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为什么美国的疫苗接种如此混乱?

为什么美国的疫苗接种如此混乱?

NICOLE GOODKIND 2021年01月08日
背后是两个“甩锅”高手。

从疫情爆发到现在已一年。在这段黑暗时期,人们将疫苗视为这片黑暗中的唯一光亮,多国医药公司和研究者日夜兼程,试图突破一款疫苗长达需十余年的研发周期。

奇迹真的发生了:制药巨头辉瑞公司与合作伙伴BioNTech于去年11月宣布,临床试验中疫苗有效性达95%,并且没有严重副作用。12月14日,美国开始了第一批新冠疫苗接种,辉瑞疫苗在全美范围内分发。

这是个转机。市场随之猛涨,群情振奋。美国在经历了近一年的集体创伤之后,似乎终于迎来圆满结局。

但情况并非如此简单。与疫苗面世一同而来的,是一系列麻烦的开始。

有关美国疫苗分发混乱的报道接连不断。

据法新社1月4日报道,美国华盛顿一名学生在去超市购物时,莫名其妙被接种了疫苗。原因是,本应优先接种这种疫苗的医务工作者没能按规定时间接种,而疫苗的储存时间有限,一旦从制冷设备中取出便会迅速变质。

与此同时,本应优先接种疫苗的人群却一剂难求。《纽约时报》在1月4日的报道中描绘了一系列疫苗接种的混乱场面:老人们为接种疫苗需在户外排队一宿;预约网站系统崩溃,很多人明明预约成功,却打不上疫苗……

据美国疾病控制和预防中心1月5日的数据称,截至当天早上,美国共有483万余人完成首剂新冠疫苗的接种,与之前美国所计划的,于2020年年底完成2000万人接种的目标相差甚远。

由于美国各州需自行决定疫苗政策,造成接种进度不一的混乱局面:实际接收疫苗数量不足、首批疫苗被延迟,以及有疫苗却缺注射器等情况在美国各地出现。多州未能完成新冠疫苗的接种目标。

1月3日,面对缓慢的接种进程,纽约州州长科莫称,那些收到疫苗后一周内没有施打完毕的医院将被处以高额罚款,并被禁止获得新一轮的疫苗。他在写给多家医院的信中说:“我不希望疫苗被放在冰柜中,而是希望它被打在别人的手臂上。”

混乱的政商关系

上个月,《纽约时报》爆料称,特朗普政府曾拒绝了再购买1亿剂辉瑞新冠疫苗的机会。

在去年夏末秋初期间,辉瑞公司人员一再对特朗普政府发出警告,敦促政府提前预订更多剂量的疫苗,以防出现供不应求的状况。但这一提议遭到了特朗普政府的拒绝。

后来辉瑞董事会成员斯科特•戈特利布博士向CNBC证实,白宫多次拒绝了增加购买辉瑞疫苗的建议。现在辉瑞转而向其他国家提供疫苗。

特朗普政府官员回复的信息相当混乱。

一位官员说,之所以拒绝加购疫苗是因为对其有效性不确定。但戈特利布表示,试验数据公布后还是被拒绝。

但在之后的周一,白宫官员又否认曾拒绝加购疫苗。与此同时,辉瑞首席执行官阿尔伯特•布尔拉在CNBC上表示,最近美国政府让公司再提供1亿剂,但现在时限可能达不到政府要求。他说,双方正在谈判。

美国卫生与公共服务部长阿扎对辉瑞公司供应能力产生了怀疑。阿扎说,对于特朗普主导的,旨在促进新冠疫苗研发、制造和分发的“曲速行动”,辉瑞公司曾表示在“生产过程中可能遇到各种挑战。”“但我们将确保他们履行合同承诺。”他说。

辉瑞反驳称,可以按时按量供应。

辉瑞发言人莎伦•卡斯提罗说:“辉瑞公司的新冠疫苗生产没有任何问题,疫苗运输也不存在搁置或推迟情况,我们正持续向美国政府指定地区发货。”

辉瑞表示,疫苗分发出现延误可能因为特朗普政府的不确定性。辉瑞称已经备好货,只要知道发货目的地就可以,但是美国政府不清楚何时往何地运送。

新冠疫苗跟不上需求,美国一些州被告知可能要削减疫苗分发数量。更让负责监督疫苗的各州领导人沮丧的是,没有任何相关解释。

“情况混乱,让人很郁闷。”华盛顿州州长杰伊•因斯利发推文称,之前他从美国疾控中心获悉,该州疫苗分发量将削减40%。“我们需要准确可预测的数字,才能计划并确保疫情防控成功。”

加州、康涅狄格州、佐治亚州、夏威夷州、伊利诺伊州、堪萨斯州、蒙大拿州、密歇根州、内布拉斯加州、内华达州、新罕布什尔州和印第安纳州接收的疫苗量也遭到大幅削减。

“没给一句解释就削减各州疫苗分发,让人混乱又迷惑。”内华达州州长斯蒂夫•西索拉克称。

特朗普政府和辉瑞公司都被指责利用媒体为自己辩护,而且他们在指责除了自己之外的所有人。

约四分之一美国民众仍对接种疫苗犹豫不决。55%犹豫的受访者表示对政府缺乏信任,51%的受访者表示担心政治在疫苗研发中施加影响。

特朗普政府和辉瑞关系如此混乱反复,显然无法缓解人们对接种疫苗的犹豫情绪。要想实现对新冠病毒群体免疫,需要有50%到80%的人群接种疫苗。相比之下,流感只需33%到44%的人群完成接种就能实现。即便只是小部分人群对接种犹豫,也会影响群体免疫进程。

矛盾的根源

在辉瑞三期试验之前,特朗普政府同意采购1亿剂疫苗。只要美国食品药品监督管理局批准紧急应用,交易就能立即达成。合同价值19.5亿美元,还附带额外采购5亿剂的选择权,这似乎是最初引发分歧的原因。

“我们早已跟辉瑞就额外采购进行谈判,而且谈判一直在持续。曲速行动从未拒绝辉瑞提供的任何疫苗,只要有确切交货日期和数量。”美国卫生部一位高级官员告诉《财富》杂志。

这位官员表示,早在去年11月辉瑞三期试验数据公布之前,曲速行动已要求“辉瑞提供超过最初1亿剂疫苗交付的时间表,以便达成最新协议”。他解释称,问题是辉瑞公司无法确定交付日期,也没给出额外剂量交付的合理时间范围。

2020年夏天,辉瑞宣布年底前可准备好1亿剂,但到了11月,由于供应链出现问题,供应量减少到可供2500万美国人接种的5000万剂,这让特朗普政府越发不满。

“不管什么时候,只要我们发现受到不公平对待,就会采取一切手段解决问题。”一位特朗普政府官员说。

这位官员指的是,辉瑞要求美国按照《国防生产法》为其提供额外的设备以制造更多疫苗。

12月初,布尔拉在CNBC谈及《国防生产法》时说:“我认为这将发挥非常积极的作用,能让我们最大限度地提高疫苗产量。我们现在正在积极要求……希望他们很快就能执行,因为在某些方面,供应受到重要的限制。”

《国防生产法》可紧急赋予总统权力,出于国防目的“分配材料、服务和设施”,将有助于增加疫苗原料供应,原料通常价格昂贵且容易出现供应短缺。

然而,双方的分歧在于《国防生产法》附带的条件,以及政府对疫苗剂量和对辉瑞行动的进一步控制。

法律学者表示,控制措施可能意味着政府将要求辉瑞优先考虑供应美国,或许还可能导致辉瑞违反全球供应合同。

12月23日,BioNTech在官网上表示,辉瑞和BioNTech同意从美国的生产基地向美国增供1亿剂新冠疫苗,总计疫苗供应量达到2亿剂,预期交付量增加了一倍。两家公司预计在7月31日之前完成交付。

法律游戏

去年11月11日,辉瑞与欧盟签订了供应2亿剂新冠疫苗的协议,预计将于2021年二季度交付。

12月16日有消息称,2021年年底前辉瑞将向中国供应1亿剂。

如果辉瑞同意遵守《国防生产法》而公司总部又在美国,只要疫苗在美国国内生产,政府就可能要求公司优先考虑本国而不是与外国交易。但政府无法控制辉瑞在海外的生产线,还可能因为迫使辉瑞放弃与外国政府的交易而陷入外交困境。

国际制药合同方面的专家表示,在某些情况下,例如美国要求获得优先供应,公司可以推迟或终止合同而不会产生重大影响,这是典型的交易模式。虽然合同尚未公开,但美国政府和辉瑞很可能正在共同寻找并讨论法律范围内允许的做法。

美国还与欧洲和全球各国签订了多份双边投资条约,通常为投资者在另一国市场上提供保护。如果美国政府强迫私营公司违背救命的药品合同,可能因为违反条款而引发一系列问题。

多年来美国一直努力跟中国达成类似协议,尽管未正式公布,但如果辉瑞违约势必会影响谈判进程。

特朗普于去年年底签署了一项行政指令,要求向其他国家提供疫苗前要优先提供给美国,不过很大程度上来说行政指令只具有象征意义。

目前尚不清楚总统有没有权力阻止辉瑞履行国际合同,而且辉瑞疫苗最后一步在比利时工厂完成,很可能总统并无控制权。为该指令召开的峰会迅速被政治化,辉瑞和Moderna的代表均未出席,拜登政府过渡团队也未派代表出席。

出个价吧

种种迹象表明,围绕疫苗的谈判更多与权力相关,与价格关系不大。如果硬说有关系的话,就是特朗普政府认为只要能控制疫苗生产,就愿意加大投入。不过政府官员称,早前的订单中仍然考虑了成本因素。

“(当初美国政府拒绝向辉瑞采购更多疫苗)最简单的原因无非就是两个。”达特茅斯学院经济学教授克里斯托弗•斯奈德说,该组织主要关注疫苗研发的财务和经济状况。

“要么谈判者知道该部分剂量对美国的巨大经济价值,只是不小心弄砸了交易;要么就是谈判者没算清楚采购如此庞大剂量能带来的巨大经济利益。”

他表示,在公开谈判的同时,却可能造成疫苗配送拖延,虽然特朗普政府有可能省下的“几百万美元”,但并不值得。

“没必要拿万亿美元的国家健康和福利冒险……花上10亿美元是值得的。”

拜登来了

不管面临什么阻碍,拜登政府都即将接手。新当选总统乔•拜登和团队将负责分发特朗普政府购买和谈判的大量疫苗。

刚开始还有人担心特朗普和美国总务署可能拒绝将权力移交给拜登过渡团队,从而导致疫苗分发过程推迟,而如今相关担心已逐渐减退。

虽然没有特朗普政府协助,拜登团队看起来已在跟制药企业高管定期会面。

“我们正与辉瑞、Moderna以及其他努力开发疫苗的企业定期对话,重点是确保全体美国人和全世界尽快获得安全有效的疫苗。”拜登过渡团队发言人TJ ·杜克洛在接受《财富》杂志采访时表示。

特朗普方面官方称,过渡团队会陆续收到有关进行中谈判的简报,但并未直接参与谈判。

辉瑞公司发言人卡斯提罗指出:“辉瑞公司与特朗普政府和拜登过渡团队都在定期沟通。”

然而即使进展顺利,拜登政府也还在努力赶上进度。

将在拜登政府担任白宫办公厅主任的罗恩•克莱恩,他告诉Meet the Press:“政府的高级科学顾问和制药公司高管将举行会议”,但“更重要的问题是制造和分发机制,以及疫苗的生产。这最终还是要看卫生及公共服务部。”

“疫苗研发出来了当然是好事,但疫苗本身无法拯救生命,被接种才能救命……这是庞大的后勤工程。”

拜登将努力降低疫苗接种的政治化因素,也是特朗普竞选团队没有实现的目标。

总统长子,也是竞选代理人的小唐纳德•特朗普在毫无证据的情况下,指责制药公司非要等到去年11月总统大选后才公布疫苗接种的临床试验结果。

“他们都知道结果了,就是故意不告诉公众。”他在推特上写道,“大型制药公司恨特朗普,因为特朗普为美国民众争取药品降价,同样的药在全球其他地区明明售价极低。”

与此同时,参议院民主党人已开始调查白宫为何没向辉瑞公司订购更多疫苗。

“我们担心,如果无法保证疫苗供应,将不必要地延长新冠病毒在美国蔓延的时间,导致更多人死亡,经济也将受到更大破坏。”一群立法者在给“曲速行动”领导人的联名信中写道。

其他选择

2020年夏天,特朗普政府与疫苗生产商签署了六份合同,其中包括第二家获批紧急应用新冠疫苗的Moderna,还有刚刚招募4.5万人参与后期疫苗试验的强生公司。

之所以多头谈判,是为了找到既有效又能当成还价筹码的疫苗。

“可以用经济方面的例子说明:‘看,我们已经有几家成功的制造商,有阿斯利康、辉瑞和Moderna。’谈判时就能更强势。”斯奈德说。他补充说,“如今看来,这依然是个非常糟糕的经济决策。”

政府已签订合同,接受1亿剂须两次接种的Moderna疫苗,可供5000万美国人完成接种。疫苗发货很迅速,在去年12月就可分发2000万剂。

跟辉瑞不同的是,政府在该疫苗研发和生产中扮演了更重要的角色。曲速行动共为Moderna提供了41亿美元,还主导了疫苗定价。

1月5日,美国政府考虑将Moderna剂量减半,目的是为了尽快让更多人对新冠病毒获得免疫力。美国官员们正在就这一想法与Moderna和食品与药物品监督管理局进行谈判。

也就是说,如果谈判成功,这种原本接种量应为两剂才能达到95%预防效果的疫苗,之后将对部分接种者只提供一剂。

辉瑞起初就拒绝接受额外资金援助的理由,就是有人担心政府的监督和干预会造成影响。结果政府官员对该公司日常经营情况了解有限,造成了互不信任的局面。

特朗普政府一位高级官员表示:“有了多款疫苗,我们坚信到2021年二季度末,所有需要疫苗的美国人都能顺利接种。” (财富中文网)

译者:冯丰

审校:夏林

编辑:徐晓彤

从疫情爆发到现在已一年。在这段黑暗时期,人们将疫苗视为这片黑暗中的唯一光亮,多国医药公司和研究者日夜兼程,试图突破一款疫苗长达需十余年的研发周期。

奇迹真的发生了:制药巨头辉瑞公司与合作伙伴BioNTech于去年11月宣布,临床试验中疫苗有效性达95%,并且没有严重副作用。12月14日,美国开始了第一批新冠疫苗接种,辉瑞疫苗在全美范围内分发。

这是个转机。市场随之猛涨,群情振奋。美国在经历了近一年的集体创伤之后,似乎终于迎来圆满结局。

但情况并非如此简单。与疫苗面世一同而来的,是一系列麻烦的开始。

有关美国疫苗分发混乱的报道接连不断。

据法新社1月4日报道,美国华盛顿一名学生在去超市购物时,莫名其妙被接种了疫苗。原因是,本应优先接种这种疫苗的医务工作者没能按规定时间接种,而疫苗的储存时间有限,一旦从制冷设备中取出便会迅速变质。

与此同时,本应优先接种疫苗的人群却一剂难求。《纽约时报》在1月4日的报道中描绘了一系列疫苗接种的混乱场面:老人们为接种疫苗需在户外排队一宿;预约网站系统崩溃,很多人明明预约成功,却打不上疫苗……

据美国疾病控制和预防中心1月5日的数据称,截至当天早上,美国共有483万余人完成首剂新冠疫苗的接种,与之前美国所计划的,于2020年年底完成2000万人接种的目标相差甚远。

由于美国各州需自行决定疫苗政策,造成接种进度不一的混乱局面:实际接收疫苗数量不足、首批疫苗被延迟,以及有疫苗却缺注射器等情况在美国各地出现。多州未能完成新冠疫苗的接种目标。

1月3日,面对缓慢的接种进程,纽约州州长科莫称,那些收到疫苗后一周内没有施打完毕的医院将被处以高额罚款,并被禁止获得新一轮的疫苗。他在写给多家医院的信中说:“我不希望疫苗被放在冰柜中,而是希望它被打在别人的手臂上。”

混乱的政商关系

上个月,《纽约时报》爆料称,特朗普政府曾拒绝了再购买1亿剂辉瑞新冠疫苗的机会。

在去年夏末秋初期间,辉瑞公司人员一再对特朗普政府发出警告,敦促政府提前预订更多剂量的疫苗,以防出现供不应求的状况。但这一提议遭到了特朗普政府的拒绝。

后来辉瑞董事会成员斯科特•戈特利布博士向CNBC证实,白宫多次拒绝了增加购买辉瑞疫苗的建议。现在辉瑞转而向其他国家提供疫苗。

特朗普政府官员回复的信息相当混乱。

一位官员说,之所以拒绝加购疫苗是因为对其有效性不确定。但戈特利布表示,试验数据公布后还是被拒绝。

但在之后的周一,白宫官员又否认曾拒绝加购疫苗。与此同时,辉瑞首席执行官阿尔伯特•布尔拉在CNBC上表示,最近美国政府让公司再提供1亿剂,但现在时限可能达不到政府要求。他说,双方正在谈判。

美国卫生与公共服务部长阿扎对辉瑞公司供应能力产生了怀疑。阿扎说,对于特朗普主导的,旨在促进新冠疫苗研发、制造和分发的“曲速行动”,辉瑞公司曾表示在“生产过程中可能遇到各种挑战。”“但我们将确保他们履行合同承诺。”他说。

辉瑞反驳称,可以按时按量供应。

辉瑞发言人莎伦•卡斯提罗说:“辉瑞公司的新冠疫苗生产没有任何问题,疫苗运输也不存在搁置或推迟情况,我们正持续向美国政府指定地区发货。”

辉瑞表示,疫苗分发出现延误可能因为特朗普政府的不确定性。辉瑞称已经备好货,只要知道发货目的地就可以,但是美国政府不清楚何时往何地运送。

新冠疫苗跟不上需求,美国一些州被告知可能要削减疫苗分发数量。更让负责监督疫苗的各州领导人沮丧的是,没有任何相关解释。

“情况混乱,让人很郁闷。”华盛顿州州长杰伊•因斯利发推文称,之前他从美国疾控中心获悉,该州疫苗分发量将削减40%。“我们需要准确可预测的数字,才能计划并确保疫情防控成功。”

加州、康涅狄格州、佐治亚州、夏威夷州、伊利诺伊州、堪萨斯州、蒙大拿州、密歇根州、内布拉斯加州、内华达州、新罕布什尔州和印第安纳州接收的疫苗量也遭到大幅削减。

“没给一句解释就削减各州疫苗分发,让人混乱又迷惑。”内华达州州长斯蒂夫•西索拉克称。

特朗普政府和辉瑞公司都被指责利用媒体为自己辩护,而且他们在指责除了自己之外的所有人。

约四分之一美国民众仍对接种疫苗犹豫不决。55%犹豫的受访者表示对政府缺乏信任,51%的受访者表示担心政治在疫苗研发中施加影响。

特朗普政府和辉瑞关系如此混乱反复,显然无法缓解人们对接种疫苗的犹豫情绪。要想实现对新冠病毒群体免疫,需要有50%到80%的人群接种疫苗。相比之下,流感只需33%到44%的人群完成接种就能实现。即便只是小部分人群对接种犹豫,也会影响群体免疫进程。

矛盾的根源

在辉瑞三期试验之前,特朗普政府同意采购1亿剂疫苗。只要美国食品药品监督管理局批准紧急应用,交易就能立即达成。合同价值19.5亿美元,还附带额外采购5亿剂的选择权,这似乎是最初引发分歧的原因。

“我们早已跟辉瑞就额外采购进行谈判,而且谈判一直在持续。曲速行动从未拒绝辉瑞提供的任何疫苗,只要有确切交货日期和数量。”美国卫生部一位高级官员告诉《财富》杂志。

这位官员表示,早在去年11月辉瑞三期试验数据公布之前,曲速行动已要求“辉瑞提供超过最初1亿剂疫苗交付的时间表,以便达成最新协议”。他解释称,问题是辉瑞公司无法确定交付日期,也没给出额外剂量交付的合理时间范围。

2020年夏天,辉瑞宣布年底前可准备好1亿剂,但到了11月,由于供应链出现问题,供应量减少到可供2500万美国人接种的5000万剂,这让特朗普政府越发不满。

“不管什么时候,只要我们发现受到不公平对待,就会采取一切手段解决问题。”一位特朗普政府官员说。

这位官员指的是,辉瑞要求美国按照《国防生产法》为其提供额外的设备以制造更多疫苗。

12月初,布尔拉在CNBC谈及《国防生产法》时说:“我认为这将发挥非常积极的作用,能让我们最大限度地提高疫苗产量。我们现在正在积极要求……希望他们很快就能执行,因为在某些方面,供应受到重要的限制。”

《国防生产法》可紧急赋予总统权力,出于国防目的“分配材料、服务和设施”,将有助于增加疫苗原料供应,原料通常价格昂贵且容易出现供应短缺。

然而,双方的分歧在于《国防生产法》附带的条件,以及政府对疫苗剂量和对辉瑞行动的进一步控制。

法律学者表示,控制措施可能意味着政府将要求辉瑞优先考虑供应美国,或许还可能导致辉瑞违反全球供应合同。

12月23日,BioNTech在官网上表示,辉瑞和BioNTech同意从美国的生产基地向美国增供1亿剂新冠疫苗,总计疫苗供应量达到2亿剂,预期交付量增加了一倍。两家公司预计在7月31日之前完成交付。

法律游戏

去年11月11日,辉瑞与欧盟签订了供应2亿剂新冠疫苗的协议,预计将于2021年二季度交付。

12月16日有消息称,2021年年底前辉瑞将向中国供应1亿剂。

如果辉瑞同意遵守《国防生产法》而公司总部又在美国,只要疫苗在美国国内生产,政府就可能要求公司优先考虑本国而不是与外国交易。但政府无法控制辉瑞在海外的生产线,还可能因为迫使辉瑞放弃与外国政府的交易而陷入外交困境。

国际制药合同方面的专家表示,在某些情况下,例如美国要求获得优先供应,公司可以推迟或终止合同而不会产生重大影响,这是典型的交易模式。虽然合同尚未公开,但美国政府和辉瑞很可能正在共同寻找并讨论法律范围内允许的做法。

美国还与欧洲和全球各国签订了多份双边投资条约,通常为投资者在另一国市场上提供保护。如果美国政府强迫私营公司违背救命的药品合同,可能因为违反条款而引发一系列问题。

多年来美国一直努力跟中国达成类似协议,尽管未正式公布,但如果辉瑞违约势必会影响谈判进程。

特朗普于去年年底签署了一项行政指令,要求向其他国家提供疫苗前要优先提供给美国,不过很大程度上来说行政指令只具有象征意义。

目前尚不清楚总统有没有权力阻止辉瑞履行国际合同,而且辉瑞疫苗最后一步在比利时工厂完成,很可能总统并无控制权。为该指令召开的峰会迅速被政治化,辉瑞和Moderna的代表均未出席,拜登政府过渡团队也未派代表出席。

出个价吧

种种迹象表明,围绕疫苗的谈判更多与权力相关,与价格关系不大。如果硬说有关系的话,就是特朗普政府认为只要能控制疫苗生产,就愿意加大投入。不过政府官员称,早前的订单中仍然考虑了成本因素。

“(当初美国政府拒绝向辉瑞采购更多疫苗)最简单的原因无非就是两个。”达特茅斯学院经济学教授克里斯托弗•斯奈德说,该组织主要关注疫苗研发的财务和经济状况。

“要么谈判者知道该部分剂量对美国的巨大经济价值,只是不小心弄砸了交易;要么就是谈判者没算清楚采购如此庞大剂量能带来的巨大经济利益。”

他表示,在公开谈判的同时,却可能造成疫苗配送拖延,虽然特朗普政府有可能省下的“几百万美元”,但并不值得。

“没必要拿万亿美元的国家健康和福利冒险……花上10亿美元是值得的。”

拜登来了

不管面临什么阻碍,拜登政府都即将接手。新当选总统乔•拜登和团队将负责分发特朗普政府购买和谈判的大量疫苗。

刚开始还有人担心特朗普和美国总务署可能拒绝将权力移交给拜登过渡团队,从而导致疫苗分发过程推迟,而如今相关担心已逐渐减退。

虽然没有特朗普政府协助,拜登团队看起来已在跟制药企业高管定期会面。

“我们正与辉瑞、Moderna以及其他努力开发疫苗的企业定期对话,重点是确保全体美国人和全世界尽快获得安全有效的疫苗。”拜登过渡团队发言人TJ ·杜克洛在接受《财富》杂志采访时表示。

特朗普方面官方称,过渡团队会陆续收到有关进行中谈判的简报,但并未直接参与谈判。

辉瑞公司发言人卡斯提罗指出:“辉瑞公司与特朗普政府和拜登过渡团队都在定期沟通。”

然而即使进展顺利,拜登政府也还在努力赶上进度。

将在拜登政府担任白宫办公厅主任的罗恩•克莱恩,他告诉Meet the Press:“政府的高级科学顾问和制药公司高管将举行会议”,但“更重要的问题是制造和分发机制,以及疫苗的生产。这最终还是要看卫生及公共服务部。”

“疫苗研发出来了当然是好事,但疫苗本身无法拯救生命,被接种才能救命……这是庞大的后勤工程。”

拜登将努力降低疫苗接种的政治化因素,也是特朗普竞选团队没有实现的目标。

总统长子,也是竞选代理人的小唐纳德•特朗普在毫无证据的情况下,指责制药公司非要等到去年11月总统大选后才公布疫苗接种的临床试验结果。

“他们都知道结果了,就是故意不告诉公众。”他在推特上写道,“大型制药公司恨特朗普,因为特朗普为美国民众争取药品降价,同样的药在全。球其他地区明明售价极低。”

与此同时,参议院民主党人已开始调查白宫为何没向辉瑞公司订购更多疫苗。

“我们担心,如果无法保证疫苗供应,将不必要地延长新冠病毒在美国蔓延的时间,导致更多人死亡,经济也将受到更大破坏。”一群立法者在给“曲速行动”领导人的联名信中写道。

其他选择

2020年夏天,特朗普政府与疫苗生产商签署了六份合同,其中包括第二家获批紧急应用新冠疫苗的Moderna,还有刚刚招募4.5万人参与后期疫苗试验的强生公司。

之所以多头谈判,是为了找到既有效又能当成还价筹码的疫苗。

“可以用经济方面的例子说明:‘看,我们已经有几家成功的制造商,有阿斯利康、辉瑞和Moderna。’谈判时就能更强势。”斯奈德说。他补充说,“如今看来,这依然是个非常糟糕的经济决策。”

政府已签订合同,接受1亿剂须两次接种的Moderna疫苗,可供5000万美国人完成接种。疫苗发货很迅速,在去年12月份就可分发2000万剂。

跟辉瑞不同的是,政府在该疫苗研发和生产中扮演了更重要的角色。曲速行动共为Moderna提供了41亿美元,还主导了疫苗定价。

1月5日,美国政府考虑将Moderna剂量减半,目的是为了尽快让更多人对新冠病毒获得免疫力。美国官员们正在就这一想法与Moderna和食品与药品监督管理局进行谈判。

也就是说,如果谈判成功,这种原本接种量应为两剂才能达到95%预防效果的疫苗,之后将对部分接种者只提供一剂。

辉瑞起初就拒绝接受额外资金援助的理由,就是有人担心政府的监督和干预会造成影响。结果政府官员对该公司日常经营情况了解有限,造成了互不信任的局面。

特朗普政府一位高级官员表示:“有了多款疫苗,我们坚信到2021年二季度末,所有需要疫苗的美国人都能顺利接种。” (财富中文网)

译者:冯丰

审校:夏林

编辑:徐晓彤

On Nov. 18, nearly a year into a pandemic that has killed more than 300,000 Americans, a modern miracle occurred: Pharmaceutical giant Pfizer and its partner BioNTech announced that its vaccine candidate had been shown in clinical trials to have a 95% efficacy rate and no serious side effects. The rollout, they said, would begin within a month of emergency use authorization.

Markets shot upwards; spirits were buoyed. After nearly a year of nationwide trauma, an end was in sight.

And then the trouble started.

Last week, the New York Times broke a story claiming that the Trump administration had turned down the chance to lock in an additional 100 million doses. Dr. Scott Gottlieb, a member of Pfizer’s board, later confirmed to CNBC that the White House had turned down multiple offers from the pharma company. Now they were promised to other countries.

Trump administration officials responded with muddled messaging. One official said that the offer was declined because there was no known efficacy rate, although Gottlieb said the doses were turned down again after trial data was released. Then, on Monday, officials denied that they had turned down any offer at all. At the same time, Pfizer CEO Albert Bourla said on CNBC that the U.S. government had recently asked him for those additional 100 million doses but that the time frame it wanted them in might now be unobtainable. Negotiations are ongoing, he said. Health and Human Services Secretary Alex Azar confirmed to reporters Wednesday that officials “are engaged in active negotiations” with Pfizer to purchase more doses.

But Azar also used the opportunity to seed some doubt about Pfizer’s abilities to deliver the basics. Pfizer had informed Operation Warp Speed “about various challenges they may have in their manufacturing,” said Azar. “We will ensure they fulfill their contractual commitment.”

Pfizer countered that it was on track to meet its supply promises. “Pfizer has not had any production issues with its COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed,” Pfizer spokesperson Sharon Castillo said. “We are continuing to dispatch orders to the locations specified by the U.S. government.”

The pharma giant said that any delays in the rollout could be chalked up to a lack of clarity from the Trump administration. Pfizer says that it has shipped 2.9 million doses of the vaccine to states, and that millions of doses are in warehouses ready to be sent out—the company just needs to know where to send them. It’s the government, Pfizer says, that’s being unclear about when and where they should go.

Now, some states are reporting that they have been told to expect far fewer doses of the Pfizer-BioNTech COVID-19 vaccine next week. There has been little explanation, a fact that has frustrated state leaders charged with overseeing the vaccination process. “This is disruptive and frustrating,” Washington Gov. Jay Inslee posted on Twitter Thursday after he learned from the Centers for Disease Control and Prevention (CDC) that his state’s allocation would be cut by 40%. “We need accurate, predictable numbers to plan and ensure on-the-ground success.”

California, Connecticut, Georgia, Hawaii, Illinois, Kansas, Montana, Michigan, Nebraska, Nevada, New Hampshire, and Indiana are also expecting slashed shipments.

“To slash allocations for states—without any explanation whatsoever—is disruptive and baffling,” said Nevada Gov. Steve Sisolak in a statement. His state’s allocation will fall by 42% next week.

Both sides have been accused of using the media to negotiate, and fingers have been pointed, quite publicly, in nearly every direction.

About a quarter of the U.S. population remains hesitant to receive the vaccine; 55% of respondents who were hesitant cited a lack of trust in the government, and 51% reported they are worried about the role politics played in the vaccine’s development. The confusion and back-and-forth between the Trump administration and Pfizer certainly won’t assuage any hesitancy around getting vaccinated. In order to reach the herd immunity threshold for COVID-19, between 50% to 80% of the population will need to be vaccinated. By contrast, the flu only needs between 33% and 44% of the population vaccinated to reach herd immunity. Even minimal levels of vaccine hesitancy could prevent that from occurring.

In July, the Trump administration agreed to purchase 100 million doses of the Pfizer vaccine ahead of Phase III trials; the deal would be made good as soon as the FDA approved emergency use of the vaccine. The $1.95 billion contract also came with an option to buy an additional 500 million doses, which appears to be the initial cause of disagreement.

“We have been and continue to negotiate with Pfizer for additional doses. At no time did Operation Warp Speed turn down an offer from Pfizer for any number of millions of doses having a firm delivery date and quantity,” a senior official at HHS told Fortune.

The official said that Warp Speed had asked for a “delivery schedule for doses in excess of the original 100 million so that we could finalize an updated agreement with Pfizer,” well before the data from Pfizer’s Phase III trial became available in November. The problem, he explained, is that Pfizer could not supply a delivery date or give a reasonable time frame for those additional doses.

This summer, Pfizer announced that it would have 100 million doses ready by the end of the year, but by November, a number of supply chain issues caused the company to scale the number back to 50 million doses, which would fully vaccinate 25 million Americans, further frustrating the Trump administration.

“Should at any time we feel we are being treated unfairly, we will use every lever at our disposal to address the situation,” the Trump administration official added, referring to ongoing negotiations.

That comment comes in reference to Pfizer’s request for the U.S. to exercise the Defense Production Act (DPA) in order to provide the company with additional equipment to aid in manufacturing more doses of the vaccine.

“I think it would be very positive, and I think that it will allow us to maximize what we can do,” said Bourla of the DPA on CNBC this week. “We are asking them right now…and I hope that they will do it very soon because, particularly in some components, we are running at critical supply limitations.” The DPA, a law that gives the President the emergency authority to “allocate materials, services, and facilities” for purposes of national defense, would help increase supplies of raw materials for the vaccines, which are often expensive and in short supply.

The disagreement, however, is over the conditions that come with the DPA—and the increased control the government would gain over the doses and Pfizer’s actions if it were invoked. Those controls could mean that the government would require Pfizer to prioritize the U.S. over other nations and perhaps renege on supply contracts across the world, say legal scholars.

The legal play

On Nov. 11, Pfizer entered into a supply agreement with the European Union for 200 million doses of its COVID-19 vaccine, which are expected to be delivered by the second quarter of 2021. On Wednesday, it was announced that the company would supply 100 million doses to China by the end of 2021.

If Pfizer agrees to the DPA, the federal government could require the U.S.-based company to prioritize the U.S. over deals with foreign countries, so long as the vaccine is produced in domestic factories. But the government won’t be able to control Pfizer’s manufacturing lines abroad and could potentially step into diplomatic trouble by forcing Pfizer to spurn its deals with foreign governments.

Experts in international pharmaceutical contracts say that it’s boilerplate for deals to include an explicit recognition that in some circumstances, such as if the U.S. demands the dosage first, the company can delay or end its contract without significant repercussions. While the contracts have not been made public, it’s likely that the federal government and Pfizer are working together to find and discuss what is possible within legal limits.

The U.S. is also engaged in a number of bilateral investment treaties with countries in Europe and across the globe, and these agreements typically provide investors with protections in one another’s markets. The federal government forcing a private company to void contracts for lifesaving medicines would likely raise some questions about violating the terms of the treaties. The U.S. has been working on such an agreement with China for years, and while nothing official is in place, there would certainly be damage done to the negotiating process.

Trump signed an executive order last week that prioritized vaccinating Americans before providing doses to other countries, but the EO was largely symbolic. It’s not clear if the President has the authority to prevent companies from fulfilling international contracts, and because Pfizer finalizes its vaccine in its Belgium factory, the President likely has little control over it. A summit held in honor of the order was quickly politicized, and representatives from Pfizer and Moderna did not attend, nor did any representatives from the Biden transition team.

Name your price

All signs indicate that ongoing negotiations around the vaccine have more to do with power than price tag. If anything, it appears that the Trump administration would like to spend more, so long as they have control over production. But cost still factored into earlier orders, according to officials.

“The simplest explanation [of why the U.S. initially turned down the extra doses of Pfizer’s COVID-19 vaccine] is one of two things,” said Christopher Snyder, a professor of economics at Dartmouth College and a member of Accelerating Health Technologies, a group focused on the financial and economic cases for vaccine development. “Either the negotiator knew the enormous economic value of the tranche of doses to the U.S. and botched the deal, or the negotiator botched the economic calculation of the enormous benefits to having these doses.”

Holding negotiations so publicly while holding up the possible delivery of more vaccination units is not worth the “couple of million of dollars” that may be saved by the Trump administration, he said. “The trillion-dollar risk to the health and welfare of the country is not worth taking…It’s worth a billion-dollar payment.”

Biden incoming

Whatever the holdup is, it will be handed over to the Biden administration a month from now. President-elect Joe Biden and his team will be left with the task of parceling out the bulk of the vaccinations that the Trump administration had purchased and negotiated for.

Initial fears that Trump and the General Services Administration’s refusal to onboard the Biden transition team would lead to delays in the vaccine distribution process have subsided, and Biden’s team appears to be regularly meeting with pharmaceutical executives without the Trump administration.

“We’re in regular conversations with Pfizer, Moderna, and other companies who are working to develop vaccines, and our focus is making sure safe and effective vaccines are available to all Americans and to the world as soon as possible,” TJ Ducklo, spokesperson for Biden’s transition team, told Fortune.

The transition team, said Trump officials, is receiving briefs about ongoing negotiations but is not directly involved. And Castillo, the Pfizer spokesperson, noted: “Pfizer is in regular communications with both the Trump administration and the Biden transition team.”

Yet, even with things on track, the Biden administration is still playing catch-up. Ron Klain, who will serve as White House chief of staff under Biden, told Meet the Press: “We’re going to have meetings between our top scientific advisers and the officials of these drug companies,” but the “bigger issue will be the mechanics of manufacture and distribution, getting this vaccine out. That really lies with folks at the Health and Human Services Department. It’s great to have a vaccine, but vaccines don’t save lives; vaccinations save lives...It’s a giant logistical project.”

Biden will work to depoliticize the nature of the vaccination, a goal that the Trump campaign had not worked toward.

Donald Trump Jr., the President’s eldest son and campaign surrogate, accused pharmaceutical companies, without evidence, of waiting to release clinical trial results of the vaccination until after November’s presidential election.

“They all knew it but kept it from the public on purpose,” he wrote on Twitter. “Big Pharma hates Trump for taking on the gouging of Americans with drug pricing while offering the same drugs elsewhere in the world for pennies in the dollar.”

Senate Democrats, meanwhile, have launched a probe into why the White House passed on Pfizer’s extra doses. “We are concerned the failure to secure an adequate supply of vaccines will needlessly prolong the COVID-19 pandemic in this country, causing further loss of life and economic devastation,” a group of lawmakers wrote to leaders of Operation Warp Speed.

Other options

This summer, the Trump administration signed six contracts with vaccine makers, including Moderna, the second company to have a COVID-19 vaccine approved for emergency use, and Johnson & Johnson, which just enrolled 45,000 participants for its late-stage vaccine trial.

The strategy was intended to maximize the success of finding a vaccine that worked—but also to be used as a bargaining chip. “You can make an economic case for saying, ‘Well, look, we have several successful manufacturers, AstraZeneca and Pfizer and Moderna, so we can be a little bit tougher in our negotiations,” said Snyder, adding that “it’s still a very bad economic decision.”

The government is contracted to receive 100 million doses of the Moderna vaccine—also a two-dose system, which would fully vaccinate 50 million Americans. Those will begin to ship immediately: Moderna plans to distribute 20 million doses this month. And unlike Pfizer, the government has a larger role in the development and manufacturing of this vaccine. Warp Speed provided Moderna with $4.1 billion in total, including the price for the doses.

Pfizer initially spurned additional funding to aid in manufacturing, claiming that there was a worry that government oversight would harm its work. That left administration officials with a limited understanding of what the company was doing on a week by week basis and an air of mistrust.

“We remain confident that across our portfolio of multiple vaccines we will have enough doses for any American who wants a vaccine by the end of Q2 2021,” said a senior Trump administration official.

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