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新冠疫苗接种出现严重不良反应,谁担责?

新冠疫苗接种出现严重不良反应,谁担责?

David Meyer 2021年04月08日
历史告诉我们,索赔并不容易。

如果某一款新冠疫苗对于部分接种人群确实有害,该怎么办?而且这种情况极有可能出现。谁将为此负责?

希望有关疫苗责任的问题,在这次疫情期间只停留在理论层面上。

然而,虽然公共卫生官员表示,拒绝接种新冠疫苗的危害远大于接种疫苗带来的危险,但责任问题依旧很重要,不只是因为阿斯利康的疫苗在欧洲可能导致了一种罕见的血栓。(两者之间并没有确切的因果关系,而且公共卫生部门仍然建议使用阿斯利康的疫苗保护民众的安全,以减少因为严重新冠病毒感染所导致的住院治疗和死亡。周三,欧洲药品管理局和英国药品主管部门英国药品和保健产品监管署重申接种阿斯利康疫苗利大于弊。)

通常情况下,制药商会对其产品的安全性负责,而且他们会花很多年的时间进行药物开发和测试,以保证使用安全。

但此次疫情期间,新冠疫苗的开发却并非如此。

BioNTech、Moderna、阿斯利康等公司研发的新冠疫苗,仅用了几个月时间,没有经过数年测试。而药品监管机构在审批任何疫苗之前,通常会要求药企提供大规模测试的最终结果,但这一次他们却在测试期间发布了临时授权。

当然,这是由本次疫情的性质决定的:新冠疫情传播速度快,对身体的破坏力强,因此速度是抗击疫情的关键。疫苗行业的从业者不可能放弃小心谨慎的原则,但同样也没有人有条件像以前那样谨慎。

所以,三家制药公司几乎都被免于承担与新冠疫苗的潜在副作用有关的任何责任。接种者如果出现问题,只能寻找其他途径获得赔偿。

不过,历史告诉我们,索赔并不容易。

“极高的门槛”

在多数情况下,要由发布紧急授权的监管机构所属国家承担责任。有些国家很早就接受了这个事实,尤其是美国和英国,这两个国家最先与药企完成了谈判,从而在全民疫苗接种方面领先了一步。

鸿鹄律师事务所荷兰纠纷解决业务负责人伊夫林·特琼恩-恩华表示:“我想政府认为风险是可控的,因为这些企业以逐利为目的。如果他们认为将一款疫苗投放到市场的收益小于风险,他们不会这样做。”

这是因为药企有过前车之鉴。

特琼恩-恩华提到了上世纪70年代和80年代与百日咳疫苗有关的不光彩的历史。当时,有人声称儿童接种DPT(白喉、百日咳和破伤风)疫苗之后,偶尔会出现罕见但永久性的脑损伤。

虽然最终证明两者之间没有因果关系,但负面的风评依旧引发了一系列针对疫苗厂商的诉讼,有些甚至索赔成功。大部分美国疫苗厂商的反应是收回DPT疫苗。他们从这些疫苗中仅能赚取较低的利润。

此事促使美国创立了国家疫苗伤害赔偿计划,对药企的每剂疫苗征税75美分用于资助该项目。作为交换,如果疫苗意外出现严重的副作用,药企不会在州或联邦民事法院遭到起诉。

然而,VICP计划仅适用于常规接种的疫苗,例如标准的儿童疫苗或普通流感疫苗等。与新冠疫苗相关的计划是根据2005年《公众使用意愿与紧急状态准备法案》(《PREP法案》)创立的医疗对策伤害赔偿计划(CICP)。

特朗普政府在2020年2月本次疫情即将爆发时启用了该项法案。该法案授予疫苗厂商和分销商四年法律保护,除非有证据证明存在故意不当行为。而且,理论上,因为接种新冠疫苗受到严重伤害的民众可以通过CICP计划获取赔偿。

但事实上,CICP计划自2010年创立以来,仅受理了551起诉讼中的39起。该计划还负责处理与埃博拉病毒和炭疽病毒等医疗事件的应对措施有关的责任。

在39起诉讼中只有29起获得赔偿,赔偿总额为600万美元。

特琼恩-恩华表示:“《PREP法案》非常严格。”原告要承担举证责任,必须证明疫苗厂商有故意不当行为。索赔门槛非常高。所以CICP计划支付的赔偿金额少之又少。我认为该计划的索赔门槛过高;你需要证明对方的心理状态。”

如果出现严重不良反应

百日咳疫苗恐慌可能是一次小题大做,但接种疫苗后出现不良后果的案例数量也不算少,索赔也不是那么容易。

2009年,也就是新冠肺炎疫情出现的10年前,另一场大流行病——H1N1流感病毒,也叫“猪流感”,死灰复燃并蔓延全球。

葛兰素史克公司在一款现有的H5N1禽流感疫苗基础上进行研发,迅速推出了猪流感疫苗。该疫苗被英国和其它欧洲国家广泛应用,用于给医护人员、儿童以及哮喘患者等高危人群接种,但美国并未批准这款疫苗上市。

“到2010年2月,多人被诊断为嗜睡症,这引起了医生的注意,”英国律师事务所Scott Moncrieff顾问彼得·托德说。“当时疫苗接种才开始几个月,他们开始怀疑,这些嗜睡症病例与猪流感疫苗接种,可能存在潜在关联。”

嗜睡症是一种罕见且不为人所知的自身免疫性疾病。病人会感到虚弱困倦,白天频繁嗜睡。目前还无法治愈。

当时英国有88名嗜睡症患者委托托德索赔。据他估计,在欧洲超过3000万人Pandemrix疫苗接种者中,约有2000人之后患上了嗜睡症。(直到2019年,葛兰素史克公司仍不承认,这两者之间存在任何因果关系。)

之后,葛兰素史克公司得到了潜在产品责任索赔赔偿,因为为了尽快推出Pandemrix疫苗,公司当时放弃了部分安全性测试,而这在新冠疫情期间同样很可能发生。

同时,英国政府拒绝根据《疫苗损害赔偿法案》进行赔付,理由是嗜睡症不够“严重”,不值得赔偿。

托德表示,他无法证实,针对葛兰素史克公司和政府的索赔是如何解决的。不过,在2017年的一起疫苗案中,一名男孩在接种疫苗后患上了嗜睡症,英国政府败诉。去年的信息显示,政府在六起案件中赔付了共计72万英镑。

“与2009年的猪流感相比,新冠肺炎疫情更危险,但两者对疫苗的需求同样迫切……所有疫苗生产商都得到了豁免权,”托德说。

在英国,理论上来说,如果疫苗被证明是“有缺陷的”,即不像人们合理预期的那样安全,生产商的豁免权就会被剥夺。

但是,托德说,“很难证明消费者对安全的合理预期”,因为大多数人都知道,为了抵抗这种极其危险的流行病,在大规模的长期测试未完成之前,新冠疫苗就已经被匆忙推出。

这样一来,就只剩下了国家疫苗损害补偿计划,向那些严重致残人士支付12万英镑的固定金额。这笔钱不算多,而且受害者的诉讼费用也只能自行承担。

“Pandemrix疫苗的教训没能让我们做出改变,”托德说。

“政府应该意识到,总会有新的流行病出现,总会需要迅速研发疫苗,这总是会威胁到临床安全。因此,我们需要的不是一个将风险和损失堆积在不幸个体身上的制度,而是一个,作为一个社会,我们可以共同承担不幸的制度。”

联合在一起

当然,如果新冠疫苗出现问题,并非每个社会都有能力补偿受害者,生产商也靠不住。除非得到赔偿,否则生产商不会主动担责。

因此,今年2月,世界上第一个也是唯一一个全球疫苗伤害赔偿基金成立了。该基金是为92个中低收入国家设立的,受益于世界卫生组织牵头的新冠疫苗全球获得机制(Covax),这些国家获得了新冠疫苗。

该基金由安达保险子公司ESIS管理,资金来源是每剂疫苗10美分的税收。在2022年年中之前,如果出现“严重不良反应事件”,该基金会提供无过失一次性赔偿基金。

但制造商获得赔偿的情况,真的不可避免吗?

欧洲的对策

欧盟一直在强调,它没有像其它国家那样,批准新冠疫苗的紧急使用授权。意识到这实际上是在批准一种未经授权的疫苗的临时使用,它转而授予了拜恩泰科/辉瑞、莫德纳、阿斯利康制药和强生公司为期一年的“有条件上市批准”。

欧盟委员会声称,这提供了“紧急使用授权可能无法提供的保障”。

委员会去年12月表示,最关键的是,获得有条件上市批准的公司不能逃避责任。

“上市批准公司需对产品质量及其安全问题负责,”委员会表示,并补充说,如果采取的是紧急使用授权,公司将不必承担这些责任。

不过,现实情况似乎与理论有些不同。

欧盟委员会公布了一份与阿斯利康签订的预购协议的修订版本。该文件称,每个欧盟国家都应赔偿阿斯利康因死亡、伤害和疾病而造成的“任何及所有损失和责任”。

合同接着描述了公司将无法得到赔偿的情况,但这一部分已经经过修订。与几乎所有涉及疫苗接种的合同一样,关键细节不可供公众审查。

委员会强调,这份合同保护了患者的权利。“患者上诉法庭时,无需在意这份预购协议,” 一位发言人表示。“如果公司需要担责,它就必须对公民做出赔偿。”

然而,欧盟的谨慎做法可能不会维持太久。相比起英国、美国和其它一些发达经济体,欧盟新冠疫苗的上市审核和推广进度相对落后,欧盟委员会和欧洲药品管理局因此受到了抨击。

因此,在3月初,欧盟委员会做出了让步,考虑改为紧急使用授权,由“成员国共同分担责任”,目前还未有进一步的消息出现。财富中文网)

翻译:刘进龙、Claire

审校:汪皓

如果某一款新冠疫苗对于部分接种人群确实有害,该怎么办?而且这种情况极有可能出现。谁将为此负责?

希望有关疫苗责任的问题,在这次疫情期间只停留在理论层面上。

然而,虽然公共卫生官员表示,拒绝接种新冠疫苗的危害远大于接种疫苗带来的危险,但责任问题依旧很重要,不只是因为阿斯利康的疫苗在欧洲可能导致了一种罕见的血栓。(两者之间并没有确切的因果关系,而且公共卫生部门仍然建议使用阿斯利康的疫苗保护民众的安全,以减少因为严重新冠病毒感染所导致的住院治疗和死亡。周三,欧洲药品管理局和英国药品主管部门英国药品和保健产品监管署重申接种阿斯利康疫苗利大于弊。)

通常情况下,制药商会对其产品的安全性负责,而且他们会花很多年的时间进行药物开发和测试,以保证使用安全。

但此次疫情期间,新冠疫苗的开发却并非如此。

BioNTech、Moderna、阿斯利康等公司研发的新冠疫苗,仅用了几个月时间,没有经过数年测试。而药品监管机构在审批任何疫苗之前,通常会要求药企提供大规模测试的最终结果,但这一次他们却在测试期间发布了临时授权。

当然,这是由本次疫情的性质决定的:新冠疫情传播速度快,对身体的破坏力强,因此速度是抗击疫情的关键。疫苗行业的从业者不可能放弃小心谨慎的原则,但同样也没有人有条件像以前那样谨慎。

所以,三家制药公司几乎都被免于承担与新冠疫苗的潜在副作用有关的任何责任。接种者如果出现问题,只能寻找其他途径获得赔偿。

不过,历史告诉我们,索赔并不容易。

“极高的门槛”

在多数情况下,要由发布紧急授权的监管机构所属国家承担责任。有些国家很早就接受了这个事实,尤其是美国和英国,这两个国家最先与药企完成了谈判,从而在全民疫苗接种方面领先了一步。

鸿鹄律师事务所荷兰纠纷解决业务负责人伊夫林·特琼恩-恩华表示:“我想政府认为风险是可控的,因为这些企业以逐利为目的。如果他们认为将一款疫苗投放到市场的收益小于风险,他们不会这样做。”

这是因为药企有过前车之鉴。

特琼恩-恩华提到了上世纪70年代和80年代与百日咳疫苗有关的不光彩的历史。当时,有人声称儿童接种DPT(白喉、百日咳和破伤风)疫苗之后,偶尔会出现罕见但永久性的脑损伤。

虽然最终证明两者之间没有因果关系,但负面的风评依旧引发了一系列针对疫苗厂商的诉讼,有些甚至索赔成功。大部分美国疫苗厂商的反应是收回DPT疫苗。他们从这些疫苗中仅能赚取较低的利润。

此事促使美国创立了国家疫苗伤害赔偿计划,对药企的每剂疫苗征税75美分用于资助该项目。作为交换,如果疫苗意外出现严重的副作用,药企不会在州或联邦民事法院遭到起诉。

然而,VICP计划仅适用于常规接种的疫苗,例如标准的儿童疫苗或普通流感疫苗等。与新冠疫苗相关的计划是根据2005年《公众使用意愿与紧急状态准备法案》(《PREP法案》)创立的医疗对策伤害赔偿计划(CICP)。

特朗普政府在2020年2月本次疫情即将爆发时启用了该项法案。该法案授予疫苗厂商和分销商四年法律保护,除非有证据证明存在故意不当行为。而且,理论上,因为接种新冠疫苗受到严重伤害的民众可以通过CICP计划获取赔偿。

但事实上,CICP计划自2010年创立以来,仅受理了551起诉讼中的39起。该计划还负责处理与埃博拉病毒和炭疽病毒等医疗事件的应对措施有关的责任。

在39起诉讼中只有29起获得赔偿,赔偿总额为600万美元。

特琼恩-恩华表示:“《PREP法案》非常严格。”原告要承担举证责任,必须证明疫苗厂商有故意不当行为。索赔门槛非常高。所以CICP计划支付的赔偿金额少之又少。我认为该计划的索赔门槛过高;你需要证明对方的心理状态。”

如果出现严重不良反应

百日咳疫苗恐慌可能是一次小题大做,但接种疫苗后出现不良后果的案例数量也不算少,索赔也不是那么容易。

2009年,也就是新冠肺炎疫情出现的10年前,另一场大流行病——H1N1流感病毒,也叫“猪流感”,死灰复燃并蔓延全球。

葛兰素史克公司在一款现有的H5N1禽流感疫苗基础上进行研发,迅速推出了猪流感疫苗。该疫苗被英国和其它欧洲国家广泛应用,用于给医护人员、儿童以及哮喘患者等高危人群接种,但美国并未批准这款疫苗上市。

“到2010年2月,多人被诊断为嗜睡症,这引起了医生的注意,”英国律师事务所Scott Moncrieff顾问彼得·托德说。“当时疫苗接种才开始几个月,他们开始怀疑,这些嗜睡症病例与猪流感疫苗接种,可能存在潜在关联。”

嗜睡症是一种罕见且不为人所知的自身免疫性疾病。病人会感到虚弱困倦,白天频繁嗜睡。目前还无法治愈。

当时英国有88名嗜睡症患者委托托德索赔。据他估计,在欧洲超过3000万人Pandemrix疫苗接种者中,约有2000人之后患上了嗜睡症。(直到2019年,葛兰素史克公司仍不承认,这两者之间存在任何因果关系。)

之后,葛兰素史克公司得到了潜在产品责任索赔赔偿,因为为了尽快推出Pandemrix疫苗,公司当时放弃了部分安全性测试,而这在新冠疫情期间同样很可能发生。

同时,英国政府拒绝根据《疫苗损害赔偿法案》进行赔付,理由是嗜睡症不够“严重”,不值得赔偿。

托德表示,他无法证实,针对葛兰素史克公司和政府的索赔是如何解决的。不过,在2017年的一起疫苗案中,一名男孩在接种疫苗后患上了嗜睡症,英国政府败诉。去年的信息显示,政府在六起案件中赔付了共计72万英镑。

“与2009年的猪流感相比,新冠肺炎疫情更危险,但两者对疫苗的需求同样迫切……所有疫苗生产商都得到了豁免权,”托德说。

在英国,理论上来说,如果疫苗被证明是“有缺陷的”,即不像人们合理预期的那样安全,生产商的豁免权就会被剥夺。

但是,托德说,“很难证明消费者对安全的合理预期”,因为大多数人都知道,为了抵抗这种极其危险的流行病,在大规模的长期测试未完成之前,新冠疫苗就已经被匆忙推出。

这样一来,就只剩下了国家疫苗损害补偿计划,向那些严重致残人士支付12万英镑的固定金额。这笔钱不算多,而且受害者的诉讼费用也只能自行承担。

“Pandemrix疫苗的教训没能让我们做出改变,”托德说。

“政府应该意识到,总会有新的流行病出现,总会需要迅速研发疫苗,这总是会威胁到临床安全。因此,我们需要的不是一个将风险和损失堆积在不幸个体身上的制度,而是一个,作为一个社会,我们可以共同承担不幸的制度。”

联合在一起

当然,如果新冠疫苗出现问题,并非每个社会都有能力补偿受害者,生产商也靠不住。除非得到赔偿,否则生产商不会主动担责。

因此,今年2月,世界上第一个也是唯一一个全球疫苗伤害赔偿基金成立了。该基金是为92个中低收入国家设立的,受益于世界卫生组织牵头的新冠疫苗全球获得机制(Covax),这些国家获得了新冠疫苗。

该基金由安达保险子公司ESIS管理,资金来源是每剂疫苗10美分的税收。在2022年年中之前,如果出现“严重不良反应事件”,该基金会提供无过失一次性赔偿基金。

但制造商获得赔偿的情况,真的不可避免吗?

欧洲的对策

欧盟一直在强调,它没有像其它国家那样,批准新冠疫苗的紧急使用授权。意识到这实际上是在批准一种未经授权的疫苗的临时使用,它转而授予了拜恩泰科/辉瑞、莫德纳、阿斯利康制药和强生公司为期一年的“有条件上市批准”。

欧盟委员会声称,这提供了“紧急使用授权可能无法提供的保障”。

委员会去年12月表示,最关键的是,获得有条件上市批准的公司不能逃避责任。

“上市批准公司需对产品质量及其安全问题负责,”委员会表示,并补充说,如果采取的是紧急使用授权,公司将不必承担这些责任。

不过,现实情况似乎与理论有些不同。

欧盟委员会公布了一份与阿斯利康签订的预购协议的修订版本。该文件称,每个欧盟国家都应赔偿阿斯利康因死亡、伤害和疾病而造成的“任何及所有损失和责任”。

合同接着描述了公司将无法得到赔偿的情况,但这一部分已经经过修订。与几乎所有涉及疫苗接种的合同一样,关键细节不可供公众审查。

委员会强调,这份合同保护了患者的权利。“患者上诉法庭时,无需在意这份预购协议,” 一位发言人表示。“如果公司需要担责,它就必须对公民做出赔偿。”

然而,欧盟的谨慎做法可能不会维持太久。相比起英国、美国和其它一些发达经济体,欧盟新冠疫苗的上市审核和推广进度相对落后,欧盟委员会和欧洲药品管理局因此受到了抨击。

因此,在3月初,欧盟委员会做出了让步,考虑改为紧急使用授权,由“成员国共同分担责任”,目前还未有进一步的消息出现。财富中文网)

翻译:刘进龙、Claire

审校:汪皓

What if—and this is the biggest of ifs—one of the COVID-19 vaccines turns out to be harmful to some of the people receiving it? Who, if anyone, would have to pay out?

The question of vaccine liability will hopefully remain theoretical throughout this pandemic.

However, while public health officials say there’s no doubt that refusing a COVID vaccine is far more dangerous than receiving one, the liability question does remain important—not least because of the possible link between AstraZeneca’s vaccine and rare blood-clotting incidents in Europe. (No causal link has been proven, and health authorities continue to recommend using the AstraZeneca vaccine to keep people safe from the hospitalization and death associated with severe COVID infections. On Wednesday, the European Medicines Agency and its British equivalent, the Medicines and Healthcare Products Regulatory Agency, repeated that the benefits of the AstraZeneca jab outweigh the risks.)

Usually, drug manufacturers are liable for the safety of their products, and they spend many years developing and testing their drugs to ensure they are safe to use.

That’s not how things work in a pandemic.

Rather than years, companies such as BioNTech, Moderna, and AstraZeneca managed to develop their COVID vaccines in a matter of months. And drug regulators, who would usually demand to see the final results of large-scale testing before approving any vaccine, have been issuing temporary authorizations while testing was still ongoing.

That’s the nature of this situation: COVID is a killer, and it spreads fast, so speed is of the essence in fighting it. Nobody in the vaccine business has thrown caution to the wind, but it is equally true that nobody has had the luxury of being quite as cautious as they might like.

Which is why, in these circumstances, the pharma companies have mostly been absolved of liability over the potential side effects of their COVID-19 vaccines. If problems were to arise, the people affected would need to look elsewhere for compensation.

And, history suggests, claiming that compensation won’t be easy.

‘A very high threshold’

In most cases, liability would rest with the countries whose regulators issued the emergency authorizations. And the countries that accepted this fact early on—notably, the United States and the United Kingdom—are the ones that managed to conclude their negotiations with manufacturers first, giving them a head start in vaccinating their populations.

“I presume that the risk is considered manageable [by governments] simply because these companies are profit-driven,” says Evelyn Tjon-En-Fa, the head of the Dutch dispute resolution practice at the law firm Bird & Bird. “If they don’t feel the benefits of bringing [a vaccine] into the market is worth the risk, they won’t do it.”

That’s because the pharma firms have been burned before.

Tjon-En-Fa points to the saga surrounding whooping cough or pertussis vaccines in the 1970s and 1980s. At the time, some people claimed the pertussis components in the DPT (diphtheria, pertussis, and tetanus) vaccines being administered to children were occasionally causing rare but permanent brain damage.

Although the link eventually turned out to be bogus, negative publicity sparked a wave of lawsuits against the vaccine manufacturers, some of which were successful. Most U.S. manufacturers responded by withdrawing their DPT vaccines, which had earned them only low margins, from the market. The affair prompted the creation of the National Vaccine Injury Compensation Program (VICP), which the drugmakers fund with a levy of 75¢ on each dose of their vaccines. In exchange, they cannot be sued in state or federal civil courts if an unanticipated and serious side effect emerges.

However, the VICP is designed for routinely administered vaccines, such as standard childhood jabs or the regular flu shot. In the case of COVID vaccines, the relevant scheme is the Countermeasures Injury Compensation Program (CICP), which was established under the 2005 Public Readiness and Emergency Preparedness (PREP) Act.

The Trump administration invoked the PREP Act in February 2020, near the start of this pandemic. It gives vaccine manufacturers and distributors four years of legal protection, unless willful misconduct can be proved. And, in theory, people suffering serious injury from COVID vaccines will be able to tap the CICP for compensation.

In reality, though, the CICP—which also handles liability for medical countermeasures against things like Ebola and anthrax—has only accepted 39 of the 551 claims that have been filed since its 2010 creation. Of those, only 29 were compensated, for a total of $6 million.

“The PREP Act is very strict,” says Tjon-En-Fa. “The burden of proof is on the claimant [who has] to show willful misconduct on the producer of the vaccine. That’s a very high threshold. And that’s the reason so little has been paid out of this fund. I think it’s too high a threshold; you have to prove state of mind.”

When vaccines really go wrong

The whooping cough vaccine scare may have been a dud, but it is not unheard of for vaccines to go genuinely wrong for some of their recipients—and claiming compensation was no simple matter.

In 2009, a decade before COVID-19 appeared, the world faced a different pandemic: a resurgence of the H1N1 influenza virus, or “swine flu” as this version was known. The drugmaker GlaxoSmithKline took a vaccine it had already developed to combat the H5N1 (bird flu) virus and quickly adapted it for swine flu. The new vaccine was pushed out in the U.K. and other European countries—it was never authorized in the U.S.—to inoculate health care workers, small children, and at-risk people such as asthmatics.

“By February 2010, doctors were noticing that there were large numbers of people being diagnosed with narcolepsy,” says Peter Todd, a consultant with British law firm Scott-Moncrieff. “This was within a few months [of the inoculations beginning], and they started to suspect that there could be a connection between these cases of narcolepsy and the pandemic vaccination campaign.”

Narcolepsy is a rare and incompletely understood condition, probably an autoimmune disease, in which sufferers experience debilitating drowsiness, often falling asleep during the day. There is no cure.

Todd—who represented 88 of the affected people in the U.K. in their battle to claim compensation—estimates around 2,000 people across Europe developed narcolepsy when they were injected with Pandemrix. That’s out of more than 30 million people who received the vaccine. (GSK, the manufacturer, continued to deny any causal link as recently as 2019.)

Much as would happen in the current COVID-19 pandemic, GSK was indemnified against potential product liability claims because of the speed at which it had to roll out Pandemrix, which meant it could not complete safety testing before the deployment began. However, the British government resisted payouts from the U.K.’s Vaccine Damage Payments Scheme, on the basis that narcolepsy was not “severe” enough to merit compensation.

Todd says he is not free to confirm how the claims against GSK and the government were resolved. However, in 2017 the government lost a test case involving a boy who had developed narcolepsy after his vaccination, and a freedom-of-information request last year revealed that the government had paid out in six cases, for a total of £720,000 ($997,000).

“COVID is massively more dangerous than the pandemic in 2009 was, but there was the same need for a vaccine, urgently…and indemnity has been given to all the manufacturers,” says Todd.

In the U.K., a manufacturer’s immunity is theoretically whipped away if its vaccine is shown to be “defective,” meaning it isn’t as safe as people should reasonably expect. But, Todd says, it “would be difficult to prove a reasonable expectation of consumer safety” when most people know COVID-19 vaccines have been rushed out before their large-scale, long-term testing can be completed, to urgently fight an extremely dangerous disease.

That leaves the statutory scheme, which pays out a fixed sum of £120,000 to those suffering severe disablement—not a lot of money in such circumstances, and legal costs are also not reimbursed.

“The lessons weren’t really learned from Pandemrix,” says Todd. “What should have happened is that [the government] should realize there will always be pandemics, and there will always be a need for vaccinations to be developed quickly. And that’s always going to threaten clinical safety. So instead of having a system that heaps the risk and loss onto unfortunate individuals, we need a system where we all stand together as a society.”

Clubbing together

Of course, not every society has the means to compensate affected people, if a problem with a COVID-19 vaccine were to emerge—but the manufacturers still won’t play ball unless they get their indemnity.

That’s what led to the creation in February of the world’s first and only global vaccine injury compensation fund, developed for the 92 low- and middle-income countries getting their doses through the World Health Organization–backed Covax facility.

The fund, which is being administered by Chubb subsidiary ESIS, will potentially provide no-fault lump sum payments in cases of “serious adverse events” until mid-2022. It’s being funded by a 10¢ levy on each dose.

But is it really inevitable that the manufacturers get indemnity?

European resistance

The European Union has made much of the fact that it isn’t issuing emergency use authorizations for vaccines, as other countries have done. Noting that this route really amounts to clearing the temporary use of an unauthorized vaccine, it has instead granted BioNTech/Pfizer, Moderna, AstraZeneca, and Johnson & Johnson one-year “conditional marketing authorizations” that—the European Commission claims—provide “safeguards that emergency use authorizations might not.”

Crucially, the Commission said in December, companies that receive conditional marketing authorizations don’t get to shed their liability and remain as on the hook as they are when obtaining a standard authorization. “The marketing authorization holder will be responsible for the product and its safe use,” it said, adding that this wouldn’t be possible with an emergency use authorization.

In reality, though, the situation looks a little different.

When the European Commission published a redacted version of its advance purchase agreement with AstraZeneca, the document said each EU country shall indemnify AstraZeneca “from and against any and all damages and liabilities” relating to death, injury, and illness.

The contract goes on to describe the situations in which the companies would not be indemnified—but this part is redacted. As with almost all the contracts involved in the vaccination push, crucial details are not available for the public to scrutinize.

The Commission stresses that its contracts preserve patients’ rights. “Patients can go to court as if the [advance purchase agreement] would not be there,” says a spokesman. “If the company is held liable it will have to compensate the citizen.”

However, the EU’s cautious approach may not last. With its vaccine rollout being tardier than those in the U.K., the U.S., and some other advanced economies, the Commission and the European Medicines Agency have come under fire over the relative slowness of the bloc’s vaccine authorizations.

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