The German government plans to record side effects of a possible vaccine against Covid-19 using an app. According to information from the Tagesspiegel, this is an application that will allow people who have already been vaccinated to report possible symptoms to the relevant authorities in real time. In Germany, this role is played by the Paul Ehrlich Institute (PEI), a federal authority responsible for, among other things, the approval of vaccines and their safety.
Reinhold Schmidt, head of the scientific advisory board of the PEI, confirmed the work on such an app to the Tagesspiegel: "The application should help us to centrally record and evaluate possible problems in a long-term analysis," said Schmidt. The Federal Ministry of Health confirmed to the Tagesspiegel that the app would become part of the National Immunization Strategy.
Preliminary approval in early 2021
After the Mainz-based company Biontech and the US pharmaceutical company Pfizer were able to announce on Monday that, according to study results, the vaccine developed jointly by them has an efficiency of 90 percent, experts expect the preliminary approval of a first vaccine against the coronavirus in Europe and the USA at the beginning of next year. However, since this vaccine was developed much faster than usual, decisive parameters for approval remain open for the time being. Little is known, for example, about how well tolerated the vaccine really is, how long its efficacy lasts and whether there are any long-term side effects. The app should help to close this gap in the course of the coming year.
Final consultation by PEI and the EMA
In a second step, the data collected with the app could then be used as the basis for a final evaluation by the PEI and the European Medicines Agency (EMA), which will decide whether a preparation receives general approval, Schmidt continued. SAP and Telekom, who developed the Corona Warning App for the German Federal Ministry of Health and the Robert Koch Institute, are not involved in the new project according to information from the Tagesspiegel.
Similar app has already been tested
In 2018, the PEI has already tested a similar app in connection with flu vaccinations. Persons who were vaccinated against influenza by company doctors in three selected study centers in Berlin, Frankfurt and Langen during the 2018/19 vaccination season can use the "SafeVac" app to record the occurrence and absence of undesired vaccination reactions on their smartphones, document them in the app and send them anonymously to the PEI via a secure Internet connection. pm, ots, mei