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The Food and Drug Administration (FDA) has authorized revisions to the Emergency Use Authorization (EUA) labeling for the Moderna COVID-19 Vaccine regarding the number of doses per vial, an additional multidose vial, and storage conditions.
For the vials that are currently available, the FDA is allowing a maximum number of 11 doses per vial, with a range of 10 to 11 doses. The FDA has also authorized the inclusion of an additional multidose vial; each vial contains a maximum of 15 doses, with a range of 13 to 15 doses. Moderna expects to begin shipping the 15-dose vials in the coming weeks.
The FDA has also updated the storage and stability conditions for the vaccine. Once removed from the refrigerator for administration, the vaccine may be kept at room temperature for 24 hours, which is an increase from the previous 12 hours. Moreover, a punctured vial is now usable for up to 12 hours, an increase from the previous 6 hours.
The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information have been updated to reflect these revisions. The revised fact sheet also states that there may not be sufficient volume to extract more doses from the vials depending on the type of syringes and needles used; any remaining vaccine from multiple vials should not be pooled to create a full dose.
The Moderna COVID-19 Vaccine is currently authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent COVID-19 in individuals 18 years of age and older. The vaccine is administered intramuscularly as a 2-dose series (0.5mL each), given 28 days apart.
References
1. Coronavirus (COVID-19) update: FDA makes two revisions to Moderna COVID-19 vaccine Emergency Use Authorization to help increase the number of vaccine doses available. [press release]. Silver Spring, MD: US Food and Drug Administration; April 1, 2021.
2. Moderna provides storage update & announces the U.S. FDA authorizes up to 15-doses per vial of its COVID-19 vaccine. [press release]. Cambridge, MA: Moderna, Inc.: April 1, 2021.
