TY - JOUR
T1 - Building capacity for active surveillance of vaccine adverse events in the Americas
T2 - A hospital-based multi-country network
AU - Bravo-Alcantara, Pamela
AU - Perez-Vilar, Silvia
AU - Molina-Leon, Helvert Felipe
AU - Sturkenboom, Miriam
AU - Black, Steven
AU - Zuber, Patrick L. F.
AU - Maure, Christine
AU - Castro, Jose Luis
N1 - Funding Information:
Center for Biologics Evaluation and Research (CBER)-U.S. Food and Drug Administration (FDA) funded this project (Grant number U01 FD004575).
Publisher Copyright:
© 2017 Pan American Health Organization
PY - 2018/1/8
Y1 - 2018/1/8
N2 - 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.
AB - 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.
KW - Adverse events following immunization (AEFI)
KW - Global Vaccine Safety Initiative (GVSI)
KW - Post-marketing surveillance
KW - Vaccine safety
UR - http://www.scopus.com/inward/record.url?scp=85028310288&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2017.04.069
DO - 10.1016/j.vaccine.2017.04.069
M3 - Article
AN - SCOPUS:85028310288
SN - 0264-410X
VL - 36
SP - 363
EP - 370
JO - Vaccine
JF - Vaccine
IS - 3
ER -