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. 2020 Jul 14;38(33):5085-5088.
doi: 10.1016/j.vaccine.2020.06.007. Epub 2020 Jun 4.

COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies?

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COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies?

G Owen Schaefer et al. Vaccine. .

Abstract

While a human challenge study holds the prospect of accelerating the development of a vaccine for the coronavirus SARS-CoV-2, it may be opposed due to risks of harm to participants and researchers. Given the increasing number of human deaths and severe disruption to lives worldwide, we argue that a SARS-CoV-2 challenge study is ethically justifiable as its social value substantially outweighs the risks. Such a study should therefore be seriously considered as part of the global research response towards the COVID-19 pandemic. In this paper, we contribute to the debate by addressing the misperception that a challenge study for the coronavirus would lower scientific and ethical standards for vaccine research and development, and examine how it could be ethically conducted. We also set out information that needs to be disclosed to prospective participants to obtain their consent.

Keywords: Coronavirus; Covid-19; Ethics; Human challenge study; Pandemic; Vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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