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輝瑞疫苗的意外之喜何以變成了一場(chǎng)大混亂?

David Z. Morris
2021-02-23

造成這種局面的主要原因是專用注射器的產(chǎn)能不足。

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輝瑞(Pfizer)/BioNTech的首批新冠疫苗在去年12月到貨之后,醫(yī)護(hù)人員和疫苗接種機(jī)構(gòu)很快就發(fā)現(xiàn)了一個(gè)寶貴的機(jī)會(huì)。雖然藥瓶上標(biāo)示每瓶能夠抽取5劑疫苗,但有經(jīng)驗(yàn)的醫(yī)護(hù)人員發(fā)現(xiàn),他們有時(shí)候可以從瓶中抽取6劑疫苗,相當(dāng)于將疫苗供應(yīng)量提高了20%。

但輝瑞的額外劑量有一個(gè)缺點(diǎn)。為了保證始終能夠抽取6劑疫苗,理想情況下,醫(yī)護(hù)人員應(yīng)該使用一種名為低死腔注射器的專用設(shè)備,簡(jiǎn)稱LDS注射器。標(biāo)準(zhǔn)注射器在注射后會(huì)殘留少量藥液,LDS注射器幾乎可以將所有藥液注射到患者的胳膊中。這種能夠減少浪費(fèi)的注射器,足以將每瓶的劑量從5劑變成6劑。

但問(wèn)題在于,LDS注射器是一種小眾產(chǎn)品,無(wú)論在美國(guó)還是全世界的供應(yīng)量,均不足以在未來(lái)幾周和幾個(gè)月內(nèi)完成所有額外劑量的施打。大部分注射器生產(chǎn)商表示無(wú)法擴(kuò)大產(chǎn)能。

拜登政府表示,已經(jīng)簽訂了足夠的注射器供應(yīng)合同,足以施打所有輝瑞疫苗劑量。這是可能做到的,因?yàn)槌薒DS注射器以外,還會(huì)有其他注射器供應(yīng)作為補(bǔ)充,白宮和輝瑞均表示這些注射器是可行的替代選擇。

但疫苗管理負(fù)責(zé)人和專家認(rèn)為,這些替代注射器無(wú)法保證始終可以抽取6劑疫苗。公共衛(wèi)生負(fù)責(zé)人表示,這會(huì)給美國(guó)穩(wěn)定的疫苗供應(yīng)帶來(lái)風(fēng)險(xiǎn)。雖然神奇的第6劑疫苗似乎面臨著威脅,但美國(guó)仍然將為此向輝瑞付費(fèi),無(wú)論這一劑疫苗是否能夠成功地注射到接種者體內(nèi)。

拯救生命的意外驚喜

對(duì)于最靈活的疫苗管理人員而言,輝瑞疫苗的額外劑量是意外之喜。

西弗吉尼亞新冠疫情工作組成員、藥劑師克里斯塔?凱普哈特說(shuō):“我們很快就收到了美國(guó)疾病與預(yù)防控制中心(CDC)發(fā)來(lái)的信息,告知我們可以使用第6劑疫苗。大部分藥劑師都收到了這條信息,他們已經(jīng)在這樣做了。”

凱普哈特是西弗吉尼亞疫苗發(fā)放工作的主要負(fù)責(zé)人,該州因?yàn)橐呙缃臃N工作開(kāi)展順利而備受好評(píng)。目前,西弗吉尼亞州的第一劑疫苗接種率為14%,居全國(guó)之首。凱普哈特表示,提早認(rèn)識(shí)到額外劑量的疫苗,對(duì)于該州疫苗接種工作的成功產(chǎn)生了影響。

新冠疫苗在美國(guó)各州的接種率(數(shù)據(jù)截至2021年2月16日)。圖片來(lái)源:美國(guó)疾病與預(yù)防控制中心

輝瑞疫苗的第6劑額外劑量仍然在繼續(xù)幫助美國(guó)和全世界加快疫苗接種。今年1月末,輝瑞宣布該額外劑量使其能夠在5月底之前,提前兩個(gè)月向美國(guó)交付2億劑疫苗。白宮官員表示,拜登政府宣布近幾周美國(guó)每周疫苗供應(yīng)量增加超過(guò)20%,其中三分之一要?dú)w功于輝瑞的額外劑量。

供應(yīng)量增加最終可以拯救數(shù)以萬(wàn)計(jì)美國(guó)人的生命,尤其是英國(guó)新出現(xiàn)的傳染性更強(qiáng)的新冠變種病毒已經(jīng)在美國(guó)傳播開(kāi)來(lái),而現(xiàn)有疫苗對(duì)這種變種病毒同樣有很好的效果。

但低死腔注射器的供應(yīng)不足卻給這種良好的勢(shì)頭蒙上了陰影。在正常時(shí)期,使用LDS注射器的主要目的是充分利用昂貴的癌癥藥物,或者用于針頭交換項(xiàng)目,以減少使用靜脈注射藥物的患者之間傳播疾病。由于LDS注射器的規(guī)模較小,因此生產(chǎn)商無(wú)法擴(kuò)大規(guī)模,以滿足疫苗接種帶來(lái)的大幅增加的需求。美國(guó)政府向美國(guó)注射器生產(chǎn)商BD公司采購(gòu)了4,000萬(wàn)個(gè)LDS注射器,但BD公司已經(jīng)表示其無(wú)法繼續(xù)擴(kuò)大產(chǎn)能。一位白宮官員告訴《財(cái)富》雜志,聯(lián)邦LDS注射器供應(yīng)很大一部分來(lái)自Retractable Technologies公司(Retractable Technologies Inc.),但其并未披露具體采購(gòu)數(shù)量。

中國(guó)也有LDS注射器生產(chǎn)商,但《環(huán)球時(shí)報(bào)》最近的報(bào)道稱,這些廠商已經(jīng)在滿負(fù)荷生產(chǎn)。中國(guó)供應(yīng)商上??档氯R企業(yè)發(fā)展集團(tuán)表示,新注射器訂單已經(jīng)排到今年8月才能夠交貨。

為了幫助增加注射器供應(yīng),白宮新冠疫苗團(tuán)隊(duì)在2月1日宣布,輝瑞疫苗套裝中配備的注射器80%為首選的LDS注射器,20%為同樣可以抽取6劑疫苗的替代注射器。由輝瑞和聯(lián)邦政府共同確定的注射器和針頭組合共有35種,都屬于可行替代注射器。

但基層疫苗接種人員看到的現(xiàn)實(shí)情況已經(jīng)令人擔(dān)憂。凱普哈特表示,最近收到的疫苗中配備了“五花八門(mén)的注射器……尤其是輝瑞疫苗,我們確實(shí)缺少”能夠有效抽取全部6劑疫苗的注射器。雖然拜登政府作出了保證,但包括新澤西州在內(nèi)美國(guó)各州的疫苗管理人員均報(bào)告輝瑞疫苗套裝中缺少適當(dāng)?shù)尼橆^。

因此,凱普哈特表示在西弗吉尼亞州,“我們并沒(méi)有像最初一樣看到這些額外劑量的疫苗。”

6劑疫苗挑戰(zhàn)

尤其是在1月6日,輝瑞疫苗的額外劑量從恩賜變成了一個(gè)更復(fù)雜的問(wèn)題,令人擔(dān)憂。美國(guó)食品與藥品管理局(FDA)修改了對(duì)輝瑞疫苗的緊急使用授權(quán),正式宣布每瓶的容量為6劑疫苗。這意味著只要配備了適當(dāng)?shù)淖⑸淦?,輝瑞就能夠收取第6劑疫苗的費(fèi)用,將額外劑量從紅利變成了期望。

但即使LDS注射器供應(yīng)充足,依舊有專家認(rèn)為,對(duì)第6劑疫苗的期望可能沒(méi)有反映更為復(fù)雜的現(xiàn)實(shí)。他們表示,關(guān)鍵在于,被認(rèn)為是“驚喜”的第6劑疫苗實(shí)際上并不是驚喜:所有疫苗都會(huì)有一定程度的過(guò)量灌裝,并且這樣做有充分的理由。

約翰斯?霍普金斯大學(xué)(Johns Hopkins)的醫(yī)療保健運(yùn)營(yíng)教授戴廷龍表示:“工程設(shè)計(jì)最重要的原則之一是有某種冗余。總是會(huì)存在某種形式的浪費(fèi)?!?/p>

冗余非常重要,因?yàn)樗枰臄?shù)量很少。輝瑞每瓶疫苗制備完成之后,其中包含的藥液只有2.25毫升。將每瓶疫苗從5劑變成6劑意味著疫苗接種人員在抽取每劑0.3毫升疫苗時(shí)需要降低誤差,每劑疫苗在注射器中的數(shù)量相當(dāng)于一名成年人小指指甲的長(zhǎng)度。

戴廷龍說(shuō):“[疫苗接種人員]告訴我,他們?cè)诖蟛糠智闆r下可以抽取第6劑疫苗,但……即使有低死腔注射器的情況下也無(wú)法保證。這需要培訓(xùn)?!?/p>

如今,輝瑞與美國(guó)政府的合同中將第6劑疫苗計(jì)算在內(nèi),因此疫苗接種人員抽取第6劑疫苗面臨的壓力更大。輝瑞在合同中承諾供應(yīng)2億劑疫苗,但并未具體說(shuō)明瓶數(shù),而且輝瑞在1月宣布,考慮到額外劑量,將減少向美國(guó)供應(yīng)的疫苗瓶數(shù),但能夠加快疫苗的供應(yīng)速度。

類似的調(diào)整在歐盟引發(fā)了爭(zhēng)議。在歐盟,輝瑞沒(méi)有提供抽取第6劑疫苗所需要的針頭,卻向客戶收取了第6劑疫苗的費(fèi)用,因此遭到指責(zé)。德國(guó)、法國(guó)、意大利等國(guó)的衛(wèi)生官員警告稱,修改疫苗標(biāo)簽會(huì)降低疫苗接種率。

如果搭配輝瑞疫苗提供五花八門(mén)的LDS注射器和“同等”注射器,同時(shí)卻假定每瓶疫苗都可以抽取6劑疫苗,拜登政府可能會(huì)在美國(guó)造成相同的局面。

錯(cuò)失良機(jī)

美國(guó)之所以缺少理想的注射器,似乎是因?yàn)樵缭?020年年初,聯(lián)邦政府、輝瑞和注射器生產(chǎn)生之間缺乏協(xié)調(diào)。而特種LDS注射器并非是引發(fā)擔(dān)憂的唯一原因。

雖然額外劑量被基層疫苗接種人員視為意外之喜,但有媒體報(bào)道,輝瑞早在2020年8月就已經(jīng)在測(cè)試抽取額外劑量的方法。但輝瑞直到12月才開(kāi)始和美國(guó)食品與藥品管理局討論第6劑疫苗的問(wèn)題。《華盛頓郵報(bào)》(Washington Post)采訪的專家表示,如果各方之間加強(qiáng)溝通,雖然不見(jiàn)得能夠消除當(dāng)前的瓶頸,但或許可以為提高LDS注射器產(chǎn)量贏得更多時(shí)間。

注射器供應(yīng)普遍存在問(wèn)題,部分原因可能在于特朗普政府的不作為。美國(guó)衛(wèi)生及公共服務(wù)部(HHS)的生物醫(yī)學(xué)高級(jí)研究與發(fā)展管理局(Biomedical Advanced Research and Development Authority)前局長(zhǎng)里克?布萊特在一封舉報(bào)信中聲稱,他早在2020年3月就曾經(jīng)多次警告各類注射器可能存在供應(yīng)不足的問(wèn)題。布萊特在投訴書(shū)中指控稱,包括時(shí)任衛(wèi)生及公共服務(wù)部部長(zhǎng)亞歷克斯?阿扎在內(nèi)的政府領(lǐng)導(dǎo)層對(duì)他的警告都嗤之以鼻,而且他還被強(qiáng)行降職,他表示這是對(duì)他堅(jiān)持舉報(bào)注射器供應(yīng)不足及相關(guān)問(wèn)題的打擊報(bào)復(fù)。布萊特不久后選擇了辭職。

有跡象表明,供應(yīng)問(wèn)題的影響不止局限于輝瑞疫苗。1月29日,凱普哈特表示,發(fā)往西弗吉尼亞州的Moderna公司的疫苗包裝中包括1.5英寸23號(hào)針頭,這種針頭的型號(hào)大于標(biāo)準(zhǔn)疫苗針頭。

凱普哈特說(shuō):“使用23號(hào)針頭就像在胳膊上扎一枚釘子?!?/p>

但比不舒服的感受更糟糕的是,這種針頭無(wú)法從Moderna的疫苗藥瓶中抽取全部10劑疫苗。凱普哈特表示,疫苗接種人員使用這種針頭只能夠抽取8劑,因此她不得不替換成本州儲(chǔ)備的針頭。

即將來(lái)臨的混亂

約翰斯?霍普金斯衛(wèi)生安全中心(Johns Hopkins Center for Health Security)的資深學(xué)者阿梅什?阿達(dá)利亞表示,如果可以保證抽取全部6劑輝瑞疫苗的注射器短缺,“你會(huì)看到取消疫苗接種預(yù)約的情況。然后他們必須下調(diào)劑量數(shù)據(jù),從而調(diào)整時(shí)間安排。這只會(huì)放慢疫苗接種的速度,使形勢(shì)變得更加復(fù)雜?!?/p>

拜登政府在1月21日發(fā)布的疫情響應(yīng)策略文件中表示,計(jì)劃動(dòng)用《國(guó)防生產(chǎn)法案》(Defense Production Act),以增加低死腔注射器和其他必要設(shè)備的供應(yīng)。但該法案能否實(shí)現(xiàn)這個(gè)目標(biāo)目前仍然是個(gè)未知數(shù)。這項(xiàng)法律僅適用于美國(guó)國(guó)內(nèi)生產(chǎn)商,而美國(guó)唯一一家生產(chǎn)LDS注射器的廠商BD已經(jīng)表示其沒(méi)有能力增加產(chǎn)量。

根據(jù)《國(guó)防生產(chǎn)法案》的規(guī)定,生產(chǎn)相關(guān)產(chǎn)品的制造商在有能力的情況下必須更換設(shè)備生產(chǎn)應(yīng)急物資,例如唐納德?特朗普在去年秋天曾經(jīng)命令通用汽車(chē)(GM)生產(chǎn)呼吸機(jī)。但美國(guó)在發(fā)展了數(shù)十年離岸外包業(yè)務(wù)之后,想找到能夠生產(chǎn)精密醫(yī)療器械的美國(guó)工廠并不容易。距離戰(zhàn)略文件發(fā)布已經(jīng)過(guò)去近一個(gè)月時(shí)間,但拜登政府并沒(méi)有啟用《國(guó)防生產(chǎn)法案》增加注射器產(chǎn)量。

與此同時(shí),新建工廠或增加投資以提高LDS注射器產(chǎn)量缺乏市場(chǎng)刺激。雖然未來(lái)幾個(gè)月將出現(xiàn)大量需求,但我們沒(méi)有理由認(rèn)為這種需求會(huì)持續(xù)下去。拜登政府的官員表示,美國(guó)將在4月開(kāi)始大范圍接種疫苗,這在一定程度上得益于更多疫苗料將獲得批準(zhǔn),例如強(qiáng)生公司(Johnson & Johnson)的疫苗。這意味著抽取第6劑輝瑞疫苗的壓力將減少,并且對(duì)LDS注射器的需求也會(huì)快速下降。

輝瑞表示,正在“幫助各國(guó)保證必要的設(shè)備供應(yīng)”,以確??梢猿槿∪?劑疫苗。但輝瑞并未說(shuō)明其是否將直接參與增加注射器供應(yīng),盡管它在所有利益相關(guān)者擁有最強(qiáng)烈的動(dòng)機(jī)。

戴廷龍說(shuō):“一個(gè)LDS注射器的成本可能只有10美分。但如果你能夠額外抽取一劑疫苗,[輝瑞]就可以向政府收取20美元。這可能是我在醫(yī)療行業(yè)聽(tīng)說(shuō)過(guò)的最高的投資回報(bào)。”(財(cái)富中文網(wǎng))

翻譯:劉進(jìn)龍

審校:汪皓

輝瑞(Pfizer)/BioNTech的首批新冠疫苗在去年12月到貨之后,醫(yī)護(hù)人員和疫苗接種機(jī)構(gòu)很快就發(fā)現(xiàn)了一個(gè)寶貴的機(jī)會(huì)。雖然藥瓶上標(biāo)示每瓶能夠抽取5劑疫苗,但有經(jīng)驗(yàn)的醫(yī)護(hù)人員發(fā)現(xiàn),他們有時(shí)候可以從瓶中抽取6劑疫苗,相當(dāng)于將疫苗供應(yīng)量提高了20%。

但輝瑞的額外劑量有一個(gè)缺點(diǎn)。為了保證始終能夠抽取6劑疫苗,理想情況下,醫(yī)護(hù)人員應(yīng)該使用一種名為低死腔注射器的專用設(shè)備,簡(jiǎn)稱LDS注射器。標(biāo)準(zhǔn)注射器在注射后會(huì)殘留少量藥液,LDS注射器幾乎可以將所有藥液注射到患者的胳膊中。這種能夠減少浪費(fèi)的注射器,足以將每瓶的劑量從5劑變成6劑。

但問(wèn)題在于,LDS注射器是一種小眾產(chǎn)品,無(wú)論在美國(guó)還是全世界的供應(yīng)量,均不足以在未來(lái)幾周和幾個(gè)月內(nèi)完成所有額外劑量的施打。大部分注射器生產(chǎn)商表示無(wú)法擴(kuò)大產(chǎn)能。

拜登政府表示,已經(jīng)簽訂了足夠的注射器供應(yīng)合同,足以施打所有輝瑞疫苗劑量。這是可能做到的,因?yàn)槌薒DS注射器以外,還會(huì)有其他注射器供應(yīng)作為補(bǔ)充,白宮和輝瑞均表示這些注射器是可行的替代選擇。

但疫苗管理負(fù)責(zé)人和專家認(rèn)為,這些替代注射器無(wú)法保證始終可以抽取6劑疫苗。公共衛(wèi)生負(fù)責(zé)人表示,這會(huì)給美國(guó)穩(wěn)定的疫苗供應(yīng)帶來(lái)風(fēng)險(xiǎn)。雖然神奇的第6劑疫苗似乎面臨著威脅,但美國(guó)仍然將為此向輝瑞付費(fèi),無(wú)論這一劑疫苗是否能夠成功地注射到接種者體內(nèi)。

拯救生命的意外驚喜

對(duì)于最靈活的疫苗管理人員而言,輝瑞疫苗的額外劑量是意外之喜。

西弗吉尼亞新冠疫情工作組成員、藥劑師克里斯塔?凱普哈特說(shuō):“我們很快就收到了美國(guó)疾病與預(yù)防控制中心(CDC)發(fā)來(lái)的信息,告知我們可以使用第6劑疫苗。大部分藥劑師都收到了這條信息,他們已經(jīng)在這樣做了?!?/p>

凱普哈特是西弗吉尼亞疫苗發(fā)放工作的主要負(fù)責(zé)人,該州因?yàn)橐呙缃臃N工作開(kāi)展順利而備受好評(píng)。目前,西弗吉尼亞州的第一劑疫苗接種率為14%,居全國(guó)之首。凱普哈特表示,提早認(rèn)識(shí)到額外劑量的疫苗,對(duì)于該州疫苗接種工作的成功產(chǎn)生了影響。

輝瑞疫苗的第6劑額外劑量仍然在繼續(xù)幫助美國(guó)和全世界加快疫苗接種。今年1月末,輝瑞宣布該額外劑量使其能夠在5月底之前,提前兩個(gè)月向美國(guó)交付2億劑疫苗。白宮官員表示,拜登政府宣布近幾周美國(guó)每周疫苗供應(yīng)量增加超過(guò)20%,其中三分之一要?dú)w功于輝瑞的額外劑量。

供應(yīng)量增加最終可以拯救數(shù)以萬(wàn)計(jì)美國(guó)人的生命,尤其是英國(guó)新出現(xiàn)的傳染性更強(qiáng)的新冠變種病毒已經(jīng)在美國(guó)傳播開(kāi)來(lái),而現(xiàn)有疫苗對(duì)這種變種病毒同樣有很好的效果。

但低死腔注射器的供應(yīng)不足卻給這種良好的勢(shì)頭蒙上了陰影。在正常時(shí)期,使用LDS注射器的主要目的是充分利用昂貴的癌癥藥物,或者用于針頭交換項(xiàng)目,以減少使用靜脈注射藥物的患者之間傳播疾病。由于LDS注射器的規(guī)模較小,因此生產(chǎn)商無(wú)法擴(kuò)大規(guī)模,以滿足疫苗接種帶來(lái)的大幅增加的需求。美國(guó)政府向美國(guó)注射器生產(chǎn)商BD公司采購(gòu)了4,000萬(wàn)個(gè)LDS注射器,但BD公司已經(jīng)表示其無(wú)法繼續(xù)擴(kuò)大產(chǎn)能。一位白宮官員告訴《財(cái)富》雜志,聯(lián)邦LDS注射器供應(yīng)很大一部分來(lái)自Retractable Technologies公司(Retractable Technologies Inc.),但其并未披露具體采購(gòu)數(shù)量。

中國(guó)也有LDS注射器生產(chǎn)商,但《環(huán)球時(shí)報(bào)》最近的報(bào)道稱,這些廠商已經(jīng)在滿負(fù)荷生產(chǎn)。中國(guó)供應(yīng)商上海康德萊企業(yè)發(fā)展集團(tuán)表示,新注射器訂單已經(jīng)排到今年8月才能夠交貨。

為了幫助增加注射器供應(yīng),白宮新冠疫苗團(tuán)隊(duì)在2月1日宣布,輝瑞疫苗套裝中配備的注射器80%為首選的LDS注射器,20%為同樣可以抽取6劑疫苗的替代注射器。由輝瑞和聯(lián)邦政府共同確定的注射器和針頭組合共有35種,都屬于可行替代注射器。

但基層疫苗接種人員看到的現(xiàn)實(shí)情況已經(jīng)令人擔(dān)憂。凱普哈特表示,最近收到的疫苗中配備了“五花八門(mén)的注射器……尤其是輝瑞疫苗,我們確實(shí)缺少”能夠有效抽取全部6劑疫苗的注射器。雖然拜登政府作出了保證,但包括新澤西州在內(nèi)美國(guó)各州的疫苗管理人員均報(bào)告輝瑞疫苗套裝中缺少適當(dāng)?shù)尼橆^。

因此,凱普哈特表示在西弗吉尼亞州,“我們并沒(méi)有像最初一樣看到這些額外劑量的疫苗?!?/p>

6劑疫苗挑戰(zhàn)

尤其是在1月6日,輝瑞疫苗的額外劑量從恩賜變成了一個(gè)更復(fù)雜的問(wèn)題,令人擔(dān)憂。美國(guó)食品與藥品管理局(FDA)修改了對(duì)輝瑞疫苗的緊急使用授權(quán),正式宣布每瓶的容量為6劑疫苗。這意味著只要配備了適當(dāng)?shù)淖⑸淦鳎x瑞就能夠收取第6劑疫苗的費(fèi)用,將額外劑量從紅利變成了期望。

但即使LDS注射器供應(yīng)充足,依舊有專家認(rèn)為,對(duì)第6劑疫苗的期望可能沒(méi)有反映更為復(fù)雜的現(xiàn)實(shí)。他們表示,關(guān)鍵在于,被認(rèn)為是“驚喜”的第6劑疫苗實(shí)際上并不是驚喜:所有疫苗都會(huì)有一定程度的過(guò)量灌裝,并且這樣做有充分的理由。

約翰斯?霍普金斯大學(xué)(Johns Hopkins)的醫(yī)療保健運(yùn)營(yíng)教授戴廷龍表示:“工程設(shè)計(jì)最重要的原則之一是有某種冗余??偸菚?huì)存在某種形式的浪費(fèi)?!?/p>

冗余非常重要,因?yàn)樗枰臄?shù)量很少。輝瑞每瓶疫苗制備完成之后,其中包含的藥液只有2.25毫升。將每瓶疫苗從5劑變成6劑意味著疫苗接種人員在抽取每劑0.3毫升疫苗時(shí)需要降低誤差,每劑疫苗在注射器中的數(shù)量相當(dāng)于一名成年人小指指甲的長(zhǎng)度。

戴廷龍說(shuō):“[疫苗接種人員]告訴我,他們?cè)诖蟛糠智闆r下可以抽取第6劑疫苗,但……即使有低死腔注射器的情況下也無(wú)法保證。這需要培訓(xùn)?!?/p>

如今,輝瑞與美國(guó)政府的合同中將第6劑疫苗計(jì)算在內(nèi),因此疫苗接種人員抽取第6劑疫苗面臨的壓力更大。輝瑞在合同中承諾供應(yīng)2億劑疫苗,但并未具體說(shuō)明瓶數(shù),而且輝瑞在1月宣布,考慮到額外劑量,將減少向美國(guó)供應(yīng)的疫苗瓶數(shù),但能夠加快疫苗的供應(yīng)速度。

類似的調(diào)整在歐盟引發(fā)了爭(zhēng)議。在歐盟,輝瑞沒(méi)有提供抽取第6劑疫苗所需要的針頭,卻向客戶收取了第6劑疫苗的費(fèi)用,因此遭到指責(zé)。德國(guó)、法國(guó)、意大利等國(guó)的衛(wèi)生官員警告稱,修改疫苗標(biāo)簽會(huì)降低疫苗接種率。

如果搭配輝瑞疫苗提供五花八門(mén)的LDS注射器和“同等”注射器,同時(shí)卻假定每瓶疫苗都可以抽取6劑疫苗,拜登政府可能會(huì)在美國(guó)造成相同的局面。

錯(cuò)失良機(jī)

美國(guó)之所以缺少理想的注射器,似乎是因?yàn)樵缭?020年年初,聯(lián)邦政府、輝瑞和注射器生產(chǎn)生之間缺乏協(xié)調(diào)。而特種LDS注射器并非是引發(fā)擔(dān)憂的唯一原因。

雖然額外劑量被基層疫苗接種人員視為意外之喜,但有媒體報(bào)道,輝瑞早在2020年8月就已經(jīng)在測(cè)試抽取額外劑量的方法。但輝瑞直到12月才開(kāi)始和美國(guó)食品與藥品管理局討論第6劑疫苗的問(wèn)題?!度A盛頓郵報(bào)》(Washington Post)采訪的專家表示,如果各方之間加強(qiáng)溝通,雖然不見(jiàn)得能夠消除當(dāng)前的瓶頸,但或許可以為提高LDS注射器產(chǎn)量贏得更多時(shí)間。

注射器供應(yīng)普遍存在問(wèn)題,部分原因可能在于特朗普政府的不作為。美國(guó)衛(wèi)生及公共服務(wù)部(HHS)的生物醫(yī)學(xué)高級(jí)研究與發(fā)展管理局(Biomedical Advanced Research and Development Authority)前局長(zhǎng)里克?布萊特在一封舉報(bào)信中聲稱,他早在2020年3月就曾經(jīng)多次警告各類注射器可能存在供應(yīng)不足的問(wèn)題。布萊特在投訴書(shū)中指控稱,包括時(shí)任衛(wèi)生及公共服務(wù)部部長(zhǎng)亞歷克斯?阿扎在內(nèi)的政府領(lǐng)導(dǎo)層對(duì)他的警告都嗤之以鼻,而且他還被強(qiáng)行降職,他表示這是對(duì)他堅(jiān)持舉報(bào)注射器供應(yīng)不足及相關(guān)問(wèn)題的打擊報(bào)復(fù)。布萊特不久后選擇了辭職。

有跡象表明,供應(yīng)問(wèn)題的影響不止局限于輝瑞疫苗。1月29日,凱普哈特表示,發(fā)往西弗吉尼亞州的Moderna公司的疫苗包裝中包括1.5英寸23號(hào)針頭,這種針頭的型號(hào)大于標(biāo)準(zhǔn)疫苗針頭。

凱普哈特說(shuō):“使用23號(hào)針頭就像在胳膊上扎一枚釘子。”

但比不舒服的感受更糟糕的是,這種針頭無(wú)法從Moderna的疫苗藥瓶中抽取全部10劑疫苗。凱普哈特表示,疫苗接種人員使用這種針頭只能夠抽取8劑,因此她不得不替換成本州儲(chǔ)備的針頭。

即將來(lái)臨的混亂

約翰斯?霍普金斯衛(wèi)生安全中心(Johns Hopkins Center for Health Security)的資深學(xué)者阿梅什?阿達(dá)利亞表示,如果可以保證抽取全部6劑輝瑞疫苗的注射器短缺,“你會(huì)看到取消疫苗接種預(yù)約的情況。然后他們必須下調(diào)劑量數(shù)據(jù),從而調(diào)整時(shí)間安排。這只會(huì)放慢疫苗接種的速度,使形勢(shì)變得更加復(fù)雜?!?/p>

拜登政府在1月21日發(fā)布的疫情響應(yīng)策略文件中表示,計(jì)劃動(dòng)用《國(guó)防生產(chǎn)法案》(Defense Production Act),以增加低死腔注射器和其他必要設(shè)備的供應(yīng)。但該法案能否實(shí)現(xiàn)這個(gè)目標(biāo)目前仍然是個(gè)未知數(shù)。這項(xiàng)法律僅適用于美國(guó)國(guó)內(nèi)生產(chǎn)商,而美國(guó)唯一一家生產(chǎn)LDS注射器的廠商BD已經(jīng)表示其沒(méi)有能力增加產(chǎn)量。

根據(jù)《國(guó)防生產(chǎn)法案》的規(guī)定,生產(chǎn)相關(guān)產(chǎn)品的制造商在有能力的情況下必須更換設(shè)備生產(chǎn)應(yīng)急物資,例如唐納德?特朗普在去年秋天曾經(jīng)命令通用汽車(chē)(GM)生產(chǎn)呼吸機(jī)。但美國(guó)在發(fā)展了數(shù)十年離岸外包業(yè)務(wù)之后,想找到能夠生產(chǎn)精密醫(yī)療器械的美國(guó)工廠并不容易。距離戰(zhàn)略文件發(fā)布已經(jīng)過(guò)去近一個(gè)月時(shí)間,但拜登政府并沒(méi)有啟用《國(guó)防生產(chǎn)法案》增加注射器產(chǎn)量。

與此同時(shí),新建工廠或增加投資以提高LDS注射器產(chǎn)量缺乏市場(chǎng)刺激。雖然未來(lái)幾個(gè)月將出現(xiàn)大量需求,但我們沒(méi)有理由認(rèn)為這種需求會(huì)持續(xù)下去。拜登政府的官員表示,美國(guó)將在4月開(kāi)始大范圍接種疫苗,這在一定程度上得益于更多疫苗料將獲得批準(zhǔn),例如強(qiáng)生公司(Johnson & Johnson)的疫苗。這意味著抽取第6劑輝瑞疫苗的壓力將減少,并且對(duì)LDS注射器的需求也會(huì)快速下降。

輝瑞表示,正在“幫助各國(guó)保證必要的設(shè)備供應(yīng)”,以確??梢猿槿∪?劑疫苗。但輝瑞并未說(shuō)明其是否將直接參與增加注射器供應(yīng),盡管它在所有利益相關(guān)者擁有最強(qiáng)烈的動(dòng)機(jī)。

戴廷龍說(shuō):“一個(gè)LDS注射器的成本可能只有10美分。但如果你能夠額外抽取一劑疫苗,[輝瑞]就可以向政府收取20美元。這可能是我在醫(yī)療行業(yè)聽(tīng)說(shuō)過(guò)的最高的投資回報(bào)?!保ㄘ?cái)富中文網(wǎng))

翻譯:劉進(jìn)龍

審校:汪皓

Soon after the first shipments of Pfizer/BioNTech’s COVID-19 vaccine began arriving in December, health care workers and administrators discovered a precious opportunity. Though the vaccine vials were labeled as containing five doses, experienced health workers found that they could sometimes extract a sixth dose, effectively expanding their vaccine supply by 20%.

But Pfizer’s extra dose comes with a catch. To consistently deliver it, health workers would ideally be using specialized equipment known as a low dead space syringe, or LDS syringe. While standard syringes retain a small amount of medicine after an injection, LDS syringes are designed to push nearly all of the liquid into a patient’s arm. That waste reduction is enough to turn five doses into six.

The problem is that LDS syringes are normally a niche product, and there are not enough available, either in the U.S. or worldwide, to administer all of those extra doses over coming weeks and months. Most producers of the syringes have said they cannot expand production capacity.

The Biden administration says it has contracted for an adequate supply of syringes to deliver all of the Pfizer doses. That’s possible because the supply of LDS syringes is being supplemented with other syringes that the White House and Pfizer say are workable alternatives.

But vaccine administrators and experts say those alternatives are not consistently extracting the sixth dose. Public health leaders say that poses a risk to a steady U.S. vaccine supply. And as threats to the miraculous sixth dose appear to rise, the U.S. is still paying Pfizer for it—whether it winds up in anyone’s arm or not.

A lifesaving surprise

For the most agile vaccine administrators, the extra Pfizer dose was a godsend.

“We very quickly got the information from the CDC that we could use that sixth dose,” says Krista Capehart, a pharmacist and member of the West Virginia COVID task force. “And most of our pharmacists were getting it because that’s what they do.”

Capehart has had a central role in managing vaccine distribution in West Virginia, which has been widely praised for its effective rollout. West Virginia currently has one of the highest first-dose vaccination rates in the country, at 14%, and Capehart says early recognition of the potential extra dose played a role in that success.

The extra sixth Pfizer dose has continued to help accelerate vaccinations across the U.S. and the world. In late January, Pfizer announced that the extra dose would enable it to deliver 200 million doses to the U.S. by the end of May, two months ahead of schedule. The Biden administration has announced a more than 20% expansion of the U.S. weekly vaccine supply in recent weeks, and about one-third of that increase is thanks to the extra Pfizer dose, according to a White House official.

That expanded supply could ultimately save tens of thousands of American lives, especially as the new and more infectious U.K. variant of the SARS-CoV-2 virus, which responds well to current vaccines, gains a foothold in the U.S.

But the shortage of low dead space syringes threatens that momentum. In normal times, LDS syringes are used to get the most out of expensive cancer medications or in needle exchange programs to reduce disease transmission among IV drug users. Producers have been unable to scale up from that small base to meet exploding demand driven by vaccinations. The U.S. government has contracted with U.S. syringe maker BD for 40 million of those syringes, but BD has signaled it is unable to further expand its production capacity. A White House official told Fortune that the bulk of the federal supply of LDS syringes is coming from Retractable Technologies Inc. (RTI) but did not specify how many the contract included.

LDS syringes are also manufactured in China, but those sources, too, are already at capacity, according to recent reporting by the Global Times. One Chinese producer, Shanghai Kindly Enterprise Development Group, said that new syringe orders are now in a queue and will not be fulfilled until August.

To help its supply go further, the White House COVID team announced on Feb. 1 that while 80% of the syringes being packed with Pfizer vaccination kits are the preferred LDS type, 20% are alternatives also capable of extracting all six doses. Thirty-five different combinations of syringe and needle, determined with involvement from both Pfizer and the federal government, fall in that category of workable alternatives.

But vaccinators on the ground are already seeing a more troubling reality. According to Capehart, recent vaccine shipments have contained “this mishmash of syringes…Particularly with Pfizer, we were definitely short” of syringes effective at extracting all six doses. Vaccine administrators in states including New Jersey have reported a similar shortfall of appropriate needles in Pfizer kits, despite assurances from the Biden administration.

As a result, Capehart says that in West Virginia, “we’re certainly not seeing the extra doses we were at the beginning.”

The six-dose challenge

That’s particularly worrying because on Jan. 6, the extra Pfizer dose was transformed from a blessing into something more complicated. The FDA revised its emergency use authorization to make it official that each vial contained six doses. This revision meant that, as long as acceptable syringes were provided, Pfizer could charge for the sixth dose, changing it from a bonus to an expectation.

But even if LDS syringes were plentiful, experts say the six-dose expectation may not reflect a more complex reality. Crucially, they say, the "surprise" sixth dose was actually not a surprise: All vaccines are delivered with some degree of overfill—and for good reason.

“One of the most important principles of engineering is you need to have some sort of redundancy,” says Tinglong Dai, a professor of health care operations at Johns Hopkins. “There’s always going to be some sort of waste.”

Redundancy is important because the volumes involved are so tiny. After preparation, each Pfizer vial amounts to just 2.25 milliliters of liquid. Turning that into six doses means a much smaller margin of error as vaccinators draw each 0.3 ml vaccine dose—roughly the length of an adult’s pinky nail—in a syringe.

“[Vaccinators] are telling me for the most part they’re getting the sixth dose,” says Dai. “But…it’s not a guaranteed thing, even with the low dead space syringes. It’s a matter of training.”

Pressure to get that dose is heightened now that Pfizer can count it toward its contract with the U.S. government. That contract promised 200 million doses, not a specific number of vials, and Pfizer announced in January that it would ship fewer vials to the U.S., though at a faster pace, to account for the extra doses.

Similar changes have led to controversy in the EU, where Pfizer has been accused of charging customers for the sixth dose, even when the needles required to extract all six doses can’t be found. Health officials in Germany, France, Italy, and elsewhere have warned that the labeling revision could actually reduce the rate of vaccination.

By providing an inconsistent mix of LDS and "equivalent" syringes with the Pfizer vaccine, while still assuming each vial will deliver six doses, the Biden administration risks re-creating the same situation in the U.S.

Missed opportunities

The shortage of ideal syringes appears to be the product of a lack of coordination between federal authorities, Pfizer, and syringe manufacturers dating back as far as early 2020. And specialized LDS syringes are not the only cause for concern.

While the extra dose came as a surprise to vaccinators in the field, Pfizer had reportedly been testing methods for extracting the extra dose since August 2020. But Pfizer did not broach the topic of the sixth dose with the FDA until December. While it wouldn’t have necessarily eliminated bottlenecks, better communication would have given more time for a ramp-up in production of LDS syringes, according to experts interviewed by the Washington Post.

Broader syringe supply issues may, in part, be due to inaction by the Trump administration. Rick Bright, the former director of the HHS Biomedical Advanced Research and Development Authority (BARDA), alleged in a whistleblower complaint that he repeatedly warned about a potential shortage of syringes of all kinds as early as March 2020. Bright’s complaint alleges not only that his warnings were dismissed by leadership including then-HHS Secretary Alex Azar, but also that Bright was effectively demoted against his will in what he claims was retaliation for his persistence on this and related issues. Bright resigned soon after.

There are signs that supply issues are having an impact beyond the Pfizer vaccine. On Jan. 29, Capehart says, packages of Moderna vaccine sent to West Virginia included 1.5-inch 23-gauge needles, much larger than standard vaccination needles.

“A 23-gauge needle is like a nail going into your arm,” Capehart says.

But worse than the discomfort is the fact that the needles couldn’t extract all 10 doses in a Moderna vial. Capehart says her vaccinators were able to get only eight doses from each vial with the needles, forcing her to replace the needles from the state’s own reserves.

Looming disruption

If there is a shortfall of syringes capable of reliably extracting all six Pfizer doses, “you’re going to see appointments canceled,” says Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “Then they’re going to have to adjust the number of doses down, and the timeline will adjust. That’s just going to further slow down the vaccine rollout, and further complicate things.”

In its Jan. 21 COVID-19 response strategy document, the Biden administration said it plans to make use of the Defense Production Act to increase the supply of low dead space syringes and other needed equipment. But it’s unclear whether the DPA can accomplish that. The law applies only to domestic U.S. producers, and the only manufacturer who produces LDS syringes in the U.S., BD, has said it has no capability to increase its output.

Manufacturers capable of retooling from related products can be compelled to produce emergency supplies under the DPA, as when Donald Trump ordered GM to make ventilators last fall. But after decades of offshoring, finding U.S. manufacturing facilities capable of producing precision medical devices isn't easy. Nearly a month after releasing the strategy document, the Biden administration has yet to invoke the DPA to expand syringe production.

Meanwhile, there is little market incentive to build new factories or otherwise invest in producing more LDS syringes. Despite huge demand over the next few months, there’s no reason to believe the need will last much beyond that. Biden officials are signaling that vaccinations will be widely available in the U.S. as soon as April, partly thanks to the expected approval of more types of vaccine, such as Johnson & Johnson's. That could mean reduced pressure to extract the sixth Pfizer dose and a rapid reduction in demand for LDS syringes.

Pfizer, for its part, says it is “helping countries secure access to the necessary equipment” to secure all six doses. But it has not yet signaled that it will directly involve itself in efforts to increase syringe supplies—despite having arguably the strongest incentives of any stakeholder.

“An LDS syringe will probably cost you 10 cents,” says Tinglong Dai. “But if you squeeze out another dose, [Pfizer] can charge the government $20. Wow, this is probably the highest return on investment I’ve ever heard of in the medical industry.”

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