While most of us are doing the best we can to stay as far away from the new coronavirus as possible, some people are willing to be infected intentionally.
As scientists are racing towards the development of a vaccine against the new coronavirus, a grassroots effort has attracted nearly more than 2 300 volunteers – should they be needed for such a trial.
This controversial approach is also known as a human-challenge trial.
The programme is called 1 Day Sooner and not affiliated with any groups or companies currently developing and funding coronavirus vaccines.
Why this approach?
Co-founder Josh Morrison is using this approach to show everyone currently involved in vaccine development that there is support for human challenge trials and that this can help speed up the development of a vaccine.
“We want to recruit as many people as possible who want to do this and pre-qualify them as likely to be able to participate in challenge trials should they occur,” stated Morrison, who is also the executive director of an organ donation advocacy group called Waitlist Zero. “At the same time, we feel that the public policy decisions around challenge trials will be better informed if they highlight the voice of people interested in participating in such trials.”
Why is a vaccine such a key component in the fight against the pandemic?
Currently, large parts of the world are in lockdown as a measure to help curb the spread of Covid-19, in an effort to avoid overloading strained health systems.
As the virus is novel, highly contagious and not yet fully understood, experts reckon that the only real solution would be a safe, efficient vaccine.
While there are currently 70 vaccine candidates leading the way, with a few in the first phases of clinical trials, it’s not guaranteed that they will be available to us any time soon. Experts are even suggesting that intermittent measures of distancing and lockdown may be the reality for years to come if a vaccine is not found soon.
Why does vaccine development take so long?
Essentially, you can speed up the vaccine development process to respond to a pandemic, but you don't want to speed it up so much that you allow a bad vaccine to enter the market, explained Dr Greg Poland, director of the Mayo Clinic's Vaccine Research Group in a previous Health24 article.
"The process of developing, testing and licensing a vaccine for widespread population use is designed to be slow, deliberative, peer-reviewed, reflective, evidence-based, so that we don't make mistakes," Poland said.
Going too fast could lead to a vaccine that's not effective or, worse, can cause serious health problems, Poland said.
Why human volunteers?
In clinical evaluation, a vaccine candidate is only ready for human testing once it has been through the necessary in vitro and animal tests. While animal tests are crucial to ensure safety, they add months, even years to the process of vaccine development.
What Morrison is aiming for is not to come forward with a vaccine himself, but to create the awareness that there are volunteers who are willing to partake in clinical trials, potentially speeding up the process.
A team led by bioethicist Nir Eyal, at the University of Rutgers in New Brunswick, New Jersey, argued that a human challenge trial could be conducted safely and ethically, in a paper in the Journal of Infectious Disease in March 2020.
What is expected of such a volunteer?
According to Morrison, the people who have signed up for the challenge trial are mostly young, live in urban areas and all want to make a constructive effort to help fight the pandemic.
“Many note that they recognise the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them,” Morrison said.
Is it safe?
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.
Volunteers are also kept safe by daily monitoring and access to medical care once they are infected, Morrison said.
What do authorities think?
According to Morrisy, their strategy is gaining some political support.
Two members of the US House of Representatives, Bill Foster (Democrat, Illinois) and Donna Shalala (Democrat, Florida), called on Department of Health and Human Services Director Alex Azar to consider human-challenge trials of coronavirus vaccines, he stated.
Charlie Weller, head of the vaccines programme at Wellcome, a biomedical-research funder in London, says the charity has begun discussing the ethics and logistics of a human-challenge trial for coronavirus.
But she says it is unclear if such a trial could actually speed up vaccine development. Researchers first need to determine how to expose humans to the virus as safely as possible, as well as consider how and even whether such studies can be done ethically. “I think there’s potential,” Weller adds, “but we’ve got so many questions to work through to understand whether it can help in the timelines we have.”
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