Rapid assessment of enhanced safety surveillance for influenza vaccine
| Autor: | A.M. Alguacil-Ramos, J. Muelas-Tirado, A. Sanchis-Ferrer, A. Portero-Alonso, Javier Díez-Domingo, E. Pastor-Villalba, J.A. Lluch-Rodrigo |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Vaccine safety Adolescent Drug-Related Side Effects and Adverse Reactions Influenza vaccine Population Immunization information system Young Adult 03 medical and health sciences 0302 clinical medicine Risk groups Risk Factors Environmental health Injection site Product Surveillance Postmarketing Adverse Drug Reaction Reporting Systems Humans Medicine Registries 030212 general & internal medicine Child education Adverse effect Aged education.field_of_study Safety surveillance Surveillance business.industry 030503 health policy & services Public Health Environmental and Occupational Health Infant General Medicine Middle Aged Influenza Rapid assessment Immunization Influenza Vaccines Spain Child Preschool Adverse events Female Seasons 0305 other medical science business Vaccine |
| Zdroj: | PUBLIC HEALTH r-FISABIO: Repositorio Institucional de Producción Científica Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) r-FISABIO. Repositorio Institucional de Producción Científica instname |
| ISSN: | 0033-3506 |
| Popis: | Objectives: The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season. Study design: It is a population-based descriptive study. Methods: Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed. Results: A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance. Conclusions: Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles. (C) 2019 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved. |
| Databáze: | OpenAIRE |
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