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dc.contributor.authorKim, Min Seo
dc.contributor.authorJung, Se Yong
dc.contributor.authorAhn, Jong Gyun
dc.contributor.authorPark, Se Jin
dc.contributor.authorShoenfeld, Yehuda
dc.contributor.authorKronbichler, Andreas
dc.contributor.authorKoyanagi, Ai
dc.contributor.authorDragioti, Elena
dc.contributor.authorTizaoui, Kalthoum
dc.contributor.authorHong, Sung Hwi
dc.contributor.authorJacob, Louis
dc.contributor.authorSalem, Joe-Elie
dc.contributor.authorYon, Dong Keon
dc.contributor.authorLee, Seung Won
dc.contributor.authorOgino, Shuji
dc.contributor.authorKim, Hanna
dc.contributor.authorKim, Jerome H
dc.contributor.authorExcler, Jean-Louis
dc.contributor.authorMarks, Florian
dc.contributor.authorClemens, John D
dc.contributor.authorEisenhut, Michael
dc.contributor.authorBarnett, Yvonne
dc.contributor.authorButler, Laurie
dc.contributor.authorIlie, Cristian Petre
dc.contributor.authorShin, Eui-Cheol
dc.contributor.authorIl Shin, Jae
dc.contributor.authorSmith, Lee
dc.date.accessioned2022-01-06T12:55:36Z
dc.date.available2022-01-06T12:55:36Z
dc.date.issued2022-03
dc.identifier.issn0146-6615
dc.identifier.otherPMC8662238
dc.identifier.other34709664
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/332209
dc.descriptionFunder: New faculty research seed money grant of Yonsei University College of Medicine for 2021 (2021-32-0049).
dc.description.abstractTwo messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.
dc.languageeng
dc.publisherWiley
dc.sourceessn: 1096-9071
dc.sourcenlmid: 7705876
dc.subjectSafety
dc.subjectInfluenza vaccine
dc.subjectMrna Vaccine
dc.subjectVigibase
dc.subjectCovid-19
dc.subjectPost-implementation Surveillance
dc.titleComparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database.
dc.typeArticle
dc.date.updated2022-01-06T12:55:35Z
prism.publicationNameJ Med Virol
dc.identifier.doi10.17863/CAM.79655
dcterms.dateAccepted2021-10-26
rioxxterms.versionofrecord10.1002/jmv.27424
rioxxterms.versionVoR
dc.contributor.orcidKim, Min Seo [0000-0003-2115-7835]
dc.contributor.orcidJung, Se Yong [0000-0003-1337-563X]
dc.contributor.orcidTizaoui, Kalthoum [0000-0001-8524-6058]
dc.contributor.orcidJacob, Louis [0000-0003-1071-1239]
dc.contributor.orcidYon, Dong Keon [0000-0003-1628-9948]
dc.contributor.orcidLee, Seung Won [0000-0001-5632-5208]
dc.contributor.orcidOgino, Shuji [0000-0002-3909-2323]
dc.contributor.orcidShin, Eui-Cheol [0000-0002-6308-9503]
dc.contributor.orcidIl Shin, Jae [0000-0003-2326-1820]
dc.identifier.eissn1096-9071
cam.issuedOnline2021-11-08


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