Fauci’s Office Rejected Protocol for a Voluntary COVID Human Challenge Trial That Could Have Tested Therapies and Vaccines Faster

(p. 2) . . . the first Covid-19 human challenge study [was] just completed in Britain, where young, healthy and unvaccinated volunteers were infected with the coronavirus that causes Covid while researchers carefully monitored how their bodies responded.

. . ., there were those who decried deliberately infecting or “challenging” healthy volunteers with disease-causing pathogens. It violates the medical principle of “do no harm.” The trade-off is a unique opportunity to discover the causes, transmission and progression of an illness, as well as the ability to more rapidly test the effectiveness of proposed treatments.

. . .

Dr. [Matthew] Memoli [the director of the Laboratory of Infectious Diseases Clinical Studies Unit at the National Institute of Allergy and Infectious Diseases] has conducted numerous influenza challenge studies, and he prepared a protocol for a Covid challenge trial that the National Institute of Allergy and Infectious Diseases rejected last year because it was felt that not enough was known about the virus and that there were no effective rescue therapies, according to a statement from the office of the director, Dr. Anthony Fauci.

The consortium formed to run Britain’s Covid challenge trial, which included scientists who trained at the Common Cold Unit, had access to the British National Health Service’s robust, real-time data on Covid hospitalizations and deaths. The researchers designing the study said they felt confident that there was little risk to the healthy unvaccinated 18-to-30-year-old volunteers they recruited for the trial. There were no severe adverse events in the 36 people who participated, and they will continue to be monitored over the next year.

The aim of the study was to identify the lowest amount of virus to safely and reliably infect someone, so researchers can later easily test the efficacy of vaccines or antivirals on future challenge trial volunteers.

. . .

Dr. Fauci’s office said the institute has no plans to fund Covid-19 human challenge trials in the future. Many bioethicists support that decision. “We don’t ask people to sacrifice themselves for the good of society,” said Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. “In the U.S., we are very much about protecting individual rights and individual life and health and liberty, while in more communal societies it’s about the greater good.”

But Josh Morrison, a co-founder of 1Day Sooner, which advocates on behalf of more than 40,000 would-be human challenge volunteers, argues it should be his and other people’s right to take risks for the greater good. “Most people aren’t going to want to be in a Covid challenge study, and that’s totally fine, but they shouldn’t project their own choices on other people,” he said.

. . .

As one participant in Britain’s Covid human challenge trial put it: “You know the phrase ‘one interesting fact about yourself’ that strikes terror into everyone? That’s now solved forever. I did something that made a difference.”

For the full commentary, see:

Kate Murphy. “Are Human Challenge Trials Ethical?” The New York Times, SundayReview Section (Sunday, October 17, 2021 [sic]): 2.

(Note: ellipses, and bracketed words, added.)

(Note: the online version of the commentary has the date Oct. 14, 2021 [sic], and has the title “Britain Infected Volunteers With the Coronavirus. Why Won’t the U.S.?”)

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