Coronavirus vaccine: Moderna wants to apply for emergency approval

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The US pharmaceutical company Moderna wants to apply for emergency approvals for its corona vaccine in the EU and the USA today. According to the company, new study data show good tolerability.

The US pharmaceutical company Moderna wants to be the first company to apply for approval for a corona vaccine in the EU. The company announced that the application for conditional approval should be submitted to the European Medicines Agency Ema today. At the same time, an application for emergency approval is to be submitted to the US FDA.

Vaccination is getting closer

With the application for approval, a corona vaccination is also approaching in Germany. Last week, EU Commission chief Ursula von der Leyen announced that a framework contract for up to 160 million vaccine doses had been concluded with Moderna. Accordingly, 80 million cans are to be delivered initially, with the option of 80 million more units.

According to Moderna, the product could be delivered in the EU as early as December, provided it receives approval.

According to Moderna, effectiveness of 94.1 percent

The Moderna vaccine mRNA-1273 has an effectiveness of 94.1 percent, as the company announced. That emerges from the latest analysis of data from the Phase III clinical trial, in which 30,000 people in the United States are participating. Half of the participants receive the vaccine, the other half a placebo. For full vaccination protection, two doses are necessary at intervals.

A total of 196 cases of the Covid-19 disease have been confirmed among the test subjects. Eleven of these cases were in the vaccine group and 185 in the placebo group. This results in an effectiveness of 94.1 percent.

The new results roughly correspond to the preliminary data that Moderna published in mid-November. In addition, Moderna announced that the total of 30 severe Covid-19 courses in the study only affected the placebo group. The effectiveness of mRNA-1273 was similar across all age groups, according to Moderna.

The preparation is an RNA vaccine

The Moderna preparation, like that from Pfizer and Biontech, is a so-called RNA vaccine. It contains genetic information about the pathogen, from which the body then produces a virus protein.

The aim of the vaccination is to stimulate the immune system to produce antibodies in order to intercept the viruses. There is still no approved vaccine of this type.

Inforadio reported on this topic on November 30, 2020 at 1:21 p.m.




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https://www.tagesschau.de/ausland/moderna-impfstoffzulassung-antrag-101.html

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