莫德纳申请其疫苗用于6岁以下儿童（在线收听）

American drugmaker Moderna is asking U.S. officials to approve its COVID-19 vaccine for the nation's youngest children. Children under 5 are the only group in the United States not yet able to be vaccinated.

美国制药商莫德纳要求美国官员批准其用于美国最低龄儿童的新冠疫苗。5岁以下儿童是美国唯一尚未接种疫苗的人群。

Families have been waiting a long time to protect their young children, even as people are gathering in higher numbers and wearing fewer face coverings. But coronavirus variants continue to spread.

家庭想要保护他们的幼儿已经等待了很长时间，即使聚集的人数越来越多，戴口罩的越来越少。但是新冠病毒变种还在传播。

Moderna provided its study results to the Food and Drug Administration (FDA). The drug company hopes the information proves that two low-dose shots can protect babies and young children.

莫德纳向美国食品和药品管理局提供了其研究结果。这家制药公司希望这些信息能证实两针低剂量疫苗可以保护婴幼儿。

"There is an important unmet medical need here with these youngest kids," said Dr. Paul Burton. He is Moderna's chief medical officer. Two shots for children "will safely protect them. I think it is likely that over time they will need additional doses."

保罗·伯顿博士表示：“这些幼儿存在一项未得到满足的重要医疗需求。”他是莫德纳的首席医疗官。为儿童注射两针疫苗“将护他们周全。我认为随着时间的推移，他们可以需要额外接种。”

Currently, Pfizer's vaccine is the only one approved for children. But that vaccine is only for children over the age of 5. That leaves 18 million young children and babies unprotected.

辉瑞疫苗是目前唯一获准用于儿童的疫苗。但是这种疫苗只适用于5岁以上儿童。这使得1800万婴幼儿得不到保护。

Pfizer is also expected to announce whether three of its even smaller-dose shots work for very young children. The FDA said in February that the company's two doses were not strong enough.

预计辉瑞也将公布该公司三针更小剂量的疫苗是否适用于非常幼儿。美国食品和药品管理局在2月份表示，该公司两针的剂量保护力不够。

Some families have questioned why a shot for young children has taken so long.

一些家庭质疑为什么幼儿疫苗耗费了这么长时间。

FDA vaccine chief Dr. Peter Marks told U.S. lawmakers this week that the FDA cannot evaluate a product until a producer completes its application. In a statement Thursday, the FDA said Moderna still must send some additional data to complete its request.

美国食品和药品管理局负责人彼得‧马克斯博士本周对美国议员表示，在生产商完成申请之前，美国食品和药品管理局无法评估其产品。美国食品和药品管理局在周四的一份声明中表示，莫德纳仍然必须发送一些额外数据以完成申请。

"It's critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize," Marks said.

马克斯表示：“我们进行适当的评估相当重要，这样父母才会信任我们授权的任何疫苗。”

If the FDA approves Moderna's vaccine for young children and babies, the U.S. Centers for Disease Control and Prevention (CDC) would then have to recommend who needs it. It could either be for all young children or just those at higher risk from COVID-19.

如果美国食品和药品管理局批准莫德纳的婴幼儿疫苗，那么美国疾控预防中心将不得不对谁需要接种做出推荐。它可能适用于所有幼儿，也可能只适用于新冠肺炎风险较高的儿童。

The FDA will face some complex questions.

美国食品和药品管理局将面临一些复杂的问题。

The two Moderna shots for young children are each one-fourth of the normal dose for an adult. In a study of kids ages 6 months through 5 years, data showed that the doses produced high levels of virus-fighting antibodies. It was the same amount produced in young adults, Burton said. There were no serious side effects reported, and the shots resulted in fewer high body temperatures than other usual vaccines for children.

为幼儿提供的两针莫德纳疫苗每针的注射剂量均为成人正常剂量的1/4。在一项针对6个月到5岁儿童的研究中，数据显示这种剂量产生了高水平的病毒抗体。伯顿表示，这与年轻人产生的抗体水平相同。没有报告严重的副作用，与其它常用儿童疫苗相比，这些疫苗导致的发烧更少。

Moderna's vaccine proved between about 40 percent and 50 percent effective at preventing symptomatic COVID-19 during the trial. Burton said the Omicron variant's ability to partly escape vaccine immunity was a reason that effectiveness was not higher.

在试验期间，经证实莫德纳的疫苗在防止新冠肺炎症状方面的有效性在40%到50%之间。伯顿表示，奥密克戎变种部分逃逸疫苗免疫能力是有效性不高的一个原因。

Moderna's COVID vaccine so far has only been available to adults in the U.S. Other countries have already been offering the shot to children as young as 6. But months ago the FDA said it had concerns about a rare heart-related side effect in teenage boys.

迄今为止，莫德纳的新冠疫苗在美国仅用于成年人。其它国家已经为年仅6岁的儿童提供疫苗。但几个月前，美国食品和药品管理局担心青少年男生会出现与罕见心脏病相关的副作用。

COVID-19 generally is not as dangerous for children as it is for adults. But a small number have become very sick or even died. About 475 children younger than 5 have died from COVID-19 since the pandemic's start, the CDC says. Child hospitalizations greatly increased during the spread of Omicron.

新冠肺炎对儿童的危害通常小于成人。但是少数儿童病得很重，甚至死亡。美国疾控预防中心表示，自大流行开始以来，约有475名5岁以下儿童死于新冠肺炎。在奥密克戎传播期间，儿童住院人数大大增加。

It is not clear how many parents plan to vaccinate their young children and babies. Less than one-third of children ages 5 to 11 have had two vaccinations.

目前尚不清楚有多少父母计划为婴幼儿接种疫苗。5-11岁儿童接种只有不到1/3完整接种了两针疫苗。