Medical Department, Swiss Tropical and Public Health Institute, Socinstrasse 57, CH-4051 Basel, Switzerland.
Travel Med Infect Dis. 2016 Jul-Aug;14(4):373-7. doi: 10.1016/j.tmaid.2016.07.003. Epub 2016 Jul 16.
Effective and easy to administer cholera vaccines are in need more than ever, for at risk populations and travellers alike. In many parts of the world cholera is still endemic, causing outbreaks and constituting repeatedly serious public health problems. The oral live cholera vaccine CVD 103-HgR (Orochol, Mutachol), the first genetically modified organism (GMO) used as vaccine, was in its time (launched 1993, Switzerland) the ideal cholera vaccine: single-dose, protective efficacy of 80-100% against moderate to severe cholera, acting within 8 days and exhibiting excellent safety, indiscernible from placebo. However, there were strong headwinds: In the 1990s the indication for cholera vaccines was generally downplayed by experts and in 1997 the European Commission called for a moratorium of GMOs which blocked the registration in the European Union. Thus, demand for this vaccine remained low and in 2003 it was taken off the market for economic reasons. After a decade in obscurity it (Vaxchora) has resurfaced again, now produced in the U.S. and equipped with a U.S. FDA license (June 10, 2016). What had happened? This commentary gives a critical account of an almost unbelievable string of misadventures, emerging adverse circumstances and man-made failures which nearly killed this single-dose live oral cholera vaccine. The good news is that patience and persistence lead to success in the end, allowing good science to prevail for the benefit of those in need.
目前非常需要有效且易于管理的霍乱疫苗，无论是针对高危人群还是旅行者。在世界上的许多地方，霍乱仍然流行，导致疫情爆发，并屡次构成严重的公共卫生问题。口服霍乱活疫苗 CVD 103-HgR（Orochol、Mutachol）是世界上第一个用作疫苗的基因改造生物体（GMO），曾在当时（1993 年在瑞士推出）是理想的霍乱疫苗：单剂，对中度至重度霍乱的保护效力为 80-100%，在 8 天内生效，具有出色的安全性，与安慰剂无法区分。然而，当时存在强烈的阻力：在 20 世纪 90 年代，专家普遍淡化了霍乱疫苗的作用，1997 年，欧盟委员会呼吁暂停使用 GMO，这阻止了该疫苗在欧盟的注册。因此，对这种疫苗的需求仍然很低，2003 年，出于经济原因，该疫苗被撤出市场。在沉寂了十年之后，它（Vaxchora）又重新出现，现在由美国生产，并获得了美国食品和药物管理局的许可（2016 年 6 月 10 日）。发生了什么事？本文批判性地描述了一连串几乎难以置信的不幸事件、新出现的不利情况和人为失败，这些事件几乎扼杀了这种单剂口服霍乱活疫苗。好消息是，最终耐心和坚持取得了成功，让良好的科学得以占上风，造福于有需要的人。
