Building capacity for active surveillance of vaccine adverse events in the Americas: A hospital-based multi-country network |
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| Affiliation: | 1. Unit of Comprehensive Family Immunization, Department of Family, Gender and Life Course, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States;2. Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands;3. International Professional Consultant, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States;4. Vaccine.GRID Foundation, Basel, Switzerland;5. Department of Global Child Health, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States;6. Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland;7. Unit of Medicines and Health Technologies, Department of Health Systems and Services, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States;1. GSK, US Health Outcomes & Epidemiology, Philadelphia, PA;2. GSK, Global Health Economics, Wavre, Belgium;3. RTI Health Solutions, Health Economics, Research Triangle, NC;1. Institut de Recherche pour le Développement, 34394 Montpellier, France;1. Department of Pathology, College of Veterinary Medicine, Kyungpook National University, 702-701 Daegu, Republic of Korea;2. Industrial Technology, Korea University, 30019 Sejong, Republic of Korea;1. Medical and Scientific Affairs, Pfizer Vaccines, Collegeville, PA 19426, USA;2. Medical and Scientific Affairs, Pfizer Vaccines, São Paulo, Brazil;3. Medical Affairs, Pfizer Vaccines, São Paulo, Brazil;4. Medical and Scientific Affairs Regional Lead, Pfizer Vaccines, Buenos Aires, Argentina;1. GSK, Avenue Fleming 20, Wavre, Belgium;2. RTI Health Solutions, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA;3. GSK, 5 Crescent Drive, Philadelphia, PA 19112, USA |
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| Abstract: | 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. |
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| Keywords: | Post-marketing surveillance Vaccine safety Global Vaccine Safety Initiative (GVSI) Adverse events following immunization (AEFI) |
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