<ol id="1lp5z"><ol id="1lp5z"><dfn id="1lp5z"></dfn></ol></ol><i id="1lp5z"><strike id="1lp5z"></strike></i>
<meter id="1lp5z"></meter>
    <address id="1lp5z"></address>

    
    

      <form id="1lp5z"></form>

        立即打開
        新冠疫苗接種出現嚴重不良反應,誰擔責?

        新冠疫苗接種出現嚴重不良反應,誰擔責?

        David Meyer 2021年04月08日
        歷史告訴我們,索賠并不容易。

        如果某一款新冠疫苗對于部分接種人群確實有害,該怎么辦?而且這種情況極有可能出現。誰將為此負責?

        希望有關疫苗責任的問題,在這次疫情期間只停留在理論層面上。

        然而,雖然公共衛生官員表示,拒絕接種新冠疫苗的危害遠大于接種疫苗帶來的危險,但責任問題依舊很重要,不只是因為阿斯利康的疫苗在歐洲可能導致了一種罕見的血栓。(兩者之間并沒有確切的因果關系,而且公共衛生部門仍然建議使用阿斯利康的疫苗保護民眾的安全,以減少因為嚴重新冠病毒感染所導致的住院治療和死亡。周三,歐洲藥品管理局和英國藥品主管部門英國藥品和保健產品監管署重申接種阿斯利康疫苗利大于弊。)

        通常情況下,制藥商會對其產品的安全性負責,而且他們會花很多年的時間進行藥物開發和測試,以保證使用安全。

        但此次疫情期間,新冠疫苗的開發卻并非如此。

        BioNTech、Moderna、阿斯利康等公司研發的新冠疫苗,僅用了幾個月時間,沒有經過數年測試。而藥品監管機構在審批任何疫苗之前,通常會要求藥企提供大規模測試的最終結果,但這一次他們卻在測試期間發布了臨時授權。

        當然,這是由本次疫情的性質決定的:新冠疫情傳播速度快,對身體的破壞力強,因此速度是抗擊疫情的關鍵。疫苗行業的從業者不可能放棄小心謹慎的原則,但同樣也沒有人有條件像以前那樣謹慎。

        所以,三家制藥公司幾乎都被免于承擔與新冠疫苗的潛在副作用有關的任何責任。接種者如果出現問題,只能尋找其他途徑獲得賠償。

        不過,歷史告訴我們,索賠并不容易。

        “極高的門檻”

        在多數情況下,要由發布緊急授權的監管機構所屬國家承擔責任。有些國家很早就接受了這個事實,尤其是美國和英國,這兩個國家最先與藥企完成了談判,從而在全民疫苗接種方面領先了一步。

        鴻鵠律師事務所荷蘭糾紛解決業務負責人伊夫林·特瓊恩-恩華表示:“我想政府認為風險是可控的,因為這些企業以逐利為目的。如果他們認為將一款疫苗投放到市場的收益小于風險,他們不會這樣做?!?/p>

        這是因為藥企有過前車之鑒。

        特瓊恩-恩華提到了上世紀70年代和80年代與百日咳疫苗有關的不光彩的歷史。當時,有人聲稱兒童接種DPT(白喉、百日咳和破傷風)疫苗之后,偶爾會出現罕見但永久性的腦損傷。

        雖然最終證明兩者之間沒有因果關系,但負面的風評依舊引發了一系列針對疫苗廠商的訴訟,有些甚至索賠成功。大部分美國疫苗廠商的反應是收回DPT疫苗。他們從這些疫苗中僅能賺取較低的利潤。

        此事促使美國創立了國家疫苗傷害賠償計劃,對藥企的每劑疫苗征稅75美分用于資助該項目。作為交換,如果疫苗意外出現嚴重的副作用,藥企不會在州或聯邦民事法院遭到起訴。

        然而,VICP計劃僅適用于常規接種的疫苗,例如標準的兒童疫苗或普通流感疫苗等。與新冠疫苗相關的計劃是根據2005年《公眾使用意愿與緊急狀態準備法案》(《PREP法案》)創立的醫療對策傷害賠償計劃(CICP)。

        特朗普政府在2020年2月本次疫情即將爆發時啟用了該項法案。該法案授予疫苗廠商和分銷商四年法律保護,除非有證據證明存在故意不當行為。而且,理論上,因為接種新冠疫苗受到嚴重傷害的民眾可以通過CICP計劃獲取賠償。

        但事實上,CICP計劃自2010年創立以來,僅受理了551起訴訟中的39起。該計劃還負責處理與埃博拉病毒和炭疽病毒等醫療事件的應對措施有關的責任。

        在39起訴訟中只有29起獲得賠償,賠償總額為600萬美元。

        特瓊恩-恩華表示:“《PREP法案》非常嚴格?!痹嬉袚e證責任,必須證明疫苗廠商有故意不當行為。索賠門檻非常高。所以CICP計劃支付的賠償金額少之又少。我認為該計劃的索賠門檻過高;你需要證明對方的心理狀態?!?/p>

        如果出現嚴重不良反應

        百日咳疫苗恐慌可能是一次小題大做,但接種疫苗后出現不良后果的案例數量也不算少,索賠也不是那么容易。

        2009年,也就是新冠肺炎疫情出現的10年前,另一場大流行病——H1N1流感病毒,也叫“豬流感”,死灰復燃并蔓延全球。

        葛蘭素史克公司在一款現有的H5N1禽流感疫苗基礎上進行研發,迅速推出了豬流感疫苗。該疫苗被英國和其它歐洲國家廣泛應用,用于給醫護人員、兒童以及哮喘患者等高危人群接種,但美國并未批準這款疫苗上市。

        “到2010年2月,多人被診斷為嗜睡癥,這引起了醫生的注意,”英國律師事務所Scott Moncrieff顧問彼得·托德說?!爱敃r疫苗接種才開始幾個月,他們開始懷疑,這些嗜睡癥病例與豬流感疫苗接種,可能存在潛在關聯?!?/p>

        嗜睡癥是一種罕見且不為人所知的自身免疫性疾病。病人會感到虛弱困倦,白天頻繁嗜睡。目前還無法治愈。

        當時英國有88名嗜睡癥患者委托托德索賠。據他估計,在歐洲超過3000萬人Pandemrix疫苗接種者中,約有2000人之后患上了嗜睡癥。(直到2019年,葛蘭素史克公司仍不承認,這兩者之間存在任何因果關系。)

        之后,葛蘭素史克公司得到了潛在產品責任索賠賠償,因為為了盡快推出Pandemrix疫苗,公司當時放棄了部分安全性測試,而這在新冠疫情期間同樣很可能發生。

        同時,英國政府拒絕根據《疫苗損害賠償法案》進行賠付,理由是嗜睡癥不夠“嚴重”,不值得賠償。

        托德表示,他無法證實,針對葛蘭素史克公司和政府的索賠是如何解決的。不過,在2017年的一起疫苗案中,一名男孩在接種疫苗后患上了嗜睡癥,英國政府敗訴。去年的信息顯示,政府在六起案件中賠付了共計72萬英鎊。

        “與2009年的豬流感相比,新冠肺炎疫情更危險,但兩者對疫苗的需求同樣迫切……所有疫苗生產商都得到了豁免權,”托德說。

        在英國,理論上來說,如果疫苗被證明是“有缺陷的”,即不像人們合理預期的那樣安全,生產商的豁免權就會被剝奪。

        但是,托德說,“很難證明消費者對安全的合理預期”,因為大多數人都知道,為了抵抗這種極其危險的流行病,在大規模的長期測試未完成之前,新冠疫苗就已經被匆忙推出。

        這樣一來,就只剩下了國家疫苗損害補償計劃,向那些嚴重致殘人士支付12萬英鎊的固定金額。這筆錢不算多,而且受害者的訴訟費用也只能自行承擔。

        “Pandemrix疫苗的教訓沒能讓我們做出改變,”托德說。

        “政府應該意識到,總會有新的流行病出現,總會需要迅速研發疫苗,這總是會威脅到臨床安全。因此,我們需要的不是一個將風險和損失堆積在不幸個體身上的制度,而是一個,作為一個社會,我們可以共同承擔不幸的制度?!?/p>

        聯合在一起

        當然,如果新冠疫苗出現問題,并非每個社會都有能力補償受害者,生產商也靠不住。除非得到賠償,否則生產商不會主動擔責。

        因此,今年2月,世界上第一個也是唯一一個全球疫苗傷害賠償基金成立了。該基金是為92個中低收入國家設立的,受益于世界衛生組織牽頭的新冠疫苗全球獲得機制(Covax),這些國家獲得了新冠疫苗。

        該基金由安達保險子公司ESIS管理,資金來源是每劑疫苗10美分的稅收。在2022年年中之前,如果出現“嚴重不良反應事件”,該基金會提供無過失一次性賠償基金。

        但制造商獲得賠償的情況,真的不可避免嗎?

        歐洲的對策

        歐盟一直在強調,它沒有像其它國家那樣,批準新冠疫苗的緊急使用授權。意識到這實際上是在批準一種未經授權的疫苗的臨時使用,它轉而授予了拜恩泰科/輝瑞、莫德納、阿斯利康制藥和強生公司為期一年的“有條件上市批準”。

        歐盟委員會聲稱,這提供了“緊急使用授權可能無法提供的保障”。

        委員會去年12月表示,最關鍵的是,獲得有條件上市批準的公司不能逃避責任。

        “上市批準公司需對產品質量及其安全問題負責,”委員會表示,并補充說,如果采取的是緊急使用授權,公司將不必承擔這些責任。

        不過,現實情況似乎與理論有些不同。

        歐盟委員會公布了一份與阿斯利康簽訂的預購協議的修訂版本。該文件稱,每個歐盟國家都應賠償阿斯利康因死亡、傷害和疾病而造成的“任何及所有損失和責任”。

        合同接著描述了公司將無法得到賠償的情況,但這一部分已經經過修訂。與幾乎所有涉及疫苗接種的合同一樣,關鍵細節不可供公眾審查。

        委員會強調,這份合同保護了患者的權利?!盎颊呱显V法庭時,無需在意這份預購協議,” 一位發言人表示?!叭绻拘枰獡?,它就必須對公民做出賠償?!?/p>

        然而,歐盟的謹慎做法可能不會維持太久。相比起英國、美國和其它一些發達經濟體,歐盟新冠疫苗的上市審核和推廣進度相對落后,歐盟委員會和歐洲藥品管理局因此受到了抨擊。

        因此,在3月初,歐盟委員會做出了讓步,考慮改為緊急使用授權,由“成員國共同分擔責任”,目前還未有進一步的消息出現。財富中文網)

        翻譯:劉進龍、Claire

        審校:汪皓

        如果某一款新冠疫苗對于部分接種人群確實有害,該怎么辦?而且這種情況極有可能出現。誰將為此負責?

        希望有關疫苗責任的問題,在這次疫情期間只停留在理論層面上。

        然而,雖然公共衛生官員表示,拒絕接種新冠疫苗的危害遠大于接種疫苗帶來的危險,但責任問題依舊很重要,不只是因為阿斯利康的疫苗在歐洲可能導致了一種罕見的血栓。(兩者之間并沒有確切的因果關系,而且公共衛生部門仍然建議使用阿斯利康的疫苗保護民眾的安全,以減少因為嚴重新冠病毒感染所導致的住院治療和死亡。周三,歐洲藥品管理局和英國藥品主管部門英國藥品和保健產品監管署重申接種阿斯利康疫苗利大于弊。)

        通常情況下,制藥商會對其產品的安全性負責,而且他們會花很多年的時間進行藥物開發和測試,以保證使用安全。

        但此次疫情期間,新冠疫苗的開發卻并非如此。

        BioNTech、Moderna、阿斯利康等公司研發的新冠疫苗,僅用了幾個月時間,沒有經過數年測試。而藥品監管機構在審批任何疫苗之前,通常會要求藥企提供大規模測試的最終結果,但這一次他們卻在測試期間發布了臨時授權。

        當然,這是由本次疫情的性質決定的:新冠疫情傳播速度快,對身體的破壞力強,因此速度是抗擊疫情的關鍵。疫苗行業的從業者不可能放棄小心謹慎的原則,但同樣也沒有人有條件像以前那樣謹慎。

        所以,三家制藥公司幾乎都被免于承擔與新冠疫苗的潛在副作用有關的任何責任。接種者如果出現問題,只能尋找其他途徑獲得賠償。

        不過,歷史告訴我們,索賠并不容易。

        “極高的門檻”

        在多數情況下,要由發布緊急授權的監管機構所屬國家承擔責任。有些國家很早就接受了這個事實,尤其是美國和英國,這兩個國家最先與藥企完成了談判,從而在全民疫苗接種方面領先了一步。

        鴻鵠律師事務所荷蘭糾紛解決業務負責人伊夫林·特瓊恩-恩華表示:“我想政府認為風險是可控的,因為這些企業以逐利為目的。如果他們認為將一款疫苗投放到市場的收益小于風險,他們不會這樣做?!?/p>

        這是因為藥企有過前車之鑒。

        特瓊恩-恩華提到了上世紀70年代和80年代與百日咳疫苗有關的不光彩的歷史。當時,有人聲稱兒童接種DPT(白喉、百日咳和破傷風)疫苗之后,偶爾會出現罕見但永久性的腦損傷。

        雖然最終證明兩者之間沒有因果關系,但負面的風評依舊引發了一系列針對疫苗廠商的訴訟,有些甚至索賠成功。大部分美國疫苗廠商的反應是收回DPT疫苗。他們從這些疫苗中僅能賺取較低的利潤。

        此事促使美國創立了國家疫苗傷害賠償計劃,對藥企的每劑疫苗征稅75美分用于資助該項目。作為交換,如果疫苗意外出現嚴重的副作用,藥企不會在州或聯邦民事法院遭到起訴。

        然而,VICP計劃僅適用于常規接種的疫苗,例如標準的兒童疫苗或普通流感疫苗等。與新冠疫苗相關的計劃是根據2005年《公眾使用意愿與緊急狀態準備法案》(《PREP法案》)創立的醫療對策傷害賠償計劃(CICP)。

        特朗普政府在2020年2月本次疫情即將爆發時啟用了該項法案。該法案授予疫苗廠商和分銷商四年法律保護,除非有證據證明存在故意不當行為。而且,理論上,因為接種新冠疫苗受到嚴重傷害的民眾可以通過CICP計劃獲取賠償。

        但事實上,CICP計劃自2010年創立以來,僅受理了551起訴訟中的39起。該計劃還負責處理與埃博拉病毒和炭疽病毒等醫療事件的應對措施有關的責任。

        在39起訴訟中只有29起獲得賠償,賠償總額為600萬美元。

        特瓊恩-恩華表示:“《PREP法案》非常嚴格?!痹嬉袚e證責任,必須證明疫苗廠商有故意不當行為。索賠門檻非常高。所以CICP計劃支付的賠償金額少之又少。我認為該計劃的索賠門檻過高;你需要證明對方的心理狀態?!?/p>

        如果出現嚴重不良反應

        百日咳疫苗恐慌可能是一次小題大做,但接種疫苗后出現不良后果的案例數量也不算少,索賠也不是那么容易。

        2009年,也就是新冠肺炎疫情出現的10年前,另一場大流行病——H1N1流感病毒,也叫“豬流感”,死灰復燃并蔓延全球。

        葛蘭素史克公司在一款現有的H5N1禽流感疫苗基礎上進行研發,迅速推出了豬流感疫苗。該疫苗被英國和其它歐洲國家廣泛應用,用于給醫護人員、兒童以及哮喘患者等高危人群接種,但美國并未批準這款疫苗上市。

        “到2010年2月,多人被診斷為嗜睡癥,這引起了醫生的注意,”英國律師事務所Scott Moncrieff顧問彼得·托德說?!爱敃r疫苗接種才開始幾個月,他們開始懷疑,這些嗜睡癥病例與豬流感疫苗接種,可能存在潛在關聯?!?/p>

        嗜睡癥是一種罕見且不為人所知的自身免疫性疾病。病人會感到虛弱困倦,白天頻繁嗜睡。目前還無法治愈。

        當時英國有88名嗜睡癥患者委托托德索賠。據他估計,在歐洲超過3000萬人Pandemrix疫苗接種者中,約有2000人之后患上了嗜睡癥。(直到2019年,葛蘭素史克公司仍不承認,這兩者之間存在任何因果關系。)

        之后,葛蘭素史克公司得到了潛在產品責任索賠賠償,因為為了盡快推出Pandemrix疫苗,公司當時放棄了部分安全性測試,而這在新冠疫情期間同樣很可能發生。

        同時,英國政府拒絕根據《疫苗損害賠償法案》進行賠付,理由是嗜睡癥不夠“嚴重”,不值得賠償。

        托德表示,他無法證實,針對葛蘭素史克公司和政府的索賠是如何解決的。不過,在2017年的一起疫苗案中,一名男孩在接種疫苗后患上了嗜睡癥,英國政府敗訴。去年的信息顯示,政府在六起案件中賠付了共計72萬英鎊。

        “與2009年的豬流感相比,新冠肺炎疫情更危險,但兩者對疫苗的需求同樣迫切……所有疫苗生產商都得到了豁免權,”托德說。

        在英國,理論上來說,如果疫苗被證明是“有缺陷的”,即不像人們合理預期的那樣安全,生產商的豁免權就會被剝奪。

        但是,托德說,“很難證明消費者對安全的合理預期”,因為大多數人都知道,為了抵抗這種極其危險的流行病,在大規模的長期測試未完成之前,新冠疫苗就已經被匆忙推出。

        這樣一來,就只剩下了國家疫苗損害補償計劃,向那些嚴重致殘人士支付12萬英鎊的固定金額。這筆錢不算多,而且受害者的訴訟費用也只能自行承擔。

        “Pandemrix疫苗的教訓沒能讓我們做出改變,”托德說。

        “政府應該意識到,總會有新的流行病出現,總會需要迅速研發疫苗,這總是會威脅到臨床安全。因此,我們需要的不是一個將風險和損失堆積在不幸個體身上的制度,而是一個,作為一個社會,我們可以共同承擔不幸的制度?!?/p>

        聯合在一起

        當然,如果新冠疫苗出現問題,并非每個社會都有能力補償受害者,生產商也靠不住。除非得到賠償,否則生產商不會主動擔責。

        因此,今年2月,世界上第一個也是唯一一個全球疫苗傷害賠償基金成立了。該基金是為92個中低收入國家設立的,受益于世界衛生組織牽頭的新冠疫苗全球獲得機制(Covax),這些國家獲得了新冠疫苗。

        該基金由安達保險子公司ESIS管理,資金來源是每劑疫苗10美分的稅收。在2022年年中之前,如果出現“嚴重不良反應事件”,該基金會提供無過失一次性賠償基金。

        但制造商獲得賠償的情況,真的不可避免嗎?

        歐洲的對策

        歐盟一直在強調,它沒有像其它國家那樣,批準新冠疫苗的緊急使用授權。意識到這實際上是在批準一種未經授權的疫苗的臨時使用,它轉而授予了拜恩泰科/輝瑞、莫德納、阿斯利康制藥和強生公司為期一年的“有條件上市批準”。

        歐盟委員會聲稱,這提供了“緊急使用授權可能無法提供的保障”。

        委員會去年12月表示,最關鍵的是,獲得有條件上市批準的公司不能逃避責任。

        “上市批準公司需對產品質量及其安全問題負責,”委員會表示,并補充說,如果采取的是緊急使用授權,公司將不必承擔這些責任。

        不過,現實情況似乎與理論有些不同。

        歐盟委員會公布了一份與阿斯利康簽訂的預購協議的修訂版本。該文件稱,每個歐盟國家都應賠償阿斯利康因死亡、傷害和疾病而造成的“任何及所有損失和責任”。

        合同接著描述了公司將無法得到賠償的情況,但這一部分已經經過修訂。與幾乎所有涉及疫苗接種的合同一樣,關鍵細節不可供公眾審查。

        委員會強調,這份合同保護了患者的權利?!盎颊呱显V法庭時,無需在意這份預購協議,” 一位發言人表示?!叭绻拘枰獡?,它就必須對公民做出賠償?!?/p>

        然而,歐盟的謹慎做法可能不會維持太久。相比起英國、美國和其它一些發達經濟體,歐盟新冠疫苗的上市審核和推廣進度相對落后,歐盟委員會和歐洲藥品管理局因此受到了抨擊。

        因此,在3月初,歐盟委員會做出了讓步,考慮改為緊急使用授權,由“成員國共同分擔責任”,目前還未有進一步的消息出現。財富中文網)

        翻譯:劉進龍、Claire

        審校: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.

        最新:
        • 熱讀文章
        • 熱門視頻
        活動
        掃碼打開財富Plus App
        亚洲AV最新在线网址18禁,夜夜天天噜狠狠爱2019,国产超碰无码最新上传,老司机久久精品最新免费
        <ol id="1lp5z"><ol id="1lp5z"><dfn id="1lp5z"></dfn></ol></ol><i id="1lp5z"><strike id="1lp5z"></strike></i>
        <meter id="1lp5z"></meter>
          <address id="1lp5z"></address>

          
          

            <form id="1lp5z"></form>