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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® between June 2021 and November 2022 in Burkina Faso. Individual case safety reports (ICSRs) were extracted from VigiBase® 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®. 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.

Introduction: Smartphone applications (apps) for pharmacovigilance present an opportunity for integration as cost-effective healthcare service intervention into basic healthcare services in low-resource settings. This study aimed to (i) evaluate the implementation of the Med Safety app in Burkina Faso, and (ii) compare the characteristics of the reports sent by the Med Safety app with those sent on paper form. Methods: The study had two components: (i) a cross-sectional online survey assessing the Med Safety app, and (ii) a retrospective analysis comparing the characteristics of the Med Safety reports with those of the paper form, received by the National Pharmacovigilance Centre of Burkina Faso (CNVPS), from January 1, 2021 to December 31, 2022. We evaluated the success of the implementation of the Med Safety intervention using measures of acceptability, usefulness and feasibility. This assessment involved a set of 14 items rated on a 4-point Likert scale. Acceptability, feasibility, and usefulness were determined based on achieving a total score higher than the mean. Subsequently, we computed the proportion of participants whose overall score for all items exceeded the mean. Continuous and categorical variables were compared using the Wilcoxon rank-sum test and the Chi2 test, respectively. The significance level of the statistical test was set at 5%. Results: The survey participation rate was 51.9% (160/308). Half of the respondents were in the 35-44 age group (50.6%), and participants were predominantly male (71.9%). The Med Safety app was acceptable, feasible, and useful to 58.1% of respondents. The most useful features of the app were "reporting" (53.1%), "news" (13.6%) and "watch list" (12.4%). During the period, a total of 1,472 reports were received, including 357 (24.3%) through Med Safety and 1,115 (75.7%) through the paper form. The reports of adverse events following immunization received at the CNVPS numbered 974 (66.2%), these were related to COVID-19 vaccines, with 256 (26.3%) through the Med Safety and 718 (73.7%) through the paper form. The median time to submit the reports to the CNVPS was 159 (IQR 59–187) days for the Med Safety and 166 (IQR 107–281) days for the paper form (p < 0.001). Conclusion: In Burkina Faso, the Med Safety was found to be acceptable, useful, and feasible by users surveyed. In addition, and compared to the paper form, the app reduces the time to submit a report, and with increase in use, the reporting timeframe could be further improved. [ABSTRACT FROM AUTHOR]