Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA.
Ther Clin Risk Manag. 2008 Feb;4(1):49-63. doi: 10.2147/tcrm.s821.
A "Meeting on Upstream Rotavirus Vaccines and Emerging Vaccine Producers" was held at the World Health Organization in Geneva, Switzerland on March 28-30, 2006. The purpose was to discuss, evaluate, and weigh the importance of additional rotavirus vaccine candidates following the successful international licensure of rotavirus vaccines by two major pharmaceutical companies (GlaxoSmithKline and Merck) that had been in development for many years. Both licensed vaccines are composed of live rotaviruses that are delivered orally as have been all candidate rotavirus vaccines evaluated in humans. Each is built on the experience gained with previous candidates whose development had either been discontinued or, in the case of the previously licensed rhesus rotavirus reassortant vaccine (Rotashield), was withdrawn by its manufacturer after the discovery of a rare association with intussusception. Although which alternative candidate vaccines should be supported for development and where this should be done are controversial topics, there was general agreement expressed at the Geneva meeting that further development of alternative candidates is a high priority. This development will help insure that the most safe, effective and economic vaccines are available to children in Third World nations where the vast majority of the >600,000 deaths due to rotavirus occur each year. This review is intended to provide the history and present status of rotavirus vaccines as well as a perspective on the future development of candidate vaccines as a means of promulgating plans suggested at the Geneva meeting.
“上游轮状病毒疫苗和新兴疫苗生产商会议”于 2006 年 3 月 28 日至 30 日在瑞士日内瓦的世界卫生组织举行。会议目的是讨论、评估和权衡在两家主要制药公司(葛兰素史克和默克)成功获得国际轮状病毒疫苗许可后,进一步开发更多轮状病毒疫苗候选物的重要性。这两种获得许可的疫苗均由活轮状病毒组成,通过口服途径接种,这与已在人体中评估的所有候选轮状病毒疫苗相同。两者都建立在以前候选疫苗的经验基础上,这些候选疫苗的开发要么已经停止,要么在之前获得许可的恒河猴轮状病毒重组疫苗(Rotashield)的情况下,由于发现与肠套叠罕见关联,其制造商撤回了疫苗。尽管支持哪些替代候选疫苗进行开发以及应在何处进行开发是有争议的话题,但日内瓦会议普遍表达了这样一种共识,即进一步开发替代候选疫苗是当务之急。这一发展将有助于确保在第三世界国家为儿童提供最安全、最有效和最经济的疫苗,这些国家每年有超过 60 万例轮状病毒死亡病例。本综述旨在提供轮状病毒疫苗的历史和现状,并展望候选疫苗的未来发展,以推广在日内瓦会议上提出的计划。