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為什么美國的疫苗接種如此混亂?

NICOLE GOODKIND
2021-01-08

背后是兩個“甩鍋”高手。

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從疫情爆發(fā)到現(xiàn)在已一年。在這段黑暗時期,人們將疫苗視為這片黑暗中的唯一光亮,多國醫(yī)藥公司和研究者日夜兼程,試圖突破一款疫苗長達(dá)需十余年的研發(fā)周期。

奇跡真的發(fā)生了:制藥巨頭輝瑞公司與合作伙伴BioNTech于去年11月宣布,臨床試驗(yàn)中疫苗有效性達(dá)95%,并且沒有嚴(yán)重副作用。12月14日,美國開始了第一批新冠疫苗接種,輝瑞疫苗在全美范圍內(nèi)分發(fā)。

這是個轉(zhuǎn)機(jī)。市場隨之猛漲,群情振奮。美國在經(jīng)歷了近一年的集體創(chuàng)傷之后,似乎終于迎來圓滿結(jié)局。

但情況并非如此簡單。與疫苗面世一同而來的,是一系列麻煩的開始。

有關(guān)美國疫苗分發(fā)混亂的報道接連不斷。

據(jù)法新社1月4日報道,美國華盛頓一名學(xué)生在去超市購物時,莫名其妙被接種了疫苗。原因是,本應(yīng)優(yōu)先接種這種疫苗的醫(yī)務(wù)工作者沒能按規(guī)定時間接種,而疫苗的儲存時間有限,一旦從制冷設(shè)備中取出便會迅速變質(zhì)。

與此同時,本應(yīng)優(yōu)先接種疫苗的人群卻一劑難求。《紐約時報》在1月4日的報道中描繪了一系列疫苗接種的混亂場面:老人們?yōu)榻臃N疫苗需在戶外排隊一宿;預(yù)約網(wǎng)站系統(tǒng)崩潰,很多人明明預(yù)約成功,卻打不上疫苗……

據(jù)美國疾病控制和預(yù)防中心1月5日的數(shù)據(jù)稱,截至當(dāng)天早上,美國共有483萬余人完成首劑新冠疫苗的接種,與之前美國所計劃的,于2020年年底完成2000萬人接種的目標(biāo)相差甚遠(yuǎn)。

由于美國各州需自行決定疫苗政策,造成接種進(jìn)度不一的混亂局面:實(shí)際接收疫苗數(shù)量不足、首批疫苗被延遲,以及有疫苗卻缺注射器等情況在美國各地出現(xiàn)。多州未能完成新冠疫苗的接種目標(biāo)。

1月3日,面對緩慢的接種進(jìn)程,紐約州州長科莫稱,那些收到疫苗后一周內(nèi)沒有施打完畢的醫(yī)院將被處以高額罰款,并被禁止獲得新一輪的疫苗。他在寫給多家醫(yī)院的信中說:“我不希望疫苗被放在冰柜中,而是希望它被打在別人的手臂上。”

混亂的政商關(guān)系

上個月,《紐約時報》爆料稱,特朗普政府曾拒絕了再購買1億劑輝瑞新冠疫苗的機(jī)會。

在去年夏末秋初期間,輝瑞公司人員一再對特朗普政府發(fā)出警告,敦促政府提前預(yù)訂更多劑量的疫苗,以防出現(xiàn)供不應(yīng)求的狀況。但這一提議遭到了特朗普政府的拒絕。

后來輝瑞董事會成員斯科特?戈特利布博士向CNBC證實(shí),白宮多次拒絕了增加購買輝瑞疫苗的建議。現(xiàn)在輝瑞轉(zhuǎn)而向其他國家提供疫苗。

特朗普政府官員回復(fù)的信息相當(dāng)混亂。

一位官員說,之所以拒絕加購疫苗是因?yàn)閷ζ溆行圆淮_定。但戈特利布表示,試驗(yàn)數(shù)據(jù)公布后還是被拒絕。

但在之后的周一,白宮官員又否認(rèn)曾拒絕加購疫苗。與此同時,輝瑞首席執(zhí)行官阿爾伯特?布爾拉在CNBC上表示,最近美國政府讓公司再提供1億劑,但現(xiàn)在時限可能達(dá)不到政府要求。他說,雙方正在談判。

美國衛(wèi)生與公共服務(wù)部長阿扎對輝瑞公司供應(yīng)能力產(chǎn)生了懷疑。阿扎說,對于特朗普主導(dǎo)的,旨在促進(jìn)新冠疫苗研發(fā)、制造和分發(fā)的“曲速行動”,輝瑞公司曾表示在“生產(chǎn)過程中可能遇到各種挑戰(zhàn)。”“但我們將確保他們履行合同承諾。”他說。

輝瑞反駁稱,可以按時按量供應(yīng)。

輝瑞發(fā)言人莎倫?卡斯提羅說:“輝瑞公司的新冠疫苗生產(chǎn)沒有任何問題,疫苗運(yùn)輸也不存在擱置或推遲情況,我們正持續(xù)向美國政府指定地區(qū)發(fā)貨。”

輝瑞表示,疫苗分發(fā)出現(xiàn)延誤可能因?yàn)樘乩势照牟淮_定性。輝瑞稱已經(jīng)備好貨,只要知道發(fā)貨目的地就可以,但是美國政府不清楚何時往何地運(yùn)送。

新冠疫苗跟不上需求,美國一些州被告知可能要削減疫苗分發(fā)數(shù)量。更讓負(fù)責(zé)監(jiān)督疫苗的各州領(lǐng)導(dǎo)人沮喪的是,沒有任何相關(guān)解釋。

“情況混亂,讓人很郁悶。”華盛頓州州長杰伊?因斯利發(fā)推文稱,之前他從美國疾控中心獲悉,該州疫苗分發(fā)量將削減40%。“我們需要準(zhǔn)確可預(yù)測的數(shù)字,才能計劃并確保疫情防控成功。”

加州、康涅狄格州、佐治亞州、夏威夷州、伊利諾伊州、堪薩斯州、蒙大拿州、密歇根州、內(nèi)布拉斯加州、內(nèi)華達(dá)州、新罕布什爾州和印第安納州接收的疫苗量也遭到大幅削減。

“沒給一句解釋就削減各州疫苗分發(fā),讓人混亂又迷惑。”內(nèi)華達(dá)州州長斯蒂夫?西索拉克稱。

特朗普政府和輝瑞公司都被指責(zé)利用媒體為自己辯護(hù),而且他們在指責(zé)除了自己之外的所有人。

約四分之一美國民眾仍對接種疫苗猶豫不決。55%猶豫的受訪者表示對政府缺乏信任,51%的受訪者表示擔(dān)心政治在疫苗研發(fā)中施加影響。

特朗普政府和輝瑞關(guān)系如此混亂反復(fù),顯然無法緩解人們對接種疫苗的猶豫情緒。要想實(shí)現(xiàn)對新冠病毒群體免疫,需要有50%到80%的人群接種疫苗。相比之下,流感只需33%到44%的人群完成接種就能實(shí)現(xiàn)。即便只是小部分人群對接種猶豫,也會影響群體免疫進(jìn)程。

矛盾的根源

在輝瑞三期試驗(yàn)之前,特朗普政府同意采購1億劑疫苗。只要美國食品藥品監(jiān)督管理局批準(zhǔn)緊急應(yīng)用,交易就能立即達(dá)成。合同價值19.5億美元,還附帶額外采購5億劑的選擇權(quán),這似乎是最初引發(fā)分歧的原因。

“我們早已跟輝瑞就額外采購進(jìn)行談判,而且談判一直在持續(xù)。曲速行動從未拒絕輝瑞提供的任何疫苗,只要有確切交貨日期和數(shù)量。”美國衛(wèi)生部一位高級官員告訴《財富》雜志。

這位官員表示,早在去年11月輝瑞三期試驗(yàn)數(shù)據(jù)公布之前,曲速行動已要求“輝瑞提供超過最初1億劑疫苗交付的時間表,以便達(dá)成最新協(xié)議”。他解釋稱,問題是輝瑞公司無法確定交付日期,也沒給出額外劑量交付的合理時間范圍。

2020年夏天,輝瑞宣布年底前可準(zhǔn)備好1億劑,但到了11月,由于供應(yīng)鏈出現(xiàn)問題,供應(yīng)量減少到可供2500萬美國人接種的5000萬劑,這讓特朗普政府越發(fā)不滿。

“不管什么時候,只要我們發(fā)現(xiàn)受到不公平對待,就會采取一切手段解決問題。”一位特朗普政府官員說。

這位官員指的是,輝瑞要求美國按照《國防生產(chǎn)法》為其提供額外的設(shè)備以制造更多疫苗。

12月初,布爾拉在CNBC談及《國防生產(chǎn)法》時說:“我認(rèn)為這將發(fā)揮非常積極的作用,能讓我們最大限度地提高疫苗產(chǎn)量。我們現(xiàn)在正在積極要求……希望他們很快就能執(zhí)行,因?yàn)樵谀承┓矫妫?yīng)受到重要的限制。”

《國防生產(chǎn)法》可緊急賦予總統(tǒng)權(quán)力,出于國防目的“分配材料、服務(wù)和設(shè)施”,將有助于增加疫苗原料供應(yīng),原料通常價格昂貴且容易出現(xiàn)供應(yīng)短缺。

然而,雙方的分歧在于《國防生產(chǎn)法》附帶的條件,以及政府對疫苗劑量和對輝瑞行動的進(jìn)一步控制。

法律學(xué)者表示,控制措施可能意味著政府將要求輝瑞優(yōu)先考慮供應(yīng)美國,或許還可能導(dǎo)致輝瑞違反全球供應(yīng)合同。

12月23日,BioNTech在官網(wǎng)上表示,輝瑞和BioNTech同意從美國的生產(chǎn)基地向美國增供1億劑新冠疫苗,總計疫苗供應(yīng)量達(dá)到2億劑,預(yù)期交付量增加了一倍。兩家公司預(yù)計在7月31日之前完成交付。

法律游戲

去年11月11日,輝瑞與歐盟簽訂了供應(yīng)2億劑新冠疫苗的協(xié)議,預(yù)計將于2021年二季度交付。

12月16日有消息稱,2021年年底前輝瑞將向中國供應(yīng)1億劑。

如果輝瑞同意遵守《國防生產(chǎn)法》而公司總部又在美國,只要疫苗在美國國內(nèi)生產(chǎn),政府就可能要求公司優(yōu)先考慮本國而不是與外國交易。但政府無法控制輝瑞在海外的生產(chǎn)線,還可能因?yàn)槠仁馆x瑞放棄與外國政府的交易而陷入外交困境。

國際制藥合同方面的專家表示,在某些情況下,例如美國要求獲得優(yōu)先供應(yīng),公司可以推遲或終止合同而不會產(chǎn)生重大影響,這是典型的交易模式。雖然合同尚未公開,但美國政府和輝瑞很可能正在共同尋找并討論法律范圍內(nèi)允許的做法。

美國還與歐洲和全球各國簽訂了多份雙邊投資條約,通常為投資者在另一國市場上提供保護(hù)。如果美國政府強(qiáng)迫私營公司違背救命的藥品合同,可能因?yàn)檫`反條款而引發(fā)一系列問題。

多年來美國一直努力跟中國達(dá)成類似協(xié)議,盡管未正式公布,但如果輝瑞違約勢必會影響談判進(jìn)程。

特朗普于去年年底簽署了一項(xiàng)行政指令,要求向其他國家提供疫苗前要優(yōu)先提供給美國,不過很大程度上來說行政指令只具有象征意義。

目前尚不清楚總統(tǒng)有沒有權(quán)力阻止輝瑞履行國際合同,而且輝瑞疫苗最后一步在比利時工廠完成,很可能總統(tǒng)并無控制權(quán)。為該指令召開的峰會迅速被政治化,輝瑞和Moderna的代表均未出席,拜登政府過渡團(tuán)隊也未派代表出席。

出個價吧

種種跡象表明,圍繞疫苗的談判更多與權(quán)力相關(guān),與價格關(guān)系不大。如果硬說有關(guān)系的話,就是特朗普政府認(rèn)為只要能控制疫苗生產(chǎn),就愿意加大投入。不過政府官員稱,早前的訂單中仍然考慮了成本因素。

“(當(dāng)初美國政府拒絕向輝瑞采購更多疫苗)最簡單的原因無非就是兩個。”達(dá)特茅斯學(xué)院經(jīng)濟(jì)學(xué)教授克里斯托弗?斯奈德說,該組織主要關(guān)注疫苗研發(fā)的財務(wù)和經(jīng)濟(jì)狀況。

“要么談判者知道該部分劑量對美國的巨大經(jīng)濟(jì)價值,只是不小心弄砸了交易;要么就是談判者沒算清楚采購如此龐大劑量能帶來的巨大經(jīng)濟(jì)利益。”

他表示,在公開談判的同時,卻可能造成疫苗配送拖延,雖然特朗普政府有可能省下的“幾百萬美元”,但并不值得。

“沒必要拿萬億美元的國家健康和福利冒險……花上10億美元是值得的。”

拜登來了

不管面臨什么阻礙,拜登政府都即將接手。新當(dāng)選總統(tǒng)喬?拜登和團(tuán)隊將負(fù)責(zé)分發(fā)特朗普政府購買和談判的大量疫苗。

剛開始還有人擔(dān)心特朗普和美國總務(wù)署可能拒絕將權(quán)力移交給拜登過渡團(tuán)隊,從而導(dǎo)致疫苗分發(fā)過程推遲,而如今相關(guān)擔(dān)心已逐漸減退。

雖然沒有特朗普政府協(xié)助,拜登團(tuán)隊看起來已在跟制藥企業(yè)高管定期會面。

“我們正與輝瑞、Moderna以及其他努力開發(fā)疫苗的企業(yè)定期對話,重點(diǎn)是確保全體美國人和全世界盡快獲得安全有效的疫苗。”拜登過渡團(tuán)隊發(fā)言人TJ ·杜克洛在接受《財富》雜志采訪時表示。

特朗普方面官方稱,過渡團(tuán)隊會陸續(xù)收到有關(guān)進(jìn)行中談判的簡報,但并未直接參與談判。

輝瑞公司發(fā)言人卡斯提羅指出:“輝瑞公司與特朗普政府和拜登過渡團(tuán)隊都在定期溝通。”

然而即使進(jìn)展順利,拜登政府也還在努力趕上進(jìn)度。

將在拜登政府擔(dān)任白宮辦公廳主任的羅恩?克萊恩,他告訴Meet the Press:“政府的高級科學(xué)顧問和制藥公司高管將舉行會議”,但“更重要的問題是制造和分發(fā)機(jī)制,以及疫苗的生產(chǎn)。這最終還是要看衛(wèi)生及公共服務(wù)部。”

“疫苗研發(fā)出來了當(dāng)然是好事,但疫苗本身無法拯救生命,被接種才能救命……這是龐大的后勤工程。”

拜登將努力降低疫苗接種的政治化因素,也是特朗普競選團(tuán)隊沒有實(shí)現(xiàn)的目標(biāo)。

總統(tǒng)長子,也是競選代理人的小唐納德?特朗普在毫無證據(jù)的情況下,指責(zé)制藥公司非要等到去年11月總統(tǒng)大選后才公布疫苗接種的臨床試驗(yàn)結(jié)果。

“他們都知道結(jié)果了,就是故意不告訴公眾。”他在推特上寫道,“大型制藥公司恨特朗普,因?yàn)樘乩势諡槊绹癖姞幦∷幤方祪r,同樣的藥在全球其他地區(qū)明明售價極低。”

與此同時,參議院民主黨人已開始調(diào)查白宮為何沒向輝瑞公司訂購更多疫苗。

“我們擔(dān)心,如果無法保證疫苗供應(yīng),將不必要地延長新冠病毒在美國蔓延的時間,導(dǎo)致更多人死亡,經(jīng)濟(jì)也將受到更大破壞。”一群立法者在給“曲速行動”領(lǐng)導(dǎo)人的聯(lián)名信中寫道。

其他選擇

2020年夏天,特朗普政府與疫苗生產(chǎn)商簽署了六份合同,其中包括第二家獲批緊急應(yīng)用新冠疫苗的Moderna,還有剛剛招募4.5萬人參與后期疫苗試驗(yàn)的強(qiáng)生公司。

之所以多頭談判,是為了找到既有效又能當(dāng)成還價籌碼的疫苗。

“可以用經(jīng)濟(jì)方面的例子說明:‘看,我們已經(jīng)有幾家成功的制造商,有阿斯利康、輝瑞和Moderna。’談判時就能更強(qiáng)勢。”斯奈德說。他補(bǔ)充說,“如今看來,這依然是個非常糟糕的經(jīng)濟(jì)決策。”

政府已簽訂合同,接受1億劑須兩次接種的Moderna疫苗,可供5000萬美國人完成接種。疫苗發(fā)貨很迅速,在去年12月就可分發(fā)2000萬劑。

跟輝瑞不同的是,政府在該疫苗研發(fā)和生產(chǎn)中扮演了更重要的角色。曲速行動共為Moderna提供了41億美元,還主導(dǎo)了疫苗定價。

1月5日,美國政府考慮將Moderna劑量減半,目的是為了盡快讓更多人對新冠病毒獲得免疫力。美國官員們正在就這一想法與Moderna和食品與藥物品監(jiān)督管理局進(jìn)行談判。

也就是說,如果談判成功,這種原本接種量應(yīng)為兩劑才能達(dá)到95%預(yù)防效果的疫苗,之后將對部分接種者只提供一劑。

輝瑞起初就拒絕接受額外資金援助的理由,就是有人擔(dān)心政府的監(jiān)督和干預(yù)會造成影響。結(jié)果政府官員對該公司日常經(jīng)營情況了解有限,造成了互不信任的局面。

特朗普政府一位高級官員表示:“有了多款疫苗,我們堅信到2021年二季度末,所有需要疫苗的美國人都能順利接種。” (財富中文網(wǎng))

譯者:馮豐

審校:夏林

編輯:徐曉彤

從疫情爆發(fā)到現(xiàn)在已一年。在這段黑暗時期,人們將疫苗視為這片黑暗中的唯一光亮,多國醫(yī)藥公司和研究者日夜兼程,試圖突破一款疫苗長達(dá)需十余年的研發(fā)周期。

奇跡真的發(fā)生了:制藥巨頭輝瑞公司與合作伙伴BioNTech于去年11月宣布,臨床試驗(yàn)中疫苗有效性達(dá)95%,并且沒有嚴(yán)重副作用。12月14日,美國開始了第一批新冠疫苗接種,輝瑞疫苗在全美范圍內(nèi)分發(fā)。

這是個轉(zhuǎn)機(jī)。市場隨之猛漲,群情振奮。美國在經(jīng)歷了近一年的集體創(chuàng)傷之后,似乎終于迎來圓滿結(jié)局。

但情況并非如此簡單。與疫苗面世一同而來的,是一系列麻煩的開始。

有關(guān)美國疫苗分發(fā)混亂的報道接連不斷。

據(jù)法新社1月4日報道,美國華盛頓一名學(xué)生在去超市購物時,莫名其妙被接種了疫苗。原因是,本應(yīng)優(yōu)先接種這種疫苗的醫(yī)務(wù)工作者沒能按規(guī)定時間接種,而疫苗的儲存時間有限,一旦從制冷設(shè)備中取出便會迅速變質(zhì)。

與此同時,本應(yīng)優(yōu)先接種疫苗的人群卻一劑難求。《紐約時報》在1月4日的報道中描繪了一系列疫苗接種的混亂場面:老人們?yōu)榻臃N疫苗需在戶外排隊一宿;預(yù)約網(wǎng)站系統(tǒng)崩潰,很多人明明預(yù)約成功,卻打不上疫苗……

據(jù)美國疾病控制和預(yù)防中心1月5日的數(shù)據(jù)稱,截至當(dāng)天早上,美國共有483萬余人完成首劑新冠疫苗的接種,與之前美國所計劃的,于2020年年底完成2000萬人接種的目標(biāo)相差甚遠(yuǎn)。

由于美國各州需自行決定疫苗政策,造成接種進(jìn)度不一的混亂局面:實(shí)際接收疫苗數(shù)量不足、首批疫苗被延遲,以及有疫苗卻缺注射器等情況在美國各地出現(xiàn)。多州未能完成新冠疫苗的接種目標(biāo)。

1月3日,面對緩慢的接種進(jìn)程,紐約州州長科莫稱,那些收到疫苗后一周內(nèi)沒有施打完畢的醫(yī)院將被處以高額罰款,并被禁止獲得新一輪的疫苗。他在寫給多家醫(yī)院的信中說:“我不希望疫苗被放在冰柜中,而是希望它被打在別人的手臂上。”

混亂的政商關(guān)系

上個月,《紐約時報》爆料稱,特朗普政府曾拒絕了再購買1億劑輝瑞新冠疫苗的機(jī)會。

在去年夏末秋初期間,輝瑞公司人員一再對特朗普政府發(fā)出警告,敦促政府提前預(yù)訂更多劑量的疫苗,以防出現(xiàn)供不應(yīng)求的狀況。但這一提議遭到了特朗普政府的拒絕。

后來輝瑞董事會成員斯科特?戈特利布博士向CNBC證實(shí),白宮多次拒絕了增加購買輝瑞疫苗的建議。現(xiàn)在輝瑞轉(zhuǎn)而向其他國家提供疫苗。

特朗普政府官員回復(fù)的信息相當(dāng)混亂。

一位官員說,之所以拒絕加購疫苗是因?yàn)閷ζ溆行圆淮_定。但戈特利布表示,試驗(yàn)數(shù)據(jù)公布后還是被拒絕。

但在之后的周一,白宮官員又否認(rèn)曾拒絕加購疫苗。與此同時,輝瑞首席執(zhí)行官阿爾伯特?布爾拉在CNBC上表示,最近美國政府讓公司再提供1億劑,但現(xiàn)在時限可能達(dá)不到政府要求。他說,雙方正在談判。

美國衛(wèi)生與公共服務(wù)部長阿扎對輝瑞公司供應(yīng)能力產(chǎn)生了懷疑。阿扎說,對于特朗普主導(dǎo)的,旨在促進(jìn)新冠疫苗研發(fā)、制造和分發(fā)的“曲速行動”,輝瑞公司曾表示在“生產(chǎn)過程中可能遇到各種挑戰(zhàn)。”“但我們將確保他們履行合同承諾。”他說。

輝瑞反駁稱,可以按時按量供應(yīng)。

輝瑞發(fā)言人莎倫?卡斯提羅說:“輝瑞公司的新冠疫苗生產(chǎn)沒有任何問題,疫苗運(yùn)輸也不存在擱置或推遲情況,我們正持續(xù)向美國政府指定地區(qū)發(fā)貨。”

輝瑞表示,疫苗分發(fā)出現(xiàn)延誤可能因?yàn)樘乩势照牟淮_定性。輝瑞稱已經(jīng)備好貨,只要知道發(fā)貨目的地就可以,但是美國政府不清楚何時往何地運(yùn)送。

新冠疫苗跟不上需求,美國一些州被告知可能要削減疫苗分發(fā)數(shù)量。更讓負(fù)責(zé)監(jiān)督疫苗的各州領(lǐng)導(dǎo)人沮喪的是,沒有任何相關(guān)解釋。

“情況混亂,讓人很郁悶。”華盛頓州州長杰伊?因斯利發(fā)推文稱,之前他從美國疾控中心獲悉,該州疫苗分發(fā)量將削減40%。“我們需要準(zhǔn)確可預(yù)測的數(shù)字,才能計劃并確保疫情防控成功。”

加州、康涅狄格州、佐治亞州、夏威夷州、伊利諾伊州、堪薩斯州、蒙大拿州、密歇根州、內(nèi)布拉斯加州、內(nèi)華達(dá)州、新罕布什爾州和印第安納州接收的疫苗量也遭到大幅削減。

“沒給一句解釋就削減各州疫苗分發(fā),讓人混亂又迷惑。”內(nèi)華達(dá)州州長斯蒂夫?西索拉克稱。

特朗普政府和輝瑞公司都被指責(zé)利用媒體為自己辯護(hù),而且他們在指責(zé)除了自己之外的所有人。

約四分之一美國民眾仍對接種疫苗猶豫不決。55%猶豫的受訪者表示對政府缺乏信任,51%的受訪者表示擔(dān)心政治在疫苗研發(fā)中施加影響。

特朗普政府和輝瑞關(guān)系如此混亂反復(fù),顯然無法緩解人們對接種疫苗的猶豫情緒。要想實(shí)現(xiàn)對新冠病毒群體免疫,需要有50%到80%的人群接種疫苗。相比之下,流感只需33%到44%的人群完成接種就能實(shí)現(xiàn)。即便只是小部分人群對接種猶豫,也會影響群體免疫進(jìn)程。

矛盾的根源

在輝瑞三期試驗(yàn)之前,特朗普政府同意采購1億劑疫苗。只要美國食品藥品監(jiān)督管理局批準(zhǔn)緊急應(yīng)用,交易就能立即達(dá)成。合同價值19.5億美元,還附帶額外采購5億劑的選擇權(quán),這似乎是最初引發(fā)分歧的原因。

“我們早已跟輝瑞就額外采購進(jìn)行談判,而且談判一直在持續(xù)。曲速行動從未拒絕輝瑞提供的任何疫苗,只要有確切交貨日期和數(shù)量。”美國衛(wèi)生部一位高級官員告訴《財富》雜志。

這位官員表示,早在去年11月輝瑞三期試驗(yàn)數(shù)據(jù)公布之前,曲速行動已要求“輝瑞提供超過最初1億劑疫苗交付的時間表,以便達(dá)成最新協(xié)議”。他解釋稱,問題是輝瑞公司無法確定交付日期,也沒給出額外劑量交付的合理時間范圍。

2020年夏天,輝瑞宣布年底前可準(zhǔn)備好1億劑,但到了11月,由于供應(yīng)鏈出現(xiàn)問題,供應(yīng)量減少到可供2500萬美國人接種的5000萬劑,這讓特朗普政府越發(fā)不滿。

“不管什么時候,只要我們發(fā)現(xiàn)受到不公平對待,就會采取一切手段解決問題。”一位特朗普政府官員說。

這位官員指的是,輝瑞要求美國按照《國防生產(chǎn)法》為其提供額外的設(shè)備以制造更多疫苗。

12月初,布爾拉在CNBC談及《國防生產(chǎn)法》時說:“我認(rèn)為這將發(fā)揮非常積極的作用,能讓我們最大限度地提高疫苗產(chǎn)量。我們現(xiàn)在正在積極要求……希望他們很快就能執(zhí)行,因?yàn)樵谀承┓矫妫?yīng)受到重要的限制。”

《國防生產(chǎn)法》可緊急賦予總統(tǒng)權(quán)力,出于國防目的“分配材料、服務(wù)和設(shè)施”,將有助于增加疫苗原料供應(yīng),原料通常價格昂貴且容易出現(xiàn)供應(yīng)短缺。

然而,雙方的分歧在于《國防生產(chǎn)法》附帶的條件,以及政府對疫苗劑量和對輝瑞行動的進(jìn)一步控制。

法律學(xué)者表示,控制措施可能意味著政府將要求輝瑞優(yōu)先考慮供應(yīng)美國,或許還可能導(dǎo)致輝瑞違反全球供應(yīng)合同。

12月23日,BioNTech在官網(wǎng)上表示,輝瑞和BioNTech同意從美國的生產(chǎn)基地向美國增供1億劑新冠疫苗,總計疫苗供應(yīng)量達(dá)到2億劑,預(yù)期交付量增加了一倍。兩家公司預(yù)計在7月31日之前完成交付。

法律游戲

去年11月11日,輝瑞與歐盟簽訂了供應(yīng)2億劑新冠疫苗的協(xié)議,預(yù)計將于2021年二季度交付。

12月16日有消息稱,2021年年底前輝瑞將向中國供應(yīng)1億劑。

如果輝瑞同意遵守《國防生產(chǎn)法》而公司總部又在美國,只要疫苗在美國國內(nèi)生產(chǎn),政府就可能要求公司優(yōu)先考慮本國而不是與外國交易。但政府無法控制輝瑞在海外的生產(chǎn)線,還可能因?yàn)槠仁馆x瑞放棄與外國政府的交易而陷入外交困境。

國際制藥合同方面的專家表示,在某些情況下,例如美國要求獲得優(yōu)先供應(yīng),公司可以推遲或終止合同而不會產(chǎn)生重大影響,這是典型的交易模式。雖然合同尚未公開,但美國政府和輝瑞很可能正在共同尋找并討論法律范圍內(nèi)允許的做法。

美國還與歐洲和全球各國簽訂了多份雙邊投資條約,通常為投資者在另一國市場上提供保護(hù)。如果美國政府強(qiáng)迫私營公司違背救命的藥品合同,可能因?yàn)檫`反條款而引發(fā)一系列問題。

多年來美國一直努力跟中國達(dá)成類似協(xié)議,盡管未正式公布,但如果輝瑞違約勢必會影響談判進(jìn)程。

特朗普于去年年底簽署了一項(xiàng)行政指令,要求向其他國家提供疫苗前要優(yōu)先提供給美國,不過很大程度上來說行政指令只具有象征意義。

目前尚不清楚總統(tǒng)有沒有權(quán)力阻止輝瑞履行國際合同,而且輝瑞疫苗最后一步在比利時工廠完成,很可能總統(tǒng)并無控制權(quán)。為該指令召開的峰會迅速被政治化,輝瑞和Moderna的代表均未出席,拜登政府過渡團(tuán)隊也未派代表出席。

出個價吧

種種跡象表明,圍繞疫苗的談判更多與權(quán)力相關(guān),與價格關(guān)系不大。如果硬說有關(guān)系的話,就是特朗普政府認(rèn)為只要能控制疫苗生產(chǎn),就愿意加大投入。不過政府官員稱,早前的訂單中仍然考慮了成本因素。

“(當(dāng)初美國政府拒絕向輝瑞采購更多疫苗)最簡單的原因無非就是兩個。”達(dá)特茅斯學(xué)院經(jīng)濟(jì)學(xué)教授克里斯托弗?斯奈德說,該組織主要關(guān)注疫苗研發(fā)的財務(wù)和經(jīng)濟(jì)狀況。

“要么談判者知道該部分劑量對美國的巨大經(jīng)濟(jì)價值,只是不小心弄砸了交易;要么就是談判者沒算清楚采購如此龐大劑量能帶來的巨大經(jīng)濟(jì)利益。”

他表示,在公開談判的同時,卻可能造成疫苗配送拖延,雖然特朗普政府有可能省下的“幾百萬美元”,但并不值得。

“沒必要拿萬億美元的國家健康和福利冒險……花上10億美元是值得的。”

拜登來了

不管面臨什么阻礙,拜登政府都即將接手。新當(dāng)選總統(tǒng)喬?拜登和團(tuán)隊將負(fù)責(zé)分發(fā)特朗普政府購買和談判的大量疫苗。

剛開始還有人擔(dān)心特朗普和美國總務(wù)署可能拒絕將權(quán)力移交給拜登過渡團(tuán)隊,從而導(dǎo)致疫苗分發(fā)過程推遲,而如今相關(guān)擔(dān)心已逐漸減退。

雖然沒有特朗普政府協(xié)助,拜登團(tuán)隊看起來已在跟制藥企業(yè)高管定期會面。

“我們正與輝瑞、Moderna以及其他努力開發(fā)疫苗的企業(yè)定期對話,重點(diǎn)是確保全體美國人和全世界盡快獲得安全有效的疫苗。”拜登過渡團(tuán)隊發(fā)言人TJ ·杜克洛在接受《財富》雜志采訪時表示。

特朗普方面官方稱,過渡團(tuán)隊會陸續(xù)收到有關(guān)進(jìn)行中談判的簡報,但并未直接參與談判。

輝瑞公司發(fā)言人卡斯提羅指出:“輝瑞公司與特朗普政府和拜登過渡團(tuán)隊都在定期溝通。”

然而即使進(jìn)展順利,拜登政府也還在努力趕上進(jìn)度。

將在拜登政府擔(dān)任白宮辦公廳主任的羅恩?克萊恩,他告訴Meet the Press:“政府的高級科學(xué)顧問和制藥公司高管將舉行會議”,但“更重要的問題是制造和分發(fā)機(jī)制,以及疫苗的生產(chǎn)。這最終還是要看衛(wèi)生及公共服務(wù)部。”

“疫苗研發(fā)出來了當(dāng)然是好事,但疫苗本身無法拯救生命,被接種才能救命……這是龐大的后勤工程。”

拜登將努力降低疫苗接種的政治化因素,也是特朗普競選團(tuán)隊沒有實(shí)現(xiàn)的目標(biāo)。

總統(tǒng)長子,也是競選代理人的小唐納德?特朗普在毫無證據(jù)的情況下,指責(zé)制藥公司非要等到去年11月總統(tǒng)大選后才公布疫苗接種的臨床試驗(yàn)結(jié)果。

“他們都知道結(jié)果了,就是故意不告訴公眾。”他在推特上寫道,“大型制藥公司恨特朗普,因?yàn)樘乩势諡槊绹癖姞幦∷幤方祪r,同樣的藥在全。球其他地區(qū)明明售價極低。”

與此同時,參議院民主黨人已開始調(diào)查白宮為何沒向輝瑞公司訂購更多疫苗。

“我們擔(dān)心,如果無法保證疫苗供應(yīng),將不必要地延長新冠病毒在美國蔓延的時間,導(dǎo)致更多人死亡,經(jīng)濟(jì)也將受到更大破壞。”一群立法者在給“曲速行動”領(lǐng)導(dǎo)人的聯(lián)名信中寫道。

其他選擇

2020年夏天,特朗普政府與疫苗生產(chǎn)商簽署了六份合同,其中包括第二家獲批緊急應(yīng)用新冠疫苗的Moderna,還有剛剛招募4.5萬人參與后期疫苗試驗(yàn)的強(qiáng)生公司。

之所以多頭談判,是為了找到既有效又能當(dāng)成還價籌碼的疫苗。

“可以用經(jīng)濟(jì)方面的例子說明:‘看,我們已經(jīng)有幾家成功的制造商,有阿斯利康、輝瑞和Moderna。’談判時就能更強(qiáng)勢。”斯奈德說。他補(bǔ)充說,“如今看來,這依然是個非常糟糕的經(jīng)濟(jì)決策。”

政府已簽訂合同,接受1億劑須兩次接種的Moderna疫苗,可供5000萬美國人完成接種。疫苗發(fā)貨很迅速,在去年12月份就可分發(fā)2000萬劑。

跟輝瑞不同的是,政府在該疫苗研發(fā)和生產(chǎn)中扮演了更重要的角色。曲速行動共為Moderna提供了41億美元,還主導(dǎo)了疫苗定價。

1月5日,美國政府考慮將Moderna劑量減半,目的是為了盡快讓更多人對新冠病毒獲得免疫力。美國官員們正在就這一想法與Moderna和食品與藥品監(jiān)督管理局進(jìn)行談判。

也就是說,如果談判成功,這種原本接種量應(yīng)為兩劑才能達(dá)到95%預(yù)防效果的疫苗,之后將對部分接種者只提供一劑。

輝瑞起初就拒絕接受額外資金援助的理由,就是有人擔(dān)心政府的監(jiān)督和干預(yù)會造成影響。結(jié)果政府官員對該公司日常經(jīng)營情況了解有限,造成了互不信任的局面。

特朗普政府一位高級官員表示:“有了多款疫苗,我們堅信到2021年二季度末,所有需要疫苗的美國人都能順利接種。” (財富中文網(wǎng))

譯者:馮豐

審校:夏林

編輯:徐曉彤

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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