Corona: Moderna wants to apply for approval for vaccine in the EU

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The US pharmaceutical company Moderna wants to be the first company to apply for approval for a corona vaccine in the EU. The application for conditional approval should be submitted to the European Medicines Agency Ema on Monday, the company announced on the same day. At the same time, an application for emergency approval is to be submitted to the US FDA.
With the application for approval at Ema, 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.
A so-called rolling review process is already running at Ema for the RNA vaccine from Moderna, which is intended to accelerate the approval process. Manufacturers can submit data on the quality, harmlessness and effectiveness of a preparation before the complete application for approval.
The Mainz manufacturer Biontech has also run such a procedure together with the US company Pfizer. Biontech and Pfizer have already applied for emergency approval in the US, but not yet in the EU. Moderna’s preparation is similar to the Biontech / Pfizer vaccine in terms of its mode of action and its effectiveness.

Vaccine prevents more than 90 percent of diseases

In Europe, there are stricter rules for rapid approval than in the USA. In the European Union (EU), however, there is also the option of conditional approval or approval subject to conditions. Such approval is conceivable if, after an interim analysis, there are “sufficiently convincing data” on safety and effectiveness, the Paul Ehrlich Institute (PEI) responsible for vaccine approval in Germany told SPIEGEL at the beginning of November.

According to the company, the Moderna vaccine mRNA-1273 has an effectiveness of 94.1 percent. That emerges from the latest analysis of data from the Phase III clinical trial, in which 30,000 people in the US 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. 11 of these cases were in the vaccine group and 185 in the placebo group. This results in the 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. So far, however, the data only shows that the vaccine prevents the majority of the diseases. How it affects non-symptomatic infections remains to be determined.

Like that from Pfizer and Biontech, the Moderna preparation 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 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.
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https://www.spiegel.de/wissenschaft/medizin/corona-moderna-will-zulassung-fuer-impfstoff-in-eu-beantragen-a-443a9f11-5f23-42f7-b2a2-49f609076543

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