Corona: US manufacturer Moderna applies for vaccine approval in the EU – News

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The vaccinations are getting closer: 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 on Monday. At the same time, an application for emergency approval is to be submitted to the US FDA.

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. According to Moderna, the city of delivery could still be in December.

A so-called rolling review process is already running at Ema, which is intended to accelerate the approval process: manufacturers submit individual parts on quality, harmlessness and effectiveness before the complete approval application.

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 USA, but not yet in the EU.
Moderna’s preparation is comparatively similar to the Biontech / Pfizer vaccine in terms of its mode of action and its effectiveness.

The Moderna vaccine mRNA-1273 has an effectiveness of 94.1 percent, as the company announced.



Source link
https://www.bild.de/news/2020/news/in-der-eu-erster-pharma-konzern-beantragt-impfstoff-zulassung-74216930.bild.html

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