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

• DOI: 10.1016/j.vaccine.2017.04.069
• Publication Date: 2017-08-10T10:15:33Z
• Authors: Pamela Bravo-Alcá...; Silvia Pérez-Vilar; Helvert Felipe Mo...; Miriam Sturkenboom; Steven Black; Patrick L.F. Zuber; Christine Maure; Jose Luis Castro; Vanesa E. Castellano; Lucia Chiarvetti; Adriana Falcó; Angela Gentile; Karina Guirau; Maria Eugenia Pér...; Susana Rasjido; Sofía Testino; Carla Vizzotti; Marcela Avendaño; Marcela González; Rosanna Lagos; Marcelo Maturana; Fernando Muñoz; Adiela Saldaña; Guillermo Soza; Martha Álvarez-Olmos; Luz Amparo Sastoque; Marcela Hernández...; Vicenta Machado; Ileana Roverssi; Angélica Vargas C...; Marco Tulio Luque; Liset Mendoza; Renne F. Aquije H...; Maria Esther Cast...; Gladys Turpo Mamani; Gustavo Giachetto; Noelia Speranza; Carlos Zunino
• Keywords: Purpura, Thrombocytopenic, Idiopathic; Capacity Building; Drug-Related Side Effects and Adverse Reactions; International Cooperation; EMC NIHES-03-77-02; World Health Organization; Proof of Concept Study; Hospitals; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; SDG 3 - Good Health and Well-being; Epidemiological Monitoring; Humans; Meningitis, Aseptic; Americas; Measles-Mumps-Rubella Vaccine; Retrospective Studies

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.