The general goal is to try and distance yourself as much as possible from the novel coronavirus. However, a controversial approach called 1 Day Sooner is aiming to purposely infect a large number of volunteers with the virus to speed up clinical trials.
When Health24 reported on this approach in late April 2020, 2 300 volunteers had already signed up for this grassroots effort. But that number has now grown to more than 16 000, according to the latest reports.
What is the goal of this approach?
Co-founder Josh Morrison wants to use this campaign to demonstrate that many people are keen to participate in helping to speed up clinical trials and the possible success of a vaccine.
Without a successful vaccine or treatment, the only reality is to live with the virus and practice measures of physical distancing. A vaccine is the only way to return to a normal world as we know it. Unfortunately, developing a vaccine takes a long time and comprises several stages – the four phases of clinical trials being crucial to establish safety and efficacy in a large, diverse group of people.
Morrison stated that the goal of 1 Day Sooner is to recruit as many people as possible to pre-qualify them as suitable to participate in human trials as they occur.
Controversial or selfless?
But what about the ethics and risks involved in voluntarily being infected with a virus? Dr Nir Eyal, director of the Center for Population-Level Bioethics at Rutgers University agrees that it’s not a standard approach, but that it may help.
“It’s not every day we give a healthy individual an exposure to a pathogen – the very same thing doctors are trying to protect people from, but it becomes increasingly clear that the only sustainable exit from the current health and societal crisis is a vaccine, and there are ways to conduct such a trial that are perfectly ethical,” he said in a statement.
What does the human challenge entail?
Initially, people who sign up for this challenge should be relatively young and healthy.
According to an article published in Nature, the risk of harm in volunteers is reduced significantly when they are between the ages of 20 and 45 and generally healthy.
The goal is not to make anyone significantly ill.
Volunteers are also kept safe by daily monitoring and access to medical care once they are infected, Morrison said.
Would authorities allow this?
While there are currently no plans for a public study in the US, several politicians and volunteers are pushing for this, and the World Health Organization (WHO) has released a document to set out criteria for an ethically acceptable plan.
The Food and Drug Administration (FDA) has never allowed a trial of this type for a disease this new, especially without a specific cure, but hasn’t ruled out the possibility completely. Right now, they are open to the idea, but advise caution.
"Human challenge studies are a way to expedite the development of a vaccine to prevent Covid-19," the FDA stated in an article. "Because these studies involve exposing volunteers to the virus, the studies raise a variety of potential scientific, feasibility, and ethical issues. The FDA will work with those who are interested in conducting human challenge trials to help them evaluate these issues."
Dr Matthew Memoli, director of clinical studies at the Laboratory of Infectious Diseases at the National Institutes of Health, also stated that a human challenge trial of this type might be pursued as the pandemic is rapidly changing our society.
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