With the smartphone app SafeVac 2.0 developed by the Paul-Ehrlich-Institut, vaccinated people can report digitally on how they tolerated the vaccination against COVID-19. Until now, participation was limited to adults. Now it is also possible for children from 12 years and adolescents. The aim is to gain further important insights into the efficacy and tolerability of COVID-19 vaccines in this age group.
Children are not small adults. Therefore, vaccines, like other medicines, are studied in clinical trials in different age groups from newborn to adult and only then authorised. In the meantime, two COVID-19 vaccines have been authorised from the age of 12. By surveying children aged 12 years and older and adolescents using the smartphone app SafeVac 2.0, further important information on the tolerability and safety of the COVID-19 vaccines is being obtained. As with the adult survey that has been running successfully since the beginning of the vaccination campaign, the children and adolescents will be asked about the effectiveness and tolerability of the vaccination up to 12 months after the initial vaccination.
In order to activate the survey of minors in the app, a person with a right of custody must consent to participation beforehand. The Ethics Committee of the State Medical Association of Hesse (Ethikkommission der Landesärztekammer Hessen) and the Federal Commissioner for Data Protection (Bundesbeauftragte für den Datenschutz) have also approved the required extension of the SafeVac 2.0 observational study.
Those who wish to participate in the COVID-19 vaccine tolerability survey can download the SafeVac 2.0 app using the following QR codes.
On 28 May 2021, the authorisation was extended for the COVID-19 vaccine Comirnaty from BioNTech/Pfizer, and on 23 July 2021, the authorisation was extended for the COVID-19 vaccine Spikevax from Moderna as vaccines for the immunisation also of children and adolescents from the age of 12 years for the protection against COVID-19 disease.
On 10 June 2021, the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) issued a recommendation for COVID-19 vaccination in children aged 12 years and older and adolescents only for certain groups of people - these included, in particular, children and adolescents with pre-existing diseases.
Based on international clinical data and experience, especially from the American vaccination programme with almost ten million vaccinated children and adolescents, risks of vaccination for this age group could be assessed more reliably and have led to an update of the STIKO recommendation: on 16 August 2021, the STIKO extended the COVID-19 vaccination recommendation to all children 12 years and older and adolescents.
Updated: 03.11.2021
