Moderna COVID-19 Vaccine Label Changes

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Good Afternoon Immunization Partners,

Please review the following COVID-19 vaccine update on Moderna label changes.

MODERNA LABEL CHANGES

• FDA recently approved updates to the label for the Moderna COVID-19 vaccine. Distribution of the Moderna vials with the updated labels (see new label below) began during the week of January 13, 2021.  

• What has changed on the label of the Moderna COVID-19 vaccine:
• The label has been updated to indicate a volume of 5.5mL.
• Doses for primary series and booster shots are now listed on the label.
• Important reminder not to exceed a maximum of 20 punctures per vial
• What remains the same for the Moderna COVID-19 vaccine:
• Formulation
• NDC [80777-273-99]
• Physical vial size
• Number of reportable doses
• Dose volumes:
• Primary series doses 1 and 2 dosage = 0.5 mL
• Additional dose (3^rd) dosage for immunocompromised persons = 0.5 mL
• Booster dosage = 0.25 mL
• Reporting requirements
• Wastage should continue to be reported based on 10 doses per vial.
• Each vial can ONLY be punctured up to 20 times. Once the vial has reached the 20-puncture limit, the vial should be discarded even if there is vaccine remaining in the vial.
• For more information, please refer to the EUA fact sheet or  Administration Overview for Moderna COVID-19 Vaccine | CDC. 

If you have questions, please contact checcimms@michigan.gov.

Thank you,

MDHHS Division of Immunization