How COVID-19 human challenge trials work -- and why I volunteered | Sophie Rose

翻译人员: Yong Xu 校对人员: psjmz mz

[ 本演讲录制于 2020 年 10 月 26 日。

[Recorded on October 26, 2020.

COVID-19 vaccine development

新冠疫苗研发进展

以及围绕 人体受控感染试验的道德思考

and ethical considerations around human challenge trials

依然在不断发展变化中。]

are constantly evolving.]

In April 2020,

2020 年 4 月，

I made what many perceive as a risky decision.

我做出了很多人认为是 非常冒险的决定。

I volunteered to be deliberately infected with COVID-19.

我自愿故意感染新冠。

This infection would be part of what is called a human challenge trial,

这种感染是所谓的人体受控感染试验 （亦称人体挑战试验）的一部分——

where young, healthy people are given a vaccine

健康的年轻人接受了疫苗注射，

and are deliberately exposed to the virus that causes COVID-19.

并被故意暴露在 导致新冠的病毒中。

These trials help researchers figure out more quickly

这些试验有助于 研究人员更快地确定

if a vaccine is working.

疫苗是否有效。

I think this research is crucial,

我认为这项研究很重要，

because today, I'm going to speak to you for six minutes.

因为今天， 我会进行六分钟的演讲。

In that time,

在这段时间内，

roughly 1,250 people will be confirmed infected with COVID-19.

将有大约 1250 人 确认感染了新冠。

Twenty-one people will die.

21 人将死去。

And then this pattern will repeat hour after hour and day by day,

然后这种模式会一小时 接一小时，一天接一天地重复，

until we're able to vaccinate most of the eight billion people

直到我们能够为受这场全球危机 影响的 80 亿人中的大多数

affected by this global crisis.

接种疫苗。

Scientists have been working around the clock

科学家们夜以继日地努力工作，

to make those vaccines a reality.

希望这些疫苗能够尽快问世。

But what should we do when the human cost of waiting for those vaccines

但是，当等待这些疫苗期间的 逝去的生命与日俱增时，

is rising by the day?

我们该怎么办？

This is where human challenge trials come in.

这就是人体受控感染试验 派上用场的地方。

They're different from the traditional phase three vaccine trials

它们不同于现在正在进行的

taking place now,

传统的疫苗三期临床试验，

where people are given a vaccine or placebo

即给人们注射疫苗或安慰剂，

and asked to go about their everyday lives.

并要求他们继续他们的日常生活。

Here, researchers have to wait to see how many people in each group

这里，研究人员 要等着观察每一组中

become infected.

有多少人被感染。

Until enough of them get sick,

在没有足够多的人患病之前，

we don't have enough data to know whether a vaccine is working.

我们没有足够的数据 确认疫苗是否有效。

Finding an effective vaccine with this method

用这种方法找到有效的疫苗

can take months or sometimes years,

可能需要数月甚至数年时间，

and it requires thousands of volunteers.

而且需要成千上万的志愿者。

A challenge trial works faster

人体受控感染试验的速度更快，

because researchers control exposure,

因为研究人员可以控制 （与病毒的）接触，

instead of waiting for people to get sick.

而不是等待人们生病。

So instead of a year,

因此，相比要等上一年，

we could know in as little as a month

我们只需一个月就能知道

whether a vaccine seems effective.

疫苗是否有效。

Instead of thousands of volunteers,

相比招募数千名志愿者，

a challenge trial relies on just 50 to 100.

受控感染试验仅需 50 到 100 人，

Because we know for certain

因为我们确切地知道

when people are exposed and develop disease,

人们什么时候接触病毒并患病，

these trials also allow us to gather data

这些试验还使我们能够收集

about the early stages of infection and our immune response.

有关感染早期阶段 和我们的免疫反应的数据。

This data is impossible to gather in any other way,

这些数据是不可能 以任何其他方式收集的，

especially for people who become infected but never show symptoms.

特别是对于那些感染了， 但从未出现症状的人。

This knowledge is important for designing policies

这些知识在设计 限制新冠传播的策略时

that limit COVID-19 transmission.

非常重要。

The time saved translates into precious months' head start

节省的时间可以 转化为提前几个月的

on manufacturing,

宝贵的生产启动时间，

getting us more working COVID-19 vaccines faster.

使我们可以更快地生产 更多的新冠疫苗。

These trials are useful --

这些试验非常有用，

even though recent phase three results sound encouraging.

尽管最近三期临床结果 听起来很令人鼓舞。

The arrival of the first vaccine is going to be a monumental breakthrough.

第一种疫苗的问世 将是个巨大的突破。

It just isn't quite the fairytale ending we're all hoping for.

这并不是我们所期待的 童话般的结局。

We're going to need multiple vaccines,

我们需要多种疫苗，

because we just don't have the infrastructure needed

因为我们还没有 所需的基础设施

to immunize all eight billion people on the planet with just one kind.

用一种疫苗为地球上 80 亿人提供免疫。

Each type of vaccine requires its own special process and equipment

每种疫苗都需要 特殊工艺和设备

to make, store and deliver it.

来制造、储存和运送。

If we had multiple working COVID-19 vaccines,

如果我们有多种有效的新冠疫苗，

we could make use of all of our equipment at the same time.

就可以同时使用所有设备进行生产。

Some of the leading candidates need to be kept extremely cold

一些领先的候选疫苗 在被交付给人们之前

before they are delivered to people.

需要在极低的温度保存。

This can be really hard,

做到这一点很难，

especially in countries where there isn't reliable electricity

尤其是在那些没有可靠电力

or a secure method to store them.

或安全储存方法的国家。

Scientists have been using human challenge trials

科学家们进行 人体受控感染试验

for hundreds of years.

已有数百年的历史。

They've sped up the development of vaccines against typhoid and cholera,

这些试验加快了 伤寒和霍乱疫苗的研发，

and they've helped us better understand how immunity develops

并帮助我们更好地 了解了人体对流感、

to things like the flu, malaria and dengue.

疟疾和登革热等疾病的 免疫力是如何发展的。

We've even used them for other types of coronavirus before.

我们以前甚至用这种方法 对付过其他类型的冠状病毒。

There's been a lot of debate

关于受控感染试验 是否风险太大

about whether challenge trials are too risky.

一直存在很多争论。

I happen to think that those risks are worth taking.

我倒是认为，这些风险值得冒。

A challenge trial would only recruit young and healthy participants --

受控感染试验只招募 年轻、健康，

think between the ages of 20 and 29.

且年龄在 20 岁 到 29 岁之间的受试者。

Fewer than one percent of people in that age-group

在这个年龄组中， 只有不到 1% 的人

need to be taken to hospital after becoming infected with COVID-19.

在感染新冠后需要住院治疗。

So it would likely be even lower in a challenge trial,

因此，在受控感染试验中， 这个数值可能会更低，

because researchers check to make sure

因为研究人员会检查参与者，

that participants have no preexisting conditions.

以确定其是否存在现有疾病。

The risk of a young healthy person dying of COVID-19

健康的年轻人死于 新冠的风险约为

is around five thousandths of a percent.

一个百分点的千分之五 （十万分之五）。

That means for every 100,000 20-year-olds who become infected with COVID-19,

这意味着每 10 万名 感染新冠的 20 岁人群中，

about five die.

大约会有 5 人死亡。

If I were to give birth in the United States,

如果我要在美国生孩子，

my risk of dying would be higher than that.

我的死亡风险比这更高。

Or you could choose to think about it this way.

或者你可以选择这样想。

If my little sister needed a kidney,

如果我妹妹需要一个肾，

I wouldn't hesitate for a moment before I offered her mine.

我会毫不犹豫地把我的肾给她。

And if I can take on that risk to benefit a loved one,

如果我能承担这种风险， 使亲人受益，

it makes sense to allow people to take on a similar risk

那么让人们承担类似的风险，

to speed up the development of a vaccine

加快疫苗的研制就是有意义的，

that would benefit not just their loved ones,

这不仅能造福亲人，

but everyone around them as well.

也造福了身边的每一个人。

There's a lot we still don't know,

还有很多我们未知的信息，

especially about the long-term effects of COVID-19 infection.

尤其是关于新冠感染的长期影响。

I volunteered despite that uncertainty

尽管存在不确定性， 我还是自愿参加了，

because like many of you, I feel frustrated

因为和你们中的许多人一样，

knowing that hundreds of thousands of people are dying.

了解到成千上万的人正在死去， 让我感到很沮丧。

And that's without mentioning the millions more who are struggling

更不用说还有 数以百万计的人在挣扎，

as measures to stop the spread take a toll on their physical,

防疫措施对他们的身体、

emotional and mental well-being.

情感和心理健康都造成了伤害。

It turns out I'm not alone in feeling this way.

事实证明，有类似感受的 不只我一个人。

Since May, over 39,000 people from across the world

自 5 月以来， 世界各地有 39000 多人

have volunteered to participate in potential COVID-19 challenge trials

通过我协助成立的非营利组织 “早一天（1Day Sooner）”

through a nonprofit I helped found called 1Day Sooner.

自愿报名参与可能的 新冠受控感染试验。

We advocate for challenge trial participants

我们鼓励人们参与试验，

and have been encouraging stakeholders to begin preparing for these trials.

并鼓励利益相关方 开始为这些试验做准备。

As early as May,

早在 5 月，

when challenge trials were still being considered

当人们仍在考虑受控感染试验

for their role in the fight against COVID-19,

在对抗新冠上面的作用时，

the World Health Organization cited 1Day Sooner

世界卫生组织就开始以“早一天”

as an example of the kind of public engagement needed

作为进行受控感染试验所需的

to run a challenge trial.

公众参与的例子。

In mid-October,

10 月中旬，

the UK government formally announced their intention

英国政府正式宣布，

to conduct a challenge trial at the beginning of 2021.

打算在 2021 年初 进行受控感染试验。

It is clear that the COVID-19 pandemic is a global crisis.

显然，新冠大流行 是一场全球性危机。

It has inspired record-shattering innovation,

它激发了破纪录的创新，

and it has highlighted the heroic acts of many frontline workers,

也凸显了许多 一线工作人员的英勇行为，

but is has also taken a catastrophic toll.

但也造成了灾难性的损失。

The arrival of each new vaccine brings us one step closer to rebuilding.

每一种新疫苗的到来都使我们 离重建又近了一步。

But the true global solution

但真正的全球解决方案在于，

lies in those vaccines being in the hands of people all over the world.

这些疫苗应掌握在 全世界人民手中。

Challenge trials could be a part of that solution.

受控感染试验可以是 解决方案的一部分。

Thank you.

非常感谢。