Monica Magalhaes

Several tuberculosis (TB) vaccine candidates are currently advancing to late-stage clinical trials. Prisons in low-and middle-income countries harbor some of the highest rates of TB in the world, making persons deprived of liberty (PDL) an important population to prioritize for the introduction of effective vaccines. However, the inclusion in clinical trials raises significant ethical concerns due to a history of exploitation and mistreatment within medical research. To date, PDL own perspectives on participating in vaccine research have been largely overlooked. This multicenter qualitative study employed focus group (FG) discussions in seven state prisons across four of the five regions of Brazil, involving 91 incarcerated individuals (64 men and 27 female) between February and August 2024. The discussions explored participants’ perceptions regarding health in prisons, TB, vaccines in general, new TB vaccines, and their potential participation in research. Participants reported encountering difficulties in accessing healthcare services within the prison system and shared personal or indirect experiences with TB, as well as concerns about their family members being at risk for TB exposure. While they generally held positive perceptions about vaccines and trials, they emphasized the need for clear and transparent information, respect for individual autonomy, and assurances of accountability from researchers as conditions of their willingness to participate in future trials. PDL perceptions regarding participation in clinical trials for new TB vaccines are significantly influenced by their prior experiences with the prison health system and their level of trust in research institutions. To ethically and effectively include PDL in future research, it is crucial to prioritize respect for autonomy and transparent communication about the risks and potential benefits involved.

In the increasingly likely event of an engineered‐virus outbreak or pandemic of catastrophic potential, managing infectious aerosols to reduce transmission will be crucial. Now is the time to start preparing our buildings, public opinion, and regulatory environments for the infectious aerosol management interventions necessary to protect the public. But which interventions should governments and institutions invest in the most? We review the leading candidate methods for infectious aerosol management and discuss their respective advantages, disadvantages, and suitable settings. There is strong emerging evidence that two recently explored technologies, direct exposure to far‐ultraviolet‐C (UVC) light and triethylene glycol, are particularly efficacious and safe, but there remain open questions about the long‐term safety and efficacy of these interventions. In the meantime, we recommend other interventions—especially upper‐room UVC and in‐room air cleaners—for settings where most occupants regularly spend more than a small fraction of their day. We conclude by listing research questions about these interventions that still need to be researched in social science, product development, medicine, engineering, economics, and ethics.

Background Several tuberculosis (TB) vaccine candidates are currently advancing to late stage clinical trials. Prisons in low- and middle-income countries harbor some of the highest rates of TB in the world, making persons deprived of liberty (PDL) an important population to prioritize for the introduction of effective vaccines. However, their inclusion in clinical trials raises significant ethical concerns due to a history of exploitation and mistreatment within medical research. To date, PDL’s own perspectives on participating in vaccine research have been largely overlooked. This study aimed to understand the perceptions of PDL regarding TB, vaccines, and their potential participation in clinical trials of new TB vaccines. Methods This multicenter qualitative study employed focus group (FG) discussions in seven state prisons across four of the five regions of Brazil, involving 91 incarcerated individuals (64 men and 27 women). Participants were selected through convenience sampling and interviewed between February and August 2024. The FGs followed a standardized structure, exploring participants' perceptions regarding health in prisons, TB, vaccines in general, new TB vaccines, and their potential participation in research. The discussions were transcribed verbatim and analyzed using thematic content analysis. Results Participants reported encountering difficulties in accessing healthcare services within the prison system. They also shared personal or indirect experiences with TB, as well concerns about their family members being at risk for tuberculosis exposure. While participants generally held positive perceptions about vaccines and vaccine trials, they emphasized the need for clear and transparent information, respect for individual autonomy, and assurances of accountability from researchers as conditions of their willingness to participate in future TB vaccine trials. Conclusions PDL perceptions regarding participation in clinical trials for new TB vaccines are significantly influenced by their prior experiences with the prison health system and their level of trust in research institutions. To ethically and effectively include PDL in future research, it is crucial to prioritize respect for participant autonomy and transparent communication about the risks and potential benefits involved.

Blumenthal-Barby et al. (2022) are right. Philosophers should pay greater attention to bioethics and bioethicists should pay greater attention to insights from philosophy. This commentary extends t...

Orphan drug policy often gives ‘special treatment’ to rare diseases, by giving additional priority or making exceptions to specific drugs, based on the rarity of the conditions they aim to treat. This essay argues that the goal of orphan drug policy should be to make prevalence irrelevant to funding decisions. It aims to demonstrate that it is severity, not prevalence, which drives our judgments that important claims are being overlooked when treatments for severe rare diseases are not funded. It shows that prioritising severity avoids problems caused by prioritising rarity, and that it is compatible with a range of normative frameworks. The implications of a severity-based view for drug development are then derived. The severity-based view also accounts for what is wrong with how the current system of drug development unfairly neglects common diseases that burden the developing world. Lastly, the implications of a severity-based view for current orphan drug policies are discussed.

In human challenge trials, volunteers are deliberately infected with a pathogen to accelerate vaccine development and answer key scientific questions. In the U.S., preparations for challenge trials with the novel coronavirus are complete, and in the U.K., challenge trials have recently begun. However, ethical concerns have been raised about the potential for invalid consent or exploitation. These concerns largely reflect worries that challenge trial volunteers may be unusually risk-seeking or too economically vulnerable to refuse the payments these trials provide, rather than being motivated primarily by altruistic goals. We conducted the first large-scale survey of intended human challenge trial volunteers and found that SARS-CoV-2 challenge trial volunteers exhibit high levels of altruistic motivations without any special indication of poor risk perception or economic vulnerability. Findings indicate that challenge trials with the novel coronavirus can attract volunteers with background conditions, attitudes, and motivations that should allay key ethical concerns.

The vast majority of smokers become dependent on nicotine in youth. Preventing dependence has therefore been crucial to the recent decline in youth smoking. The advent of vaping creates an opportunity for harm reduction to existing smokers (mostly adults) but simultaneously also undermines prevention efforts by becoming a new vehicle for young people to become dependent on nicotine, creating an ethical dilemma. Restrictions to access to some vaping products enacted in response to the increase in vaping among youth observed in the United States since 2018 have arguably prioritized prevention of new cases of dependence—protecting the young—over harm reduction to already dependent adults. Can this prioritization of the young be justified? This article surveys the main bioethical arguments for prioritizing giving health benefits to the young and finds that none can justify prioritizing dependence prevention over harm reduction: any reasons for prioritizing the current cohort of young people at risk from vaping will equally apply to current adult smokers, who are overwhelmingly likely to have become nicotine-dependent in their own youth. Public health authorities’ current tendency to prioritize the young, therefore, does not seem to be ethically justified. Implications: This article argues that commonsense reasons for prioritizing the young do not apply to the ethical dilemma surrounding restricting access to vaping products.