Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon

BackgroundA national Oral Cholera Vaccine (OCV) Euvichol-Plus® campaign was launched in Lebanon, in response to the first outbreak in three decades, recorded in October 2022. The OCV vaccination campaign was carried out between November 2022 and February 2023. This study aims to cover adverse events...

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Main Authors: Abeer Zeitoun, Aya Ibrahim, Sarah Reda El Sayed, Eva Hobeika, Rita Karam
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-11-01
Series:Frontiers in Public Health
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Online Access:https://www.frontiersin.org/articles/10.3389/fpubh.2024.1480744/full
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author Abeer Zeitoun
Aya Ibrahim
Sarah Reda El Sayed
Eva Hobeika
Rita Karam
Rita Karam
Rita Karam
author_facet Abeer Zeitoun
Aya Ibrahim
Sarah Reda El Sayed
Eva Hobeika
Rita Karam
Rita Karam
Rita Karam
author_sort Abeer Zeitoun
collection DOAJ
description BackgroundA national Oral Cholera Vaccine (OCV) Euvichol-Plus® campaign was launched in Lebanon, in response to the first outbreak in three decades, recorded in October 2022. The OCV vaccination campaign was carried out between November 2022 and February 2023. This study aims to cover adverse events reports, received at the Lebanese National Pharmacovigilance Program’s (LNPVP) passive surveillance system.MethodsCase reports were extracted from the LNPVP’s database. SPSS software was used to perform statistical analysis, with categorical variables compared using Pearson’s χ2 test. A descriptive analysis was performed based on age, gender, vaccine administered, and adverse event(s) associated with the administered vaccine.ResultsA total of 115 Adverse Events Following Immunization (AEFIs) were reported, which corresponded to 46 case reports. The top three reported AEFIs were fever (39.13%), diarrhea (30.43%), and vomiting (30.43%). Reported cases were non-serious (82.6%). The highest proportion of Individual Case Safety Reports (ICSRs) received is attributed to females (56.5%), and the age category of 2 and 11 years old (41.3%). Reporters’ age range was 1–74 years old.ConclusionMonitoring AEFIs through the cholera outbreak’s emergency campaign favors the safety profile of OCV.
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spelling doaj-art-bb2400ffa56a42f1adc209a892d6b0142024-11-20T06:27:43ZengFrontiers Media S.A.Frontiers in Public Health2296-25652024-11-011210.3389/fpubh.2024.14807441480744Descriptive analysis of adverse events following immunization with oral cholera vaccine in LebanonAbeer Zeitoun0Aya Ibrahim1Sarah Reda El Sayed2Eva Hobeika3Rita Karam4Rita Karam5Rita Karam6Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, LebanonQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, LebanonQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, LebanonFaculty of Arts and Sciences, Holy Spirit University of Kaslik, Beirut, LebanonQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, LebanonDepartment of Chemistry and Biochemistry, Faculty of Sciences, Lebanese University, Beirut, LebanonPharmacology Department, Faculty of Medical Sciences, Lebanese University, Beirut, LebanonBackgroundA national Oral Cholera Vaccine (OCV) Euvichol-Plus® campaign was launched in Lebanon, in response to the first outbreak in three decades, recorded in October 2022. The OCV vaccination campaign was carried out between November 2022 and February 2023. This study aims to cover adverse events reports, received at the Lebanese National Pharmacovigilance Program’s (LNPVP) passive surveillance system.MethodsCase reports were extracted from the LNPVP’s database. SPSS software was used to perform statistical analysis, with categorical variables compared using Pearson’s χ2 test. A descriptive analysis was performed based on age, gender, vaccine administered, and adverse event(s) associated with the administered vaccine.ResultsA total of 115 Adverse Events Following Immunization (AEFIs) were reported, which corresponded to 46 case reports. The top three reported AEFIs were fever (39.13%), diarrhea (30.43%), and vomiting (30.43%). Reported cases were non-serious (82.6%). The highest proportion of Individual Case Safety Reports (ICSRs) received is attributed to females (56.5%), and the age category of 2 and 11 years old (41.3%). Reporters’ age range was 1–74 years old.ConclusionMonitoring AEFIs through the cholera outbreak’s emergency campaign favors the safety profile of OCV.https://www.frontiersin.org/articles/10.3389/fpubh.2024.1480744/fulloral cholera vaccineadverse events following immunizationvaccinespharmacovigilancecholeradescriptive analysis
spellingShingle Abeer Zeitoun
Aya Ibrahim
Sarah Reda El Sayed
Eva Hobeika
Rita Karam
Rita Karam
Rita Karam
Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
Frontiers in Public Health
oral cholera vaccine
adverse events following immunization
vaccines
pharmacovigilance
cholera
descriptive analysis
title Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
title_full Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
title_fullStr Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
title_full_unstemmed Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
title_short Descriptive analysis of adverse events following immunization with oral cholera vaccine in Lebanon
title_sort descriptive analysis of adverse events following immunization with oral cholera vaccine in lebanon
topic oral cholera vaccine
adverse events following immunization
vaccines
pharmacovigilance
cholera
descriptive analysis
url https://www.frontiersin.org/articles/10.3389/fpubh.2024.1480744/full
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