Active Surveillance for Adverse Events After a Mass Vaccination Campaign With a Group A Meningococcal Conjugate Vaccine (PsA-TT) in Mali.

• Type of Material: Article
• Authors: Kirsten S. Vannice, Johns Hopkins University; Modibo Keita, Ministère de la Santé, Mali; Samba O. Sow, Ministère de la Santé, Mali; Anna P. Durbin, Johns Hopkins University; Saad Omer, Emory University; Lawrence H. Moulton, Johns Hopkins University; Téné M. Yaméogo, Université Polytechnique de Bobo-Dioulasso; Patrick L. F. Zuber, World Health Organization; Uma Onwuchekwa, Ministère de la Santé, Mali; Massambou Sacko, World Health Organization; Fabien V. K. Diomandé, 7 Centers for Disease Control and Prevention; Neal A. Halsey, Johns Hopkins University
• Language: English
• Date: 2015-11-15
• Publisher: Oxford University Press (OUP): Policy A1 - Oxford Open Option C
• Publication Version: Final Published Version
• Copyright Statement: © 2015 World Health Organization; license Oxford Journals. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/legalcode), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.
• Final Published Version (URL): http://dx.doi.org/10.1093/cid/civ497
• Title of Journal or Parent Work: Clinical Infectious Diseases
• ISSN: 1058-4838
• Volume: 61
• Issue: Suppl 5
• Start Page: S493
• End Page: S500
• Grant/Funding Information: This article appears as part of the supplement “The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group A Meningococcal Conjugate Vaccine for Africa,” sponsored by the Meningitis Vaccine Project through a grant from the Bill & Melinda Gates Foundation.; Funding for the study in Mali was provided by the WHO and independent funds from the Johns Hopkins Bloomberg School of Public Health.
• Keywords: vaccine safety; MenAfriVac; PsA-TT; meningococcal vaccine; meningitis belt
• Research Categories: Health Sciences, Public Health; Health Sciences, Immunology; Health Sciences, Epidemiology

Abstract

BACKGROUND: The monovalent meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed for use in the "meningitis belt" of sub-Saharan Africa. Mali was 1 of 3 countries selected for early introduction. As this is a new vaccine, postlicensure surveillance is particularly important to identify and characterize possible safety issues. METHODS: The national vaccination campaign was phased from September 2010 to November 2011. We conducted postlicensure safety surveillance for PsA-TT in 40 government clinics from southern Mali serving approximately 400 000 people 1-29 years of age. We conducted analyses with individual-level data and population-level data, and we calculated rates of adverse events using the conditional exact test, a modified vaccine cohort risk interval method, and a modified self-controlled case series method for each outcome of interest, including 18 prespecified adverse events and 18 syndromic categories. RESULTS: An increased rate of clinic visits for fever within 3 days after vaccination was found using multiple methods for all age groups. Although other signals were found with some methods, complete assessment of all other prespecified outcomes and syndromic categories did not reveal that PsA-TT was consistently associated with any other health problem. CONCLUSIONS: No new safety concerns were identified in this study. These results are consistent with prelicensure data and other studies indicating that PsA-TT is safe. The approach presented could serve as a model for future active postlicensure vaccine safety monitoring associated with large-scale immunization campaigns in low-income countries.