title: Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010-2013.
abstract: BACKGROUND
  The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns.
  
  
  METHODS
  National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects.
  
  
  RESULTS
  Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits.
  
  
  CONCLUSIONS
  Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Fabien V K
authors.initials: FV
authors.lastname: Diomandé
authors.affiliation: Institut Supérieur des Sciences de la Santé, Université Polytechnique de Bobo-Dioulasso, Burkina Faso.
authors.forename: Téné M
authors.initials: TM
authors.lastname: Yaméogo
authors.affiliation: Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.
authors.forename: Kirsten S
authors.initials: KS
authors.lastname: Vannice
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Preziosi
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Viviani
authors.affiliation: Direction Générale de la Pharmacie du Médicament et des Laboratoire, Ministère de la santé, Ouagadougou, Burkina Faso.
authors.forename: Claude-Roger
authors.initials: CR
authors.lastname: Ouandaogo
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Modibo
authors.initials: M
authors.lastname: Keita
authors.affiliation: Inter-country Support Team for West Africa, World Health Organization, Ouagadougou, Burkina Faso.
authors.forename: Mamoudou H
authors.initials: MH
authors.lastname: Djingarey
authors.affiliation: Inter-country Support Team for West Africa, World Health Organization, Ouagadougou, Burkina Faso.
authors.forename: Nehemie
authors.initials: N
authors.lastname: Mbakuliyemo
authors.affiliation: Department of Immunization Vaccines and Emergency, World Health Organization, Regional Office for Africa, Brazzaville, Republic of Congo.
authors.forename: Bartholomew Dicky
authors.initials: BD
authors.lastname: Akanmori
authors.affiliation: Centre pour le Développement des Vaccins, Ministère de la Santé, Bamako, Mali.
authors.forename: Samba O
authors.initials: SO
authors.lastname: Sow
authors.affiliation: Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland.
authors.forename: Patrick L F
authors.initials: PL
authors.lastname: Zuber
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000349:Africa; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D060735:Pharmacovigilance; D055815:Young Adult
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines
keywords: AEFI; African meningitis belt; PsA-TT; group A meningococcal vaccine; pharmacovigilance systems