Public trust in vaccination programmes is crucial to their success. History tells us that trust is easily undermined by misinformation, but this should not prevent an open and informed debate on the evidence for the effectiveness and safety of vaccines.
Peter Doshi tells a tale of two vaccines rapidly deployed by GSK in 2009 amid fears of a flu pandemic (doi:10.1136/bmj.k3948). There were early internal safety reports showing a higher rate of serious adverse events logged in relation to one of the vaccines, Pandemrix, but these reports were not actively shared with the public, and the vaccine continued to be promoted well into 2010. Cases of suspected serious adverse events, namely incidents of narcolepsy, are currently the subject of legal action against GSK and public health bodies, which is how new documentation has come to light. But why, asks Doshi, was the public not alerted?
In the rapid responses to Doshi’s investigation (bmj.com/content/362/bmj.k3948/rapid-responses), GSK and UK and European regulators argue that relevant information was shared, among them at least, and was also made publicly available on their websites. But it took the legal case for GSK’s internal safety reports to come to light and a diligent reviewer, Tom Jefferson, to study and compare the rates of adverse events. When he did so, he “just fell off the chair,” so striking were the differences between GSK’s vaccines. As one solicitor involved in the legal action is quoted as saying, “Any person contemplating taking the Pandemrix vaccine would be likely, if in receipt of this information, not to choose . . . vaccination.”
Doshi clearly states that the information does not prove causation. But it should have warranted urgent investigation at the time and still deserves this now, he says. He believes this case raises big questions about transparency. When do public health officials have a duty to warn the public over possible harms detected through pharmacovigilance? How much detail should the public be provided with, and who should provide it?
Other rapid responders take up this refrain (bmj.com/content/362/bmj.k3948/rapid-responses). Retired paediatrician Allan Cunningham says that in far too many cases the systems for collecting adverse events are simply window dressing to give the appearance of safety monitoring. Retired nurse Wendy Stephen asks where what has happened leaves informed consent, especially as the Montgomery ruling in the UK requires that people be given all the information they need to make a fully informed decision (doi:10.1136/bmj.h1414). Elizabeth Hart quotes a Reuters special report about the problems encountered by researchers who questioned vaccine safety. And on the vexed question of whether raising these concerns does more harm than good, Jefferson concludes that “non response and obfuscation are gifts to those who are ideologically opposed to vaccines and their use.”
The spectre of Andrew Wakefield should not deter us from proper scrutiny and openness about vaccine safety.

中文翻译：

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两种疫苗的故事

公众对疫苗接种计划的信任对于其成功至关重要。历史告诉我们，错误的信息很容易破坏信任，但这不应阻止就疫苗有效性和安全性证据进行公开而知情的辩论。
彼得·多西（Peter Doshi）讲述了GSK在2009年因担心流感大流行而迅速部署的两种疫苗的故事（doi：10.1136 / bmj.k3948）。早期的内部安全报告显示，与其中一种疫苗Pandemrix相关的严重不良事件的发生率更高，但并未与公众积极分享这些疫苗，并且该疫苗一直在积极推广到2010年。严重的不良事件，即发作性睡病，目前已成为针对葛兰素史克和公共卫生机构的法律诉讼的主题，这是如何发现新文件的方法。但是，多西问，为什么公众没有受到警觉？
在对Doshi的调查做出快速反应（bmj.com/content/362/bmj.k3948/rapid-responses）时，葛兰素史克（GSK）和英国和欧洲监管机构争辩说，相关信息至少是在彼此之间共享的，并且在他们的网站。但是，随着法律案件的曝光，葛兰素史克的内部安全报告和勤奋的审稿人汤姆·杰斐逊（Tom Jefferson）研究并比较了不良事件的发生率。当他这样做时，他“只是从椅子上掉下来了”，GSK疫苗之间的差异如此惊人。引用该诉讼案的一位律师的话说：“任何正在考虑服用Pandemrix疫苗的人，如果收到此信息，可能会选择。。。疫苗接种。”
Doshi明确指出，该信息不构成因果关系。他说，但是它应该在当时应进行紧急调查，现在仍然值得这样做。他认为此案引发了有关透明度的重大问题。公共卫生官员何时有责任就药物警戒发现的可能危害向公众发出警告？应该为公众提供多少细节，谁应该提供？
其他快速反应者则对此有所保留（bmj.com/content/362/bmj.k3948/rapid-responses）。退休的儿科医生艾伦·坎宁安（Allan Cunningham）说，在太多情况下，用于收集不良事件的系统只是用来装饰橱窗，以提供安全监控的外观。退休护士温迪·斯蒂芬（Wendy Stephen）询问发生了什么事情，这需要知情同意，尤其是在英国的蒙哥马利（Montgomery）裁决要求向人们提供做出充分知情决定所需的所有信息时（doi：10.1136 / bmj.h1414）。伊丽莎白·哈特（Elizabeth Hart）引用了路透社的一份特别报道，报道了质疑疫苗安全性的研究人员所遇到的问题。在这个令人烦恼的问题上，提出这些担忧是否弊大于利，
安德鲁·韦克菲尔德（Andrew Wakefield）的幽灵不应阻止我们对疫苗安全性进行适当的审查和公开。