The Food and Drug Administration issued the world's first approval of a vaccine against respiratory syncytial virus (RSV), an achievement that researchers have worked toward for decades after a catastrophic clinical trial in the 1960s.

美国食品和药物管理局(Food and Drug Administration)批准了世界上第一个抗呼吸道合胞病毒(RSV)的疫苗，这是研究人员在20世纪60年代灾难性的临床试验后几十年努力取得的成就。

The vaccine, called Arexvy from pharmaceutical giant GSK, is approved for adults aged 60 and over. The Centers for Disease Control and Prevention will need to recommend the vaccine before it will be available for use. The agency's advisory committee for immunizations is next scheduled to meet June 21 to 22 and could discuss the vaccine then.

这种名为Arexvy的疫苗来自制药巨头葛兰素史克，被批准用于60岁及以上的成年人。在疫苗投入使用之前，疾病控制和预防中心需要推荐疫苗。该机构的免疫咨询委员会定于6月21日至22日举行会议，届时可能会讨论疫苗。

RSV is a common, highly contagious seasonal respiratory infection. It's often associated with infants, who are at especially high risk of developing severe disease. In fact, bronchitis from RSV infections is the leading cause of hospitalization among infants under the age of 1 in the US. But the virus is also dangerous for older adults, causing an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths in older adults each year in the country.

呼吸道合胞病毒是一种常见的、高度传染性的季节性呼吸道感染。它通常与婴儿有关，婴儿患严重疾病的风险特别高。事实上，呼吸道合胞病毒感染引起的支气管炎是美国1岁以下婴儿住院的主要原因。但这种病毒对老年人也很危险，据估计，该国每年有6万至16万人住院治疗，6000至1万人死亡。

In an ongoing, randomized, placebo-controlled clinical study of adults aged 60 and older—in which about 12,500 participants received Arexvy, and 12,500 participants received a placebo— the vaccine reduced the risk of developing lower-respiratory tract infection from RSV by 82.6 percent, and reduced the risk of developing a severe RSV infection by 94.1 percent, the FDA noted.

FDA指出，在一项正在进行的、随机的、安慰剂对照的60岁及以上成年人临床研究中，约12500名参与者接受了Arexvy, 12500名参与者接受了安慰剂，该疫苗将发生下呼吸道感染RSV的风险降低了82.6%，将发生严重RSV感染的风险降低了94.1%。

"Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. The approval Wednesday of this first RSV vaccine is "an important public health achievement to prevent a disease which can be life-threatening," he added.

FDA生物制品评估和研究中心主任彼得·马克斯在一份声明中说:“老年人，特别是那些有潜在健康问题的人，如心脏病、肺病或免疫系统较弱的人，患RSV引起的严重疾病的风险很高。”他补充说，周三批准的首个RSV疫苗是“预防一种可能危及生命的疾病的重要公共卫生成就”。