Name: 柯維德疫苗。疫苗如何獲得準許？- BBC新聞 (Covid vaccine: How does a vaccine get approved? - BBC News)
Uploaded: 2020-12-17T19:00:25.000Z
Duration: 3 min 14 s

進階被動語態

The reason why a covert 19 vaccine has come around so quickly is because a lot of money and resources have been thrown at it.

隱蔽的19號疫苗之所以這麼快就出現了，是因為投入了大量的資金和資源。

These are all the steps normally taken to create a safe and working vaccine.

這些都是製作安全有效的疫苗通常採取的步驟。

It usually takes at least a decade to complete them all, but with co vid, they've all been done in less than a year.

通常至少需要十年才能全部完成，但有了co vid，不到一年就全部完成了。

So, as is the case with all medicines, a vaccine goes through extensive and rigorous testing before it could be approved and rolled out to a country's population.

是以，與所有藥品一樣，疫苗在獲得準許並推廣到一個國家的人口之前，要經過廣泛而嚴格的測試。

For any testing happens in humans, the vaccine is tested on animals in a laboratory.

對於任何發生在人類身上的測試，疫苗都是在實驗室裡對動物進行測試。

In the case of covert, 19 ferrets, mice and monkeys have all been used.

在隱蔽的情況下，19只雪貂、老鼠和猴子都被使用。

That's because they're similar to humans in their physiology and biology.

那是因為它們在生理和生物上與人類相似。

If the vaccine works and is safe for animals, clinical trials begin.

如果疫苗有效，對動物安全，就開始臨床試驗。

Phase one trials involved giving the vaccine to a small number of healthy volunteers between 20 and 50 people.

一期試驗包括給20到50人的少量健康志願者注射疫苗。

在這裡，他們看的是安全檢查。

It generates an immune response on to determine the correct dosage.

它產生的免疫反應上，以確定正確的劑量。

Phase two trials involves several 100 volunteers on look at how effective a vaccine is in humans.

第二階段的試驗涉及幾百名志願者，看疫苗在人類中的效果如何。

This group involves adults of all ages and sexes and, ideally, all ethnicities.

這個群體涉及所有年齡和性別的成年人，最好是所有種族的成年人。

Phase three trials are similar to phase two, but they involve several 1000 volunteers.

三期試驗與二期試驗類似，但它們涉及幾千名志願者。

They're still looking at how effective the vaccine is, but on a much broader scale.

他們還在研究疫苗的有效性，但在更廣泛的範圍內。

Usually, these clinical trials run one after another, with time given for the data on how safe, effective and stable the vaccine is to be looked at, and to make a decision about whether the trial should progress to the next stage.

通常，這些臨床試驗會陸續進行，有時間看疫苗的安全性、有效性和穩定性的數據，並決定是否進入下一階段的試驗。

But because of the seriousness of the cove in 19 pandemic, thes phases sometimes overlapped.

但由於19年大流行的嚴重性，這些階段有時會重疊。

The checks that would normally happen was still being done.

Countries have been so keen to find solutions that money has been thrown at organizations to recruit more.

各國都熱衷於尋找解決辦法，以至於向各組織投錢招兵買馬。

Scientists toe work around the clock on to hire more staff to help find volunteers more quickly.

科學家們晝夜不停地工作，以僱傭更多的工作人員，幫助更快地找到志願者。

Because covert 19 has been so widespread, finding volunteers to test the vaccine on has been easier than in other trials.

由於隱蔽19已經如此廣泛，尋找志願者對疫苗進行測試比其他試驗更容易。

When enough data has been gathered, it's submitted to a country's regulators for approval.

當收集到足夠多的數據後，就會提交給一個國家的監管部門進行審批。

Scientific and clinical experts review it to see how effective the vaccine is, how safe it is, how stable it is it's quality and check that is being manufactured and stored in a way that meets safety standards on public health policy in the U.

科學和臨床專家審查它，看看如何有效的疫苗，它是如何安全，如何穩定它是它的品質和檢查，正在製造和存儲的方式，符合安全標準的公共衛生政策在美國。

This is the job of the Ciara, the Commission on Human Medicines and even members.

慈嵐、人醫委甚至委員的工作。

Normally, this happens after all, the trials have ended.

一般情況下，這種情況畢竟是審判結束了。

K's regulatory body was being given data as the trials went along.

隨著試驗的進行，K公司的監管機構正在獲得數據。

If the vaccine is then approved, it could be given to a wider population.

如果屆時該疫苗獲得準許，可以給更多的人使用。

But the regulators keep monitoring health records on data on anyone who gets one the same as for any vaccine or medicine on every batch.

但監管部門一直在監測健康記錄上的數據，任何人得到一個人的數據，就像任何疫苗或藥品的每一個批次一樣。

 The vaccine that is made is checked for purity and quality before it's sent anywhere. 

做出來的疫苗在送到任何地方之前，都要檢查純度和品質。