COVID-19疫苗冷链物流管理：一个范围回顾外文翻译资料

Management of COVID-19 vaccines cold chain logistics: a scoping review

Fahrni Mathumalar Loganathan;ensp;Ismail Intan An Nisaarsquo;;ensp;Refi Dalia Mohammed;ensp;Almeman Ahmad;ensp;Yaakob Norliana Che;ensp;Saman Kamaliah Md;ensp;Mansor Nur Farhani;ensp;Noordin Noorasmah;ensp;Babar Zaheer Ud Din

[J]Journal of Pharmaceutical Policy and PracticeVolume 15, Issue 1. 2022. PP 16-16

Abstract

Background

Successful mass vaccination programmes are public health achievements of the contemporary world. While pharmaceutical companies are actively developing new vaccines, and demonstrating results of effectiveness and safety profiles, concerns on COVID-19 vaccine management are under-reported. We aimed to synthesise the evidence for efficient cold chain management of COVID vaccines.

Methods

The scoping reviewrsquo;s conduct and reporting were based on the PRISMA–ScR 2018 checklist. We searched from April 2020 to January 2022 for publications in PubMed (LitCovid), Scopus and ScienceDirect. All review stages were pilot-tested to calibrate 2 reviewers. Articles on cold chain logistics and management were included, while publications solely describing COVID vaccines, their development and clinical aspects of the vaccine, were excluded. To capture relevant data, charting was conducted by one reviewer and verified by another. Results were analysed thematically and summarised descriptively in a table and in-text.

Results and discussion

We assessed 6984 potentially relevant citations. We included 14 publications originating from USA (nthinsp;=thinsp;6), India (nthinsp;=thinsp;2), Finland, Spain, Bangladesh, Netherlands, Switzerland and Ethiopia. They were reported as reviews (4), policy or guidance documents (3), experimental studies (2), case reports (2), expert commentary (1), phenomenological study (1), and decision-making trial and evaluation laboratory trial (1). The findings were presented in three themes: (i) regulatory requirements for cold-chain logistics, (ii) packaging and storage, and (iii) transportation and distribution. A conceptual framework emerged linking regulatory requirements, optimal logistics operation and formulation stability as the key to efficient cold chain management. Recommendations were made for improving formulation stability, end-product storage conditions, and incorporating monitoring technologies.

Conclusion

COVID-19 vaccines require special end-to-end supply cold chain requirements, from manufacture, and transportation to warehouses and healthcare facilities. To sustain production, minimise wastage, and for vaccines to reach target populations, an efficient and resilient vaccine supply chain which is assisted by temperature monitoring technologies is imperative.

Supplementary Information

The online version contains supplementary material available at 10.1186/s40545-022-00411-5.

Keywords: Cold chain logistics, mRNA vaccines, Adenovirus vector, Supply and distribution chain, Equitable access, Temperature control, Biologics

Background

The COVID-19 outbreak had single-handedly crippled healthcare systems, induced political instability, and transformed cultural and social norms worldwide. At the financial forefronts, and as part of Operation Warp Speed, the US government had invested an initial $6.5 billion (pound;4.8 billion equivalent) in COVID-19 therapeutics and vaccines—an effort aimed at delivering 300 million doses of vaccines, with first doses made available as early as January 2021 [1]. The amount included at least $1 billion (pound;738 million equivalent) each to Novavax, the University of Oxford and AstraZeneca, GlaxoSmithKline and Sanofi, and Johnson amp; Johnson. Similarly, the UK government in the early stages purchased a total of 340 million doses at fixed prices, while Australia had invested approximately A$3.3 billion (pound;1.7 billion equivalent) for five different vaccines [1].

Recently, the World Health Organisation (WHO), by observations of superspreading events, uncovered that COVID-19 transmissions are airborne and that containing the outbreak will, therefore, be challenging [2]. The organisation recommends that general ventilation is supplemented with airborne infection controls, such as local exhaust, high efficiency air filtration, and germicidal ultraviolet lights, particularly in hospitals, schools, public buildings, workplace environments, and aged care homes. On the parallel, maintaining hygiene and good hand-washing techniques, practising social distancing, efficient contact tracing and mass-testing, and droplet precautions are still advocated, at the time of writi

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新冠疫情背景下医药行业冷链运输研究

引用文献：

COVID-19疫苗冷链物流管理：一个范围回顾

原文作者：Fahrni Mathumalar Loganathan;ensp;Ismail Intan An Nisaarsquo;;ensp;Refi Dalia Mohammed;ensp;Almeman Ahmad;ensp;Yaakob Norliana Che;ensp;Saman Kamaliah Md;ensp;Mansor Nur Farhani;ensp;Noordin Noorasmah;ensp;Babar Zaheer Ud Din

COVID-19冠状病毒疾病的爆发，导致了医疗系统的单一瘫痪，引发了政治不稳定，改变了世界范围内的文化和社会规范。在财政前线，作为运营速度的一部分，美国政府在C0VID-19治疗和疫苗中投入了65亿美元（相当于48亿英镑），旨在提供3亿剂疫苗，其中最早的剂量是在2021年1月获得的。其中包括诺瓦克斯、牛津大学和阿斯利康、葛兰素史克和赛诺菲以及强生公司各获得至少10亿美元（相当于7.38亿英镑）。同样，英国政府在早期阶段以固定价格总共购买了3.4亿剂疫苗，而澳大利亚则为五种不同的疫苗投资了约33亿澳元（约合17亿英镑）。最近，世界卫生组织（WHO）通过对超级传播事件的观察发现，COVID-19的传输是机载的，因此爆发的将是具有挑战性的。该组织建议，特别是在医院、学校、公共建筑、工作场所环境和老年护理院，全面通风应辅以空气传播感染控制，如局部排气、高效空气过滤和杀菌紫外线灯。与此同时，在撰写本文时，仍提倡保持卫生和良好的洗手技术、保持社交距离、有效的接触追踪和大规模检测，以及预防雾滴。显然，以这样的规模和速度接种疫苗，包括加强注射，从来没有这样做过。制药公司专注于满足COVID-19疫苗供应的需求，并展示其在所有特殊利益集团中各自的候选疫苗的良好免疫应答和合理安全性的结果。直到2021年5月，在CVID-19的170个候选疫苗中，研究人员在正在进行的人类临床试验中测试了90种疫苗，其中27种已进入第3阶段，并被批准用于不同国家的人群，并且目前正在进行疫苗免疫后的不良反应监测。虽然我们不断地面临着发展后免疫的不利影响的风险，并且出现了更有力的变异并产生新的感染波，但我们仍然依赖于由COVID-19疫苗提供的主动获得性免疫。

全球2019冠状病毒疾病疫苗接种政策表明，不同群体疫苗的传播和推广在很大程度上是普遍的，或者至少是弱势群体的目标是。厄立特里亚有一个例外，该国人口中没有人接种疫苗。在阿富汗和利比里亚，疫苗可供其主要工作人员、临床弱势群体或老年群体使用。沙特政府记录到，到2022年2月初，成功施用了5900万剂，其中100万剂分配给了老年人[4]。虽然有几个国家没有报告其疫苗接种数据，但大多数国家都成立了特别工作组来管理疫苗和相关数据。东南亚的情况也不例外。2019冠状病毒疾病2019冠状病毒疾病疫苗接种委员会，在马来西亚，例如一个特别委员会，被称为确保获得COVID-19疫苗供应的特别委员会，JKVAV，负责确保及时进入COVID-19疫苗供应。除了JKJAV，NPRA在确保疫苗的效力、质量和安全性方面发挥着至关重要的作用。六的COVID-19疫苗，从辉瑞BioTeCo（CimiARTY），牛津阿斯利康（VAXZEVIRAA），SoOVAC（CARONAVAC），CVILO（SoopPurm），约翰逊和约翰逊（詹森COVID-19疫苗），和CanSino（ValIDeCiA）已经获得了来自监管机构的有条件的批准。在感染率不断上升的浪潮之后，截至2022年2月10日，该国98%有资格接种疫苗的成年人口已经完成了所需剂量并成功接种，而53.9%的人已经接受了加强注射[6]。为5岁以下的青少年和幼儿以及其他特殊利益群体接种疫苗的计划已经获得批准，并正在分阶段推出[7]。2019冠状病毒疾病疫苗的大规模生产、储存和分发相关问题仍在研究和报道中。这些挑战如果不及时解决，将严重影响我们实现群体免疫的竞赛。“冷链”的作用是通过确保疫苗在推荐的温度范围内储存和运输，从生产时到给药时保持生物产品的质量。疫苗可根据其开发方法进行分类，即使用的不同方法，例如使用mRNA使机体产生病毒蛋白的基因疫苗；使用腺病毒等转基因病毒携带冠状病毒遗传物质片段的病毒载体疫苗；提供病毒蛋白质（但不是遗传物质）以诱导免疫反应的蛋白质疫苗；灭活或减毒冠状病毒全株疫苗；重新利用现有疫苗，如卡介苗。由于涉及极端的温度，因此，导致微妙和脆弱疫苗的成功研发和管理的过程将谨慎进行。因此，这使得其冷链的管理成为高度优先事项，疫苗的处理要谨慎，否则，后果可能对公共健康有害。2019冠状病毒疾病的研究结果是，总结和综合证据，为COVID-19疫苗的有效冷链管理，并提出相关的实际建议。

冷链可以是标准（-2°C至-8°C）或Deepfreze（尽可能冷）minus;70摄氏度）。冷链需要建立广泛的基础设施，维护成本非常高。冷链的复杂性如CDC疫苗储存和处理工具包[12]等文件所示。疫苗冷链物流的有效管理需要在各个流程之间进行精确协调，以确保通过温度监测和可追溯性的最新记录来保持疫苗的效力[7]。目前，在生产、多式联运、储存、分发和向需要疫苗的人平等支付疫苗方面存在着制约因素。在欧盟委员会（EC）资助的冷藏项目中，大多数与易腐商品（包括疫苗）的高质量标准的偏差发生在装运和运输过程中。如果检测到偏差，则归因于缺乏适当的冷链设备，如冷链箱、冷链卡车和高效制冷系统。此外，接受疫苗和维护相关冷链设备的管理人员的作用值得认可。他们还负责运送重组注射器、安全箱和疫苗稀释剂（不需要冷藏）。此外，经理的任务是满足不断变化的冷藏需求，并在需要时腾出更多空间。

理想情况下，2019冠状病毒疾病疫苗供应链管理者将获得获得这些医疗对策的预先批准。为做好后续配送的准备，确定了作为最终用户重要路线的运输走廊；对从入口到配送点的主要和次要运输方式进行了评估。在此过程中，还将在中权衡对各自政府和非政府组织应对紧急情况的能力的评估，包括检查政策、海关、港口、航空、铁路和公路运营、储存、疫苗供应、通信、电力和燃料生产、供应和分配。了解供应链中的每个系统性环节，包括它们的优势和不足，以及潜在的解决方案或替代方案是至关重要的。此外，政府、联合国机构、非政府组织和私营部门实体之间的职能联系都是业务的关键方面。了解区域和国家两级在地理位置上的业务连续性工作的程度也至关重要。

外文文献出处：Journal of Pharmaceutical Policy and PracticeVolume 15, Issue 1. 2022. PP 16-16

附外文文献原文：

The COVID-19 outbreak had single-handedly crippled healthcare systems, induced political instability, and transformed cultural and social norms worldwide. At the financial forefronts, and as part of Operation Warp Speed, the US government had invested an initial $6.5 billion (pound;4.8 billion equivalent) in COVID-19 therapeutics and vaccines—an effort aimed at delivering 300 million doses of vaccines, with first doses made available as early as January 2021 [1]. The amount included at least $1 billion (pound;738 million equivalent) each to Novavax, the University of Oxford and AstraZeneca, GlaxoSmithKline and Sanofi, and Johnson amp; Johnson. Similarly, the UK government in the early stages purchased a total of 340 million doses at fixed prices, while Australia had invested approximately A$3.3 billion (pound;1.7 billion equivalent) for five different vaccines [1].

Recently, the World Health Organisation (WHO), by observations of superspreading events, uncovered that COVID-19 transmissions are airborne and that containing the outbreak will, therefore, be challenging [2]. The organisation recommends that general ventilation is supplemented with airborne infection controls, such as local exhaust, high efficiency air filtration, and germicidal ultraviolet lights, particularly in hospitals, schools, public buildings, workplace environments, and aged care homes. On the parallel, maintaining hygiene and good hand-washing techniques, practising social distancing, efficient contact tracing and mass-testing, and droplet precautions are still advocated, at the time of writing.

Evidently, administering vaccines including booster shots on this scale and at this speed has never been done. Pharmaceutical companies are focused on meeting the demands for COVID-19 vaccine supply, and on demonstrating results of good immune responses and reasonable safety profiles of their respective candidate vaccines in all special interest groups. Up until May 2021, of the 170 vaccine candidates for COVID-19 developed, researchers were testing 90 vaccines in ongoing human clinical trials, with 27 having reached phase 3 and approved to be used for the population in various countries and currently undergoing post-marketing surveillance for adverse effect following immunisations [3]. While we constantly face the risks of adverse effects developing post-immunisation, and more potent variants emerging and creating new waves of infections, we continue to rely on the active acquired immunity offered by the COVID-19 vaccines.

The global data for COVID-19 vaccination policy demonstrated that the delivery and outreach of the vaccines for the different groups have been largely universal or that at least the vulnerable groups were targeted [4]. An exception existed for Eritrea, where none of its population was provided with the vaccine. In Afghanistan and Liberia, the vaccines were available for either their key workers or clinically vulnerable groups or the older-age groups. The Saudi government recorded that by early February 2022, 59 million doses were successfully adminis

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