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U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV.
美国官员周一批准了第一种保护婴幼儿免受呼吸道合胞病毒侵袭的长效药。
RSV sends tens of thousands of American children to the hospital each year.
每年有数以万计的美国儿童因感染呼吸道合胞病毒而入院。
The virus is a cold-like disease for most healthy people.
对于大多数健康的人来说，这种病毒是一种类似感冒的疾病。
But it can be life-threatening in the very young and very old.
但对于非常年幼和非常年老的人来说，它可能会危及生命。
Last year, a large increase in RSV cases crowded U.S. hospitals with sick children.
去年，感染呼吸道合胞病毒的病例大幅增加，这使得美国的医院挤满了患病的儿童。
The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.
美国食品药品监督管理局批准了这种药品，该药适用于面临感染呼吸道合胞病毒高风险的婴儿和2岁以下儿童。
The approval helps "reduce the impact of RSV disease on children, families and the health care system" said FDA's Dr. John Farley in a statement.
美国食品药品监督管理局的约翰·法利博士在一份声明中表示，批准该药品有助于“降低呼吸道合胞病毒对儿童、家庭和医疗保健系统的影响”。
The drugmaker AstraZeneca developed the drug.
阿斯利康制药公司开发了这种药物。
It will be sold under the name Beyfortus.
该药将以Beyfortus的名字出售。
It is a laboratory-made version of an antibody that helps the immune system fight off RSV.
这是一种实验室制造的抗体药，可以帮助免疫系统对抗呼吸道合胞病毒。
Under the FDA approval, babies — including small infants — can receive a single injection to protect against their first season of RSV, which usually lasts about five months.
根据美国食品药品监督管理局的批文，婴儿——包括小婴儿——可以注射一剂，以预防他们在第一个呼吸道合胞病毒季节感染病毒，通常有效期大约五个月。
Children up to age 2 can receive another dose to protect them during their second season facing the virus.
2岁以下的儿童可以注射第二剂，以保护他们在第二个呼吸道合胞病毒季节免受病毒侵袭。
Beyfortus is already approved in Canada, Europe and Britain.
Beyfortus已经在加拿大、欧洲和英国获得批准。
It did not immediately announce the U.S. price of the treatment.
该公司没有立即宣布该药品在美国的价格。
FDA officials approved the drug based on three studies.
美国食品药品监督管理局官员根据三项研究批准了该药物。
They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent among infants and children 2 and younger.
他们表明，Beyfortus将婴儿和2岁以下儿童人群感染呼吸道合胞病毒的风险降低了70%至75%。
Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.
疾病预防控制中心的顾问将于下个月初开会，确切地说明哪些人应该注射这种药物。
A similar antibody drug won FDA approval more than 20 years ago.
20多年前，一种类似的抗体药物获得了美国食品药品监督管理局的批准。
But the drug is only recommended for high-risk babies and requires monthly injections.
但这种药物只建议高危婴儿注射，并且需要每月注射一次。
Doctors say that drug is underused.
医生说，这种药物没有得到充分利用。
But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.
但他们预计，阿斯利康注射剂的更持久的效果会更受欢迎。
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die.
在美国，每年约有5.8万名5岁以下的儿童因感染呼吸道合胞病毒而住院。数百人死亡。
After years of setbacks for RSV research, drugmakers have made big improvements this year.
在呼吸道合胞病毒研究经历了多年的挫折后，制药商今年取得了重大进展。
In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer.
今年5月，美国食品药品监督管理局批准了葛兰素史克和辉瑞公司为老年人生产的两种呼吸道合胞病毒疫苗。
In August, the FDA is expected to make a decision on approving Pfizer's vaccine for pregnant women.
预计美国食品药品监督管理局将会在8月份就是否批准辉瑞公司生产的孕妇疫苗做出决定。
The aim is for the vaccine to pass along protection to their newborns.
其目的是让疫苗将保护作用传递给新生儿。
I'm Dan Novak.
丹·诺瓦克为您播报。
译文为可可英语翻译，未经授权请勿转载！
