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Fauci's 'Plan D': US to manufacture coronavirus strain to use in human challenge trials to speed up vaccines

Human challenge trials involve injecting a group of healthy and young volunteers with a potential vaccine and then deliberately infecting them with a coronavirus strain
PUBLISHED AUG 15, 2020
(Getty Images)
(Getty Images)

The US is open to the option of embracing human challenge trials --a controversial approach that could speed up the vaccine development process -- if a situation demands it. To that end, scientists are working on manufacturing a strain of the new coronavirus.

Human challenge trials involve injecting a group of healthy and young volunteers with a potential vaccine and then deliberately exposing them to a manufactured coronavirus strain. The experimental vaccine will be deemed effective only if it can keep a large number of participants from catching the disease.

Currently, the work is preliminary, the National Institute of Allergy and Infectious Diseases' (NIAID) told Reuters. The human challenge studies will not replace the ongoing large-scale, phase 3 trials by Moderna and Pfizer, they added. Reports suggest that manufacturers such as AstraZeneca and Johnson & Johnson are willing to consider human challenge trials to test their vaccine candidates if the need arises.

"Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for SARS-CoV-2, NIAID has begun investigations of the technical and ethical considerations of conducting human challenge studies,” the agency statement said. In other words, the efforts will ensure a strain is ready if the country has to adopt human challenge trials.

 Dr. Anthony Fauci, a member of the White House Coronavirus Task Force and the director of NIAID, described human challenge trials as "Plan D"(Getty Images)

Confirming the news, Dr Anthony Fauci, a member of the White House Coronavirus Task Force and the director of NIAID, called the approach "Plan D". "Quite frankly, I don't think this is something we're going to use," he told CNN.To prepare for human challenge trials, scientists are looking at ways of manufacturing a new coronavirus strain, drafting a protocol, and identifying resources that can help conduct such studies, NIAID explained. 

Fauci, however, said human challenge studies help when a disease is not circulating, which is not the case with Covid-19.  He also added that the controversial measure might not be necessary. The decision to consider it "was more or less because of a lot of pressure about what happens if you don't do it. We kept on getting asked," he explained.

Human challenge studies are not new: it was used against smallpox, yellow fever, and malaria in the past. But some experts have said it is unethical to apply it for Covid-19 because some victims are young. Besides, there are no “rescue therapies” for volunteers who gravely fall sick. "A single death or severe illness in an otherwise healthy volunteer would be unconscionable and would halt progress," they wrote in a commentary in New England Journal of Medicine. 

There is also another issue with human challenge studies: they are only tested on young and healthy people. “A 20-year-old in a challenge study isn’t really going to give us the answer of will this vaccine keep an older person, someone with chronic kidney disease, from ending up in the hospital,” University of Maryland School of Medicine’s Dr. Kathleen Neuzil, told Reuters. She is a co-leader of the Coronavirus Vaccine Prevention Network, which was formed by NIAID and is testing Covid-19 vaccines.

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