Moderna Covid Vaccine Granted Emergency Use Authorization By FDA

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Moderna announced that the Food and Drug Administration's 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.

Delivery to the U.S. Government will begin immediately, the company said. Moderna added that it will continue to gather additional data and plans to file a Biologics License Application with the FDA requesting full licensure in 2021. Allocation and distribution will be prioritized according to populations identified by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Approximately 20M doses will be delivered to the U.S. government by the end of December. The company expects to have between 100M and 125M doses available globally in the first quarter of 2021, with 85M to 100M of those available in the U.S.


 

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