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Covid-19 vaccines: Should we allow human challenge studies to infect healthy volunteers with SARS-CoV-2?

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4258 (Published 09 November 2020) Cite this as: BMJ 2020;371:m4258

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Vacuity of the ethical case against challenge studies for Covid

Dear Editor

Penetrate the padding of the “No” to challenge studies [1] and you’ll reach the bare skeletal essence – what is called “ethics”, the revelation of which is believed to make the “Yes” case disappear, as once did the showing of garlic to the devil. I am reminded of what Hermann Goring is not known to have said, “Whenever I hear the word ethics I reach for my revolver”; the term is used as if it has the same absolute power as the second law of thermodynamics: so if something’s “unethical” that’s it; case made.

Weijer must, of course, be allowed his personal belief that “It would be unethical to allow healthy volunteers to be infected with wild type SARS-CoV-2”, but he cannot present it as evidence based. “Unethical” says nothing about the strength of the case needed for its support; nor does it refute the logic of the simple “Yes” case for challenge studies with Covid, that has already been made: namely, that the risk to healthy volunteers aged 20 to 30 is minuscule and individual, and the benefits are universal and enormous. The ethicists who consider one life lost more important than thousands saved should retreat to their corner to play with their philosophical toy.

Sam Shuster

1 Weijer BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4258 (Published 09 November 2020)

Competing interests: No competing interests

24 November 2020
Sam Shuster
emeritus professor of dermatology
Newcastle University
Woodbridge, Suffolk

Re: Covid-19 vaccines: Many ADRs are already expected

Dear Editor

The Ted-tenders electronic daily: Supplement to the Official Journal of the EU, details a contract negotiated by the Medicines and Healthcare Products Agency (MHRA), dated 14.9.20 (1).

It states: “The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed”.

It further explains: “For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool…… it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health”.

Why do they expect that a high volume of ADRs will be generated?

And would it not be more sensible to determine the safety profile of a Covid-19 vaccine while the stable door is shut, rather than monitor the galloping horse once it has bolted?

(1) https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0

Competing interests: No competing interests

11 November 2020
Janet Menage
GP retired
None
Wales, UK
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