How fast can a vaccine be made? - Dan Kwartler

翻译人员: Su Wang 校对人员: Yolanda Zhang

When a new pathogen emerges,

当一个全新的病原体出现时，

our bodies and healthcare systems are left vulnerable.

我们的身体很容易受到侵害。

In times like these, there’s an urgent need for a vaccine

这时候，我们就迫切需要疫苗

to create widespread immunity with minimal loss of life.

来激活人体的免疫系统， 挽救更多的生命。

So how quickly can we develop vaccines when we need them most?

那么在紧急状态下， 最快需要多久可以研发出疫苗呢？

Vaccine development can generally be split into three phases.

疫苗研发大体可以分为三个阶段。 [ 研发 ] [临床试验 ] [ 生产 ]

In exploratory research, scientists experiment with different approaches

在早期研发阶段中， 科学家们会尝试各种各样的方法，

to find safe and replicable vaccine designs.

去寻找安全并且可以复制的疫苗。

Once these are vetted in the lab, they enter clinical testing,

在经过实验室检验后， 它们将进入临床测试阶段，

where vaccines are evaluated for safety, efficacy, and side effects

针对不同群体， 对疫苗的安全性、高效性

across a variety of populations.

和副作用进行评估。

Finally, there’s manufacturing,

最后，是制药阶段，

where vaccines are produced and distributed for public use.

疫苗将被生产和发配给大众接种。

Under regular circumstances, this process takes an average of 15 to 20 years.

在正常情况下， 这个过程会持续 15 到 20 年。

But during a pandemic, researchers employ numerous strategies

但是在疫情大流行期间， 研究人员会应用大量的方法，

to move through each stage as quickly as possible.

去尽可能快的通过每个阶段的试验。

Exploratory research is perhaps the most flexible.

早期研发阶段是最具有灵活性的，

The goal of this stage is to find a safe way

这个阶段的目的是找到一个安全的途径

to introduce our immune system to the virus or bacteria.

将病毒或细菌引入人体的免疫系统，

This gives our body the information it needs to create antibodies

这将给人体提供所需要的信息，

capable of fighting a real infection.

以产生足以对抗真正感染的抗体。

There are many ways to safely trigger this immune response,

许多方法可以安全地激活免疫反应，

but generally, the most effective designs are also the slowest to produce.

但通常来说，最有效的方法， 其研发时间也是最久的。

Traditional attenuated vaccines create long lasting resilience.

传统的减毒活疫苗 会产生长效的免疫效力。

But they rely on weakened viral strains

但是它所依赖的弱毒株

that must be cultivated in non-human tissue over long periods of time.

必须在非人体组织中 培养很长一段时间。

Inactivated vaccines take a much faster approach,

灭活疫苗则需要花费 更长的时间去研发，

directly applying heat, acid, or radiation to weaken the pathogen.

它需要通过加热，酸处理 或者辐射来弱化病原体。

Sub-unit vaccines, that inject harmless fragments of viral proteins,

亚单位疫苗， 即注射病毒蛋白的无害片段，

can also be created quickly.

也可以被快速的研制。

But these faster techniques produce less robust resilience.

但是这些相对快速的技术 会导致较弱的效力。

These are just three of many vaccine designs,

这些只是众多疫苗设计中的三种方法，

each with their own pros and cons.

每一种都有其优缺点。

No single approach is guaranteed to work,

没有任何一种技术是 100% 有效的，

and all of them require time-consuming research.

并且所有的技术 都需要经历耗时的研究。

So the best way to speed things up is for many labs

所以加快疫苗研发的最佳方法

to work on different models simultaneously.

是让许多实验室同时研究不同的模型。

This race-to-the-finish strategy

这种竞争策略

produced the first testable Zika vaccine in 7 months,

让科学家们在 7 个月内 研制出了可实验的寨卡疫苗，

and the first testable COVID-19 vaccine in just 42 days.

并且在 42 天内研制出了 第一支可实验的新冠病毒疫苗。

Being testable doesn’t mean these vaccines will be successful.

拥有实验性疫苗并不代表 这些疫苗已经研发成功，

But models that are deemed safe and easily replicable

但那些被认为安全 并且易于复制的模型

can move into clinical testing while other labs continue exploring alternatives.

可以在研发其他方案的同时 进行临床试验。

Whether a testable vaccine is produced in four months or four years,

无论实验性疫苗在四个月 还是四年内研制出来，

the next stage is often the longest and most unpredictable stage of development.

下一个阶段往往是研发过程中 最漫长且最不可预测的。

Clinical testing consists of three phases, each containing multiple trials.

临床试验由四个阶段组成， 每个阶段包含多次试验。

Phase I trials focus on the intensity of the triggered immune response,

[ 1. 免疫反应 ] 第一阶段重点观察引起免疫反应的强度，

and try to establish that the vaccine is safe and effective.

并且确保疫苗是安全有效的。

Phase II trials focus on determining the right dosage and delivery schedule

[ 2. 剂量和接种 ] 第二阶段着重确定对大范围群体的

across a wider population.

注射剂量和接种方案。

And Phase III trials determine safety

[ 3. 安全性和副作用 ] 第三阶段试验负责确认疫苗

across the vaccine’s primary use population,

在主要群体中的安全性，

while also identifying rare side effects and negative reactions.

以及疫苗引起的副作用和不良反应。

Given the number of variables and the focus on long-term safety,

面对如此多的不确定因素 并且着眼于长期的安全性，

it’s incredibly difficult to speed up clinical testing.

想要加快临床试验是极其困难的。

In extreme circumstances, researchers run multiple trials

在极端情况下， 研究人员会在同一个阶段

within one phase at the same time.

进行很多次实验。

But they still need to meet strict safety criteria before moving on.

但是他们在进入下一个阶段前， 仍然需要满足严格的安全标准。

Occasionally, labs can expedite this process by leveraging

偶尔，实验室可以通过 借助已批准的技术

previously approved treatments.

来加快这个过程。

In 2009, researchers adapted the seasonal flu vaccine to treat H1N1—

在 2009 年， 研究人员曾采用 季节性流感疫苗来治疗 H1N1——

producing a widely available vaccine in just six months.

在六个月内生产出了 可大规模接种的疫苗。

However, this technique only works when dealing with familiar pathogens

然而，这项技术只有在处理 和已拥有成熟疫苗设计的病毒

that have well-established vaccine designs.

相似的病原体时才可以使用。

After a successful Phase III trial, a national regulatory authority

当第三阶段实验成功后， 国家监管机构

reviews the results and approves safe vaccines for manufacturing.

会审查结果并批准 安全达标的疫苗投入生产。

Every vaccine has a unique blend of biological and chemical components

每种疫苗都拥有其独特的 生物和化学成分，

that require a specialized pipeline to produce.

需要一种专门的生产线进行生产。

To start production as soon as the vaccine is approved,

为了让疫苗在得到批准后 尽快投入生产，

manufacturing plans must be designed in parallel to research and testing.

生产计划必须和 疫苗的研发、测试同步进行。

This requires constant coordination between labs and manufacturers,

这需要实验室 和生产商之间不断协调，

as well as the resources to adapt to sudden changes in vaccine design—

并随时调整资源配置，以应对 疫苗设计中的突然变化——

even if that means scrapping months of work.

尽管那意味着 几个月的努力将付诸东流。

Over time, advances in exploratory research and manufacturing

随着时间的推移， 探索性研究和生产中的技术进步

should make this process faster.

应该会加快这一进程。

Preliminary studies suggest that future researchers

初步研究已表明， 未来的研究人员

may be able to swap genetic material from different viruses

将有可能在同一种疫苗设计中

into the same vaccine design.

替换不同病毒的遗传物质。

These DNA and mRNA based vaccines could dramatically expedite

这些基于 DNA 和 mRNA 的疫苗 会大大加快

all three stages of vaccine production.

疫苗研发的所有三个阶段。

But until such breakthroughs arrive,

但是在取得这项突破之前，

our best strategy is for labs around the world to cooperate

最好的策略就是 全世界的实验室共同合作，

and work in parallel on different approaches.

并且同时进行多种方案的研发。

By sharing knowledge and resources,

通过共享知识和资源，

scientists can divide and conquer any pathogen.

科学家们将能够 辨别并且攻克任何病毒。