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Rotavirus Vaccine Offers Earlier Protection
New Vaccine Could Prevent Thousands of Childhood Diarrhea-Related Hospitalizations Each Year
April 8, 2008 -- A new vaccine approved by the FDA promises to provide earlier protection against a leading cause of potentially deadly diarrhea in children. GlaxoSmithKline's Rotarix vaccine helps prevent rotavirus gastroenteritis, a common childhood condition responsible for as many as 70,000 hospitalizations each year in the United States.
The two-dose vaccine is a liquid taken by mouth and fully vaccinates infants by 4 months of age, 2 months earlier than the existing Rotateq vaccine, which is manufactured by Merck. The CDC recommends that rotavirus vaccination be completed by the time a child is 6 months old. However, one out of every five children admitted to the hospital with such infections is younger than 6 months.
Becoming protected against the disease at an earlier age could reduce the number of emergency room visits made by families. About 2.7 million children in the U.S. develop rotavirus disease every year. Rotavirus-related gastrointestinal illness typically strikes the southwestern U.S. during the late fall and early winter and the Northeast by spring.
\"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children,\" Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.
The CDC, The American Academy of Pediatrics, and the American Academy of Family Physicians all recommend rotavirus immunization for infants. According to an FDA news release, \"without vaccination, nearly every child in the U.S. would likely be infected at least once with rotavirus by age 5.\"
Studies involving 24, 000 infants showed that the Rotarix vaccine helped protect against both mild and severe rotavirus-associated gastroenteritis in children under age 2. The vaccine protects against the most commonly circulating strains of rotavirus.
Some children who receive the vaccine may experience side effects including fussiness, irritability, cough, runny nose, fever, lose of appetite, and vomiting.
An earlier rotavirus vaccine manufactured by Wyeth was pulled from the U.S. market after several children developed a potentially life-threatening intestinal condition called intussusception after being immunized. Researchers with GlaxoSmithKline evaluated more than 63,000 infants who received their vaccine and found no increased risk. However, the FDA has requested post-market testing to provide additional safety information.
{http://www.webmd.com/news/200804 ... n-against-rotavirus}
新的疫苗每年能够保护数以千计的儿童痢疾相关的疾病免于住院治疗。
2008年4月8日,一种FDA批准的新的疫苗承诺能够对儿童的一种致命的痢疾提供保护,原理是针对这种疾病其中的一个主要的潜在因素。GlaxoSmithKline's Rotarix 疫苗能够预防轮状病毒胃肠炎,这是一种常见的儿童疾病,每年在美国有70000儿童因此住院。
两次剂量的疫苗是一种液体制剂,经过口服和完全的疫苗接种(当婴儿4个月大时),比现有的由默克公司生产的Rotateq疫苗早两个月。疾控中心建议,轮状病毒疫苗接种应该在儿童6个月之前完成。但是,五分之一的儿童会在6个月之前就受到感染。
在更早的阶段预防这种疾病能够减少家庭急诊的数量。在美国大概每年有2.7百万的儿童发生轮状病毒疾病。轮状病毒相关的胃肠疾病在深秋和初冬时袭击了美国西南部和东北部。
,FDA的生物制品评价和研究中心主管Jesse L. Goodman,在一次新闻发布中说到:这种疫苗提供了与疾病做斗争的另外一种选择,并且减少了影响这么多儿童的一种潜在的严重疾病。
疾控中心,美国儿科学会和美国家庭医师学会都建议对儿童使用这种疫苗。根据FDA发布的数据显示,如果不使用疫苗,几乎每个美国儿童都会在5岁以前受到轮状病毒感染至少一次。
对24000儿童的研究显示,轮状病毒疫苗能够对2岁以下儿童轻微的和严重的轮状病毒相关的胃肠炎提供保护。疫苗主要预防轮状病毒常见的类型。
接种疫苗的儿童可能会有些副作用,包括易怒、过敏、咳嗽、发烧、食欲不振和呕吐。
更早的轮状病毒疫苗由Wyeth生产,对一些有危及生命的肠病的儿童免疫后做市场调查。研究发现没有明显的风险。但是,FDA仍然要求做上市后测试,以提供更多的安全数据。 国产疫苗效果也显著,也可以推荐!
轮状病毒疫苗的副作用有肠套叠.不仅包括易怒、过敏、咳嗽、发烧、食欲不振和呕吐。 |
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