| アブストラクト | The association between vaccines and peripheral facial palsy (PFP), an issue that has been the subject of debate for many years, has been raised again following results of clinical trials assessing mRNA based COVID-19 vaccines. To review the available literature on this topic, PubMed was searched from inception until February 25, 2022. Inclusion criteria were case reports with documented rechallenge and comparative epidemiological studies. Cases of COVID-19 vaccine-induced PFP with available data on vaccine rechallenge were also identified from Vigibase until December 31, 2021. Of the 347 articles retrieved, 32 comparative epidemiological studies, 1 meta-analysis and 4 case reports met our criteria, of which 13 involved COVID-19 vaccines. Eight studies found an association between at least one vaccine and the occurrence of PFP, whereas 24 did not. Positive studies involved seasonal or pandemic H1N1 influenza vaccines administered parenterally (4 studies) or intranasally (1 study with a toxin-adjuvanted vaccine), BNT162b2, a mRNA COVID-19 vaccine (1 disproportionality analysis and 1 observed-to-expected analysis) and an inactivated virus COVID-19 vaccine (CoronaVac(R)) (1 study combining a case-control and an observed-to-expected approach). Strong evidence was found only for the intranasal influenza vaccine while other positive studies detected only a marginal association between PFP and vaccination. Of the four case reports with documented rechallenge, only two were positive and involved an influenza vaccine and tozinameran in one case each. In Vigibase, rechallenge was documented in 49 reports with 29 (59.2%) cases being negative and 20 (40.8%) positive. The available data did not confirm an excess risk of PFP after vaccination in most studies. Moreover, of the eight epidemiological studies suggesting a possible excess risk of PFP after any vaccine, three were disproportionality analyses and two observed-to excepted analyses, suggesting great caution should be taken when interpreting these results. |
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| ジャーナル名 | Therapie |
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| 投稿日 | 2022/8/30 |
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| 投稿者 | Bertin, Blandine; Grenet, Guillaume; Pizzoglio-Billaudaz, Veronique; Lepelley, Marion; Atzenhoffer, Marina; Vial, Thierry |
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| 組織名 | Pharmacovigilance Center, Hospital University Pharmacotoxicology Department,;Hospices civils de Lyon, 69003 Lyon, France.;Poison control and toxicovigilance center, Hospital University Pharmacotoxicology;Department, Hospices civils de Lyon, 69003 Lyon, France; Laboratoire de Biometrie;et Biologie Evolutive UMR 5558, CNRS, Universite Lyon 1, Universite de Lyon,;69100 Villeurbanne, France.;Clinical Pharmacology and Pharmacovigilance Department, Grenoble Alpes University;Hospital, 38000 Grenoble, France.;Hospices civils de Lyon, 69003 Lyon, France. Electronic address:;thierry.vial@chu-lyon.fr. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36038397/ |
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