Paul-Ehrlich-Institut

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"SafeVac" – App based capture of adverse effects after influenza vaccinations in a first field study

In a current study, a research team of the Helmholtz Centre for Infection Research (Helmholtz-Zentrum für Infektionsforschung, HZI) and the Paul-Ehrlich-Institut (PEI) is testing the smartphone app "SafeVac", designed to capture symptoms after an influenza vaccination. The purpose of this research project is to develop user-friendly reporting facilities to improve the safety of vaccines.

Safevac App on the Smartphone (Source: PEI / Helmholtz-Zentrum)

Vaccinations represent an important means of protecting the population from infectious diseases and their serious consequences for those affected. They serve the health protection of all parts of the population, since vaccination gaps can lead to an outbreak of avoidable diseases. Vaccines are biomedical products and provide a high degree of safety.

To guarantee this safety level, but also, to strengthen the idea of vaccinations, it is important to transmit information on vaccination reactions to the supervising medicines authorities in a timely manner and with all the relevant details. Previous reports were often transmitted incompletely and with a delay so that any possible adverse effects could no longer be attributed to the vaccination, the vaccine or a particular vaccine batch. In this context, mobile technologies provide the opportunity to capture data in real time and to speed up the transmission processes for the relevant information.

This potential is tested by the Paul-Ehrlich-Institut as the competent German senior federal authority for the testing and evaluation of safety of vaccines in Germany and the Department of Epidemiology of the Helmholtz Centre for Infection Research (Helmholtz-Zentrum für Infektionsforschung, HZI), at Braunschweig, in an epidemiology field study funded by the German federal ministry of health. Persons vaccinated against influenza by occupational doctors in the vaccination season of 2018/2018 in three selected study centres in Berlin, Frankfurt, and Langen can capture the occurrence of absence of adverse vaccination reactions by means of the “SafeVac” app using their smartphones, document it in the app, and transmit it anonymously to the PEI using a secured internet connection.

If the SafeVac app proves useful in the testing phase, the PEI will consider extending the capture of reports on suspected vaccination complications using this app. This development is in line with the modern E-Health approach of the PEI and the German Federal Ministry of Health, which understands digitalisation as an opportunity in health care.

Further information:

Mentzer D, Keller-Stanislawski B, Ott JJ, Krause G (2018): Digitalisierung: Epidemiologische Studie mit App-basierter Erfassung von Symptomen nach betriebsärztlicher Influenzaimpfung.
Bulletin zur Arzneimittelsicherheit 9: 30-32.
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Updated: 16.11.2018