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Sunday, January 24, 2021

Moderna seeks U.S., EU vaccine authorization

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Moderna seeks U.S., EU vaccine authorization
Moderna seeks U.S., EU vaccine authorization

[NFA] Moderna will apply for U.S. and European emergency-use authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said.

Lisa Bernhard produced this report.

In another major step forward in combatting the coronavirus, pharmaceutical company Moderna will apply for U.S. and European emergency authorization for its COVID-19 vaccine on Monday after the company said full results from a late-stage study showed it was 94.1% effective with no serious safety concerns.

Moderna also reported that its vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people worldwide.

After seeing the results, Moderna’s Chief Medical Officer told Reuters he became overwhelmed with emotion, saying "It was the first time I allowed myself to cry.

At this level of effectiveness, when you just do the math of what it means for the pandemic that's raging around us, it's just overwhelming." Moderna is the second company to seek emergency-use authorization after Pfizer, which reported that its vaccine, made in conjunction with BioNTech, had a 95% efficacy rate.

In an interview on CBS This Morning on Monday, Health and Human Services Secretary Alex Azar said it wouldn’t be long before those most vulnerable – like nursing home residents and front line health care workers – would be receiving the vaccines.

"We could be seeing both of these vaccines out and into people's arms before Christmas." Moderna's distribution is expected to be easier than Pfizer’s because while Moderna’s vaccine needs to be stored in a freezer, it does not require the ultra-cold temperature that Pfizer’s does.

In addition to filing its U.S. application, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data.

Moderna shares jumped to a record high on Monday – a rise of more than 600% this year.

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