Moderna plans to apply for approval of vaccine in EU

The US pharmaceutical company Moderna wants to be the first company to apply for approval of a CoV vaccine in the EU. The application for a conditional approval is to be submitted to the European Medicines Agency (EMA) today, the company now announced.

An application for emergency approval in the USA is also to be filed today in parallel, the company said. “We believe that we have a vaccine that is highly effective. We now have the data to prove it,” said Tal Zaks, Chief Medical Officer at Moderna. “We expect to play an important role in turning this pandemic around.”

According to a final analysis of the pivotal study, the vaccine showed 94.1 percent efficacy against Covid-19. Severe disease progression was prevented and no serious side effects were observed.

Moderna’s vaccine could become the second vaccine in the U.S. to receive emergency approval there. The partners Biontech and Pfizer had already applied for this for their vaccine on November 20 and expect a green light by mid-December. In Europe, accelerated approval processes at the EMA are already underway for both vaccine projects.

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