How Vaccines Are Developed – and Why They’re Safe | Body Stuff with Dr. Jen Gunter | TED

For people who want to have a baby,

翻译人员: Jie Tian 校对人员: suya f.

对于想生孩子的人来说，

false messages about fertility can be especially powerful.

关于生育的虚假信息 可以产生很大的影响。

So I want to say upfront

所以我想提前声明

that the COVID-19 vaccine is safe for fertility.

新冠疫苗疫苗不会损害生育能力。

[Body Stuff with Dr. Jen Gunter]

[珍·冈特医生（Dr. Jen Gunter）的 《身体秘密》（Body Stuff）节目]

The data on this is clear.

相关数据很明确。

COVID-19 vaccination saves lives for everyone,

新冠疫苗挽救所有人的生命，

especially pregnant people and their babies.

特别是孕妇和胎儿。

But the fog of the pandemic has made it extra challenging

但疫情之下消除 关于新冠疫苗的虚假信息

to dispel the misinformation surrounding the COVID-19 vaccine.

更具挑战。

So I want to address some of these worries

所以我想解决大家在这方面的一些困惑

by talking about how a vaccine becomes a vaccine in the first place.

给大家讲讲疫苗一开始是如何制成的。

To show that each step of creating the vaccine

我会向大家展示， 制作疫苗的每一个步骤

is closely evaluated for safety.

都经过了严格的安全评估。

One of the early stages of vaccine development

疫苗开发的早期阶段之一

involves exploratory research.

涉及探索性研究。

In the case of the coronavirus that causes COVID-19,

对于导致新冠肺炎的冠状病毒，

researchers already had years of knowledge and insight to work from.

研究人员已经积累了 多年的知识和见解来开展工作。

Scientists already knew a lot about other coronaviruses.

科学家对于其他类型的 冠状病毒已经了解很多。

And because of knowledge sharing,

由于知识共享，

they were able to simply download the virus’s genetic code off a website.

他们能够直接从网站上 下载病毒的基因序列。

They were also able to take advantage

他们也能够利用

of the advances made in mRNA vaccine technology,

信使核糖核酸(mRNA) 疫苗技术的进步。

which you might have heard about.

你可能听说过 信使核糖核酸(mRNA)疫苗。

While mRNA vaccines are new to the public,

虽然信使核糖核酸(mRNA) 对公众来说是新事物，

researchers have been studying and working with them for decades.

几十年来研究人员一直 在从事相关的研究与研发。

I want to underscore this point.

这里要划重点。

One worry about the vaccine is that it felt rushed.

民众对疫苗的一个疑虑是 它的研发看起来比较仓促。

But while the COVID-19 vaccine was developed rapidly,

然而，虽然新冠疫苗的研发十分迅速，

its creation was based on decades of research.

但那是基于几十年的研究成果。

Once the exploratory stage is finished,

一旦探索性阶段结束，

researchers move on to the preclinical stage,

研究进入临床前阶段，

where testing is done in petri dishes or on animals.

研发人员会在在培养皿 或动物身上进行测试。

The goal of preclinical tests is to see if the vaccine truly works

临床前测试的目的是看疫苗是否

on the pathogen --

真能作用于病原体——

in this case, the virus that causes COVID-19 --

对于此次疫情而言，即新冠病毒——

and also to test the safety of a vaccine.

以及测试疫苗安全与否。

This is where researchers perform toxicity testing,

在这一步研究人员会进行毒性测试，

using a dosage far greater than what they might use in humans

测试使用的剂量远远大于 在人类身上使用的剂量

to make sure it's safe.

以确保疫苗的安全性。

By testing on animals,

通过对动物进行测试，

they're able to see if vaccines have any impact on functions

研究人员能够了解 疫苗是否对机体功能

like the reproductive system.

例如生殖系统有任何影响。

You might be surprised to learn that the chemical signaling

你可能会惊讶地发现， 在小白鼠子宫内

that happens in a rat uterus

发生的化学信号传递

is very similar to what happens in a human uterus.

与人类子宫内的十分相似。

Here's what's important.

重要的是，

Researchers don’t move on from the preclinical testing phase

在证明疫苗不太可能 对人体有伤害之前，

until they prove that the vaccine is unlikely to harm anyone.

研究不会从临床前 测试阶段进入下一阶段。

This is a rigorous process that goes through FDA approval.

这一过程十分严格， 需要食品与药物监督管理局的批准。

Once the FDA approves,

一旦食药局批准通过，

the next step is the clinical development

下一步是临床研发

or clinical trials, testing in humans, which is a three-phase process.

又称临床试验，会在人体上进行测试， 这一步分三个阶段。

Phase one starts with a small group of people,

第一阶段从一小群人开始，

usually less than 100 very healthy adults.

通常包含不到 100 名 非常健康的成年人。

By phase three,

到了第三阶段，

researchers are working with thousands or even tens of thousands of people.

成千上万名被试者接受试验。

Because of the urgency of COVID-19,

由于新冠疫情情况紧急，

researchers save time by overlapping these phases,

研究人员使这些阶段相互重叠来节约时间

using early data from each phase to design for the next.

使用每个阶段的早期数据设计下一阶段。

In other words, no steps were skipped.

也就是说，没有跳过任何步骤。

Now, it's true that clinical trials for the COVID-19 vaccines

目前，新冠疫苗的临床试验的确

didn't include pregnant people, and that's not unusual.

并未涉及孕妇，这种情况并不罕见。

Pregnant people are currently part of a protected class

孕妇目前属于受保护人群

that typically aren't included in testing new vaccines or new drugs.

通常不接受新疫苗或新药的测试。

I completely understand the worries around this,

我完全理解关于这方面的担忧，

but remember, testing in animals is a proven way to ensure vaccine safety.

但请记住，动物实验 已被证实可以确保疫苗安全。

The preclinical data for the COVID-19 mRNA vaccine

新冠肺炎mRNA疫苗的临床数据显示

showed no impact on fertility in animals

mRNA疫苗对于 动物的生殖系统没有影响

that would lead researchers to suspect there would be issues with humans.

研究人员没有理由 怀疑疫苗会在人类身上出问题

Even after the vaccine has been approved by the FDA

即使疫苗被美国食品 和药物监督管理局批准

and made available to the public, there's still work to be done.

并向公众提供，相关工作仍在继续。

These are called phase four trials,

这就是第四个试验阶段，

where researchers and regulatory agencies

研究人员和监管机构

track how the public responds to the vaccine long-term.

会长期跟踪公众对疫苗的反应

Monitoring side effects,

监测副作用

collecting and analyzing data from a much wider population.

并收集和分析来更广泛人群的数据。

And now we have even more data to reassure us about fertility.

如今我们有更多的数据 来确保疫苗不会损害生育能力。

After the COVID-19 vaccine was rolled out,

新冠疫苗推出后，

there were reports online of people experiencing irregular periods

网上出现了人们经期不规律

or changes in their menstrual cycle.

或月经周期变化的报道。

This, understandably, made people nervous about a potential effect on fertility

能够理解这使人们对于疫苗对生育的影响

or an unknown effect of the vaccine.

或其他未知影响感到焦虑。

We didn't have any data

我们没有任何

about irregular menstrual cycles from clinical trials to point to,

关于月经不调的临床试验数据，

and that is problematic.

这确实有问题。

But given the rush to get the data,

但是由于急需获取疫苗临床数据，

it would have been hard to collect

像月经不调这样的数据是比较难采集的

because people would have had to track cycles before the vaccine.

因为这需要人们在疫苗接种前 记录她们的月经周期。

Differences people notice in their menstrual cycles are valid,

人们注意到的她们月经周期的变化 是真实存在的，

and it's scary and uncertain to notice a change in our bodies.

而发现我们身体的变化 是一件可怕并且充满不确定性的事。

And because the endometrium,

以及，因为来月经时，

the lining of the uterus that sheds during a period,

子宫内膜的脱落，

is part of our immune system,

是免疫系统的一部分，

it is theoretically possible a vaccine could have a temporary effect

理论上，疫苗可能造成了一种暂时的影响

in the same way a vaccine causes temporary swelling in the lymph nodes

类似于疫苗导致一些人的淋巴结

for some people

暂时发生肿胀

or a temporary fever.

或暂时发烧。

Researchers responded to the concerns raised online

研究人员回应了网友的疑虑

and looked into data from almost 4,000 people

并研究了近 4000 人的数据

who tracked their cycles using an app

这 4000 人使用一个 应用程序记录她们的月经周期

and compared data from the vaccinated group

研究人员将其中接种了疫苗的人的数据

to those who didn't get vaccinated.

与未接种疫苗的人的数据进行了对比。

On average,

平均下来，

the menstrual cycles of people who were vaccinated

接种疫苗后月经周期的浮动

varied in length by less than one day,

小于一天，

which is interesting but not medically significant

这是一个有趣的现象但缺乏临床意义

since normal menstrual cycles vary by up to seven days each cycle.

因为正常情况下 每个月经周期浮动最多达七天。

The only group that was more likely to show a meaningful difference

唯一一组有临床意义的结果显示

in their menstrual cycle length

月经周期的变化

were those who received two doses of the vaccine in one cycle.

发生在一个月内 接种了两剂疫苗的人群中。

Even then, what they observed was temporary.

即便如此，观察到的变化也是暂时的。

Their cycles went back to normal within three cycles.

她们的月经在三个周期内便回归正常。

And we've continued to gather data.

数据收集仍在继续。

We now see the importance of vaccination for those who are pregnant

我们现在了解了孕妇接种疫苗的重要性

as the risk of mortality in pregnancy with COVID-19 is 1.6 percent.

因为感染新冠的孕妇 死亡率为 1.6% 。

That's 22 times higher than the risk of mortality in pregnancy

这比未感染新冠的孕妇死亡率

for those without COVID.

高 22 倍。

And unvaccinated mothers

而未接种疫苗

and pregnant people who do get COVID-19

而感染了新冠的孕妇

have a much higher chance of being admitted to the intensive care unit.

有极高的几率被收入重症监护室治疗。

We also now have data showing

我们还有数据表明

that infants from people vaccinated during pregnancy

母体怀孕时接种了疫苗的胎儿

do have antibodies to help protect them from COVID-19.

拥有可以保护他们的抗体。

If your goal is a healthy pregnancy,

如果你的目标是度过一个健康的孕期，

one of the best ways to achieve that is by getting vaccinated.

最好的方式之一是接种疫苗。

And we can have confidence

我们确信

that the COVID-19 vaccines have been rigorously tested

新冠疫苗经过了严格的试验

and are being closely followed.

并且研究人员还在密切关注着。