Building capacity for active surveillance of vaccine adverse events in the Americas: A hospital-based multi-country network

• Published in: Vaccine Vol. 36; no. 3; pp. 363 - 370
• Main Authors: Bravo-Alcántara, Pamela, Pérez-Vilar, Silvia, Molina-León, Helvert Felipe, Sturkenboom, Miriam, Black, Steven, Zuber, Patrick L.F., Maure, Christine, Castro, Jose Luis, Castellano, Vanesa E., Chiarvetti, Lucia, Falcó, Adriana, Gentile, Angela, Guirau, Karina, Carrega, Maria Eugenia Pérez, Rasjido, Susana, Testino, Sofía, Vizzotti, Carla, Avendaño, Marcela, González, Marcela, Lagos, Rosanna, Maturana, Marcelo, Muñoz, Fernando, Saldaña, Adiela, Soza, Guillermo, Álvarez-Olmos, Martha, Sastoque, Luz Amparo, Mezerville, Marcela Hernández-de, Machado, Vicenta, Roverssi, Ileana, Camacho, Angélica Vargas, Luque, Marco Tulio, Mendoza, Liset, Hernández, Renne F. Aquije, Díaz, Maria Esther Castillo, Mamani, Gladys Turpo, Giachetto, Gustavo, Speranza, Noelia, Zunino, Carlos
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 08.01.2018; Elsevier Limited
• Subjects: Adverse events following immunization (AEFI); Americas - epidemiology; Aseptic meningitis; Capacity Building - organization & administration; Collaboration; Data collection; Drug dosages; Drug-Related Side Effects and Adverse Reactions - epidemiology; Epidemiological Monitoring; Epidemiology; Feasibility studies; Global Vaccine Safety Initiative (GVSI); Hospitals; Humans; Hypothesis testing; Immunization; Income; Initiatives; International Cooperation; Laboratories; Measles; Measles-Mumps-Rubella Vaccine - administration & dosage; Measles-Mumps-Rubella Vaccine - adverse effects; Meningitis; Meningitis, Aseptic - epidemiology; Mumps; Pediatrics; Pharmacology; Pharmacovigilance; Post-marketing surveillance; Proof of Concept Study; Purpura; Purpura, Thrombocytopenic, Idiopathic - epidemiology; Quality; Retrospective Studies; Rubella; Safety; Surveillance; Thrombocytopenic purpura; Vaccine safety; Vaccines; World Health Organization; MMR; ITP; SCCS; LMIC; PAHO/WHO; AEFI; Vaccine safety; Global Vaccine Safety Initiative (GVSI); ICD; Adverse events following immunization (AEFI); WHO; Post-marketing surveillance
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2017.04.069

New vaccines designed to prevent diseases endemic in low and middle-income countries are being introduced without prior utilization in countries with robust vaccine pharmacovigilance systems. Our aim was to build capacity for active surveillance of vaccine adverse events in the Americas. We describe the implementation of a proof-of-concept study for the feasibility of an international collaborative hospital-based active surveillance system for vaccine safety. The study was developed and implemented in 15 sentinel sites located in seven countries of the region of the Americas, under the umbrella of the World Health Organization (WHO) Global Vaccine Safety Initiative. The study evaluated the associations between measles-mumps-rubella vaccines and two well-recognized adverse events: Immune thrombocytopenic purpura (ITP) and aseptic meningitis. The regional network contributed 63 confirmed ITP and 16 confirmed aseptic meningitis eligible cases to the global study, representing, respectively, 33% and 19% of the total cases. To ensure long-term sustainability and usefulness to investigate adverse events following new vaccine introductions in low and middle-income countries, the network needs to be strengthened with additional sites and integrated into national health systems.