Vaccinated individuals participating in the observational study can use the SafeVac 2.0 smartphone app to digitally report on how they have tolerated their vaccination against COVID-19. The SafeVac 2.0 study is now entering its final phase: The recruitment of new study participants will end on 30 September 2022. Until that date, individuals who receive their first COVID-19 vaccination for primary immunisation can still register to participate in the study. As of 1 October 2022, no new participants will be allowed to register for the SafeVac 2.0 study. The tracking of the persons registered up to that point remains unchanged. Adverse vaccination reactions can still be reported digitally to the Paul-Ehrlich-Institut via www.nebenwirkungen.bund.de. More than 730,000 people have participated in the SafeVac 2.0 observational study on the tolerability of COVID-19 vaccines.
Data collection within the observational study does not conclude with the end of the recruitment phase. In accordance with the SafeVac 2.0 study protocol (see further information), the SafeVac app will remain available to all already registered participants for at least 12 months after the last primary vaccination course. The study design stipulates that participants will be asked again about their state of health one year after completion of the primary vaccination course. In addition, all participants can also provide information on a booster vaccination – if they have not done so already. The app cannot distinguish between the new vaccines adapted to the Omicron variant and the original vaccines. After completion of the data collection at the end of 2023, the Paul-Ehrlich-Institut will evaluate the study and publish the results.
To date, over 730,000 people have provided information on how they have tolerated their COVID-19 vaccinations via the SafeVac 2.0 smartphone app. All reports of adverse reactions associated with COVID-19 vaccination made by vaccinated individuals via the SafeVac app have been registered in the Paul-Ehrlich-Institut's adverse reaction database. The Paul-Ehrlich-Institut evaluated the data together with reports from other reporting channels and analysed it for new signals. The results have been published by the Paul-Ehrlich-Institut in its periodic safety reports.
The period in which the SafeVac app would be considered useful as a part of the observational study was considered limited from the outset. However, even after the end of the study, suspected adverse reactions after vaccination can be reported digitally to the Paul-Ehrlich-Institut via www.nebenwirkungen.bund.de. The reporting page is still active, so vaccinated individuals or their relatives can easily report adverse events in connection with a vaccination via their smartphone, even without an app. The Paul-Ehrlich-Institut continuously analyses any suspected reports received and monitors the safety of the COVID-19 vaccines, including the vaccines adapted to the Omicron variants, which have been approved for booster vaccination. The Paul-Ehrlich-Institut will continue to provide information on the safety of COVID-19 vaccines.
Updated: 27.09.2022
