COVID-19 vaccines are an important tool in managing the pandemic. On 21 December 2020, the European Commission authorised the first COVID-19 vaccine, with additional approvals in the pipeline. The nationwide vaccination campaign will start before the end of the year. Shortly, a very large number of people will be vaccinated with newly authorised COVID-19 vaccines. It is therefore important to record the tolerability of the vaccines promptly and on a broad data basis. To this end, the Paul-Ehrlich-Institut has developed the smartphone app SafeVac 2.0, which vaccinated people can use to provide digital information on how they tolerated the vaccination. That way, participants in this observational study will actively contribute to gaining further knowledge about COVID-19 vaccines.
The Paul-Ehrlich-Institut is conducting the observational study on the tolerability of COVID-19 vaccines using a smartphone app - SafeVac App 2.0. The more vaccinated adults who participate and submit information, the more informational value the corresponding data will provide.
Using the app, participants will be asked about health complaints intensively three and four weeks after each COVID-19 vaccination (seven times within 3 weeks after the first vaccination and eight times within 4 weeks after the second vaccination). Further surveys on health complaints will be conducted six and 12 months after the last vaccination. The questionnaire also asks whether the vaccination has protected against SARS-CoV-2 infection or whether an infection or COVID-19 disease has occurred.
All information of the study participants is stored encrypted on the smartphone and transmitted to the Paul-Ehrlich-Institut with a random number as soon as an online connection is established. The Paul-Ehrlich-Institut cannot track the message at any time and the name or mobile phone number from the participants will not come into the institute's knowledge. The survey is also voluntary and can be terminated at any time.
In Germany, the Paul-Ehrlich-Institut is responsible for monitoring the safety of vaccines and biomedicines. The Germany Federal Ministry of Health (Bundesgesundheitsministerium, BMG) provided financial support for the study.
Updated: 22.12.2020
