Register of possible risks and side effects: implementation of federal government plans for vaccination against coronavirus – policy



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The federal government plans to use an app to record the side effects of a possible Covid-19 vaccine. According to information from the Daily Mirror, it is an application in which people who have already been vaccinated can transmit possible symptoms to the responsible authorities in real time.

In Germany, this role is assumed by the Paul Ehrlich Institute (PEI), which as a federal authority is responsible for the approval of vaccines and their safety, among other things.

Reinhold Schmidt, head of PEI’s scientific advisory board, confirmed the work on such an app when asked, “The app should help us centrally record and assess potential issues 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.

The headquarters of Biontech, the developer of the vaccine.Photo: AFP

After the Mainz company Biontech and the US pharmaceutical company Pfizer announced on Monday that the vaccine they jointly developed is 90 percent efficient according to study results, experts await preliminary approval of a first coronavirus vaccine in Europe. and early next year. UNITED STATES.

However, since this developed much faster than usual, the decisive parameters for approval remain open for now. Little is known about how well the vaccine really is tolerated, how long it works, and whether there are long-term side effects. The app should help fill this gap over the next year.

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The developers of the Corona app are not involved.

In a second step, the data collected with the app could be used as the basis for a final evaluation by the PEI and the European Medicines Agency (EMA), which decides whether a preparation will receive blanket approval, Schmidt explained. 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 Tagesspiegel.

In 2018, PEI tested a similar application in relation to flu vaccines. People who were vaccinated against influenza by company physicians at three selected study centers in Berlin, Frankfurt and Langen in the 2018/19 vaccination season can use the “SafeVac” app on their smartphones to record the occurrence and absence of unwanted vaccination reactions, and document them in the application. Submit anonymously to the PEI over a secure Internet connection. The goal of the research project is to develop easy-to-use and mobile reporting options to strengthen drug safety.

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