Paul-Ehrlich-Institut

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FAQ App SafeVac 2.0

What is the SafeVac 2.0 app?

The Paul-Ehrlich-Institut developed the SafeVac 2.0 smartphone app as part of a study for the active monitoring of the safety and tolerability of authorised COVID-19 vaccines used in Germany. The aim of the app was to rapidly obtain quantitative information on the safety profile of the COVID-19 vaccines, going beyond the marketing authorisation data. The SafeVac 2.0 app should not be confused with the established online spontaneous reporting system for the recording of suspected adverse reactions, which could be used in parallel and will continue to be available.

Users of the SafeVac 2.0 app voluntarily took part in an observational study carried out by the Paul-Ehrlich-Institut, which will ran until the end of 2023. The vaccinated persons’ agreement and consent to participate in the Paul-Ehrlich-Institut’s observational study were preconditions for using the app. Participants who registered in the app by 30 September 2022 were asked questions via the app about their current state of health at defined points in time. The recruiting phase ended on 1 October 2022. No new participants will be included in the SafeVac 2.0 survey.

The SafeVac 2.0 app survey enabled the Paul-Ehrlich-Institut to determine the frequency, severity and duration of an adverse reaction. This app not only gave the Paul-Ehrlich-Institut information on suspected adverse reactions, but also on the proportion of vaccinated persons who tolerated vaccination well.

Updated: 19.04.2024

Who developed the SafeVac 2.0 app?

The SafeVac 2.0 app is a further development of the SafeVac 1.0 smartphone app, which was designed in collaboration with Materna Information & Communications SE and the Helmholtz Centre for Infection Research (HZI) in Braunschweig, and was used to record adverse events after seasonal influenza vaccination. The app was commissioned by the Paul-Ehrlich-Institut and was developed as a cross-platform app for the iOS (Apple) and Android (Google) operating systems.

Updated: 18.04.2024

What did participation in the SafeVac 2.0 study look like?

Individuals who had received the first COVID-19 vaccination in their primary vaccination course by 30 September 2022 had the opportunity to participate in the study. As of 1 October 2022, no new participants were allowed to register for the SafeVac 2.0 study. The tracking of the persons registered up to that point continued according to the study protocol.

The vaccinated persons’ agreement and consent to participate in the Paul-Ehrlich-Institut’s observational study were preconditions for using the SafeVac 2.0 app. Participants were asked questions via the app on seven occasions after the first vaccination and on eight occasions after the second vaccination; this took place within three weeks after the first dose and four weeks after the second dose and was designed to determine how well the vaccines are tolerated. In addition, participants were asked final questions about their state of health after six and twelve months.

The data protection concept was assessed by the Federal Commissioner for Data Protection. Steps were taken to ensure that no participant or individual smartphone could be identified at any time. On the first occasion that data was transmitted to the Paul-Ehrlich-Institut, a random number was created on the federal server and then stored in encrypted form in the participant's smartphone memory; with each new data transmission, this number was checked to ensure it was correct and then transferred with the random key to the Paul-Ehrlich-Institut in a secure connection via the federal government server.
None of this information contained any personal data and nor was it traceable by the Paul-Ehrlich-Institut. Details about the user or his/her smartphone could not be derived from the case ID.

A distinction was made in the requested information between required details and data that was not absolutely necessary. The required fields included the details on age and gender, the vaccine name and the batch number. If required information was not entered, the user received a message and was not be able to move to the other fields until these mandatory fields were completed.

The transmitted data were evaluated for the occurrence of possible adverse reactions. This included a record of how often the vaccination was well tolerated and how often adverse reactions occurred. The type, severity and time interval between vaccination and reactions were also analysed. The data after six and twelve months were evaluated with regard to the frequency of possible SARS-CoV-2 infections and the severity of possible COVID-19 illness after the vaccination.

Reports on vaccination reactions were also included in the Paul-Ehrlich-Institut’s database of adverse reactions. The Paul-Ehrlich-Institut is legally obliged to collect and evaluate all reported suspected cases of adverse reactions and to forward them to the European database of suspected adverse drug reactions.

Updated: 19.04.2024

What are the particular benefits of the SafeVac 2.0 study?

Suspected adverse reactions to vaccination are indeed recorded via regular spontaneous reporting. What is left unknown, however, is how many reactions are not reported for various reasons. The SafeVac 2.0 study enabled the Paul-Ehrlich-Institut to make quantitative evaluations of the possible adverse reactions, since the number of participants was known and adverse reactions were documented on a daily basis. The Paul-Ehrlich-Institut did not only obtain information via the study’s SafeVac 2.0 app on suspected adverse reactions, but also on the percentage of vaccinated persons who tolerated the vaccination well.

Updated: 19.04.2024

When will the information entered by participants in the SafeVac 2.0 app be evaluated?

By the conclusion of the recruitment phase at the end of September 2022, more than 730,000 people had provided information on how they had tolerated their COVID-19 vaccinations via the SafeVac 2.0 smartphone app. All suspected reports of adverse reactions associated with COVID-19 vaccination made by vaccinated individuals via the SafeVac app have also 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 of these assessments are incorporated into the COVID-19 safety reports published periodically by the Paul-Ehrlich-Institut.

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, the SafeVac app will remain available to all already registered participants for at least 12 months after the last vaccination in the 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 does not make a distinction between the new vaccines adapted to the Omicron variant and the original vaccines. After completion of data collection at the end of 2023, the Paul-Ehrlich-Institut will evaluate the study and publish the results.

Updated: 04.10.2022