FAQ App SafeVac 2.0
What is the SafeVac 2.0 app?
The Paul-Ehrlich-Institut has developed the SafeVac 2.0 smartphone app as part of an active monitoring of the safety and tolerability of COVID-19 vaccines. The aim is that quantitative information on the safety profile of the COVID-19 vaccines, going beyond the marketing authorisation data, will be rapidly obtained using this app. The SafeVac 2.0 app should not be confused with the established online reporting system for the recording of suspected adverse reactions.
Users of the SafeVac 2.0 app are voluntarily taking part in an observational study carried out by the Paul-Ehrlich-Institut. The vaccinated persons’ agreement and consent to participate in the Paul-Ehrlich-Institut’s observational study is a precondition for using the app. Via the app, the participants will be asked questions about their current state of health at defined points in time. The SafeVac 2.0 app survey will enable the Paul-Ehrlich-Institut to determine the frequency, severity and duration of an adverse reaction. This app will not only give the Paul-Ehrlich-Institut information on suspected adverse reactions, but also on the proportion of vaccinated persons who tolerate the vaccination well.
Who developed the SafeVac 2.0 app?
SafeVac 2.0 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; it supports iOS 12-14 and Android 5.0-10.0.
Can a vaccinated person who does not wish to take part in the SafeVac 2.0 app survey also report adverse reactions?
Yes, vaccinated persons who do not wish to take part in the survey using the SafeVac 2.0 app can report suspected adverse vaccination reactions via the online reporting portal www.nebenwirkungen.bund.de.
What does participation in the SafeVac 2.0 study look like?
The vaccinated persons’ agreement and consent to participate in the Paul-Ehrlich-Institut’s observational study is a precondition for using the SafeVac 2.0 app. Via the app, the participants will be asked questions on seven occasions after the first vaccination and on eight occasions after the second vaccination; this will take place within three weeks after the first dose and four weeks after the second dose, and is designed to determine how well the vaccines are tolerated. In addition, the participants will be 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. At no time can a participant or his/her smartphone be identified. On the first occasion that data is transmitted to the Paul-Ehrlich-Institut, a random number is created on the federal server and then stored in encrypted form in the participant's smartphone memory; with each new data transmission, this number is checked to ensure it is 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 contains any personal data and it cannot be traced by the Paul-Ehrlich-Institut. Details about the user or his/her smartphone cannot be derived from the case ID.
In the requested information, a distinction is made between required details and data that is not absolutely necessary. The required fields include the details on age and gender, the vaccine name and the batch number. If required information is not entered, the user will receive a message and will not be able to move to the other fields until these mandatory fields have been completed.
The transmitted data will be evaluated with reference to the occurrence of possible adverse reactions. This will include a record of how often the vaccination was well tolerated and how often possible adverse reactions have occurred. The type, severity and time interval between vaccination and reactions will also be analysed. The data after six and twelve months will be 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 will also be 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.
What are the particular benefits of the SafeVac 2.0 app?
In the regular spontaneous recording of suspected adverse reactions to vaccination, suspected cases are indeed recorded, but what is not known is how many reactions are not reported for various reasons. The SafeVac 2.0 app will enable the Paul-Ehrlich-Institut to make quantitative evaluations of the possible adverse reactions, since the number of participants will be known and adverse reactions will be documented on a daily basis. With this app, the Paul-Ehrlich-Institut will not only obtain information on suspected adverse reactions, but also on the percentage of vaccinated persons who have tolerated the vaccination well. The larger the number of participants, the more meaningful the corresponding data will be.
When will it be possible to start using the SafeVac 2.0 app?
It will be possible to use the app as soon as vaccination against COVID-19 begins in Germany. It is already available in the app stores.
Where can I download the SafeVac 2.0 app?
If you would like to take part in the survey on the tolerability of COVID-19 vaccines, you can download the SafeVac 2.0 app using the following QR codes.
I didn't succeed in entering the batch number of the vaccine into the SafeVac 2.0 app. What can I do?
Please check whether you have a stable internet connection via LTE or WIFI. This is a requirement, enabling you to get feedback to your smartphone when the batch number ist checked. This feedback in turn is necessary for the app to function correctly.
The app checks the batch number very carefully. Entering special characters can lead to problems. In this case please enter the batch number without any special characters or space characters in its combination of numerals and letters.