Moderna and BioNTech Looking at Imminent EU Vaccine Approval

Moderna and BioNTech are expected to receive conditional EU approval to distribute their Covid-19 vaccines starting next month in a synchronized effort with the U.S.
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Moderna  (MRNA) - Get Report and BioNTech  (BNTX) - Get Report could receive conditional European Union authorization to distribute their respective Covid-19 vaccines at the same time as the U.S. in order to synchronize efforts to begin vaccinating U.S. and EU citizens as early as next month.

The European Medicines Agency and the U.S. Food and Drug Administration are in daily contact in an effort to synchronize their efforts to begin distributing their respective vaccines in the second half of December, Bloomberg reported.

The discussions center around the evaluation of the vaccines in order to “synchronize” assessment, according to European Commission President Ursula von der Leyen. The EMA has said conditional approval could come as early as the second half of December, von der Leyen told reporters after EU leaders discussed the Covid-19 pandemic via video conference on Thursday.

The speedy regulatory assessment and focus on multi-regional efforts comes as the U.S. and many European countries face fierce new waves of the disease. More than 1 million new coronavirus cases have been reported in the U.S. over the past week, prompting the Centers for Disease Control and Prevention to urge Americans to avoid travel for Thanksgiving.

As of Thursday, the U.S. had recorded more than 11.7 million cases of Covid-19 and 252,564 deaths, according to figures tallied by John Hopkins University. Europe, meanwhile, has recorded nearly 15.5 million cases, with France, Russia, Spain, the U.K. and Italy posting the biggest infection and mortality rates, according to the European Centre for Disease Prevention and Control.

This week, Moderna said its Covid-19 vaccine was 94.5% effective in a preliminary analysis of a large late-stage clinical trial. Pfizer  (PFE) - Get Report, meanwhile, which is developing its own vaccine with BioNTech, said its vaccine was 95% effective in a final analysis of clinical-trial data, and that was applying to the FDA for emergency-use authorization.

The EU has already secured up to 300 million doses of the Pfizer-BioNTech vaccine, and has also cut supply agreements with other frontrunner candidates from AstraZeneca  (AZN) - Get Report, Sanofi  (SNY) - Get Report, Johnson & Johnson  (JNJ) - Get Report, and CureVac  (CVAC) - Get Report, according to Bloomberg.

Von der Leyen said the Brussels-based commission will “hopefully soon” reach a vaccine-supply agreement with Moderna and is also in discussions with Novavax  (NVAX) - Get Report, another biotech company with a trial vaccine in the works.

In the U.S., Pfizer and BioNTech on Friday officially filed with the FDA for emergency use authorization of their Covid-19 vaccine.