Do coronavirus vaccine challenge trials have a distinctive generalisability problem?

Journal of Medical Ethics 48 (9):586-589 (2022)
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Abstract

Notwithstanding the success of conventional field trials for vaccines against COVID-19, human challenge trials that could obtain more information about these and about other vaccines and further strategies against it are about to start in the UK. One critique of COVID-19 HCTs is their distinct paucity of information on crucial population groups. For safety reasons, these HCTs will exclude candidate participants of advanced age or with comorbidities that worsen COVID-19, yet a vaccine should protect such populations. We turn this cliché on its head. The truth is that either an HCT or a field trial has intrinsic generalisability limitations, that an HCT can expedite protection of high-risk participants even without challenging them with the virus, and that an important route to obtaining results generalisable to high-risk groups under either strategy is facilitated by HCTs. There are no data in this work.

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Nir Eyal
Harvard University