Vaccine Information: Moderna COVID-19 Vaccine

MODERNA COVID-19 VACCINE- cx-024414 injection, suspension
Moderna US, Inc.


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Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
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Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

PRIMARY SERIES

6 years through 11 years of age

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older.

There are 2 presentations of Moderna COVID-19 Vaccine authorized for use to provide primary series doses to individuals 6 years through 11 years of age:

The presentation supplied in a multiple-dose vial with a dark blue cap and a label with a purple border (see image below). The cartons and vial labels state “BOOSTER DOSES ONLY.” This presentation may be used to provide primary series doses to individuals 6 years through 11 years of age. The Moderna COVID-19 Vaccine is not authorized to provide booster doses to individuals 6 years through 11 years of age.1

multiple-dose vial
(click image for full-size original)
Label with purple border
(click image for full-size original)

The presentation supplied in a multiple-dose vial with a dark blue cap and a label with a teal border (currently not available). The cartons state “For age 6 years through 11 years.” The vial labels state “Age 6y through 11y.”

This Fact Sheet pertains only to Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border which are authorized for use to provide a two-dose primary series to individuals 6 years through 11 years of age. The vaccine is also authorized to provide a third primary series dose to individuals 6 years through 11 years of age who have been determined to have certain kinds of immunocompromise.2

Moderna COVID-19 Vaccine supplied in multiple-dose vials with a dark blue cap and a label with a teal border intended for use in individuals 6 years through 11 years of age should not be used in individuals 6 months through 5 years of age, and individuals 12 years of age and older because of the potential for vaccine administration errors, including dosing errors.3,4


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The multiple-dose vials with dark blue caps and labels with a purple border are authorized to provide 0.5 mL primary series doses to individuals 6 years through 11 years of age and to provide 0.5 mL booster doses to individuals 18 years of age and older.
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Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
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Notwithstanding the age limitations for use of the different presentations of the Moderna COVID-19 Vaccine, individuals who will turn from 5 years to 6 years of age between doses in the primary series may receive, for any dose in the primary series, either: (1) the Moderna COVID-19 Vaccine authorized for use in individuals 6 months through 5 years of age (each 0.25 mL dose containing 25 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a magenta border; (2) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a purple border stating “BOOSTER DOSES ONLY”; or (3) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a teal border.Similarly, individuals who will turn from 11 years to 12 years of age between doses in the primary series may receive, for any dose in the primary series, either: (1) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a purple border stating “BOOSTER DOSES ONLY”; (2) SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine authorized for use in individuals 12 years of age and older (each 0.5 mL dose containing 100 mcg mRNA) supplied in multiple-dose vials with red caps and labels with a light blue border; or (3) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a teal border.
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For primary vaccination of individuals 6 months through 5 years of age and 12 years of age and older, refer to the respective Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Moderna COVID-19 Vaccine is a suspension for intramuscular injection.

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border is administered as a primary series of two doses (0.5 mL each) 1 month apart to individuals 6 years through 11 years of age.

A third primary series dose (0.5 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border is authorized for administration at least 1 month following the second dose to individuals 6 years through 11 years of age with certain kinds of immunocompromise.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine-eua.

For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

Storage and Handling

The information in this Fact Sheet supersedes the information on the vial and carton labels.

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Frozen Storage

Store frozen between -50°C to -15°C (-58°F to 5°F).

Storage after Thawing

Storage at 2°C to 8°C (36°F to 46°F):
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Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use.
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Vials should be discarded 12 hours after the first puncture.
Storage at 8°C to 25°C (46°F to 77°F):
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Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.
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Vials should be discarded 12 hours after the first puncture.
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Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.

Do not refreeze once thawed.

Thawed vials can be handled in room light conditions.

Transportation of Thawed Vials at 2°C to 8°C (36°F to 46°F)

If transport at -50°C to -15°C (-58°F to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2°C to 8°C (36°F to 46°F) when shipped using shipping containers which have been qualified to maintain 2°C to 8°C (36°F to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2°C to 8°C (36°F to 46°F), vials should not be refrozen and should be stored at 2°C to 8°C (36°F to 46°F) until use.

Dosing and Schedule

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border is administered as a primary series of two doses (0.5 mL each) 1 month apart to individuals 6 years through 11 years of age.

A third primary series dose (0.5 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border is authorized for administration at least 1 month following the second dose to individuals 6 years through 11 years of age with certain kinds of immunocompromise.

Preparation for Administration

The Moderna COVID-19 Vaccine multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine multiple-dose vial with a dark blue cap and a label with a teal border contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.
Verify that the vial of Moderna COVID-19 Vaccine has a dark blue cap and a label with a purple border or a dark blue cap and a label with a teal border.
Thaw each vial before use following the instructions below.

Thawing Instructions for Moderna COVID-19 Vaccine Multiple-Dose Vials with Dark Blue Caps and Labels with a Purple Border or Multiple-Dose Vials with Dark Blue Caps and Labels with a Teal Border

Thaw in Refrigerator

Thaw at Room Temperature

Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours. Let each vial stand at room temperature for 15 minutes before administering.

Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 45 minutes.

After thawing, do not refreeze.
Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.
Each multiple-dose vial with a dark blue cap and a label with a purple border and each multiple-dose vial with a dark blue cap and a label with a teal border contains 5 doses of 0.5 mL.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
After the first 0.5 mL dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine vial label. Discard vial after 12 hours. Do not refreeze.

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