Moderna COVID-19 Vaccine EUA Updates

Arizona Department of Health Services sent this bulletin at 04/30/2021 10:00 AM MST
2019 AIPO

Moderna EUA Updates

The FDA has authorized an EUA amendment for the Moderna COVID-19 vaccine. Among these changes is the introduction of the maximum 15-dose vial (range 13-15 doses per vial). The maximum 15-dose vial has begun to be distributed, along with the maximum 11-dose vial (range 10-11 doses). When the maximum 15-dose vial becomes more widely available, the maximum 11-dose vial will be phased out, beginning in May 2021.

Both vial presentations and boxes look similar, but have separate NDC numbers and storage and handling requirements and will need to be recorded and handled accordingly. Providers ordering Moderna vaccine should be mindful of the differences between the maximum 11-dose vial and maximum 15-dose vial. As a reference, providers can look for the following differences and follow the respective thawing conditions:

Maximum 11-Dose Vial (Range 10-11 Doses)

  • Vial and box are white (shown in diagrams below)
  • NDC 80777-273-99
  • Thaw in refrigerated conditions between 2.0° C to 8.0° C (36.0° F to 46.0° F) for 2 hours and 30 minutes OR
  • Thaw at room temperature between 15.0° C to 25° C (59.0° F to 77.0° F) for 1 hour
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Maximum 15-Dose Vial (Range 13-15 Doses)

  • Vial and box are white with a blue band (shown in diagrams below)
  • NDC 80777-273-98
  • Thaw in refrigerated conditions between 2.0° C to 8.0° C (36.0° F to 46.0° F) for 3 hours OR
  • Thaw at room temperature between 15.0° C to 25° C (59.0° F to 77.0° F) for 1 hour and 30 minutes
  • If thawing in refrigerated conditions, let vials stand at room temp for 15 minutes before administering
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Other updates to the Moderna EUA include the following:

  • Can be stored in freezer within temperature range -50° C to -15° C (wider temperature range)
  • Can be stored at room temperature (8° C to 25° C) for up to 24 hours (previously 12 hours)
  • Vials should be discarded 12 hours after the first puncture (previously 6 hours)

For all guidelines on Moderna storage and handling, providers can refer to the ADHS Moderna COVID-19 Reference Sheet, which can be found at azdhs.gov/covid19vaccine within Provider Resources, or the Moderna COVID-19 Vaccine EUA Fact Sheet for Health Care Providers. As both vial presentations are being distributed, providers should be attentive to the differences between vial presentations to ensure doses decrement properly from their ASIIS inventory.