Registration of possible risks and side effects: Federal government plans app for vaccination policy

The federal government plans to use an app to record side effects of a possible vaccine against Covid-19. According to information from the day mirror, this is an application that allows already vaccinated persons to report possible symptoms in real time to the responsible authorities. In Germany, this role is taken over by the Paul Ehrlich Institute (PEI), which as a federal authority is responsible, among other things, for the approval of vaccines and their safety.

Reinhold Schmidt, head of the PEI’s scientific advisory board, confirmed work on such an app when asked, “The application should help us centrally capture and evaluate potential problems in a long-term analysis,” Schmidt said.

The Federal Ministry of Health confirmed to Tagesspiegel that the app would become part of the national vaccination strategy.

After Mainz-based company Biontech and US pharmaceutical company Pfizer announced on Monday that the vaccine they co-developed has an efficiency of 90 percent according to study results, experts expect preliminary approval of a first vaccine against the coronavirus in Europe and early next year. UNITED STATES.

However, as this has developed much faster than usual, the overriding parameters for approval remain open for the time being. Little is known about how tolerable the vaccine really is, how long it is effective and whether there are any long-term side effects. The app should help fill this gap in the coming year.

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The developers of the Corona app are not involved

In a second step, the data collected with the app can then be used as the basis for a final assessment by the PEI and the European Medicines Agency (EMA), which decides whether a preparation will receive general approval, Schmidt explains. SAP and Telekom, which developed the Corona Warning app for the Federal Ministry of Health and the Robert Koch Institute, are not involved in the new project, according to information from the Tagesspiegel.

In 2018, the PEI tested a similar app related to flu vaccinations. People vaccinated against influenza by occupational physicians in three selected study centers in Berlin, Frankfurt and Langen during the 2018/19 vaccination season can use the ‘SafeVac’ app on their smartphone to record and document the occurrence and absence of adverse vaccination reactions in the app Submit anonymously to the PEI through a secure internet connection. The aim of the research project is to develop mobile, easy-to-use reporting options to enhance drug safety.

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