Skansberg Annika, Sauer Molly, Tan Marissa, Santosham Mathuram, Jennings Mary Carol
International Vaccine Access Center, Department of International Health, Johns Hopkins University, Baltimore, MD, USA.
International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Hum Vaccin Immunother. 2021 Apr 3;17(4):1223-1234. doi: 10.1080/21645515.2020.1804245. Epub 2020 Oct 29.
Rotavirus is the leading cause of severe dehydrating gastroenteritis and death due to diarrhea among children under 5, causing over 180,000 under-5 deaths annually. Safe, effective rotavirus vaccines have been available for over a decade and are used in over 98 countries. In addition to the globally available, WHO-prequalified ROTARIX (GSK) and RotaTeq (Merck), several new rotavirus vaccines have attained national licensure - ROTAVAC (Bharat Biotech) and ROTASIIL (Serum Institute of India), licensed and manufactured in India and now WHO-prequalified, and Rotavin-M1 (PolyVac), licensed and manufactured in Vietnam. In this review, we summarize the available clinical trial and post-introduction evidence for these three new orally administered rotavirus vaccines. All three vaccines have demonstrated safety and efficacy against rotavirus diarrhea, although publicly available preclinical data are limited in some cases. This expanding product landscape presents a range of options to optimize immunization programs, and new presentations of each vaccine are currently under development.
轮状病毒是5岁以下儿童严重脱水型胃肠炎及腹泻致死的主要原因，每年导致超过18万5岁以下儿童死亡。安全、有效的轮状病毒疫苗已问世十余年，在98个以上国家使用。除了全球通用的、获得世卫组织预认证的罗特威（葛兰素史克公司）和五价重配轮状病毒疫苗（默克公司）外，几种新型轮状病毒疫苗已获得国家许可——印度巴拉特生物技术公司生产的Rotavac和印度血清研究所生产的Rotasiil已在印度获得许可并生产，现已获得世卫组织预认证；越南生产的Rotavin-M1（PolyVac）也已获得许可。在本综述中，我们总结了这三种新型口服轮状病毒疫苗的现有临床试验及引入后证据。尽管在某些情况下公开的临床前数据有限，但这三种疫苗均已证明对轮状病毒腹泻具有安全性和有效性。这种不断扩大的产品格局为优化免疫规划提供了一系列选择，目前每种疫苗都有新的剂型正在研发中。
