EU Could Approve BioNTech, Moderna Vaccines in December

BioNTech SE and Moderna Inc. could receive conditional European Union marketing authorization for their Covid-19 vaccines in the second half of next month, according to the head of the EU’s executive arm, putting the bloc on track to start distributing the shots at the same time as the U.S.

The European Medicines Agency is in daily contact with the U.S. Food and Drug Administration about the evaluation of the vaccines in order to “synchronize” assessment, said European Commission President Ursula von der Leyen.

“If all proceeds with no problems, EMA tells us that the conditional marketing authorization for BioNTech and Moderna could happen as early as the second half of December 2020,” von der Leyen told reporters after EU leaders discussed the Covid-19 pandemic via video conference on Thursday.

The speedy regulatory assessment comes as many European countries battle fierce new waves with the onset of colder weather, forcing governments to impose new lockdowns over weary populations. Faced with the prospects of another recession and uncertainty over how long the crisis may last, European leaders are increasingly counting on vaccines to provide relief.

This week, Moderna said its Covid-19 vaccine was 94.5% effective in a preliminary analysis of a large late-stage clinical trial. Pfizer Inc. said its shot being developed with BioNTech was 95% effective in a final analysis of clinical-trial data and it’s applying to the U.S. FDA for emergency-use authorization.

The extraordinary results have sparked euphoria as the unprecedented compression of vaccine development timelines from years to months looks to be paying off.

The EU has confirmed a purchase of up to 300 million doses of Pfizer and BioNTech’s vaccine and has also inked supply agreements with other frontrunner candidates from AstraZeneca Plc, Sanofi, Johnson & Johnson, and CureVac NV.

In total, it’s pre-ordered some 1.2 billion doses, according to a database run by the Duke Global Health Innovation Center, although it’s unclear how the shots will be distributed among member nations.

Von der Leyen said the Brussels-based commission will “hopefully soon” reach a vaccine-supply agreement with Moderna and is also in talks with Novavax Inc.

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