FDA批准辉瑞-BioNTech为5至11岁儿童接种疫苗

Kid-sized doses of the COVID vaccine are one step closer to getting an OK from regulators.

儿童剂量的新冠疫苗离获得监管机构的批准又近了一步。

Advisers to the FDA voted in favor of authorizing the Pfizer-BioNTech vaccine for children ages 5 to 11.

FDA顾问投票赞成批准辉瑞-BioNTech为5至11岁儿童接种疫苗。

A decision from the FDA either agreeing with or rejecting the could come at any time.

FDA可能随时会做出同意或拒绝该建议的决定。

So what's the evidence that the vaccine will be effective for little kids 5 to 11?

那么，有什么证据表明疫苗对5到11岁的儿童有效呢?

Well, the advisers considered data from a Pfizer clinical trial that included more than 2,000 kids.

顾问考虑了辉瑞的一项包括2000多名儿童在内的临床试验数据。

It found the vaccine was about 91% effective against symptomatic infection.

研究发现，该疫苗对有感染症状的有效性约为91%。

Now, throughout the pandemic, there have been more than 8,600 young children hospitalized with COVID,

现在，在整个疫情期间，已有8600多名较小儿童因新冠肺炎住院，

and nearly 100 kids aged 5 to 11 have died from COVID.

近100名5至11岁的儿童死于新冠肺炎。

So when it came time to vote, one committee member did abstain,

所以当投票的时候，一位委员投了弃权票，

but all the others voted that the benefits of vaccinating this age group outweighs the risks.

但其他所有人都认为，给这个年龄段的人接种疫苗的好处大于风险。

Dr. Amanda Cohn explained her vote.

阿曼达·科恩博士解释了她投票的原因。

COVID-19 now is a vaccine preventable disease, from my perspective,

在我看来，COVID-19现在是一种用疫苗可预防的疾病，

and COVID is also the eighth highest killer of kids in this age group over the past year.

而且在过去一年里，COVID-19也是该年龄组儿童的第八大杀手。

And so use of this vaccine will prevent deaths, will prevent ICU admissions and will prevent significant long-term adverse outcomes in children.

因此，使用这种疫苗将预防儿童死亡，预防儿童进展到ICU住院并预防儿童出现长期严重的不良后果。

Now, some committee members said they think, for now, it should be a parent's choice to vaccinate their kids, not a mandate.

现在，一些委员会成员表示，他们认为，就目前而言，给孩子接种疫苗应该是父母的选择，而不是强制要求。

Based on your reporting, do you think the FDA is going to agree with those advisers and go ahead and authorize the vaccine?

根据你的报告，你认为FDA会同意那些顾问的意见并批准疫苗吗?

You know, the FDA typically does follow the advice of its advisory committee, and the agency's own scientists have already weighed in, Noel.

你知道，FDA通常会听从其顾问委员会的建议，而且该机构的科学家已经参与了，诺埃尔。

They concluded that the vaccine's benefit in preventing hospitalizations and deaths likely outweigh the risks of any potential rare serious side effects.

他们的结论是，疫苗在预防住院和死亡方面的益处可能超过任何潜在的罕见严重副作用的风险。

So, yes, the agency's analysis does support authorization.

所以，是的，该机构的分析确实支持授权。

One thing I bet parents will be very curious about - what are the side effects for kids who get the shot?

有一件事我敢打赌父母们会非常好奇——孩子注射疫苗会有什么副作用?

You know, the common side effects tend to be the same seen in adults - sore arm, headache, aches, chills.

你知道，常见的副作用也往往出现在成年人身上，比如，手臂酸痛，头痛，疼痛，发冷。

Now, when it comes to serious side effects, the main concern is myocarditis, which is inflammation in the heart.

现在，说到严重的副作用，主要担心的是心肌炎，这是心脏的炎症。

There have been rare instances following vaccination, mostly in young men.

接种疫苗后出现了罕见的病例，主要是年轻男子。

Now, no children in the Pfizer trial developed myocarditis, but some older kids have.

现在，在辉瑞的试验中没有儿童患上心肌炎，但一些年龄较大的儿童患上了。

Dr. Matthew Oster of the CDC outlined what is known from 10 cases among 12- to 17-year-olds

美国疾控中心的马修·奥斯特博士从12至17岁的10个病例中总结了已知的情况

who developed the condition after receiving the Pfizer vaccine.

这些儿童是在接种辉瑞公司的疫苗后患上这种疾病的。

About 30% of those 12 to 17 have been given a status of recovered, meaning no medications, no exercise restrictions, no ongoing symptoms.

在这12到17人中，大约30%的人处于康复状态，这意味着没有药物治疗，没有活动限制，没有持续的症状。

This was one month after vaccination.

这是在接种疫苗一个月后。

Typically, he says, the long-term outlook of children who get myocarditis is good,

他说，一般来说，对于患心肌炎的儿童来说，其长期前景是好的，

but this is something CDC will track closely through surveillance if the vaccine is authorized.

但如果疫苗获得批准，疾控中心将通过监控密切跟踪。

And let's say it is authorized. How likely is it that parents will be on board?

假设这是授权的。家长们同意的可能性有多大?

You know, about 44% of adolescents 12 to 17 years old have been fully vaccinated, so that's one data point.

你知道，12到17岁的青少年中有44%的人已经接种了疫苗，这是一个数据。

And a recent poll from the COVID-19 Vaccine Education Equity Project found about two-thirds of parents of 5- to 11-year-olds say they are likely to vaccinate their children.

COVID-19疫苗教育公平项目最近的一项调查发现，大约三分之二的5至11岁儿童的父母表示，他们可能会给孩子接种疫苗。

So typically, adults who have been vaccinated are more likely to say they'll get their young children vaccinated.

所以通常情况下，已经接种疫苗的成年人更有可能说他们会给自己年幼的孩子接种疫苗。

Among those who say that they won't vaccinate their children right away,

那些说他们不会马上给孩子接种疫苗的家长，

many say full approval from the FDA or a school mandate would prompt them to change their minds.

许多家长说，FDA 完全批准或学校强制执行会促使他们改变自己的主意。