SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues

August 12, 2020

Baay, Marc, and Pieter Neels

Biologicals : Journal of the International Association of Biological Standardization

Jenner applied the 1st vaccine with a hypothesis about the immunological mechanism he had just elucidated and his best intentions that he was right and the procedure would work. Today, more than a century later, here we are again, hands tied to the imminent effects of a pandemic; and we can not avoid to think that in order to reach that day of an effective and safe vaccine approval and global distribution, perhaps there’s a step of Jenner’s eureka we are missing. This article unfolds ethical sharp points about the human experiment models being discussed at ethical committees and thoroughly reflected on by the WHO. A controlled human infection model (CHIM) involves several ethical standards for the participants, which SARS-CoV-2 does not yet allow. It is outlined a nonexistent rescue therapy, and how even the lowest possible risk subject population can, in fact, end up with a delicate condition. The need of as much genetic diversity as possible for effective potential challenge agents could lead to misinformed volunteers to sign up for a life threatening experiment from which, as usual, they could back up from, but would now actually have to stay locked up in a quarantined Isolation Unit until the study ended. On the other hand, the authors write that we might be losing precious time with issues that a consent form and potential study subjects education could frankly solve. CHIMs are indeed promising, and maybe could be useful to speed up vaccine development, but we are no longer in the 1700s; therefore hypothesis and good intentions are not good enough, we need to know more about SARS-CoV-2 before we inoculate it on anyone.

Baay, Marc, and Pieter Neels. “SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues.” Biologicals : journal of the International Association of Biological Standardization, S1045-1056(20)30096-8. 15 Aug. 2020, doi:10.1016/j.biologicals.2020.08.006

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