Vesikari Timo
University of Tampere, Medical School, Vaccine Research Center, Finland.
Scand J Infect Dis. 2008;40(9):691-5. doi: 10.1080/00365540802040570.
Two live attenuated oral rotavirus vaccines were licensed in 2006 for prevention of severe acute gastroenteritis in children: Rotarix (GSK), a human rotavirus vaccine with G1P[8] serotype characteristics and RotaTeq (Merck), a bovine-human reassortant vaccine expressing human G1-4 and P[8] antigens. In prelicensure trials both vaccines showed high efficacy against severe RV gastroenteritis, low reactogenicity and no increased risk for intussusception (IS) (Ruiz-Palacios et al., 2006; Vesikari et al., 2006). Both vaccines have now been distributed in millions of doses. Post-marketing data have not shown any gross signal for IS with either vaccine, but further data and analyses are required for final conclusion on safety of these vaccines.
2006年,两种口服减毒活轮状病毒疫苗被批准用于预防儿童严重急性胃肠炎:Rotarix(葛兰素史克公司生产),一种具有G1P[8]血清型特征的人轮状病毒疫苗;以及RotaTeq(默克公司生产),一种表达人G1 - 4和P[8]抗原的牛 - 人重组疫苗。在上市前试验中,两种疫苗对严重轮状病毒胃肠炎均显示出高效力、低反应原性且肠套叠(IS)风险未增加(Ruiz - Palacios等人,2006年;Vesikari等人,2006年)。两种疫苗现已分发数百万剂。上市后数据未显示任何一种疫苗存在肠套叠的明显信号,但需要进一步的数据和分析才能对这些疫苗的安全性得出最终结论。