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Moderna COVID-19 Vaccine Dosage

Generic name: CX-024414 0.1mg in 1mL
Dosage form: injection, suspension

Medically reviewed by Drugs.com. Last updated on Jun 17, 2022.

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):
o
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.
o
Vials should be discarded 12 hours after the first puncture.
Storage at 8°C to 25°C (46°F to 77°F):
o
Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.
o
Vials should be discarded 12 hours after the first puncture.
o
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 magenta border is administered as a primary series of two doses (0.25 mL each) 1 month apart to individuals 6 months through 5 years of age.

A third primary series dose (0.25 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a magenta border is authorized for administration at least 1 month following the second dose to individuals 6 months through 5 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 magenta border is supplied as 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 magenta 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 Magenta 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 magenta border contains 10 primary series doses of 0.25 mL each; low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
o
Each dose must contain 0.25 mL of vaccine;
o
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.25 mL, discard the vial and content;
o
Do not pool excess vaccine from multiple vials.
After the first 0.25 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.

Administration

Administer the Moderna COVID-19 Vaccine intramuscularly.

For intramuscular injection only.

The storage, preparation, and administration information in this EUA Prescribing Information apply to the Moderna COVID-19 Vaccine for individuals 6 months through 5 years of age, which is supplied in a multiple-dose vial with a dark blue cap and a label with a magenta border.

Preparation for Administration

The Moderna COVID-19 Vaccine multiple-dose vial with a dark blue cap and a label with a magenta border is supplied as 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 magenta 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 Magenta 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 magenta border contains 10 primary series doses of 0.25 mL each;. low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
o
Each dose must contain 0.25 mL of vaccine;
o
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.25 mL, discard the vial and content;
o
Do not pool excess vaccine from multiple vials.
After the first 0.25 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.

Administration

Administer the Moderna COVID-19 Vaccine intramuscularly.

Dosing and Schedule

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a magenta border is administered as a primary series of two doses (0.25 mL each) 1 month apart to individuals 6 months through 5 years of age.

A third primary series dose (0.25 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a magenta border is authorized for administration at least 1 month following the second dose to individuals 6 months through 5 years of age with certain kinds of immunocompromise.

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