ABSTRACT

Introduction

Rotavirus (RV) disease remains a prominent cause of disease burden in children <5 years of age worldwide. However, implementation of RV vaccination has led to significant reductions in RV mortality, compared to the pre-vaccination era. This review presents 15 years of real-world experience with the oral live-attenuated human RV vaccine (HRV; Rotarix). HRV is currently introduced in ≥80 national immunization programs (NIPs), as 2 doses starting from 6 weeks of age.

Areas covered

The clinical development of HRV and post-marketing experience indicating the impact of HRV vaccination on RV disease was reviewed.

Expert opinion

In clinical trials, HRV displayed an acceptable safety profile and efficacy against RV-gastroenteritis, providing broad protection against heterotypic RV strains by reducing the consequences of severe RV disease in infants. Real-world evidence shows substantial, rapid reduction in the number of RV infections and associated hospitalizations following introduction of HRV in NIPs, regardless of economic setting. Indirect effects against RV disease are also observed, such as herd protection, decrease in nosocomial infections incidence, and a reduction of disease-related societal/healthcare costs. However, not all countries have implemented RV vaccination. Coverage remains suboptimal and should be improved to maximize the benefits of RV vaccination.

中文翻译：

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口服减毒人类轮状病毒疫苗的十五年经验：对经验教训的反思。

摘要

介绍

轮状病毒（RV）疾病仍然是世界范围内<5岁儿童疾病负担的重要原因。但是，与疫苗接种前相比，实施RV疫苗接种已导致RV死亡率大大降低。这篇综述介绍了口服减毒人类RV疫苗（HRV; Rotarix）的15年实际经验。目前，HRV已在≥80个国家免疫计划（NIP）中引入，从6周龄开始以2剂的剂量使用。

覆盖区域

回顾了HRV的临床发展和上市后的经验，这些经验表明HRV疫苗接种对RV疾病的影响。

专家意见

在临床试验中，HRV显示出可接受的安全性和抵抗RV胃肠炎的功效，通过减少婴儿严重RV疾病的后果，为异型RV株提供了广泛的保护。现实世界的证据表明，在NIP中引入HRV后，无论经济环境如何，RV感染和相关住院治疗的数量都将迅速减少。还观察到了对RV疾病的间接影响，例如畜群保护，医院感染发生率的降低以及疾病相关的社会/医疗费用的减少。但是，并非所有国家都已实施RV疫苗接种。覆盖率仍然不是最理想的，应该加以改善，以使RV疫苗接种的收益最大化。