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Vaccine . Assessing the risks of current COVID-19 challenge trials systematically

tetano

Editor, Senior Moderator
Vaccine


. 2025 Feb 26:126877.
doi: 10.1016/j.vaccine.2025.126877. Online ahead of print. Assessing the risks of current COVID-19 challenge trials systematically

Nir Eyal[SUP] 1 [/SUP], David Wendler[SUP] 2 [/SUP]



Affiliations
Abstract

A large international collaboration has started a series of SARS-CoV-2 (COVID) human challenge trials (HCTs). However, critics of previously proposed COVID HCTs deemed them unethical for posing excessive risks to participants. These concerns raise the need to evaluate the risks of the planned COVID HCTs. Systematic analysis reveals that, although the risks of these trials would be high in some populations, they are clearly acceptable for eligible individuals and may even qualify as "minimal" for them. This conclusion is important for evaluating the planned COVID HCTs and highlights the importance of assessing the risks of later COVID HCTs and HCTs in future pandemics systematically.

Keywords: Assessment; Challenge trials; Coronavirus; Ethics; Minimal risk; Risk benefit; SARS-CoV-2 omicron variant.

 
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