Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination
Por:
Perez-Vilar S, Weibel D, Sturkenboom M, Black S, Maure C, Castro JL, Bravo-Alcántara P, Dodd CN, Romio SA, de Ridder M, Nakato S, Molina-León HF, Elango V, Zuber PLF and WHO Global Vaccine Safety-Multi Country Collaboration
Publicada:
8 ene 2018
Ahead of Print:
27 may 2017
Resumen:
New vaccines designed to prevent diseases endemic in low and middle -income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis. The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5-9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2-27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7-157.6), Edmonston- Zagreb (IRR: 11.1; 95% CI: 1.4-90.3), and Enders'Edmonston (IRR: 8.5; 95% CI: 1.9-38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3-87.4) was also found. This proof-of-concept study has shown, for the first time, that an international hospital-based network for the investigation of rare vaccine adverse events, using common standardized procedures and with high participation of LMICs, is feasible, can produce reliable results, and has the potential to characterize differences in risk between vaccine strains. The completion of this network by adding large reference hospitals, particularly from tropical countries, and the systematic WHO-led implementation of this approach, should permit the rapid post-marketing evaluation of safety signals for serious and rare adverse events for new and existing vaccines in all settings, including LMICs. (C) 2017 World Health Organization. Published by Elsevier Ltd. All rights reserved.
Filiaciones:
:
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
Weibel D:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
VACCINE.GRID Foundation, Basel, Switzerland
Sturkenboom M:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
VACCINE.GRID Foundation, Basel, Switzerland
Black S:
VACCINE.GRID Foundation, Basel, Switzerland
Center for Global Child Health, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States
Maure C:
Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland
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
Dodd CN:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
Romio SA:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy
de Ridder M:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
Nakato S:
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands
Molina-León HF:
International Professional Consultant, Pan American Health Organization (PAHO/WHO), Washington DC, DC, United States
Elango V:
International Professional Consultant, World Health Organization, Geneva, Switzerland
Zuber PLF:
Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland
Green Published, Green Accepted
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