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More than 20,000 people have signed up to be voluntarily exposed to the new coronavirus in a “human classified trial” that has yet to be formulated. The trial, led by a group called 1Day Sooner, aims to accelerate vaccine development, but has no connection to the companies currently working on one.
The group is looking for healthy volunteers between the ages of 20 and 45 who have no underlying medical conditions.
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“We want to recruit as many people as possible who wish to do so and pre-qualify them as likely to be able to participate in challenge events if they occur,” Josh Morrison, co-founder of 1Day Sooner, previously told Nature. “At the same time, we believe that public policy decisions regarding challenge trials will be better informed if they highlight the voices of those interested in participating in such trials.”
Human provocation tests deliberately expose volunteers to infection in order to study possible diseases and vaccines or treatments. Similar trials are conducted each year with seasonal flu. In one case, the Center for Vaccine Development at St. Louis University offered $ 3,500 to volunteers who wish to become exposed to the flu virus after receiving the vaccine or a placebo.
“It is currently uncertain how many COVID-19 people will affect in the world and how quickly its impacts will be felt,” said the 1Day Sooner website. “Possible outcomes are determined by interventions such as social isolation, the capacity of health systems, potential drug treatments and many other factors. A vaccine may arrive after the peak of infection or after effective pharmaceutical treatments have mitigated the impact of COVID-19. But it is clear that COVID-19 will continue to change daily life until an effective vaccine is fully deployed. “
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On Thursday, more than 20,000 people from 102 countries signed up to volunteer for the hypothetical test. The human provocation tests for the coronavirus have the support of 35 members of the House of Representatives who have written to the Food and Drug Administration and the Department of Health and Human Services arguing that they should be authorized.
According to the group’s website, the trial, which has no potential start date and could by some estimates take up to two years, aims to recruit volunteers who are already likely to have been exposed to COVID- 19, and they would be isolated in “highly controlled environments under constant observation”. Participants would receive the candidate vaccine or placebo and then be exposed to a live coronavirus so that researchers can determine the effectiveness of the candidate vaccine.
“If an infection is detected, they will receive excellent medical treatment,” the group said. “Hopefully pharmaceutical treatments will also be available when a study is conducted. “
However, Anna Durbin, a vaccine researcher at Johns Hopkins University, who was involved in an unsuccessful attempt at a human provocation trial involving the Zika virus, said that a problem for the COVID-19 challenge could be to determine the amount of virus to be exposed to participants. to develop a detectable disease.
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“What will your endpoints be? She said, speaking to Stat News. “You know, do you want to give people pneumonia?” I hope not. You want people who feel bad to some extent, who definitely know they are sick. And what is this balance or what is the line between feeling crappy and developing pneumonia, I think one of the scary things is that we really don’t know what it is. “
Morrison told Nature that the volunteers “generally recognize the risk but believe that the benefits of accelerating the vaccine are so huge that it will be worth it for them.”