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Friday, December 18, 2020 8:08:49 PM
U.S. FDA authorizes mRNA vaccine against COVID-19 for emergency use
Total of 200 million doses ordered by the U.S government to date; U.S. government retains option to purchase up to an additional 300 million doses
Approximately 20 million doses will be delivered by the end of December 2020
Moderna intends to submit a Biologics License Application for full U.S. licensure in 2021
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration’s (FDA) has authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA). Delivery to the U.S. Government will begin immediately. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.
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