IMPORTANT UPDATE on Moderna Vaccine, Including Storage and Handling Guidance as of April 28, 2021

Hello Immunization Partners,

 

MDHHS wanted to provide an update regarding Moderna COVID-19 vaccine. Recent changes include vaccine vial fill volume, updated labeling, and storage and handling modifications. The key updates are below:

• Recent emergency use authorization (EUA) revision includes that the Moderna vaccine will be available in 2 different vials by early May. Shipments of the new vials could occur as early as May 3^rd.

• The current maximum 11 dose vial and a new maximum 15 dose vial.

• The vial will remain the same size but will be filled to the higher volume.
• Each vial is clearly marked as either a maximum of 11 doses or a maximum of 15 doses.
• The label for the maximum of 15 dose vial also has distinctive blue shading on the bottom half of the label.
• Moderna is planning to transition all manufacturing to the new vial during May.
• The recently updated Moderna COVID-19 Vaccine EUA Fact Sheet for Health Care Providers includes the maximum 15 dose vial information.
• A new NDC has been issued for the larger volume Moderna vial, which has been given a range of 13-15 doses in the EUA.

• Carton NDC: 80777-273-98
• Vial NDC: 80777-273-15

• Ancillary kits will be reconfigured to extract a maximum of 14 doses per vial, plus a 5% surplus.

• Min. order quantity: 140 doses
• An unextracted 15th dose from the larger volume vial does NOT result in reportable waste.

• Updated storage and handling guidance for Moderna COVID-19 vaccine. Time frames have been changed, see updated storage time frames below. We also verified with the manufacturer, Moderna, to clarify vaccine temperatures and storage timeframes.

• Frozen: Moderna vaccine via may be stored in the freezer between -50 to -15C (-58 to 5F).
• Refrigerated/Unpunctured vials: An unpunctured Moderna vaccine vial may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours. This is an increase from 12 hours.
• Punctured Vials: A punctured Moderna vaccine vial may be stored between 2° to 25°C (36° to 77°F) for up to 12 hours. Vials should be discarded 12 hours after the first puncture. This is an increase from 6 hours.
• Updates are reflected on the Moderna S&H Summary and the Moderna COVID-19 Vaccine Preparation and Administration Summary

 

Moderna COVID-19 Vaccine Storage and Handling Question and Answer:

During a clinic we had an unpunctured vial of Moderna move from a refrigerated state cool cube into room temps. The vaccine thawed but we ended up not using the vial (it was at room temperature for about 2 hours). Can we place the unpunctured vial back into the cool cube at refrigerated temperatures? If we do this, will it “pause” the 24-hour guideline?

Per Moderna (response as of 4/27/21) —one should refrain from mixing and matching temperature. So, for example, unpunctured refrigerated vials can be stored in the refrigerator for 30 days at 2 to 8°C, and the unpunctured vial can be stored at 8 to 25°C for a total of 24 hours. If it is kept at refrigerated temperatures, it can be stored under those conditions for 30 days, if the vial is thawed and at room temperature then it really should stay at room temperature and needs to be used within 24 hours. (do not mix and match temperatures). The 24-hour countdown starts as soon as the vial is removed from the refrigerator and DOES NOT stop if the vial is returned to the refrigerator, there is no “pause”. 

 

Additionally, clinical materials for healthcare workers will be updated and available on the web the first week of May.

 

The following resources are attached to this email:                                                               

• Talking points to use in communication with providers
• Frequently asked questions
• Images of the new Moderna cartons and vial labels
• Wastage Reporting Table

Thank you for all your hard work to protect Michiganders from vaccine-preventable diseases!

 

-The Immunization Nurse Education Team, Andrea, Heidi, Maria, and Terri

 

• Moderna EUA FAQs Final 4.26.21.pdf
• Wastage_Reporting_Table.pdf
• Moderna_Packaging_Images.pdf
• Moderna EUA TPs Final 4.26.21.pdf