FDA批准Boostrix用于预防老人的破伤风、白喉和百日咳

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FDA NEWS RELEASE

FDA新闻发布
For Immediate Release: July 8, 2011

及时发布：2011-7-8
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

媒体咨询处：Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

消费者咨询处： 888-INFO-FDA

FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people

FDA批准Boostrix用于预防老人的破伤风、白喉和百日咳。

The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.

今日，FDA批准疫苗用于预防65岁含以上的老人的破伤风、白喉和百日咳。

Currently, there are vaccines approved for the prevention of tetanus and diphtheria that can be used in adults 65 and older. Boostrix, which is given as a single-dose booster shot, is the first vaccine approved to prevent all three diseases in older people.

目前，已有多种疫苗批准用于预防65岁含以上的老人的破伤风、白喉和百日咳。Boostrix是第一个获得批准用于老人预防3种疾病的单剂量加强针给药的产品。

Tetanus can cause paralysis and is caused by bacteria that live in soil, dust, and manure. The bacteria usually enter the body through a deep cut. Diphtheria is a serious bacterial infection that usually causes a bad sore throat, swollen glands, fever, and chills. If not properly diagnosed and treated, serious complications such as heart failure or paralysis can result. Pertussis is a disease that causes uncontrollable coughing; the infected person makes a noise when they breathe after coughing that sounds like “whoop.” The incidence of pertussis disease in the United States has been increasing since 2007, with large local outbreaks occurring in 2010 in California, Michigan, and Ohio.

破伤风可导致瘫痪，可因土壤、灰尘和粪便中的细菌引起发病。此种细菌通常可通过深部体表伤口进入人体。白喉是一种严重的细菌感染，通常引起严重的咽痛、淋巴结肿大、发热和颤栗。如果不进行正确的诊断和治疗，可能会导致严重的并发症，例如心衰或麻痹。百日咳可引起无法控制的咳嗽；在感染患者咳嗽后，呼吸时伴有杂音，如“呼”的声音。美国的百日咳发病率自2007年以来一直增加，在2010年时，加利福尼亚、密歇根和俄亥俄曾出现过大暴发的情况。

“Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research. “With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria.”

“百日咳是一种传染性极强的疾病，老人常在养老院和医院出现发病情况。”FDA生物制品评价研究中心负责人Karen Midthun, M.D.如是说。“本品的批准，65岁含以上的老人，现在能有机会接收一种疫苗来同时预防百日咳与破伤风和白喉。”

The safety and effectiveness of Boostrix was based on a study of about 1,300 people ages 65 and older. To demonstrate its ability to protect against pertussis, the antibody levels among participants were measured and found comparable to the levels in infants who received a closely related vaccine that was shown to prevent pertussis.

Boostrix的安全性和有效性是基于一项约1 300例的65岁含以上人群的研究而得出的。为了能证明，本品能有效对抗百日咳，对参与者进行了抗体水平进行测量，发现这与婴儿接收预防百日咳的相关疫苗的抗体水平相当。

The antibody responses to the tetanus and diphtheria components were compared with a licensed tetanus and diphtheria vaccine, and were found comparable. The most common adverse reactions reported by the older adults after receiving Boostrix were headache, and fatigue and pain at the injection site.

破伤风和白喉的抗体应答与一个已批准的破伤风和白喉的疫苗相比，显示具有可比性。最常见的不良反应报道有老人在接收Boostrix后出现头痛、疲乏、注射部位疼痛。

Boostrix was originally approved on May 3, 2005, for use in adolescents ages 10 years through 18 years. It subsequently was approved in December 2008, to include adults 19 years through 64 years of age. Boostrix is manufactured by GlaxoSmithKline Biologicals, based in Rixensart, Belgium.

Boostrix于2005年5月3日获得首次批准，适用于10到18岁的青少年。之后于2008年12月批准增加适用于19到64岁的成人。Boostrix由总部设在比利时的里克桑萨尔的GSK生物制品公司生产。

For more information:

更多信息：

Boostrix Product Page

Boostrix产品页
1

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA是美国卫生与公共服务部内设的一个机构，通过确保人和兽用药、人用疫苗和其他生物制品以及医疗器械的安全性、有效性，从而保障公众健康。该机构也负责国内食品供应、化妆品、食品补充剂、电子辐射产品和规范的烟草制品的安全。

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FDA批准Boostrix用于预防老年人破伤风、白喉及百日咳

原发布日期：     来源：
转载发布日期：20110809
      美国食品药品管理局（FDA）2011年7月8日批准Boostrix疫苗用于预防65岁及以上人群破伤风、白喉及百日咳。Boostrix最初于2005年5月3日获批用于10-18岁的青少年，随后又于2008年12月获批用于19-64岁的成人。
      目前已有上市疫苗用于预防65岁及以上人群的破伤风及白喉。Boostrix为单剂量加强型疫苗，是首个获批用于预防老年人破伤风、白喉及百日咳三种疾病的疫苗。
      破伤风可致麻痹，由存活于土壤、尘土、粪肥的细菌引起，细菌常通过深度伤口进入人体内。白喉是一种重度细菌感染，通常会导致咽喉剧痛、腺体肿大、发烧以及寒栗，一旦未被恰当诊断与治疗，可导致例如心力衰竭或麻痹等严重并发症。百日咳是可引起不止咳嗽的一种疾病；感染人群咳嗽后可发出吸气性吼声。在美国，百日咳的发生率自2007年一直攀升，2010年加利福尼亚州、密歇根州及俄亥俄州发生了局部大爆发。
      Boostrix的安全性及有效性通过一项约有1300名65岁及以上老年人的研究进行评价。为证明Boostrix对百日咳的防御能力，研究对受试者的抗体水平进行了监测，发现受试者与接种过百日咳疫苗的婴幼儿抗体水平相当。破伤风及白喉的组合抗体应答与已获批的破伤风疫苗及白喉疫苗的效果相当。在Boostrix接种的老年人中，报告的最常见不良反应包括头疼、疲乏以及注射点疼痛。