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

For people who want to have a baby,

譯者: Lilian Chiu 審譯者: Helen Chang

對於想要孩子的人而言，

false messages about fertility can be especially powerful.

生育能力相關的假訊息， 影響會特別強大。

So I want to say upfront

所以我想先直說，

that the COVID-19 vaccine is safe for fertility.

新冠肺炎疫苗 在生育能力方面是安全的。

[Body Stuff with Dr. Jen Gunter]

〔關於人體〕 〔珍‧甘特博士主持〕

The data on this is clear.

這方面的資料很清楚。

COVID-19 vaccination saves lives for everyone,

接種新冠肺炎疫苗能救命， 對所有人都是如此，

especially pregnant people and their babies.

對孕婦和其孩子更是如此。

But the fog of the pandemic has made it extra challenging

但疫情讓人困惑，造成特別難

to dispel the misinformation surrounding the COVID-19 vaccine.

消除關於新冠肺炎疫苗的錯誤資訊。

So I want to address some of these worries

所以我想幫大家化解一些憂慮，

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

就讓我來談談疫苗最初 是怎麼變成疫苗的。

To show that each step of creating the vaccine

我會說明創造疫苗的每一步

is closely evaluated for safety.

都有做非常謹慎的安全評估。

One of the early stages of vaccine development

開發疫苗的早期階段之一

involves exploratory research.

和探索性研究有關。

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

就引起新冠肺炎的新冠病毒來說，

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

現在就已有數年的知識和洞見 可以供研究者著手。

Scientists already knew a lot about other coronaviruses.

科學家對其他的新冠病毒 已經知道很多。

And because of knowledge sharing,

且，因為知識分享，他們可以直接

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

從網站上下載病毒的基因遺傳密碼。

They were also able to take advantage

他們也可以利用

of the advances made in mRNA vaccine technology,

mRNA 疫苗技術領域中的新進展，

which you might have heard about.

你可能聽過。

雖然對大眾來說 mRNA 疫苗是新東西，

While mRNA vaccines are new to the public,

researchers have been studying and working with them for decades.

研究者已經研究、 使用它們長達數十年了。

I want to underscore this point.

我想要強調這一點。

One worry about the vaccine is that it felt rushed.

對疫苗的擔憂之一， 就是感覺開發太倉促。

But while the COVID-19 vaccine was developed rapidly,

雖然新冠肺炎疫苗 是快速開發出來的，

its creation was based on decades of research.

它的製造基礎卻是數十年的研究。

Once the exploratory stage is finished,

探索階段完成之後，

researchers move on to the preclinical stage,

研究者就會進入到臨床前階段，

where testing is done in petri dishes or on animals.

用培養皿或動物做試驗。

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

臨床前試驗的目標是要看看 疫苗對病原體是否真的有效。

on the pathogen --

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

這裡的病原體就是造成 新冠肺炎的病毒——

and also to test the safety of a vaccine.

同時也測試疫苗的安全性。

This is where researchers perform toxicity testing,

在這個階段，研究者會做毒性試驗，

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

採用的劑量比要用在 人類身上的劑量多很多，

to make sure it's safe.

以確保它很安全。

By testing on animals,

用動物做實驗，

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

可以看看疫苗對於功能 是否會有任何影響，

like the reproductive system.

比如生殖系統。

You might be surprised to learn that the chemical signaling

這可能會讓你很驚訝：

老鼠子宮中所發生的化學訊號傳遞

that happens in a rat uterus

is very similar to what happens in a human uterus.

和人類子宮中的非常相似。

Here's what's important.

重要的是，

Researchers don’t move on from the preclinical testing phase

研究者若要從臨床前階段 繼續往下走，

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

就得要能證明疫苗 不太可能傷害任何人。

This is a rigorous process that goes through FDA approval.

這是個嚴格的流程， 要食品及藥物管理局核准。

Once the FDA approves,

管理局核准之後，

the next step is the clinical development

下一個階段是臨床開發， 或稱臨床試驗，

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

用人類來做試驗，

這個流程有三個階段。

Phase one starts with a small group of people,

第一階段從一小群人開始，

usually less than 100 very healthy adults.

通常是不到一百位非常健康的成人。

By phase three,

到了第三階段，

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

研究者會用數千 甚至數萬人來做試驗。

Because of the urgency of COVID-19,

因為新冠肺炎非常緊急，

researchers save time by overlapping these phases,

研究者省時間的方式 是把這些階段重疊。

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

用每個階段的早期資料 來設計下一個階段。

In other words, no steps were skipped.

換言之，沒有跳過任何步驟。

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

的確，新冠肺炎疫苗的臨床試驗

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

沒有包含孕婦，那很常見。

Pregnant people are currently part of a protected class

孕婦目前是屬於受保護的類別，

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

在測試新疫苗或新藥物時 通常都不會包含她們。

I completely understand the worries around this,

我完全可以理解這方面的擔憂，

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

但，別忘了，動物試驗

就是已經證明可以確保 疫苗安全的方式。

The preclinical data for the COVID-19 mRNA vaccine

新冠肺炎 mRNA 疫苗的臨床前資料

showed no impact on fertility in animals

顯示疫苗對動物的 生育能力沒有影響，

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

這點讓研究者認為 人類也不會有這方面的問題。

Even after the vaccine has been approved by the FDA

就連疫苗被食品及藥物管理局 核准並開放供大眾使用之後，

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

仍然還有要做的事。

These are called phase four trials,

這些事叫做第四階段試驗，

where researchers and regulatory agencies

在這個階段，研究者和管理機構

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

要長期追蹤大眾對於疫苗的反應、

Monitoring side effects,

監控副作用、

collecting and analyzing data from a much wider population.

收集並分析來自更廣大群眾的資料。

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

現在我們有更多資料確保 生育能力不受影響了。

After the COVID-19 vaccine was rolled out,

在新冠肺炎疫苗推出後，

there were reports online of people experiencing irregular periods

線上有些報告指出 接種者遇到經期不規律

or changes in their menstrual cycle.

或經期改變。

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

可以理解，這會讓人緊張，

擔心疫苗可能影響生育能力，

or an unknown effect of the vaccine.

或是有還未知的影響存在。

We didn't have any data

我們沒有任何和不規則經期 相關的臨床試驗資料，

about irregular menstrual cycles from clinical trials to point to,

and that is problematic.

那是個問題。

But given the rush to get the data,

但因為資料取得倉促，

it would have been hard to collect

很難收集到這類資料， 因為受試者必須要在接種前

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

就已經追蹤經期了。

Differences people notice in their menstrual cycles are valid,

確實，會有人注意到經期有所不同，

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

發現我們的身體有改變的確 很讓人害怕且感到不確定。

And because the endometrium,

且因為子宮內膜，

the lining of the uterus that sheds during a period,

也就是經期過程會剝落的子宮內層，

is part of our immune system,

屬於免疫系統的一部分，

it is theoretically possible a vaccine could have a temporary effect

理論上疫苗是有可能 會造成暫時性的影響，

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

就如同疫苗會造成某些人 暫時性的淋巴節腫大，

for some people

or a temporary fever.

或暫時性發燒。

Researchers responded to the concerns raised online

研究者有回應了線上提出的擔憂，

and looked into data from almost 4,000 people

並研究了近四千人的資料，

who tracked their cycles using an app

這些人用 app 來追蹤他們的經期，

and compared data from the vaccinated group

比較接種組和未接種組的這些資料，

to those who didn't get vaccinated.

On average,

平均來說，

the menstrual cycles of people who were vaccinated

接種組的經期長度變化不到一天，

varied in length by less than one day,

which is interesting but not medically significant

這很有趣，但在醫學上沒有顯著性，

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

因為正常的經期本來就有 高達每週期七天的變動。

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

只有一組受試者比較可能 發現有意義的經期長度差異，

in their menstrual cycle length

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

那就是在一次經期之間 接種兩劑疫苗的人。

Even then, what they observed was temporary.

就算如此，觀察到的現象 也是暫時性的。

Their cycles went back to normal within three cycles.

在三次經期之內， 他們的經期就恢復正常了。

And we've continued to gather data.

而我們持續在收集資料。

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

現在我們知道接種疫苗 對孕婦的重要性，

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

因為懷孕得了新冠肺炎的 死亡率是 1.6%，

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

比沒有得新冠肺炎的孕婦高 22 倍。

for those without COVID.

And unvaccinated mothers

且未接種的母親及孕婦

and pregnant people who do get COVID-19

若得了新冠肺炎，

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

被送進加護病房的機率也高很多。

We also now have data showing

我們現在也有資料指出，

that infants from people vaccinated during pregnancy

在懷孕期間接種者生出的嬰兒

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

確實會有抗體來幫他們 對抗新冠肺炎。

If your goal is a healthy pregnancy,

如果你的目標是健康懷孕，

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

最好的方式之一就是去接種疫苗。

And we can have confidence

且我們可以相信，

that the COVID-19 vaccines have been rigorously tested

新冠肺炎疫苗已經通過嚴格的試驗

and are being closely followed.

且持續被密切追蹤中。