Viral Gastroenteritis Section, MS-A47, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Expert Rev Vaccines. 2009 Nov;8(11):1555-64. doi: 10.1586/erv.09.106.
Two live oral rotavirus vaccines (RotaTeq) and Rotarix) have recently been recommended by the WHO for inclusion into the national immunization programs of countries worldwide. Owing to the association of the withdrawn Rotashield vaccine with intussusception, these two new rotavirus vaccines underwent large clinical trials of over 60,000 infants each to assess safety with regard to this medical condition. For these two new vaccines, clinical trials and available postmarketing safety monitoring data do not indicate a risk of intussusception after vaccination, although a low-level risk cannot be excluded at present. We review these safety data for the new vaccines and for Rotashield to provide background information relevant for considering age recommendations for rotavirus vaccination.
两种活的口服轮状病毒疫苗(RotaTeq 和 Rotarix)最近被世界卫生组织推荐纳入全球各国的国家免疫规划。由于撤回的 Rotashield 疫苗与肠套叠有关,这两种新的轮状病毒疫苗进行了超过 60,000 例婴儿的大型临床试验,以评估针对这种医疗状况的安全性。对于这两种新疫苗,临床试验和可用的上市后安全性监测数据并未表明接种后存在肠套叠的风险,但目前不能排除低水平的风险。我们回顾了这些新疫苗和 Rotashield 的安全性数据,为考虑轮状病毒疫苗接种的年龄建议提供相关背景信息。