Human infection trials are ethically problematic (UPDATE)

Sam Wood
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"Human infection trials with SARS-CoV-2 raises ethically challenging questions."

Human infection trials have a long and infamous history and should be considered with extreme caution. Professor Martin Michaelis and Dr Mark Wass of the School of Biosciences explain:

‘The announcement of human infection trials with SARS-CoV-2, the coronavirus that causes COVID-19, raises ethically challenging questions.

‘In recent decades, people have only been deliberately infected with pathogens for which a highly effective treatment has been available. In the case of COVID-19, this is not the case. If a participant develops severe disease, an effective treatment is lacking. Hence, such trials push the boundaries of what has been ethically acceptable in recent decades, in particular with regard to pre-pandemic perceptions.

‘Informed consent is also a challenging issue. You never really know whether people do understand what they sign up for. Although severe disease is less likely in young and healthy individuals, it is not without risk. And this is not just about the risk of death, it is also about long-term sequelae.

‘It is also not clear what kind of novel insights can be gained from such trials. Proponents argue that they will deliver new information on the disease and the immune response. However, the aim is to establish mild infections and it remains unclear what you can learn from this about severe and life-threatening disease.

‘Moreover, human infection experiments may enable challenge trials that test and directly compare the efficacy of vaccines in preventing SARS-CoV-2 infection. However, it remains unclear whether the response in young healthy individuals reflects that in individuals from high-risk groups.

‘Finally, there are typically more than 300,000, often more than 400,000 new confirmed COVID-19 cases globally per day and probably many more undetected ones. Hence, there should be enough scope for studying vaccines, the disease, and the immune response without a need to infect healthy individuals.

‘Taken together, human infection trials have a problematic history. The use of a pathogen, for which no effective treatment is available, challenges the boundaries of what is currently ethically acceptable and puts healthy individuals at risk. Hence, such decisions cannot be taken lately, in particular if the anticipated gain remains unclear.

Professor Martin Michaelis and Dr Mark Wass, School of Biosciences, University of Kent

Professor Michaelis and Dr Wass run a joint computational/ wet laboratory.  Dr Wass is a computational biologist with expertise in structural biology and big data analysis. Prof Michaelis’ research is focused on the identification and investigation of drugs and their mechanisms of action, with a focus on cancer and viruses. With regard to viruses, Prof Michaelis and Dr Wass work on virus-host cell interactions and antiviral drug targets.

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