Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.
Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.
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考虑在妊娠期使用的COVID-19疫苗组分和平台的安全性：快速审查。
DOI：
10.1016/j.vaccine.2021.08.034
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发表时间：
2021-09-24
期刊：
影响因子：
5.5
通讯作者：
Buekens PM
中科院分区：
文献类型：
--
作者：
Ciapponi A;Bardach A;Mazzoni A;Alconada T;Anderson SA;Argento FJ;Ballivian J;Bok K;Comandé D;Erbelding E;Goucher E;Kampmann B;Karron R;Munoz FM;Palermo MC;Parker EPK;Rodriguez Cairoli F;Santa María V;Stergachis AS;Voss G;Xiong X;Zamora N;Zaraa S;Berrueta M;Buekens PM
迫切需要对妊娠期间COVID-19疫苗的安全性进行快速评估。我们进行了一项快速系统性审查，以评估2020年8月COVID-19疫苗全球计划-孕产妇免疫工作组选定的COVID-19疫苗的安全性，包括其成分及其用于孕妇的其他疫苗的技术平台。我们检索了文献数据库、COVID-19疫苗妊娠登记处，并探索了从开始日期到2021年2月的参考文献列表，无语言限制。由成对的审查者通过COVIDENCE独立选择研究，并进行数据提取和偏倚风险评估。分歧以协商一致方式解决。在PROSPERO上注册（CRD 42021234185）。我们从检索策略中检索到6757条记录和12个COVID-19妊娠登记;纳入了38项临床和非临床研究（涉及2，398，855名妊娠人员和56只妊娠动物）。大多数研究（89%）在高收入国家进行，并且是队列研究（57%）。大多数研究（76%）比较了怀孕三个月期间疫苗暴露与未暴露的情况。在A/H1N1大流行性流感疫苗的背景下，最常见的暴露是AS 03佐剂（n = 24）和铝基佐剂（n = 11）。只有一项研究报告了脂质纳米颗粒COVID-19疫苗中的信使RNA暴露。除1份关于甲型H1N1流感疫苗（佐剂AS 03）的初步报告（作者在更全面的分析中进行了纠正）外，所有研究均得出无安全性问题的结论。这项快速审查没有发现COVID-19疫苗或其组分或平台在用于其他疫苗时与妊娠相关的安全性问题的证据。然而，鉴于其新奇，需要关于几种疫苗平台和组件的进一步数据。我们的研究结果支持世卫组织目前的指导方针，建议孕妇可以考虑接种COVID-19疫苗，特别是如果他们处于高暴露风险或患有增加严重疾病风险的合并症。
Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.
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影响因子：
5.5
作者：
Glenn, Gregory M.;Fries, Louis F.;Flyer, David
通讯作者：
Flyer, David
DOI：
10.1111/1468-0009.12503
发表时间：
2021-06
期刊：
The Milbank quarterly
影响因子：
--
作者：
Eccleston-Turner M;Upton H
通讯作者：
Upton H
DOI：
10.1136/bmj.j2249
发表时间：
2017-05-30
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Feldkamp ML;Carey JC;Byrne JLB;Krikov S;Botto LD
通讯作者：
Botto LD
DOI：
10.1002/14651858.cd001269.pub6
发表时间：
2018-02-01
期刊：
The Cochrane database of systematic reviews
影响因子：
--
作者：
Demicheli, Vittorio;Jefferson, Tom;Di Pietrantonj, Carlo
通讯作者：
Di Pietrantonj, Carlo
影响因子：
4.2
作者：
Chavant, F.;Ingrand, I.;Perault-Pochat, M. C.
通讯作者：
Perault-Pochat, M. C.