研制一种疫苗需要多久? Dan Kwartler: How fast can a vaccine be made?

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演员: Dan Kwartler

When a new pathogen emerges,
our bodies and healthcare systems are left vulnerable.
In times like these, there’s an urgent need for a vaccine
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.
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.
Finally, there’s manufacturing,
where vaccines are produced and distributed for public use.
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.
Exploratory research is perhaps the most flexible.
The goal of this stage is to find a safe way
to introduce our immune system to the virus or bacteria.
This gives our body the information it needs to create antibodies
capable of fighting a real infection.
There are many ways to safely trigger this immune response,
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
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.
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,
each with their own pros and cons.
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
to work on different models simultaneously.
This race-to-the-finish strategy
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.
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.
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,
while also identifying rare side effects and negative reactions.
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.
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.
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.
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.
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.
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.
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
into the same vaccine design.
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.
But until such breakthroughs arrive,
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.
By sharing knowledge and resources,
scientists can divide and conquer any pathogen.
科学家们将能够 辨别并且攻克任何病毒。