The final, formatted version of the article will be published soon.
ORIGINAL RESEARCH article
Front. Public Health
Sec. Infectious Diseases: Epidemiology and Prevention
Volume 12 - 2024 |
doi: 10.3389/fpubh.2024.1480744
Descriptive Analysis of Adverse Events Following Immunization with Oral Cholera Vaccine in Lebanon
Provisionally accepted- 1 Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, Lebanon, Beirut, Lebanon
- 2 Faculty of Arts and Sciences, Holy Spirit University of Kaslik, Jounieh P.O. Box 446, Lebanon, Beirut, Lebanon
- 3 Department of Chemistry and Biochemistry, Faculty of Sciences, Lebanese University, Beirut, Lebanon, Beirut, Lebanon
- 4 Pharmacology Department, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon, Beirut, Lebanon
Background: A 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 to February 2023. This study aims to cover adverse events reports, received at the Lebanese National Pharmacovigilance Program's (LNPVP) passive surveillance system.Methods: Case reports were extracted from the LNPVP's database. SPSS software was used to perform statistical analysis, with categorical variables compared using Pearson's χ 2 test. A descriptive analysis was performed based on age, gender, vaccine administered, and adverse event(s) associated with the administered vaccine.Results: A 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.Monitoring AEFIs through the cholera outbreak's emergency campaign favors the safety profile of OCV.
Keywords: oral cholera vaccine, Adverse events following immunization, Vaccines, Pharmacovigilance, Cholera, descriptive analysis
Received: 14 Aug 2024; Accepted: 04 Nov 2024.
Copyright: © 2024 Zeitoun, Ibrahim, Reda El Sayed, Hobeika and Karam. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Rita Karam, Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, Lebanon, Beirut, Lebanon
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.