Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative
Por:
Guillard-Maure C, Elango V, Black S, Perez-Vilar S, Castro JL, Bravo-Alcántara P, Molina-León HF, Weibel D, Sturkenboom M, Zuber PLF and WHO Global Vaccine Safety-Multi Country Collaboration
Publicada:
8 ene 2018
Ahead of Print:
2 ago 2017
Resumen:
Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle-income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC. We describe the process for the establishment and operationalization of such a network and the lessons learned in conducting a multi-country collaborative initiative. 24 out of the 26 sites successfully contributed data for the global analysis using standardised tools and procedures. Our study successfully confirmed the well-known risk estimates for the outcomes of interest. The main challenges faced by investigators were lack of adequate information in the medical records for case ascertainment and classification, and access to immunization data. The results suggest that sentinel hospitals intending to participate in vaccine safety studies strengthen their systems for discharge diagnosis coding, medical records and linkage to vaccination data. Our study confirms that a multi-country hospital-based network initiative for vaccine safety monitoring is feasible and demonstrates the validity and utility of large collaborative international studies to monitor the safety of new vaccines introduced in LMICs. (C) 2017 Published by Elsevier Ltd.
Filiaciones:
Guillard-Maure C:
Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland.
Elango V:
International Professional Consultant, World Health Organization, Geneva, Switzerland
Black S:
Center for Global Child Health, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States
VACCINE.GRID Foundation, Basel, Switzerland
:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, FISABIO, Valencia, Spain
Castro JL:
Unit of Medicines and Health Technologies, Department of Health Systems and Services, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States
Bravo-Alcántara P:
Unit of Comprehensive Family Immunization, Department of Family, Gender and Life Course, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States
Molina-León HF:
International Professional Consultant, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States
Sturkenboom M:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
Utrecht University Medical Center, Julius Global Health, The Netherlands
Zuber PLF:
Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland
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