USFDA authorizes up to 15 doses per vial of Moderna COVID-19 vaccine
Cambridge: Pharma major, Moderna, has recently announced that based on submitted stability data, the U.S. Food and Drug Administration (FDA) has authorized the Moderna COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours.
Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours. These new guidelines are reflected in an updated Emergency Use Authorization (EUA) label. The Moderna COVID-19 Vaccine is ready for use and does not need to be diluted.
The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, from the previously authorized 10 doses per vial. The Moderna COVID-19 Vaccine now can be supplied in two vial presentations (a multiple-dose vial containing a maximum of 11 doses or a multiple-dose vial containing a maximum of 15 doses). The Company expects that the 15-dose vials will begin shipping in the coming weeks.
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