Pfizer/BioNTech COVID-19 vaccine authorized for use in the EU

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The European Commission has granted conditional marketing authorisation to the vaccine against COVID-19 produced by BioNTech and Pfizer.

The decision was taken yesterday [December 21] following the positive review of the vaccine by the European Medicines Agency (EMA). The EU regulator concluded that the Pfizer/BioNTech candidate is safe and effective against COVID-19.

Based on this scientific assessment, we proceeded to authorize it for the European Union market.

“As we have promised, this vaccine will be available for all EU countries, at the same time, on the same conditions. The first batches of this vaccine will be shipped from Pfizer's manufacturing site here in Belgium within the next days.

“I have always said, during this pandemic, that we are in this together. So vaccination can start at the same time, during the EU vaccination days, on December 27, 28 and 29. This is a very good way to end this difficult year, and to finally start turning the page on COVID-19,” said European Commission President, Ursula von der Leyen.

The Pfizer/BioNTech is a product of European innovation, stressed von der Leyen.

“BioNTech has received more than €9m of EU research funding over the past decade, to develop these really groundbreaking technologies. And it secured a €100m loan from the European Investment Bank (EIB), that is backed by the EU, in June. This helped expand its manufacturing capacities and supply the vaccine quickly worldwide. And this is a true European success story.”

The EMA is also due to issue an opinion on its assessment of the Moderna COVID-19 vaccine on January 6.