Article(id=1198624469112685379, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1198624466902287155, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2022-1099, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1665331200000, receivedDateStr=2022-10-10, revisedDate=1678550400000, revisedDateStr=2023-03-12, acceptedDate=null, acceptedDateStr=null, onlineDate=1763703942802, onlineDateStr=2025-11-21, pubDate=1681228800000, pubDateStr=2023-04-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763703942802, onlineIssueDateStr=2025-11-21, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763703942802, creator=13701087609, updateTime=1763703942802, updator=13701087609, issue=Issue{id=1198624466902287155, tenantId=1146029695717560320, journalId=1189982191388893191, year='2023', volume='58', issue='4', pageStart='1', pageEnd='1092', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1763703942275, creator=13701087609, updateTime=1763704125380, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1198625234971619912, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1198624466902287155, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1198625234971619913, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1198624466902287155, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=867, endPage=874, ext={EN=ArticleExt(id=1198624470203204434, articleId=1198624469112685379, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Allergic reactions of COVID-19 vaccine based on mRNA-LNP and its pharmacokinetics in vivo, columnId=null, journalTitle=Acta Pharmaceutica Sinica, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Vaccination has been proved to be the most effective strategy to prevent the Corona Virus Disease 2019 (COVID-19). The mRNA vaccine based on nano drug delivery system (NDDS) - lipid nanoparticles (LNP) has been widely used because of its high effectiveness and safety. Although there have been reports of severe allergic reactions caused by mRNA-LNP vaccines, the mechanism and components of anaphylaxis have not been completely clarified yet. This review focuses on two mRNA-LNP vaccines, BNT162b2 and mRNA-1273. After summarizing the structural characteristics, potential allergens, possible allergic reaction mechanism, and pharmacokinetics of mRNA and LNP in vivo, this article then reviews the evaluation methods for patients with allergic history, as well as the regulations of different countries and regions on people who should not be vaccinated, in order to promote more safe injection of vaccines. LNP has become a recognized highly customizable nucleic acid delivery vector, which not only shows its value in mRNA vaccines, but also has great potential in treating rare diseases, cancers and other broad fields in the future. At the moment when mRNA-LNP vaccines open a new era of nano medicine, it is expected to provide some inspiration for safety research in the process of research, development and evaluation of more nano delivery drugs, and promote more nano drugs successfully to market.

, correspAuthors=Bo ZHANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2023 Acta Pharmaceutica Sinica. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Chun-su LIANG, Wei ZUO, Li-ping DU, Bo ZHANG), CN=ArticleExt(id=1198624471532798879, articleId=1198624469112685379, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=mRNA-LNP新冠疫苗过敏反应及其体内药代动力学, columnId=1198624468278018876, journalTitle=药学学报, columnName=专题报道: 纳米药物药代动力学研究, runingTitle=null, highlight=null, articleAbstract=

接种新型冠状病毒感染(Corona Virus Disease 2019, COVID-19) 疫苗在阻止COVID-19中起到了关键作用。基于纳米药物递送系统(nano drug delivery system, NDDS)——脂质纳米粒(lipid nanoparticles, LNP) 的mRNA疫苗因其较高的有效性和安全性已实现了广泛应用。尽管已有基于mRNA-LNP的新冠疫苗严重过敏反应的报道, 但目前过敏反应发生的机制和成分尚未完全明确。本文关注BNT162b2和mRNA-1273两种已上市的mRNA-LNP新冠疫苗, 在讨论其结构特点、潜在的过敏原、过敏反应机制、mRNA和LNP的体内药代动力学之后, 还对有过敏史人群的评估方法, 以及各国家、地区对接种疫苗人群的范围进行综述, 以期在一定程度上促进疫苗的安全接种。LNP已成为一种公认的高度可定制的核酸递送载体, 不仅在mRNA疫苗中显示出价值, 在治疗罕见疾病和癌症等广阔领域更有着巨大的潜力。在mRNA-LNP疫苗开启纳米医学的新时代之际, 期望能为更多纳米递送药物研发及评价过程中安全性研究提供一些启发, 助力更多纳米药物成功实现临床转化。

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Vaccine, 2022, 40: 5322-5332., articleTitle=Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: a multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial, refAbstract=null)], funds=[Fund(id=1198702042811302499, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, awardId=2022-PUMCH-B-059, language=CN, fundingSource=中央高水平医院临床科研业务费(2022-PUMCH-B-059), fundOrder=null, country=null), Fund(id=1198702043050377850, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, awardId=2022-PUMCH-B-060, language=CN, fundingSource=中央高水平医院临床科研业务费(2022-PUMCH-B-060), fundOrder=null, country=null), Fund(id=1198702043218150027, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, awardId=2022-PUMCH-A-199, language=CN, fundingSource=中央高水平医院临床科研业务费(2022-PUMCH-A-199), fundOrder=null, country=null), Fund(id=1198702043343979160, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, awardId=2021-I2M-1-003, language=CN, fundingSource=中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-003), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1198702036905721916, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, xref=null, ext=[AuthorCompanyExt(id=1198702036909916221, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, companyId=1198702036905721916, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China), AuthorCompanyExt(id=1198702036918304830, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, companyId=1198702036905721916, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=中国医学科学院, 北京协和医院药剂科, 北京 100730)])], figs=[ArticleFig(id=1198702041628508640, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, language=EN, label=null, caption=null, figureFileSmall=3crsL8huvpFoOO3ro+v7hg==, figureFileBig=3ryZvCipFARJQA9BxArAPg==, tableContent=null), ArticleFig(id=1198702041855001069, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, language=CN, label=Figure 1, caption= , figureFileSmall=3crsL8huvpFoOO3ro+v7hg==, figureFileBig=3ryZvCipFARJQA9BxArAPg==, tableContent=null), ArticleFig(id=1198702042056327686, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, language=EN, label=null, caption=null, figureFileSmall=1bZSAWJLNzZbtA2yEDObUQ==, figureFileBig=7hJWupllliEro9+mdXYgTg==, tableContent=null), ArticleFig(id=1198702042194739732, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, language=CN, label=Figure 2, caption= , figureFileSmall=1bZSAWJLNzZbtA2yEDObUQ==, figureFileBig=7hJWupllliEro9+mdXYgTg==, tableContent=null), ArticleFig(id=1198702042345734698, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=

Description	Pfizer-BioNTech BNT162h2 mRNA-LNP SARS-CoV-2 vaccine	Moderna 1273 mRNA-LNP SARS-CoV-2 vaccine
Active component[20]	mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2
Carrier or vector[20]	PEGylated lipid nanoparticle
mRNA dose[22]	30 μg in 0.3 mL	100 μg in 0.5 mL
LNPs[22]	0.43 mg ALC-0315 (((4-hydroxybutyl) azanediyl)bis (hexane-6, 1-diyl)bis(2-hexyldecanoate)), 0.05 mg ALC-0159 (2-((polyethyleneglycol)-2000)-N,N-ditetradecylacetamide), 0.09 mg DSPC, 0.2 mg cholesterol, total lipids: 2.57 mg·mL-1, 0.77 mg per 0.3 mL dose	SM-102 (proprietary ionizable lipid) (heptadecan-9-yl-8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy)hexyl)amino)octanoate), PEG2000-DMG (1-monomethoxypolyethyleneglycol 2000-2, 3-dimyristylglycerol), DSPC, cholesterol, total lipids: 3.86 mg·mL-1, 1.93 mg per 0.5 mL dose
Molar lipid ratios (%) (ionizable cationic lipid ∶ PEGylated lipid ∶ DSPC ∶ cholesterol)	46.3∶1.5∶9.4∶42.7	50∶1.5∶10∶38.5
Molar N/P ratio[22]	6	5
Buffer[22]	0.01 mg phosphate (potassium dihydrogen phosphate, 0.07 mg disodium hydrogen phosphate dihydrate)	Tris (tromethamine) (0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride)
Other excipients[22]	0.01 mg potassium chloride, 0.36 mg sodium chloride, 6 mg sucrose, water for injection	0.043 mg acetic acid, 0.12 mg sodium acetate, 43.5 mg sucrose, water for injection

), ArticleFig(id=1198702042505118269, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1198624469112685379, language=CN, label=Table 1, caption=

Composition of Pfizer-BioNTech and Moderna SARS-CoV-2 mRNA vaccines. DSPC: 1, 2-Distearoyl-sn-glycero-3-phosphocholine; LNPs: Lipid nanoparticles

, figureFileSmall=null, figureFileBig=null, tableContent=

Description	Pfizer-BioNTech BNT162h2 mRNA-LNP SARS-CoV-2 vaccine	Moderna 1273 mRNA-LNP SARS-CoV-2 vaccine
Active component[20]	mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2
Carrier or vector[20]	PEGylated lipid nanoparticle
mRNA dose[22]	30 μg in 0.3 mL	100 μg in 0.5 mL
LNPs[22]	0.43 mg ALC-0315 (((4-hydroxybutyl) azanediyl)bis (hexane-6, 1-diyl)bis(2-hexyldecanoate)), 0.05 mg ALC-0159 (2-((polyethyleneglycol)-2000)-N,N-ditetradecylacetamide), 0.09 mg DSPC, 0.2 mg cholesterol, total lipids: 2.57 mg·mL-1, 0.77 mg per 0.3 mL dose	SM-102 (proprietary ionizable lipid) (heptadecan-9-yl-8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy)hexyl)amino)octanoate), PEG2000-DMG (1-monomethoxypolyethyleneglycol 2000-2, 3-dimyristylglycerol), DSPC, cholesterol, total lipids: 3.86 mg·mL-1, 1.93 mg per 0.5 mL dose
Molar lipid ratios (%) (ionizable cationic lipid ∶ PEGylated lipid ∶ DSPC ∶ cholesterol)	46.3∶1.5∶9.4∶42.7	50∶1.5∶10∶38.5
Molar N/P ratio[22]	6	5
Buffer[22]	0.01 mg phosphate (potassium dihydrogen phosphate, 0.07 mg disodium hydrogen phosphate dihydrate)	Tris (tromethamine) (0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride)
Other excipients[22]	0.01 mg potassium chloride, 0.36 mg sodium chloride, 6 mg sucrose, water for injection	0.043 mg acetic acid, 0.12 mg sodium acetate, 43.5 mg sucrose, water for injection

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