Extraordinary diseases require extraordinary solutions

Plotkin, Stanley А.; Caplan, Arthur L.

doi:10.1016/j.vaccine.2020.04.039

Cited by 64 publications

(64 citation statements)

References 8 publications

(8 reference statements)

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“…SARS-CoV-2 CHIMs could minimize the uncertainty about exposure or disease acquisition inherent in field trials, thereby reducing the number of participants needed to establish the desired end point, and elucidate the duration of immunity conferred by vaccines undergoing field trials [108]. Importantly, ethical considerations related to SARS-CoV-2 CHIMs have been raised as to whether the societal benefits are sufficient to justify the risks posed by deliberately exposing humans to SARS-CoV-2 [109][110][111].…”

Section: Generating More Reliable Data Under Time Constraintsmentioning

confidence: 99%

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

et al. 2020

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Accumulating evidence suggests that obesity is a major risk factor for the initiation, progression, and outcomes of coronavirus disease 2019 (COVID-19). The European Association for the Study of Obesity (EASO), as a scientific and medical society dedicated to the promotion of health and well-being, is greatly concerned about the concomitant obesity and COVID-19 pandemics and their impact on health and society at large. In this perspective, we will address the inherent immunological perturbations and alterations in the renin-angiotensin-aldosterone system in patients with obesity and COVID-19, and discuss how these impairments may underlie the increased susceptibility and more detrimental outcomes of COVID-19 in people with obesity. Clearly, this has important implications for preventive measures, vaccination, and future therapeutic strategies to combat COVID-19. Furthermore, we will highlight important knowledge gaps and provide suggestions for future research and recommendations for policy actions. Since many new reports on COVID-19 rapidly appear, the present perspective should be seen as a focus for discussion to drive forward further understanding, research initiatives, and clinical management of COVID-19.

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Section: Generating More Reliable Data Under Time Constraintsmentioning

confidence: 99%

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

et al. 2020

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“…3 In other cases, emergencies will inspire proposals for new, extraordinary research strategies, such as the human challenge trials that recently have received renewed attention as a potential component of stage III clinical trials for COVID-19 vaccines. 6 Rather than necessitating entirely novel medical ethics, such extraordinary proposals must be-and are being-scrutinised through the lens of well-established ethical frameworks. 7 There are certain conditions, where researchers and bioethicists have raised questions as to whether clinical trials should proceed in the first place.…”

Section: Introductionmentioning

confidence: 99%

Ethical considerations for epidemic vaccine trials

Monrad

2020

J Med Ethics

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

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“…While it is uncertain if this approach will be required, the WHO is progressing a framework, including key criteria, that will be required by ethical review boards in order to facilitate “human challenge” trials ( 172 ). As noted by Stanley Plotkin, “Extraordinary diseases require extraordinary solutions” ( 173 ).…”

Section: Potential Challenges In Sars-cov-2 Vaccine Developmentmentioning

confidence: 99%

Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines

et al. 2020

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There are currently around 200 SARS-CoV-2 candidate vaccines in preclinical and clinical trials throughout the world. The various candidates employ a range of vaccine strategies including some novel approaches. Currently, the goal is to prove that they are safe and immunogenic in humans (phase 1/2 studies) with several now advancing into phase 2 and 3 trials to demonstrate efficacy and gather comprehensive data on safety. It is highly likely that many vaccines will be shown to stimulate antibody and T cell responses in healthy individuals and have an acceptable safety profile, but the key will be to confirm that they protect against COVID-19. There is much hope that SARS-CoV-2 vaccines will be rolled out to the entire world to contain the pandemic and avert its most damaging impacts. However, in all likelihood this will initially require a targeted approach toward key vulnerable groups. Collaborative efforts are underway to ensure manufacturing can occur at the unprecedented scale and speed required to immunize billions of people. Ensuring deployment also occurs equitably across the globe will be critical. Careful evaluation and ongoing surveillance for safety will be required to address theoretical concerns regarding immune enhancement seen in previous contexts. Herein, we review the current knowledge about the immune response to this novel virus as it pertains to the design of effective and safe SARS-CoV-2 vaccines and the range of novel and established approaches to vaccine development being taken. We provide details of some of the frontrunner vaccines and discuss potential issues including adverse effects, scale-up and delivery.

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Extraordinary diseases require extraordinary solutions

Cited by 64 publications

References 8 publications

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

Ethical considerations for epidemic vaccine trials

Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines

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