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  1. The Ethics of Human Challenge Trials Using Emerging SARS-CoV-2 Virus Variants.Abie Rohrig & Nir Eyal - manuscript
    The world’s first COVID-19 human challenge trial using the D614G strain of SARS-CoV-2 is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta variant (B.1.351) for a follow-up human challenge trial, and researchers at Imperial College London are considering conducting that trial. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. While vaccine resistance as such does not increase risks for volunteers in (...)
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    Exploring the ethics of tuberculosis human challenge models.Abie Rohrig, Josh Morrison, Gavriel Kleinwaks, Jonathan Pugh, Helen McShane & Julian Savulescu - forthcoming - Journal of Medical Ethics.
    We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3–5 years earlier, then (...)
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  3. Exploring the Ethics of Tuberculosis Human Challenge Models.Abie Rohrig, Josh Morrison, Jonathan Pugh, Julian Savulescu & Helen McShane - manuscript
    TB human challenge studies could accelerate TB vaccine development by reducing uncertainty in early-stage vaccine testing, selecting promising vaccine candidates for large-scale field trials, and identifying an immune correlate of protection. However, ethical concerns regarding the exposure of trial participants and bystanders to significant risk have been a limiting factor for TB human challenge models. We analyze the expected social value and risks of different types of TB human challenge models, and conclude that given the massive public health burden of (...)
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  4. Ethical Considerations for International Recruitment in COVID-19 Human Challenge Trials.Kaleem Ahmid, Abie Rohrig, Paul Ndebele, Zacharia Kafuko & Josh Morrison - manuscript
    Ongoing and anticipated COVID-19 human challenge studies in the UK may advance our understanding of COVID-19 and facilitate the licensure of safe, effective, and easily deployable next-generation COVID-19 vaccines and boosters. We argue that international volunteer recruitment for COVID-19 human challenge trials can help promote diversity in these trials and ensure a sufficient number of eligible volunteers, both of which will increase the benefits of challenge research. We explore the ethical ramifications of dealing with unfair background conditions of global vaccine (...)
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