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.

Additional Metadata
Keywords Adverse events following immunization (AEFI), Global Vaccine Safety Initiative (GVSI), Post-marketing surveillance, Vaccine safety
Persistent URL dx.doi.org/10.1016/j.vaccine.2017.04.069, hdl.handle.net/1765/112359
Journal Vaccine
Citation
Bravo-Alcántara, P. (Pamela), Pérez-Vilar, S, Molina-León, H.F. (Helvert Felipe), Sturkenboom, M.C.J.M, Black, S, Zuber, P, … Zunino, C. (Carlos). (2018). Building capacity for active surveillance of vaccine adverse events in the Americas: A hospital-based multi-country network. Vaccine, 36(3), 363–370. doi:10.1016/j.vaccine.2017.04.069