Covid ‘challenge trial’ launched in U.K. could see healthy volunteers infected with virus
LONDON — Volunteers in the United Kingdom look set to be intentionally infected with Covid-19 as part of an experimental trial that could change scientists’ understanding of the virus.
The U.K. government announced Tuesday that it is investing 33.6 million pounds (about $43.5 million) in the first stage of what are known as “challenge trials.”
These groundbreaking but contentious studies involve injecting volunteers with a potential vaccine before being given a dose of Covid-19.
First, scientists need to artificially manufacture the virus and work out the smallest dose that will infect volunteers, all healthy adults ages 18 to 30.
If that stage passes regulatory and ethical approval, the challenge trials themselves would take place next January to March, the U.K. government said in a statement.
“We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine,” Business Secretary Alok Sharma said.
The trials are being conducted by a specialist pharmaceuticals company called hVIVO, a subsidiary of Open Orphan plc, which describes itself as “the world leader” in challenge trials.
After the first stage is complete, the company will submit its proposal for how the trials should work to the government’s medical and ethical regulators for approval in November, according to Dr. Martin Johnson, chief medical officer at hVIVO.
“It’s not quite the greenlight, but it’s an amber light for the challenge trials to go ahead,” he told NBC News by telephone Tuesday. “It’s a massive step forward.”
Johnson said gaining regulatory approval was no done deal but he was “hopeful” of success.
Supporters say challenge trials can be far quicker than regular vaccine tests, potentially shortening the wait until the world has access to an effective inoculation.
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But critics argue that too little is known about Covid-19 to make challenge trials safe. While young people rarely die of the disease, there is increasing evidence that they can be left with long-term debilitating illnesses.
Sue Tansey, a pharmaceutical physician who is a member of the Nuffield Council on Bioethics, an independent British watchdog, said that there was still “disagreement among experts” about whether it’s appropriate to go ahead with challenge trials. “People are divided because it’s an ethical conundrum,” she said.
There are more than 150 vaccines in development around the world, a handful of which have reached phase 3 tests, where large numbers of people — as many as tens of thousands — are given the vaccine, while others get a placebo.
In ordinary studies volunteers are sent out into the world and regularly tested for Covid-19 in the hope that there will be some noticeable difference between the vaccinated and nonvaccinated groups. However this can take a long time — many of the participants will take months to get infected if they do at all.
China has taken a different route, with health officials in the city of Jiaxing offering an experimental vaccine to health workers and other high risk groups for $60 each, according to Reuters.
A challenge trial could shorten the timeline: All volunteers get the vaccine, and all of them get the virus, too. Researchers say a group of just 40 volunteers would likely tell them a huge amount about any vaccine candidate in just a short time. Everyone accepts there are risks.
The U.K. government has reserved the first three places in hVIVO’s prospective challenge trial — paying 2.5 million pounds per place — the company said in its statement Tuesday. It is not yet clear which drug companies’ vaccine candidates will fill those places when the time comes, Johnson at hVIVO said.
Sir Patrick Vallance, the U.K.’s chief scientific adviser, said in July that two things needed to happen for challenge trials to be considered safe. Scientists need to know the right dose to administer and to have discovered antiviral drugs that can “rescue” patients who become seriously ill.
Asked what the answers to these questions were, he said, “We don’t yet know.”
Although young people aged 18 to 30 — who typically volunteer for medical trials — rarely die from coronavirus, there is increasing data and anecdotal evidence of young, healthy people crushed by debilitating long-term conditions affecting the heart, brain and lungs.
“The argument against doing it is that we don’t know enough about the cases where some younger people have these long term problems afterwards,” Tansey said. “The other downside is that although we’ve got some treatments that seem to improve the outcome in the very sick patients, it’s not what we call a ‘rescue’ therapy like an antibiotic that could treat an infection and resolve it.”
To some volunteers, these concerns are real but worth the end goal.
“It’s a scary thought,” said Alastair Fraser-Urquhart, 18, who is volunteering as part of the campaign group 1Day Sooner, which advocates for challenge trials.
“It’s easy for me to sit here now and say I think this is a great idea,” he said. “But if I end up on a ventilator then I think I would still think the same thing because it’s providing so much good to so much of humanity that nothing I do would be in vain.”
CORRECTION (Oct. 20, 2020, 9:40 a.m. ET:) An earlier version of this article misstated that volunteers will be intentionally infected with Covid-19 as part of the experimental vaccine trial. That would happen only if the first stage of the trial is successful and passes regulatory and ethical approval; volunteers will not be intentionally infected before then