| アブストラクト | The rapid deployment of COVID-19 vaccines to a large proportion of the population requires a focus on safety. However, few studies have assessed the safety of COVID-19 vaccines in Africa. In Burkina Faso, this issue has not yet been addressed. The objective of this study was to contribute to the description of the characteristics of adverse events following immunization (AEFIs) related to COVID-19 vaccines in Burkina Faso. This was a cross-sectional descriptive retrospective study of spontaneous reports of COVID-19 vaccine-related AEFIs recorded in VigiBase(R) between June 2021 and November 2022 in Burkina Faso. Individual case safety reports (ICSRs) were extracted from VigiBase(R) using the Anatomical Therapeutic Chemical level 2 (ATC2) code. The proportion of ICSRs according to the reporter's qualification, the reporting rate, the time taken to submit and record ICSRs, and the completeness score were calculated. A total of 973 ICSRs concerned COVID-19 vaccines and represented 32.6% of all 2,988 reports in VigiBase(R). Overall, 82.0% of the reporters were nurses/midwives, 7.8% were physicians, 6.7% were pharmacists, and 3.4% were patients. The median time between the onset of AEFIs and the submission of the report to the Pharmacovigilance Center was 180 days (IQR: 136; 281). The median registration time was 188 days (IQR: 149; 286). The mean ICSR completeness score was 0.8 (standard deviation = 0.1). The overall AEFI reporting rate was 27.8 per 100,000 vaccine doses. The AEFI reporting rates for the ChAdOx1-nCoV-19, JNJ 78436735, Elasomeran, Tozinameran, and HB02 vaccines were 454.2, 17.4, 11.0, 10.2, and 0.4 per 100,000 vaccine doses, respectively. The majority of AEFIs were systemic in nature (90.1%). Headache (21.2%), fever (19.4%), and myalgia (11.0%) were the most frequently reported AEFIs. Eighteen cases (1.8%) of serious AEFIs (9 hospitalizations, 4 life threatening, 3 temporary disabilities, and 2 others unspecified) were reported. The majority of AEFIs reported were systemic in nature and mild. However, there have been reports of serious AEFIs. The overall AEFI reporting rate was low. There is a need to strengthen the monitoring of these vaccines to better organize strategies to optimize the adherence of the population of Burkina Faso. |
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| ジャーナル名 | Sante publique (Vandoeuvre-les-Nancy, France) |
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| 投稿日 | 2024/2/23 |
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| 投稿者 | Sawadogo, Ruth; Ouoba, Joel; Ilboudo, Dieudonne; Tchoumbi, Edmond; Lankoande-Haro, Sougrimani; Fofana, Souleymane; Sombie, Issiaka; Samadoulougou, Sekou; Kirakoya-Samadoulougou, Fati |
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| 組織名 | Institut superieur des sciences de la sante (IN.S.SA), Universite Nazi BONI;(UNB), Bobo-Dioulasso, Burkina Faso;Agence nationale de regulation pharmaceutique (ANRP), ministere de la Sante,;Ouagadougou, Burkina Faso.;Service de pharmacovigilance, pharmacie clinique et assurance qualite des;medicaments, Departement de pharmacie, Centre Hospitalier Universitaire Souro;SANOU (CHUSS), Bobo-Dioulasso, Burkina Faso;Organisation Ouest Africaine de la Sante (OOAS), departement de sante publique et;recherche, 175 avenue Ouezzin Coulibaly, Bobo-Dioulasso, Burkina Faso;Laval University, Institut Universitaire de Cardiologie et de Pneumologie de;Quebec, Canada;Centre de Recherche en Epidemiologie, Biostatistique et Recherche Clinique, Ecole;de Sante Publique, Universite Libre de Bruxelles (ULB), Route de Lennik, 808,;1070 Brussels, Belgium |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38388395/ |
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