SafeVac – Observational Study via App
The Pharmacovigilance unit of the Paul-Ehrlich-Institut has developed the SafeVac app to monitor the efficacy and tolerability of COVID-19 vaccines in good time and based on a large amount of data.
On 21 December 2020, the European Commission issued a conditional marketing authorisation for the first COVID-19 vaccine and the vaccination of the initial population groups began immediately, including in Germany. Further COVID-19 vaccines were authorised in early 2021. Prior to that, the vaccines had undergone clinical trials involving tens of thousands of people, which had proven that their benefits far outweigh the risks. It is, however, important to continue to monitor the safety profile of the vaccines after marketing authorisation, especially in the case of novel vaccines, which will be used to vaccinate a large number of people in a short time.
In order to monitor the efficacy and tolerability of COVID-19 vaccines in the context of prospective surveillance, the Paul-Ehrlich-Institut has developed the SafeVac 2.0 smartphone app. Once installed on a smartphone, it asks the vaccinated person about their health – immediately after the relevant vaccination and at specified times within the next four weeks. In this way, the “Pharmacovigilance I” unit rapidly obtains wide-ranging quantitative information on the efficacy and tolerability of the COVID-19 vaccines. Six and twelve months after the final vaccination, participants are asked again about their current state of health and whether they have contracted COVID-19 in spite of being vaccinated.
With the SafeVac app, we are using today’s technology to monitor the vaccines’ safety profile in good time and gain additional information on their efficacyDr Dirk Mentzer , Head of the Pharmacovigilance I Unit
Participation expressly desired
The more vaccinated people who participate and provide information, the better the assessment of the tolerability of the vaccines will be. Participation is open to persons aged 18 and over who have been vaccinated in the preceding 48 hours. Participants must enter the trade name and batch number of the vaccine, which appear on their vaccination certificate, in the app – and then the survey can start. Data protection is very important to the Paul-Ehrlich-Institut: the data is stored on the smartphone in encrypted form and transmitted with a random number. At no time is it possible to trace the participant’s identity or mobile phone number. Participation is voluntary and can be terminated at any time.
QR codes for the SafeVac app
Independently of the SafeVac app, vaccinated persons can report suspected vaccine complications directly via the side effects portal.
Federal Ministry of Health (BMG)
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