Spikevax Dosage

Generic name: CX-038839 OMICRON (XBB.1.5) 50ug in 0.5mL
Dosage form: injection, suspension
Drug class: Viral vaccines

Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.

For intramuscular injection only.

2.1 Preparation for Administration

•: SPIKEVAX multiple-dose vials, single dose vials, and single dose pre-filled syringes contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.
•: There are 3 presentations of SPIKEVAX.
•: Thaw each vial or pre-filled syringe before use following the instructions below.

	Thaw in Refrigerator	Thaw at Room Temperature
Multiple-Dose Vial Containing 5 Doses	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.
0.5 mL Single Dose Vial	Thaw between 2°C to 8°C (36°F to 46°F) for 45 minutes. 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 15 minutes.
0.5 mL Single Dose Pre-Filled Syringe	Thaw between 2°C to 8°C (36°F to 46°F) for 1 hour. Let each syringe 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.

•

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

•

SPIKEVAX 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.

•

For multiple-dose vials:

o: Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
o: Each 2.5 mL multiple-dose vial contains 5 doses of 0.5 mL.
o: If the amount of vaccine remaining in the vial cannot provide a full dose appropriate for the individual being vaccinated, discard the vial and contents. Do not pool excess vaccine from multiple vials.
o: After the first dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F).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 SPIKEVAX vial label. Discard multiple-dose vials after 12 hours. Do not refreeze.

•

For single dose vials:

o: Swirl vial gently after thawing. Do not shake. Do not dilute the vaccine.
o: Each vial is single use only. Discard after single use.

•

For single dose pre-filled syringes:

o: Do not shake. Do not dilute the vaccine.
o: Use a sterile needle of the appropriate size for intramuscular injection.
o: With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting.
o: Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
o: Administer the entire dose intramuscularly.
o: Discard syringe after use.

Administration

Administer SPIKEVAX intramuscularly.

2.3 Dosing and Schedule

SPIKEVAX is administered as a single 0.5 mL dose.

For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of SPIKEVAX at least 2 months after the last dose of COVID-19 vaccine.