Koch J, Wiese-Posselt M, Remschmidt C, Wichmann O, Bertelsmann H, Garbe E, Hengel H, Meerpohl J J, Mas Marques A, Oppermann H, Hummers-Pradier E, von Kries R, Mertens T
Immunization Unit, Robert Koch Institute, Berlin, Germany.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2013 Jul;56(7):957-84. doi: 10.1007/s00103-013-1777-3.
Two rotavirus (RV) vaccines were introduced to the European market in 2006. To support the decision-making process of the German Standing Committee on Vaccination ("Ständige Impfkommission", STIKO) regarding adoption of routine RV vaccination into the national vaccination schedule in Germany relevant scientific background was reviewed. According to STIKO’s Standard Operating Procedures for the development of evidence-based vaccination recommendations, a set of key questions was addressed and systematic reviews were performed with a focus on the efficacy, effectiveness, impact and safety of RV vaccines. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was applied to assess the quality of available evidence. Data from 5 randomized controlled trials demonstrated a high efficacy of RV vaccines in preventing severe RV-associated gastroenteritis (91%) and hospitalization (92%) in settings comparable to Germany. Post-marketing observational studies confirmed these findings. In several countries, impact studies suggest that age groups not eligible for vaccination might also benefit from herd effects and demonstrated a decrease in the number of nosocomial RV infections after RV vaccine introduction. The vaccines were considered safe, except for a slightly increased risk of intussusception shortly after the first dose, corresponding to 1-2 additional cases per 100,000 infants vaccinated (relative risk =1.21, 95% confidence interval [CI] 0.68-2.14). RV case-fatality is extremely low in Germany. However, RV incidence among children aged <5 years is high (reported 8-14 cases per 1000 children annually), and of these almost half require hositalization. In view of the available evidence and expected benefits, STIKO recommends routine rotavirus vaccination of children under the age of 6 months with the main goal of preventing RV-associated hospitalizations in Germany, especially among infants and young children.
2006年，两种轮状病毒（RV）疫苗被引入欧洲市场。为支持德国疫苗接种常设委员会（“Ständige Impfkommission”，STIKO）就是否将常规RV疫苗接种纳入德国国家疫苗接种计划做出决策，对相关科学背景进行了审查。根据STIKO制定基于证据的疫苗接种建议的标准操作程序，提出了一系列关键问题，并进行了系统评价，重点关注RV疫苗的有效性、效果、影响和安全性。采用推荐分级评估、制定与评价（GRADE）方法评估现有证据的质量。来自5项随机对照试验的数据表明，在与德国类似的环境中，RV疫苗在预防严重RV相关胃肠炎（91%）和住院（92%）方面具有很高的有效性。上市后观察性研究证实了这些发现。在几个国家，影响研究表明，不符合疫苗接种条件的年龄组也可能从群体效应中受益，并表明引入RV疫苗后医院内RV感染数量有所减少。除了首剂接种后不久肠套叠风险略有增加外，这些疫苗被认为是安全的，每10万名接种疫苗的婴儿中额外增加1 - 2例（相对风险=1.21，95%置信区间[CI] 0.68 - 2.14）。德国的RV病死率极低。然而，<5岁儿童的RV发病率很高（每年报告每1000名儿童中有8 - 14例），其中近一半需要住院治疗。鉴于现有证据和预期益处，STIKO建议对6个月以下儿童进行常规轮状病毒疫苗接种，主要目标是在德国预防与RV相关的住院治疗，尤其是在婴幼儿中。
