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  • This is a chart of Covid-19 cases in the UK.

  • In April, the UK's rate of new cases climbed so high that it was second only to the US.

  • Around that time, researchers at Oxford University who were developing a Covid-19 vaccine

  • had started planning to do a large-scale test of the vaccine in the UK.

  • But by July, new Covid-19 cases in the country had fallen.

  • It was good news -- but it also meant the UK was no longer a good place to test a vaccine.

  • And that's because of a crucial part of the process of testing any new vaccine:

  • What's called the Phase III human trials.

  • Before we can end the coronavirus pandemic, a vaccine developer will have to give tens

  • of thousands of participants either the vaccine or a placebo.

  • And then... we wait, for months, or possibly years,

  • to see how many of each group eventually gets Covid-19,

  • while the participants go about their lives; which, right now,

  • probably means they are living under Covid-19 restrictions,

  • like wearing masks and staying at home.

  • But until enough of those participants get sick, there won't be enough data

  • on whether the vaccine is working.

  • And in the meantime, thousands of people are dying of covid-19 every day.

  • That's why, some people are starting to advocate a different, more controversial model:

  • Instead of waiting for the coronavirus to eventually infect some of these people....

  • What if we gave a group of willing volunteers the virus on purpose?

  • “I'm a young guy, I'm 23 years old, I'm relatively healthy.”

  • “I have no pre-existing health conditions.

  • I have no children, no dependents.”

  • It's really important that we do everything we can to speed up research and development.”

  • It's 2016, and this man is about to drink a test tube of the bacteria that causes typhoid.

  • He's one of about 100 participants who deliberately infected themselves with it

  • to test a new vaccine in the UK.

  • In March 2016 I downed a shot of typhoid.”

  • Daina was another participant.

  • She was a PhD student, who needed the money, but she also liked the idea of it.

  • It was like, you know, I'm helping to make this disease less deadly.”

  • This kind of study is called a human challenge trial.

  • And in the case of the typhoid vaccine, researchers told the New York Times

  • that doing the challenge trial saved them three or four years.

  • To put that in context, it helps to look at the bigger picture of how a vaccine normally gets developed.

  • The first step in the process is to test a vaccine in a lab on either human cells, or on animals,

  • just to see if it causes any harm.

  • This is called the preclinical phase.

  • If it passes that test, it enters human trials.

  • This is the longest and most important part.

  • If it passes human trials, the vaccine gets licensed by regulators,

  • and can be manufactured and distributed to the public.

  • Human trials typically have 3 phases, each one testing a larger and larger group of people.

  • Phase 1 involves a very small group of people, maybe 50, and mainly tests if the vaccine is safe.

  • Phase 2 usually involves a few hundred participants.

  • This is where we start learning if the vaccine actually works.

  • And then there's the final test: the Phase 3 trial.

  • It's expensive, it takes time, it requires tens of thousands of volunteers, and it involves

  • as broad a cross-section of participants as possible.

  • The entire process of developing a vaccine usually takes around ten years.

  • But many Covid-19 vaccine developers are racing to compress this entire process into about

  • a year and a half.

  • One way they're doing this is to overlap the different phases,

  • conducting several different trials at once.

  • Or, to ramp up the manufacturing of a vaccine

  • while it's still being tested, so that if it works, it can be distributed right away.

  • As of the making of this video,

  • there were 166 Covid-19 vaccines in various stages of development.

  • 24 vaccine candidates are already in the human trial phase.

  • And 5 of them are already in Phase III.

  • For these leading candidates, a human challenge trial could save weeks, or months,

  • by augmenting a Phase III trial that isn't getting data fast enough.

  • And for any of these candidates in pre-clinical phases,

  • a challenge study, followed by a larger-scale safety study for the vaccine,

  • could replace a Phase III trial altogether.

  • A challenge trial that successfully shrinks down this timeline could save thousands of lives.

  • And so far, a grassroots movement has recruited more than 30,000 volunteers, from over 100 countries,

  • who said they would participate in a challenge trial for covid-19 if it happens.

  • My moral values say that I kind of have an obligation to do what I can to help.”

  • “I see it as very similar to other acts of public service, like trying to fight climate change,

  • and disastrous events that are forthcoming that are the consequences of a lack of care.”

  • It's affecting, literally, pretty much every person globally.

  • I feel like I need to do something to help.”

  • Here's the problem. Human challenge studies have been used before

  • for cholera, typhoid, malaria, influenza and the common cold.

  • But there's a big, important difference that sets covid-19 apart.

  • For each of those conditions, we do have effective treatments so that we know,

  • to my knowledge, no one has ever actually ever died in those studies.”

  • Peter Smith is one of the world's leading epidemiologists, and he was one of the first

  • to advocate for the possibility of human challenge trials, in March of this year.

  • He says, because there's no covid-19 treatment, it limits who could participate in a challenge study.

  • The challenge trial would necessarily be done in people

  • who were at very low risk of serious disease."

  • In other words, unlike in a typical Phase III trial, where you'd recruit the widest range of people possible,

  • a Covid-19 challenge trial would produce data on a much narrower group of young, healthy people.

  • And we don't know if a vaccine that works for that group would work for everyone.

  • But the immediate goal is not to get a single Covid-19 vaccine that offers perfect protection.

  • In the US, to be deemed sufficiently effective, a vaccine just has to work 50% better than

  • not being vaccinated.

  • An imperfect vaccine could still slow the spread of the virus.

  • The bigger issue with a covid-19 challenge study

  • is that there's no way to guarantee that it's actually safe for participants.

  • On one hand, the risk of hospitalization for young people is relatively low.

  • And a study of the outbreak in New York City suggests the risk of death for young people

  • is as low as 0.01 percent.

  • And advocates for Covid-19 challenge trials say that's a level of risk we already accept

  • in similar situations.

  • They point out it's even lower than the risk of fatality from donating a kidney.

  • But any risk of harm or death at all would still set it way apart from any other challenge study.

  • And the long-term risks of Covid-19 for those who recover are still almost entirely unknown.

  • We emailed nearly all of the institutions who were reachable who are currently developing

  • a vaccine, to see whether they would consider human challenge trials.

  • And none would go on the record saying they are considering it.

  • But we know at least one is seriously considering it.

  • Developers of the Oxford University vaccine said that they hope to do challenge trials

  • by the end of the year.

  • In 2016, the World Health Organization's stance on challenge studies was that

  • "it would not be ethical or safeto use them for a disease that isvirulent,” and has

  • noexisting therapiesto treat it.

  • But in May of this year, they released new guidelines, saying that they could theoretically

  • be considered if there was confidence thatthe potential benefits of SARS-CoV-2 challenge studies

  • outweigh the risks.”

  • If challenge studies do reduce the time it takes to get a vaccine, those benefits are clear.

  • If the current leading candidates have quick, successful Phase III trials, we may never

  • need to do a challenge trial for Covid-19 at all.

  • But if we do, it'll only be possible because there are people out there willing to take on this risk.

  • It's worth it to me to save the lives of a countless number of people.

  • “I'm happy to take that small risk to myselfand make things better for a lot of people.”

  • Feeling like I was doing nothing, and just feeling miserable and demoralized,

  • to being like, OK, I have something I can do here.”

  • “I'm a lot less at risk than my parents and grandparents are,

  • And my moral imperative tells me I have to do it.”

This is a chart of Covid-19 cases in the UK.

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