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辉瑞疫苗的意外之喜何以变成了一场大混乱?

辉瑞疫苗的意外之喜何以变成了一场大混乱?

David Z. Morris 2021年02月23日
造成这种局面的主要原因是专用注射器的产能不足。

辉瑞(Pfizer)/BioNTech的首批新冠疫苗在去年12月到货之后,医护人员和疫苗接种机构很快就发现了一个宝贵的机会。虽然药瓶上标示每瓶能够抽取5剂疫苗,但有经验的医护人员发现,他们有时候可以从瓶中抽取6剂疫苗,相当于将疫苗供应量提高了20%。

但辉瑞的额外剂量有一个缺点。为了保证始终能够抽取6剂疫苗,理想情况下,医护人员应该使用一种名为低死腔注射器的专用设备,简称LDS注射器。标准注射器在注射后会残留少量药液,LDS注射器几乎可以将所有药液注射到患者的胳膊中。这种能够减少浪费的注射器,足以将每瓶的剂量从5剂变成6剂。

但问题在于,LDS注射器是一种小众产品,无论在美国还是全世界的供应量,均不足以在未来几周和几个月内完成所有额外剂量的施打。大部分注射器生产商表示无法扩大产能。

拜登政府表示,已经签订了足够的注射器供应合同,足以施打所有辉瑞疫苗剂量。这是可能做到的,因为除了LDS注射器以外,还会有其他注射器供应作为补充,白宫和辉瑞均表示这些注射器是可行的替代选择。

但疫苗管理负责人和专家认为,这些替代注射器无法保证始终可以抽取6剂疫苗。公共卫生负责人表示,这会给美国稳定的疫苗供应带来风险。虽然神奇的第6剂疫苗似乎面临着威胁,但美国仍然将为此向辉瑞付费,无论这一剂疫苗是否能够成功地注射到接种者体内。

拯救生命的意外惊喜

对于最灵活的疫苗管理人员而言,辉瑞疫苗的额外剂量是意外之喜。

西弗吉尼亚新冠疫情工作组成员、药剂师克里斯塔•凯普哈特说:“我们很快就收到了美国疾病与预防控制中心(CDC)发来的信息,告知我们可以使用第6剂疫苗。大部分药剂师都收到了这条信息,他们已经在这样做了。”

凯普哈特是西弗吉尼亚疫苗发放工作的主要负责人,该州因为疫苗接种工作开展顺利而备受好评。目前,西弗吉尼亚州的第一剂疫苗接种率为14%,居全国之首。凯普哈特表示,提早认识到额外剂量的疫苗,对于该州疫苗接种工作的成功产生了影响。

新冠疫苗在美国各州的接种率(数据截至2021年2月16日)。图片来源:美国疾病与预防控制中心

辉瑞疫苗的第6剂额外剂量仍然在继续帮助美国和全世界加快疫苗接种。今年1月末,辉瑞宣布该额外剂量使其能够在5月底之前,提前两个月向美国交付2亿剂疫苗。白宫官员表示,拜登政府宣布近几周美国每周疫苗供应量增加超过20%,其中三分之一要归功于辉瑞的额外剂量。

供应量增加最终可以拯救数以万计美国人的生命,尤其是英国新出现的传染性更强的新冠变种病毒已经在美国传播开来,而现有疫苗对这种变种病毒同样有很好的效果。

但低死腔注射器的供应不足却给这种良好的势头蒙上了阴影。在正常时期,使用LDS注射器的主要目的是充分利用昂贵的癌症药物,或者用于针头交换项目,以减少使用静脉注射药物的患者之间传播疾病。由于LDS注射器的规模较小,因此生产商无法扩大规模,以满足疫苗接种带来的大幅增加的需求。美国政府向美国注射器生产商BD公司采购了4,000万个LDS注射器,但BD公司已经表示其无法继续扩大产能。一位白宫官员告诉《财富》杂志,联邦LDS注射器供应很大一部分来自Retractable Technologies公司(Retractable Technologies Inc.),但其并未披露具体采购数量。

中国也有LDS注射器生产商,但《环球时报》最近的报道称,这些厂商已经在满负荷生产。中国供应商上海康德莱企业发展集团表示,新注射器订单已经排到今年8月才能够交货。

为了帮助增加注射器供应,白宫新冠疫苗团队在2月1日宣布,辉瑞疫苗套装中配备的注射器80%为首选的LDS注射器,20%为同样可以抽取6剂疫苗的替代注射器。由辉瑞和联邦政府共同确定的注射器和针头组合共有35种,都属于可行替代注射器。

但基层疫苗接种人员看到的现实情况已经令人担忧。凯普哈特表示,最近收到的疫苗中配备了“五花八门的注射器……尤其是辉瑞疫苗,我们确实缺少”能够有效抽取全部6剂疫苗的注射器。虽然拜登政府作出了保证,但包括新泽西州在内美国各州的疫苗管理人员均报告辉瑞疫苗套装中缺少适当的针头。

因此,凯普哈特表示在西弗吉尼亚州,“我们并没有像最初一样看到这些额外剂量的疫苗。”

6剂疫苗挑战

尤其是在1月6日,辉瑞疫苗的额外剂量从恩赐变成了一个更复杂的问题,令人担忧。美国食品与药品管理局(FDA)修改了对辉瑞疫苗的紧急使用授权,正式宣布每瓶的容量为6剂疫苗。这意味着只要配备了适当的注射器,辉瑞就能够收取第6剂疫苗的费用,将额外剂量从红利变成了期望。

但即使LDS注射器供应充足,依旧有专家认为,对第6剂疫苗的期望可能没有反映更为复杂的现实。他们表示,关键在于,被认为是“惊喜”的第6剂疫苗实际上并不是惊喜:所有疫苗都会有一定程度的过量灌装,并且这样做有充分的理由。

约翰斯•霍普金斯大学(Johns Hopkins)的医疗保健运营教授戴廷龙表示:“工程设计最重要的原则之一是有某种冗余。总是会存在某种形式的浪费。”

冗余非常重要,因为它所需要的数量很少。辉瑞每瓶疫苗制备完成之后,其中包含的药液只有2.25毫升。将每瓶疫苗从5剂变成6剂意味着疫苗接种人员在抽取每剂0.3毫升疫苗时需要降低误差,每剂疫苗在注射器中的数量相当于一名成年人小指指甲的长度。

戴廷龙说:“[疫苗接种人员]告诉我,他们在大部分情况下可以抽取第6剂疫苗,但……即使有低死腔注射器的情况下也无法保证。这需要培训。”

如今,辉瑞与美国政府的合同中将第6剂疫苗计算在内,因此疫苗接种人员抽取第6剂疫苗面临的压力更大。辉瑞在合同中承诺供应2亿剂疫苗,但并未具体说明瓶数,而且辉瑞在1月宣布,考虑到额外剂量,将减少向美国供应的疫苗瓶数,但能够加快疫苗的供应速度。

类似的调整在欧盟引发了争议。在欧盟,辉瑞没有提供抽取第6剂疫苗所需要的针头,却向客户收取了第6剂疫苗的费用,因此遭到指责。德国、法国、意大利等国的卫生官员警告称,修改疫苗标签会降低疫苗接种率。

如果搭配辉瑞疫苗提供五花八门的LDS注射器和“同等”注射器,同时却假定每瓶疫苗都可以抽取6剂疫苗,拜登政府可能会在美国造成相同的局面。

错失良机

美国之所以缺少理想的注射器,似乎是因为早在2020年年初,联邦政府、辉瑞和注射器生产生之间缺乏协调。而特种LDS注射器并非是引发担忧的唯一原因。

虽然额外剂量被基层疫苗接种人员视为意外之喜,但有媒体报道,辉瑞早在2020年8月就已经在测试抽取额外剂量的方法。但辉瑞直到12月才开始和美国食品与药品管理局讨论第6剂疫苗的问题。《华盛顿邮报》(Washington Post)采访的专家表示,如果各方之间加强沟通,虽然不见得能够消除当前的瓶颈,但或许可以为提高LDS注射器产量赢得更多时间。

注射器供应普遍存在问题,部分原因可能在于特朗普政府的不作为。美国卫生及公共服务部(HHS)的生物医学高级研究与发展管理局(Biomedical Advanced Research and Development Authority)前局长里克•布莱特在一封举报信中声称,他早在2020年3月就曾经多次警告各类注射器可能存在供应不足的问题。布莱特在投诉书中指控称,包括时任卫生及公共服务部部长亚历克斯•阿扎在内的政府领导层对他的警告都嗤之以鼻,而且他还被强行降职,他表示这是对他坚持举报注射器供应不足及相关问题的打击报复。布莱特不久后选择了辞职。

有迹象表明,供应问题的影响不止局限于辉瑞疫苗。1月29日,凯普哈特表示,发往西弗吉尼亚州的Moderna公司的疫苗包装中包括1.5英寸23号针头,这种针头的型号大于标准疫苗针头。

凯普哈特说:“使用23号针头就像在胳膊上扎一枚钉子。”

但比不舒服的感受更糟糕的是,这种针头无法从Moderna的疫苗药瓶中抽取全部10剂疫苗。凯普哈特表示,疫苗接种人员使用这种针头只能够抽取8剂,因此她不得不替换成本州储备的针头。

即将来临的混乱

约翰斯•霍普金斯卫生安全中心(Johns Hopkins Center for Health Security)的资深学者阿梅什•阿达利亚表示,如果可以保证抽取全部6剂辉瑞疫苗的注射器短缺,“你会看到取消疫苗接种预约的情况。然后他们必须下调剂量数据,从而调整时间安排。这只会放慢疫苗接种的速度,使形势变得更加复杂。”

拜登政府在1月21日发布的疫情响应策略文件中表示,计划动用《国防生产法案》(Defense Production Act),以增加低死腔注射器和其他必要设备的供应。但该法案能否实现这个目标目前仍然是个未知数。这项法律仅适用于美国国内生产商,而美国唯一一家生产LDS注射器的厂商BD已经表示其没有能力增加产量。

根据《国防生产法案》的规定,生产相关产品的制造商在有能力的情况下必须更换设备生产应急物资,例如唐纳德•特朗普在去年秋天曾经命令通用汽车(GM)生产呼吸机。但美国在发展了数十年离岸外包业务之后,想找到能够生产精密医疗器械的美国工厂并不容易。距离战略文件发布已经过去近一个月时间,但拜登政府并没有启用《国防生产法案》增加注射器产量。

与此同时,新建工厂或增加投资以提高LDS注射器产量缺乏市场刺激。虽然未来几个月将出现大量需求,但我们没有理由认为这种需求会持续下去。拜登政府的官员表示,美国将在4月开始大范围接种疫苗,这在一定程度上得益于更多疫苗料将获得批准,例如强生公司(Johnson & Johnson)的疫苗。这意味着抽取第6剂辉瑞疫苗的压力将减少,并且对LDS注射器的需求也会快速下降。

辉瑞表示,正在“帮助各国保证必要的设备供应”,以确保可以抽取全部6剂疫苗。但辉瑞并未说明其是否将直接参与增加注射器供应,尽管它在所有利益相关者拥有最强烈的动机。

戴廷龙说:“一个LDS注射器的成本可能只有10美分。但如果你能够额外抽取一剂疫苗,[辉瑞]就可以向政府收取20美元。这可能是我在医疗行业听说过的最高的投资回报。”(财富中文网)

翻译:刘进龙

审校:汪皓

辉瑞(Pfizer)/BioNTech的首批新冠疫苗在去年12月到货之后,医护人员和疫苗接种机构很快就发现了一个宝贵的机会。虽然药瓶上标示每瓶能够抽取5剂疫苗,但有经验的医护人员发现,他们有时候可以从瓶中抽取6剂疫苗,相当于将疫苗供应量提高了20%。

但辉瑞的额外剂量有一个缺点。为了保证始终能够抽取6剂疫苗,理想情况下,医护人员应该使用一种名为低死腔注射器的专用设备,简称LDS注射器。标准注射器在注射后会残留少量药液,LDS注射器几乎可以将所有药液注射到患者的胳膊中。这种能够减少浪费的注射器,足以将每瓶的剂量从5剂变成6剂。

但问题在于,LDS注射器是一种小众产品,无论在美国还是全世界的供应量,均不足以在未来几周和几个月内完成所有额外剂量的施打。大部分注射器生产商表示无法扩大产能。

拜登政府表示,已经签订了足够的注射器供应合同,足以施打所有辉瑞疫苗剂量。这是可能做到的,因为除了LDS注射器以外,还会有其他注射器供应作为补充,白宫和辉瑞均表示这些注射器是可行的替代选择。

但疫苗管理负责人和专家认为,这些替代注射器无法保证始终可以抽取6剂疫苗。公共卫生负责人表示,这会给美国稳定的疫苗供应带来风险。虽然神奇的第6剂疫苗似乎面临着威胁,但美国仍然将为此向辉瑞付费,无论这一剂疫苗是否能够成功地注射到接种者体内。

拯救生命的意外惊喜

对于最灵活的疫苗管理人员而言,辉瑞疫苗的额外剂量是意外之喜。

西弗吉尼亚新冠疫情工作组成员、药剂师克里斯塔•凯普哈特说:“我们很快就收到了美国疾病与预防控制中心(CDC)发来的信息,告知我们可以使用第6剂疫苗。大部分药剂师都收到了这条信息,他们已经在这样做了。”

凯普哈特是西弗吉尼亚疫苗发放工作的主要负责人,该州因为疫苗接种工作开展顺利而备受好评。目前,西弗吉尼亚州的第一剂疫苗接种率为14%,居全国之首。凯普哈特表示,提早认识到额外剂量的疫苗,对于该州疫苗接种工作的成功产生了影响。

辉瑞疫苗的第6剂额外剂量仍然在继续帮助美国和全世界加快疫苗接种。今年1月末,辉瑞宣布该额外剂量使其能够在5月底之前,提前两个月向美国交付2亿剂疫苗。白宫官员表示,拜登政府宣布近几周美国每周疫苗供应量增加超过20%,其中三分之一要归功于辉瑞的额外剂量。

供应量增加最终可以拯救数以万计美国人的生命,尤其是英国新出现的传染性更强的新冠变种病毒已经在美国传播开来,而现有疫苗对这种变种病毒同样有很好的效果。

但低死腔注射器的供应不足却给这种良好的势头蒙上了阴影。在正常时期,使用LDS注射器的主要目的是充分利用昂贵的癌症药物,或者用于针头交换项目,以减少使用静脉注射药物的患者之间传播疾病。由于LDS注射器的规模较小,因此生产商无法扩大规模,以满足疫苗接种带来的大幅增加的需求。美国政府向美国注射器生产商BD公司采购了4,000万个LDS注射器,但BD公司已经表示其无法继续扩大产能。一位白宫官员告诉《财富》杂志,联邦LDS注射器供应很大一部分来自Retractable Technologies公司(Retractable Technologies Inc.),但其并未披露具体采购数量。

中国也有LDS注射器生产商,但《环球时报》最近的报道称,这些厂商已经在满负荷生产。中国供应商上海康德莱企业发展集团表示,新注射器订单已经排到今年8月才能够交货。

为了帮助增加注射器供应,白宫新冠疫苗团队在2月1日宣布,辉瑞疫苗套装中配备的注射器80%为首选的LDS注射器,20%为同样可以抽取6剂疫苗的替代注射器。由辉瑞和联邦政府共同确定的注射器和针头组合共有35种,都属于可行替代注射器。

但基层疫苗接种人员看到的现实情况已经令人担忧。凯普哈特表示,最近收到的疫苗中配备了“五花八门的注射器……尤其是辉瑞疫苗,我们确实缺少”能够有效抽取全部6剂疫苗的注射器。虽然拜登政府作出了保证,但包括新泽西州在内美国各州的疫苗管理人员均报告辉瑞疫苗套装中缺少适当的针头。

因此,凯普哈特表示在西弗吉尼亚州,“我们并没有像最初一样看到这些额外剂量的疫苗。”

6剂疫苗挑战

尤其是在1月6日,辉瑞疫苗的额外剂量从恩赐变成了一个更复杂的问题,令人担忧。美国食品与药品管理局(FDA)修改了对辉瑞疫苗的紧急使用授权,正式宣布每瓶的容量为6剂疫苗。这意味着只要配备了适当的注射器,辉瑞就能够收取第6剂疫苗的费用,将额外剂量从红利变成了期望。

但即使LDS注射器供应充足,依旧有专家认为,对第6剂疫苗的期望可能没有反映更为复杂的现实。他们表示,关键在于,被认为是“惊喜”的第6剂疫苗实际上并不是惊喜:所有疫苗都会有一定程度的过量灌装,并且这样做有充分的理由。

约翰斯•霍普金斯大学(Johns Hopkins)的医疗保健运营教授戴廷龙表示:“工程设计最重要的原则之一是有某种冗余。总是会存在某种形式的浪费。”

冗余非常重要,因为它所需要的数量很少。辉瑞每瓶疫苗制备完成之后,其中包含的药液只有2.25毫升。将每瓶疫苗从5剂变成6剂意味着疫苗接种人员在抽取每剂0.3毫升疫苗时需要降低误差,每剂疫苗在注射器中的数量相当于一名成年人小指指甲的长度。

戴廷龙说:“[疫苗接种人员]告诉我,他们在大部分情况下可以抽取第6剂疫苗,但……即使有低死腔注射器的情况下也无法保证。这需要培训。”

如今,辉瑞与美国政府的合同中将第6剂疫苗计算在内,因此疫苗接种人员抽取第6剂疫苗面临的压力更大。辉瑞在合同中承诺供应2亿剂疫苗,但并未具体说明瓶数,而且辉瑞在1月宣布,考虑到额外剂量,将减少向美国供应的疫苗瓶数,但能够加快疫苗的供应速度。

类似的调整在欧盟引发了争议。在欧盟,辉瑞没有提供抽取第6剂疫苗所需要的针头,却向客户收取了第6剂疫苗的费用,因此遭到指责。德国、法国、意大利等国的卫生官员警告称,修改疫苗标签会降低疫苗接种率。

如果搭配辉瑞疫苗提供五花八门的LDS注射器和“同等”注射器,同时却假定每瓶疫苗都可以抽取6剂疫苗,拜登政府可能会在美国造成相同的局面。

错失良机

美国之所以缺少理想的注射器,似乎是因为早在2020年年初,联邦政府、辉瑞和注射器生产生之间缺乏协调。而特种LDS注射器并非是引发担忧的唯一原因。

虽然额外剂量被基层疫苗接种人员视为意外之喜,但有媒体报道,辉瑞早在2020年8月就已经在测试抽取额外剂量的方法。但辉瑞直到12月才开始和美国食品与药品管理局讨论第6剂疫苗的问题。《华盛顿邮报》(Washington Post)采访的专家表示,如果各方之间加强沟通,虽然不见得能够消除当前的瓶颈,但或许可以为提高LDS注射器产量赢得更多时间。

注射器供应普遍存在问题,部分原因可能在于特朗普政府的不作为。美国卫生及公共服务部(HHS)的生物医学高级研究与发展管理局(Biomedical Advanced Research and Development Authority)前局长里克•布莱特在一封举报信中声称,他早在2020年3月就曾经多次警告各类注射器可能存在供应不足的问题。布莱特在投诉书中指控称,包括时任卫生及公共服务部部长亚历克斯•阿扎在内的政府领导层对他的警告都嗤之以鼻,而且他还被强行降职,他表示这是对他坚持举报注射器供应不足及相关问题的打击报复。布莱特不久后选择了辞职。

有迹象表明,供应问题的影响不止局限于辉瑞疫苗。1月29日,凯普哈特表示,发往西弗吉尼亚州的Moderna公司的疫苗包装中包括1.5英寸23号针头,这种针头的型号大于标准疫苗针头。

凯普哈特说:“使用23号针头就像在胳膊上扎一枚钉子。”

但比不舒服的感受更糟糕的是,这种针头无法从Moderna的疫苗药瓶中抽取全部10剂疫苗。凯普哈特表示,疫苗接种人员使用这种针头只能够抽取8剂,因此她不得不替换成本州储备的针头。

即将来临的混乱

约翰斯•霍普金斯卫生安全中心(Johns Hopkins Center for Health Security)的资深学者阿梅什•阿达利亚表示,如果可以保证抽取全部6剂辉瑞疫苗的注射器短缺,“你会看到取消疫苗接种预约的情况。然后他们必须下调剂量数据,从而调整时间安排。这只会放慢疫苗接种的速度,使形势变得更加复杂。”

拜登政府在1月21日发布的疫情响应策略文件中表示,计划动用《国防生产法案》(Defense Production Act),以增加低死腔注射器和其他必要设备的供应。但该法案能否实现这个目标目前仍然是个未知数。这项法律仅适用于美国国内生产商,而美国唯一一家生产LDS注射器的厂商BD已经表示其没有能力增加产量。

根据《国防生产法案》的规定,生产相关产品的制造商在有能力的情况下必须更换设备生产应急物资,例如唐纳德•特朗普在去年秋天曾经命令通用汽车(GM)生产呼吸机。但美国在发展了数十年离岸外包业务之后,想找到能够生产精密医疗器械的美国工厂并不容易。距离战略文件发布已经过去近一个月时间,但拜登政府并没有启用《国防生产法案》增加注射器产量。

与此同时,新建工厂或增加投资以提高LDS注射器产量缺乏市场刺激。虽然未来几个月将出现大量需求,但我们没有理由认为这种需求会持续下去。拜登政府的官员表示,美国将在4月开始大范围接种疫苗,这在一定程度上得益于更多疫苗料将获得批准,例如强生公司(Johnson & Johnson)的疫苗。这意味着抽取第6剂辉瑞疫苗的压力将减少,并且对LDS注射器的需求也会快速下降。

辉瑞表示,正在“帮助各国保证必要的设备供应”,以确保可以抽取全部6剂疫苗。但辉瑞并未说明其是否将直接参与增加注射器供应,尽管它在所有利益相关者拥有最强烈的动机。

戴廷龙说:“一个LDS注射器的成本可能只有10美分。但如果你能够额外抽取一剂疫苗,[辉瑞]就可以向政府收取20美元。这可能是我在医疗行业听说过的最高的投资回报。”(财富中文网)

翻译:刘进龙

审校: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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