities' financial leverage. This article aims to explore and discuss ethical facilitators and barriers to the implementation of physical distancing measures within three dimensions: political, socio-economic, and scientific. Furthermore, we would like to discuss ways to ethically promote restrictive and physical distancing measures in a large and unequal country like Brazil. There is an urgent need for transparent, consistent, and inclusive communication with the public, respecting the most vulnerable populations and attempting to minimize the disproportionate burden on them.

Ethical conditions for accelerating COVID-19 vaccine research [version 1;peer review: awaiting peer review]

There is a dire need to produce a safe and effective coronavirus disease 2019 (COVID-19) vaccine as quickly as possible to avert an enormous burden of morbidity and mortality. This need for speed has thus far resulted in significant deviations from standard approaches to vaccine research and regulatory approval. Yet, pandemics do not obviate the need for rigorous scientific evaluation of potential interventions and adherence to universal ethical standards. Consequently, steps taken to accelerate clinical research in the context of the current pandemic require an explicit ethical justification, particularly if we expect public trust in the vaccine. We argue that accelerating COVID-19 vaccine research can be ethically justified, but only if social value, scientific validity, and a favourable risk-benefit ratio can be maintained or enhanced when doing so.

Adults at high-risk of severe coronavirus disease-2019 (Covid-19) in Brazil.

OBJECTIVE To estimate the proportion and total number of the general adult population who may be at higher risk of severe Covid-19 in Brazil. METHODS We included 51,770 participants from a nationally representative, household-based health survey (PNS) conducted in Brazil. We estimated the proportion and number of adults (≥ 18 years) at risk of severe Covid-19 by sex, educational level, race/ethnicity, and state based on the presence of one or more of the following risk factors: age ≥ 65 years or medical diagnosis of cardiovascular disease, diabetes, hypertension, chronic respiratory disease, cancer, stroke, chronic kidney disease and moderate to severe asthma, smoking status, and obesity. RESULTS Adults at risk of severe Covid-19 in Brazil varied from 34.0% (53 million) to 54.5% (86 million) nationwide. Less-educated adults present a 2-fold higher prevalence of risk factors compared to university graduated. We found no differences by sex and race/ethnicity. São Paulo, Rio de Janeiro, Minas Gerais, and Rio Grande do Sul were the most vulnerable states in absolute and relative terms of adults at risk. CONCLUSIONS Proportion and total number of adults at risk of severe Covid-19 are high in Brazil, with wide variation across states and adult subgroups. These findings should be considered while designing and implementing prevention measures in Brazil. We argue that these results support broad social isolation measures, particularly when testing capacity for SARS-CoV-2 is limited.