Research Projects (Third party funds)



SafeVac

SafeVac – Epidemiological study on app-based reporting of adverse events following influenza vaccination

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3.3_EPID_SAFEVAC2.jpgInfluenza infection spreads from person to person and can become a serious illness. Since the properties of influenza viruses constantly change, the composition of the influenza vaccine is adapted annually. Vaccination can prevent infection and numerous individuals receive the seasonal influenza vaccine every year. Although severe side effects are rare, vaccine safety is important and implies the precise reporting of such events, even after a vaccine has passed the process of approval.1, 2, 3

The Department of Epidemiology at the Helmholtz Centre for Infection Research (HZI) and the Paul-Ehrlich-Institute (PEI), the Federal Institute for Vaccines and Biomedicines, conducted an epidemiological study, which designed and applied a software application (app) to report adverse events following influenza vaccination and its potential determinants. A pre-study was initiated to assess users’ preferences for the development of the app SafeVac. The field phase of the main study took place during the 2018 annual occupational influenza vaccination in three different institutions (e.g. a university hospital). Vaccinated participants used the app SafeVac and responded to app-notifications that collected information on presence or absence of adverse events over a period of up to 3 months. Further information about the received vaccine, prior (influenza) vaccinations, demographics and other health conditions were asked in the app.

The first results show, that out of 377 study participants 66.47% are female, 44.51% are aged 18-30 years and 83.98% have the “Abitur”. In descriptive analysis, sex and level of education have minor effects on adherence to app usage until the end of the study. Statistical verifications on determinants of app usage and the exploration of reported adverse events following vaccination (e.g. type and frequency) are ongoing. These results can contribute to a better understanding of benefits and risks of influenza vaccines. The study shall generate evidence for the potential implementation of an app-based self-reporting system for vaccine safety (e.g. new vaccines and other population).

References
1 European Medicines Agency/ Pharmacovigilance Risk Assessment Committee. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU, 2014.
2 World Health Organization. Influenza Spotlight, 2018.
3 Robert Koch Institut. Influenza (Teil 1): Erkrankungen durch saisonale Influenza-Viren. RKI Ratgeber, 2018.


(Own) Publications/Publikationen
Nguyen MTH, Hoodgarzadeh M, Klett-Tammen C, Linnig S, Mentzer D, Ott JJ, Krause G. Evaluation of acceptance and preferences of app-based reporting of suspected adverse events following immunization. Jahrestagung der DGEpi. Bremen. Abstract Book 2018: 215.

Mentzer D, Keller-Stanislawski B, Ott JJ, Krause G. Digitalisierung: Epidemiologische Studie mit App-basierter Erfassung von Symptomen nach betriebsärztlicher Influenzaimpfung. Bulletin zur Arzneimittelsicherheit, 3-2018: 30-32.

Nguyen MTH, Keller-Stanislawski B, Mentzer D, Schlüter M, Krause G, Ott JJ. Die App SafeVac zur Erfassung von ausbleibenden und auftretenden unerwünschten Wirkungen nach betriebsärztlicher Influenza-Impfung. 6. Nationale Impfkonferenz. Hamburg. Abstractband 2019: 57-58.

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Funding agency

BMG - Bundesministerium für Gesundheit

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