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Wednesday, January 27, 2021
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Moderna to seek U.S. and EU authorization for its vaccine on Monday

Moderna will apply for U.S. and European emergency authorization for its COVID-19 vaccine on Monday (November 30) after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said.

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.

The filing sets Moderna’s product up to be the second vaccine likely to receive U.S. emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate.

Of the 196 people who contracted COVID-19 out of over 30,000 volunteers, 185 had received a placebo and 11 got the vaccine.

Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective against severe cases.

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, and would continue to talk with other regulators doing similar rolling reviews.

(Production: Aleksandra Michalska)

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