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(CNN) – The British government is exploring the possibility of clinical trials in which volunteers deliberately expose themselves to the coronavirus to test the effectiveness of vaccine candidates, the UK’s Department for Business, Energy and Industrial Strategy (BEIS) revealed on Wednesday in a release.
“We are working with partners to understand how we could collaborate on the potential development of a COVID-19 vaccine through human challenge studies,” said a government spokesman.
“These discussions are part of our work to investigate ways to treat, limit and hopefully prevent the virus so that we can end the pandemic sooner,” the spokesperson added.
In so-called “challenge trials,” researchers give study subjects an experimental vaccine and then intentionally expose them to the coronavirus to see if the vaccine works. These trials were used in the early investigations of smallpox, yellow fever, and malaria.
However, deliberately infecting study participants poses more risks and ethical concerns, compared to randomized controlled trials, where study subjects are given a vaccine or placebo, and researchers monitor to see if they get sick as they they move forward in their daily life.
The World Health Organization issued guidance in May saying challenge studies can be “substantially faster” and more effective than other methods, in part because fewer participants need to be exposed to experimental vaccines and because they can be used to compare potential vaccines. .
He also said that controlled infection trials could be ethically acceptable if they met certain criteria. These include choosing healthy young adults as participants, starting with low doses, ensuring public participation, and providing high-quality care and close follow-up.
But in July, members of the US National Institutes of Health’s “Accelerating Covid-19 Vaccines and Therapeutic Interventions” (ACTIV) task force said such trials would not accelerate the development of a vaccine.
In a comment published in the New England Journal of Medicine, ACTIV members wrote that the use of controlled human infection models to support vaccine development requires “essential criteria” to limit risk to participants and could lead to “one or two years”. He also noted that even “a single death or serious illness” caused by the trial would eventually “stop progress.”
Despite the risks, some people have already raised their hands to participate in trials of challenge.
1Day Sooner, an organization of “potential Covid-19 trial volunteers” advocating for the use of such trials, said Wednesday that controlled infection trials would support the development of a vaccine that is equally accessible to all.
“As an organization of potential COVID-19 challenge trial volunteers, we have appreciated our collaborative contribution to the UK government’s challenge plans, and we hope and hope that the voices of volunteers are further incorporated into publicly available protocols for these studies, “said 1Day Sooner. in a statement shared with CNN.
The organization says it has already petitioned the British government to build a ‘Challenge Study Center’ to house between 100 and 200 participants at a time, suggesting that some candidate vaccines could be ready for testing before the end of this year.
“We have filed the petition. It is currently under review,” said 1Day Sooner.
This story was first published on CNN.com, “UK is considering vaccine trials deliberately exposing volunteers to Covid-19.”
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