SafeVac

The population-wide use of vaccinations in generally healthy people requires intensive monitoring of the tolerability and safety of these vaccines. For vaccinations with the new COVID-19 vaccines, it is expected that large populations will be vaccinated in a short period of time. The recording of reports of suspected undesirable vaccine reactions is an essential part of monitoring vaccine safety.

The increasing use of mobile technologies in health care offers new possibilities to record suspicions of an undesirable vaccine reaction. For this purpose, the Paul Ehrlich Institute has developed a mobile application (SafeVac) that will be used on smartphones. The SafeVac app is used for timely and detailed recording of possible complaints after vaccination or their absence.

Please note the following requirements in order to be able to take part in the survey:

• Minimum age 12 years. For adolescents aged 12-15 years, the legal guardians must give consent and initialization

• Know the vaccine name and lot number

• You must have been vaccinated no more than 48 hours ago

The SafeVac app is a vaccination diary that documents the occurrence and non-occurrence of vaccination reactions. You will be asked about your health status at set times. For this reason, registration is required within 48 hours after the vaccination date. Your reports will be collected for up to 12 months. The above requirements are necessary for statistical reasons and cannot be changed during the current survey.

The survey on the tolerance of the COVID-19 vaccines using the SafeVac app is only part of the monitoring of vaccine safety. You can therefore alternatively report your side effects to the Paul Ehrlich Institute via https://nebenektiven.bund.de.

The SafeVac app was funded by the Federal Ministry of Health in Germany.

The SafeVac app is only used to monitor vaccine safety and can only be used with express consent (electronically in the app).

The information entered by the participants is encrypted and stored on the smartphone and transmitted anonymously to the Paul Ehrlich Institute as soon as there is an online connection. The Paul Ehrlich Institute cannot track the report at any time and does not find out the names or mobile phone numbers of the participants. Therefore, the password (optional) assigned when using the app cannot be reset by the Paul Ehrlich Institute if it is lost. Participation in the surveys is voluntary and can be ended at any time.

You can find more information about the SafeVac app and an explanatory video at: www.pei.de/safevac-app.