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Moderna Wins Permission to Submit Coronavirus Vaccine Candidate for Fast-Track Approval in Europe

By Eric Volkman – Oct 14, 2020 at 8:04PM

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If approved, the busy biotech would be able to distribute mRNA-1273 to 27 countries on the continent.

Fresh off its announcement that it has submitted its coronavirus vaccine candidate for regulatory approval in Canada, Moderna (MRNA -3.17%) said Wednesday it is in a similar situation in Europe. The company announced that the European Medicines Agency (EMA) has formally notified it that mRNA-1273 is eligible for submission of an application for fast-track approval.

If granted European Union Marketing Authorization, Moderna would be able to distribute the approved vaccine throughout the 27-country economic bloc that includes such nations as Germany and Spain.

A researcher studying a sample in a petri dish.

Image source: Getty Images.

"We are pleased with the productive interactions with the European regulatory authorities at the National level and at the EMA level to date and we appreciate their valuable guidance and confidence in Moderna to pursue an MAA submission for approval in Europe for our COVID-19 vaccine candidate," the biotech quoted its CEO Stephane Bancel as saying.

"European partners, investors, and citizens have been part of Moderna from the beginning of the company and have played an important role in Moderna's progress," he added.

The company is already poised to manufacture the vaccine in Europe, should it be approved. It has contracted with Spain-based ROVI and Switzerland's Lonza to manufacture and fill-finish mRNA-1273. 

The vaccine candidate is currently in the midst of Phase 3 trials, making it one of only a handful of potential vaccines in such a late stage of testing. That, plus the fact that it has shown to be very efficacious in early stage testing, puts it high on the leaderboard for relatively early approval throughout the world.

In spite of all that, Moderna's stock fell in Wednesday trading. It closed down by 2.2%, compared to only a 0.7% slide for the S&P 500 index.


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