By Alexander Smith - NBC News
Healthy volunteers in the UK will be infected with COVID-19 as part of an experimental trial that could help accelerate the development of vaccines against the disease.
The British government announced on Tuesday that it will invest $ 43.5 million in the first stage of the program, known as human challenge trials.
These groundbreaking but controversial studies involve injecting volunteers with a possible vaccine before receiving a dose of COVID-19.
To do this, scientists must first artificially manufacture the virus and calculate the smallest dose that will infect the volunteers, all healthy adults between 18 and 30 years old.
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If that stage passes regulatory and ethical standards, the human defiance trials themselves would take place between January and March, the British government reported in a statement.
"We are doing everything possible to combat the coronavirus, including the support of our best and brightest scientists and researchers in the search for a safe and effective vaccine," explained Minister of Enterprise Alok Sharma.
[The vaccine will be free, it will take two doses and it will begin to be distributed 24 hours after its approval]
The trials are being conducted by a specialty pharmaceutical company called hVIVO, a subsidiary of Open Orphan plc, which describes itself as "the world leader" in these types of trials.
After the first stage is complete, the company will submit its proposal on how the trials should work to government medical and ethical regulators for approval in November, according to Martin Johnson, medical director of hVIVO.
"It's not quite a green light, but it's an amber light for testing to go ahead," he told NBC News by phone Tuesday, "it's a big step forward."
Johnson clarified that obtaining regulatory approval is not yet done, but that he had "hopes" of success.
A woman receives a COVID-19 vaccine in a test.Getty Images
Supporters say these kinds of tests can be much faster than regular vaccine trials, which could shorten the wait until the world has access to an effective vaccine.
But, critics argue that too little is known about COVID-19 for challenge tests to be safe.
While young people rarely die from the disease, there is growing evidence that they may suffer long-term sequelae.
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Sue Tansey, a pharmacist who is a member of the Nuffield Council on Bioethics, an independent British watchdog, said there was still "disagreement among experts" on whether it is appropriate to go ahead with challenge trials.
"People are divided because it is an ethical enigma," he said.
There are more than 150 vaccines in development around the world, some of which have reached phase 3 testing, in which large numbers of people, up to tens of thousands, receive the vaccine, while others receive a placebo.
In routine studies, vaccinated volunteers are regularly tested for COVID-19 in the hope that there will be a noticeable difference between those inoculated and those not.
However, that process can take a long time;
in addition, many of the participants will take months to become infected, if they do.
[USA. it will not return to normal until the end of 2021 although the vaccine will be ready in a few months, says Dr. Fauci]
China has taken a different route, health officials in the city of Jiaxing have offered an experimental vaccine to health workers and other high-risk groups at $ 60 per dose, according to the Reuters news agency.
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A challenge test can shorten the time: all volunteers get the vaccine and all get the virus too.
The researchers say that a group of just 40 volunteers would likely shed a great deal of information on any vaccine candidate in a short time, although they all accept that there are risks.
The UK government has reserved the top three spots for hVIVO's potential 'challenge test', paying $ 3.2 million per seat, the company said in its statement Tuesday.
It's not yet clear which vaccine candidates from drug companies will fill those spots when the time comes, hVIVO's Johnson said.
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Sir Patrick Vallance, the UK's chief scientific advisor, stressed in July that two things had to happen for
challenge trials to
be considered safe: Scientists need to know the correct dose to administer and have discovered antiviral drugs that can "rescue" to patients who become seriously ill.
When asked what the answers to these questions were, he made it clear: "We don't know yet."
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Although young people between the ages of 18 and 30, who generally volunteer for medical trials, rarely die of coronavirus, there is growing data and evidence from healthy adults who, after overcoming the disease, experience long-term sequelae that affect the heart. , the brain and the lungs.
"The argument against doing so is that we don't know enough about the cases where some younger people have these long-term problems after getting COVID-19," Tansey said.
"The other downside is that although we have some treatments that seem to improve outcome in very sick patients, it is not what we call 'rescue' therapy like an antibiotic that could treat an infection and resolve it," he added.
[The pause in the Oxford vaccine is an example of why the process cannot be accelerated, according to this health authority]
For some volunteers, these concerns are real, but the end goal is worth reaching.
"It's a scary thought," said Alastair Fraser-Urquhart, 18, who volunteers as part of the 1Day Sooner group's campaign, which advocates for challenge trials.
"It's easy for me to sit here right now and say I think it's a great idea," he noted, "but if I end up on a respirator, I think I'd still think the same because it's doing humanity so much good that nothing I do it would be in vain. "