COVID-19: Vaccinator Guidance for Moderna (Spikevax) Vaccine

The Wisconsin Department of Health Services (DHS) supports the CDC (Centers for Disease Control and Prevention’s) recommendation that children 6 months through 5 years of age are now eligible to receive the bivalent Moderna COVID-19 vaccine as a booster dose at least two months after completing their two-dose monovalent Moderna primary series.

Labeling, dosage, and ordering

The bivalent Moderna COVID-19 for children 6 months through 5 years old has a dark pink cap and yellow (yellow) label border. The vial is labeled “Moderna COVID-19 Vaccine, Bivalent” with text directly under it reading “Original and Omicron BA.4/BA.5.” It is also labeled “BOOSTER DOSES ONLY” and “Age 6m through 5y.”

There are two 0.2mL doses per vial. Note that this bivalent Moderna vaccine booster has a shorter shelf life after first puncture (discard after eight hours) than the bivalent Moderna booster presentation for people 6 years of age and older (discard after 12 hours).

The bivalent booster can be ordered using the same process used to order all COVID-19 vaccines.

Unauthorized uses

Mix and match use of the bivalent Pfizer and Moderna COVID-19 vaccines is not currently authorized for children ages 6 months through 4 years. Since the bivalent Pfizer COVID-19 vaccine is authorized as part of the Pfizer pediatric primary series and the bivalent Moderna COVID-19 vaccine is authorized a booster after completion of the monovalent Moderna pediatric primary series, mix-and-match use is not FDA authorized at this time.

However, children 5 years of age who complete a monovalent Moderna COVID-19 primary series may receive either the bivalent Pfizer COVID-19 booster dose or the bivalent Moderna COVID-19 booster dose at least two months after completion of the monovalent Moderna COVID-19 primary series.

Wisconsin Immunization Registry verification

Vaccinators are encouraged to check the Wisconsin Immunization Registry (WIR) and/or a patient’s CDC vaccination card before administering the bivalent Pfizer and Moderna COVID-19 vaccines to verify that individuals are meeting the authorized uses noted previously.

Resources

• CDC Interim Clinical Considerations
• Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine
• Emergency Use Authorization Fact Sheet for Recipients and Caregivers
• FDA Dear Healthcare Provider Letter
• Special Situations for COVID-19 Vaccination of Children and Adolescents: Age Transitions and Interchangeability

The Moderna bivalent booster with the blue cap and gray label border consists of one vaccine product for two age cohorts (6Y-11Y and 12Y+). Different dose sizes are administered for each cohort. Since two valid dose sizes can be drawn from the same vial, WIR inventory will need to be handled as follows.

All vials of Moderna bivalent vaccine (blue cap, gray label border) will be accepted into WIR inventory with a dose size of 0.5mL. If providers are accepting their orders and transfers as directed, no changes to the dose size need to be made in WIR, as it will already be set at 0.5 mL.

Direct entry into WIR

When entering a Moderna bivalent (blue cap, gray label border) immunization directly into WIR, see below for instructions for each dose size:

• 0.25 mL dose for children 6Y-11Y: Change the dose size in the dropdown menu from “Full” to “Half” each time a dose size of 0.25 mL is administered and documented in WIR. A half dose will be subtracted from inventory.
• 0.5 mL dose for people 12Y+: Do not make any changes when entering an administered dose. Leave the dose size as “Full,” and a full dose will be subtracted from inventory as expected.

Data Exchange partners

Providers who do not reduce WIR inventory through data exchange

• These providers need to manually adjust their Moderna bivalent vaccine inventory in WIR at the end of each clinic day to make sure it matches the physical inventory of Moderna bivalent vaccine on hand.
• To do this, providers must subtract doses from inventory.
• In WIR, go to: Manage Inventory > Show Inventory > Modify Quantity.
• Subtract the total number of doses administered during that clinic day.
• Be sure to use the reason of “Doses Administered.”

Providers who do reduce WIR inventory through data exchange

The dose of “Full” that you see in WIR, is representative of the amount of vaccine from inventory. This means that for every reported immunization, whether it is for someone over the age of 12 years (0.5mL) or a child 6-11 years old (0.25mL), one 0.5 mL dose will be deducted from your inventory in WIR.

This means that for each 0.25 mL dose that you administer to a child 6-11 years old, staff will need to add half of a dose back into the inventory in WIR.

The table below can help providers who do reduce WIR inventory through data exchange in knowing how many doses need to be added back to their WIR inventory. The column on the left indicates the number of 0.25 mL doses administered from a vial during a clinic day (for example, 3 booster doses for children 6-11 years old). The corresponding number in the right-hand column gives you the number of doses to add back into inventory to reconcile your inventory (for example, 1.5 doses). Beneath the chart, in the Modify Quantify on Hand section, 1.5 doses are added back to inventory using the reason Error Correction.

Adding inventory back to WIR - Modify Quantity on Hand

If you have any further questions regarding bivalent vaccine inventory, please contact the WIR Help Desk at 608-266-9691 or DHSWIRHelp@wisconsin.gov.

Moderna vaccines have dynamic expiration dates which can change over time as additional stability data become available. It is important for vaccinators to check the latest expiry information on the Moderna website.

• Do not store on dry ice.
• Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
• Unpunctured vials may be stored between 8° and 25°C (46° and 77°F) for up to 24 hours.
• Do not refreeze once thawed.
• Check the expiration date before preparing or administering vaccine. Never use expired vaccine or diluent. As additional stability data become available, the expiration dates for some products may change.

You can use the Moderna Temperature Excursion Tool to determine what should be done with vials that may have experienced a temperature excursion.

On January 31, the U.S. Food and Drug Administration (FDA) granted full approval of the Moderna COVID-19 vaccine for individuals 18 years of age and older. The vaccine can now be marketed under the name Spikevax for the prevention of COVID-19 in people 18 years of age and older.

The decision to grant full approval is the result of a rigorous review of thousands of pages of additional safety and efficacy data, as well as inspections of vaccine production sites, consistent with all other full approval processes. The FDA’s decision to issue full approval to the Moderna vaccine reinforces what we have known since the initial emergency use authorization – this vaccine is safe and effective. The vaccine also continues to be available under emergency use authorization (EUA) for the administration of a third dose in individuals who are immunocompromised and as primary series for people 6 months–17 years old.

Vaccine name changes

The COVID-19 vaccines that are currently available were contractually purchased by the U.S. Government after the FDA granted authorizations for EUA in 2020. Companies may market their vaccines under brand names once approval is granted.

The Moderna COVID-19 vaccine branded as SPIKEVAX was approved by the FDA on January 31, 2022, as a two-dose series for individuals aged 18 years and older. No change was made to the vaccine’s formula for this age group.

At this time, there is no concrete timeline for when the brand name vaccine, SPIKEVAX, will be available directly to consumers. Moderna continues to distribute EUA labeled vaccine to fulfill the U.S. Government contractual agreements.

For more information on the Moderna COVID-19 vaccine, please visit the Center for Disease Control and Prevention's (CDC) webpage: Moderna COVID-19 Vaccine Overview and Safety.

CDC COVID-19 vaccination program provider agreements

Providers are responsible for adhering to all requirements outlined in the agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of the CDC, ACIP, and the FDA. This applies to both EUA and FDA-approved COVID-19 vaccines. Accordingly, use of these products outside of those that have been approved and authorized by FDA (often referred to as “off-label use”) is not recommended. It would violate the provider agreement and could expose providers to the following risks:

• Administration of the product off label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
• Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
• CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the U.S. government-provided vaccines may be used in the program. Providers giving off-label doses would be in violation of the CDC Program provider agreement potentially impacting their ability to remain a provider in the CDC program.
• Administration fees may not be reimbursable by payers.

Interchangeability of FDA-authorized and FDA-approved Moderna COVID-19 products for people 18 years and older

The FDA-approved Moderna product Spikevax (COVID-19 vaccine, mRNA) and the FDA-authorized Moderna COVID-19 vaccine under EUA for people 18 years and older have the same formulation and can be used interchangeably to provide the COVID-19 vaccination primary series without presenting any safety or effectiveness concerns. Therefore, vaccinators can use doses distributed under the EUA to administer the vaccination series for anyone 18 years and older seeking the approved vaccine. Vaccinators should continue to use the vaccines on their shelves.

Additional resources

• EUA fact sheets for recipients and health care providers
• Moderna COVID-19 Vaccine Letter of Authorization (Reissued)
• Package insert for Spikevax
• Patient package insert for Spikevax
• Approval letter for Spikevax
• FDA webpage: Moderna COVID-19 Vaccines
• DHS press release: DHS Urges Vaccination as the Moderna COVID-19 Vaccine Gains Full FDA Approval

The Moderna COVID-19 vaccines should be stored and transported in the frozen state at -50°C to -15°C (-58°F to 5°F). If transport at frozen temperatures is not feasible, transportation of one or more thawed vials for up to 12 hours at 2°C to 8°C is permissible with precautions to minimize shaking and vibration.

If the vaccine is being transported at refrigerated temperatures, the total time for transport is 12 hours (cumulative). For example, if the vaccine is transported one hour to a clinic and one hour back to the primary storage unit, the returned vials have used two out of the 12 hour timeframe. These vials can be transported for 10 more hours. The beyond-use date labels for this vaccine have been updated to help providers keep track of transport times. In addition, care should be taken to ensure thawed vaccine does not refreeze.

This information is also included in the latest update of the CDC’s:

• Vaccine Storage and Handling Toolkit
• Moderna COVID-19 Vaccine Information

Providers must report all temperature excursions (any out-of-range temperatures) to the Wisconsin COVID-19 Vaccine Program within 24 hours at DHSCOVIDVACCINATOR@dhs.wisconsin.gov.

Vaccine shipments to providers will be preceded by two emails from McKesson. Both of these emails will be sent from cdcnotifications@mckesson.com and will be sent to the provider (facility) level email address that is transmitted with the order in VTrckS. This includes the following emails:

1. An order acknowledgment email that is sent once the order has been received into the McKesson system.
2. An advance shipment email that is sent once the order has shipped from the McKesson depot and contains the carrier tracking details.

Please note depending on when orders are placed and McKesson’s shipping timeline, you may receive the vaccine before receiving the shipping email.

If you have questions, please contact McKesson Specialty Customer Care at 833-343-2703 Monday-Friday, 7 a.m.–7 p.m. CST or email covidvaccinesupport@mckesson.com.