Adverse events following immunization reported with COVID-19 vaccines in Burkina Faso: Analysis of spontaneous reports

被引:1
作者
Sawadogo, Ruth [1 ,2 ]
Ouoba, Joel [1 ]
Ilboudo, Dieudonne [1 ]
Tchoumbi, Edmond [1 ]
Lankoande-Haro, Sougrimani [2 ]
Fofana, Souleymane [1 ,3 ]
Sombie, Issiaka [1 ,4 ]
Samadoulougou, Sekou [5 ,6 ]
Kirakoya-Samadoulougou, Fati [6 ]
机构
[1] Univ Nazi BONI UNB, Inst Super Sci Sante INSSA, Bobo Dioulasso, Burkina Faso
[2] Minist Sante, Agence Natl Regulat Pharmaceut ANRP, Ouagadougou, Burkina Faso
[3] Ctr Hosp Univ Souro SANOU CHUSS, Dept Pharm, Serv Pharmacovigilance Pharm Clin & Assurance Qua, Bobo Dioulasso, Burkina Faso
[4] Org Ouest Africaine Sante OOAS, Dept Sante Publ & Rech, 175 Ave Ouezzin Coulibaly, Bobo Dioulasso, Burkina Faso
[5] Laval Univ, Inst Univ Cardiol & Pneumol Quebec, Quebec City, PQ, Canada
[6] Univ Libre Bruxelles ULB, Ctr Rech Epidemiol Biostat & Rech Clin, Ecole Sante Publ, Route Lennik 808, B-1070 Brussels, Belgium
来源
SANTE PUBLIQUE | 2023年 / 35卷 / 06期
关键词
COVID-19; vaccines; Vaccination; Adverse event following immunization; VigiBase; Burkina Faso;
D O I
10.3917/spub.236.0149
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
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.
引用
收藏
页码:149 / 159
页数:11
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