FDA unveils game-changing revisions to Moderna vaccine

Moderna revealed that based on submitted stability data, the FDA has authorized its Covid-19 vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for up to 24 hours, an increase from the previous 12 hours. Further, a punctured vial is now useable for up to 12 hours, up from the previous six hours. These new guidelines are now reflected in an updated emergency use authorization (EUA) label.

FDA has also authorized a new vial with a maximum of 15 doses, which is expected to start shipping in the coming weeks. The agency also authorized a maximum of 11 doses of its vaccine in the current format, up from the previously authorized 10 doses per vial.