Help protect your patients against COVID-19
Canadian-made pre-filled syringes
Spikevax mRNA is manufactured in Laval, QC and fill-finished in Cambridge, ON.
Stay up to date with the latest Spikevax information in our quick reference DASH (dosing, administration, storage and handling) guide
Dosing schedule1
Individuals aged ≥12 years
COVID-19 vaccination history | Not previously vaccinated |
|---|---|
Schedule | 1 dose |
Presentation | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label (50 mcg/0.5 mL): coral blue label |
Dose | 50 mcg / 0.5 ML |
COVID-19 vaccination history | Schedule | Presentation | Dose |
|---|---|---|---|
Not previously vaccinated | 1 dose | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label (50 mcg/0.5 mL): coral blue label | 50 mcg / 0.5 ML |
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
In severely immunocompromised individuals ≥18 years of age:
- an additional dose may be given ≥2 months following the initial vaccination
- any additional doses may be given ≥4 months following the most recent dose of a COVID-19 vaccine
Individuals aged 5-11 years
COVID-19 vaccination history | Not previously vaccinated |
|---|---|
Schedule | 1 dose |
Presentation | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label |
Dose | 25 mcg/ 0.25 mL (per dose) |
COVID-19 vaccination history | Schedule | Presentation | Dose |
|---|---|---|---|
Not previously vaccinated | 1 dose | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label | 25 mcg/ 0.25 mL (per dose) |
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
Individuals aged 6 months to 4 years
COVID-19 vaccination history | Not previously vaccinated |
|---|---|
Schedule | 2 dose series given |
Presentation | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label |
Dose | 25 mcg / 0.25 ML (per dose) |
COVID-19 vaccination history | previously vaccinated (≥1 previous doses) |
|---|---|
Schedule | 1 dose |
Presentation | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label |
Dose | 25 mcg / 0.25 ML (per dose) |
COVID-19 vaccination history | Schedule | Presentation | Dose |
|---|---|---|---|
Not previously vaccinated | 2 dose series given | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label | 25 mcg / 0.25 ML (per dose) |
previously vaccinated (≥1 previous doses) | 1 dose | Multidose vial (0.1 mg/mL): royal blue cap, coral blue label | 25 mcg / 0.25 ML (per dose) |
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
Administration instructions1
Spikevax is preservative free and comes ready to use once thawed. Swirl vial gently after thawing and between each withdrawal. Do not shake or dilute the vial or pre-filled syringe.
1
Confirm liquid is white to off-white
Visually inspect Spikevax multidose vials or pre-filled syringes for foreign particulate matter/discolouration
prior to injection
- Spikevax may contain white or translucent product-related particulates
- Do not administer the vaccine if it is discoloured or contains other particulate matter
2
Prepare for the injection
MULTIDOSE VIAL:
- Verify syringe volume based on recommended dose and dose volume
- If the amount of Spikevax remaining in the vial cannot provide a full dose, discard the vial and contents – do not pool excess Spikevax from multiple vials
- Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab
- Withdraw each dose of vaccine from the vial using a new sterile needle and syringe (preferentially a low dead-volume syringe and/or needle) for each injection
- Pierce the stopper preferably at a different site each time
PRE-FILLED SYRINGE:
- Thaw each pre-filled syringe before use
- The pre-filled syringes may be stored at room temperature for a total of 12 hours after removal from refrigerated conditions
- Discard the pre-filled syringe if not used within this time
- Use a sterile needle of the appropriate size for IM injection (21-gauge or thinner)
- 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
- Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe
- Uncap the needle when ready for administration
3
Administer Spikevax
- Administer Spikevax by IM injection only using aseptic technique
- Preferred site is the deltoid muscle of the upper arm, or
- The anterolateral aspect of the thigh in infants and young children
- If using a prefilled syringe, discard after use
Provide card to the recipient or their caregiver. Be sure to include the date they received their dose.
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
IM = intramuscular.
Storage & Handling1
Frozen storage
- Spikevax multidose vials and pre-filled syringes can be stored frozen until expiration date
- Store at -50°C to -15°C in the original carton and protect from light
- Thaw each multidose vial or pre-filled syringe before use
Multidose Vial
For illustrative purposes only
Thawing instructions
- Vials can be thawed in the refrigerator or at room temperature
Thaw in the refrigerator
Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours.
Thaw at room temperature
Thaw between 15°C to 25°C (59°F to 77°F) for 45 minutes.
Thawed storage
- Thawed vials and filled syringes can be handled in room light conditions
Storage Condition | Unpunctured vial (prior to 1st use) | Punctured vial (after 1st dose has been withdrawn) |
|---|---|---|
Refrigerator (2C ̊ to 8 ̊C) | 50 days | 24 hours |
Cool storage up to room temperature (8 ̊C to 25 ̊C) | 12 hours | 12 hours |
NEVER refreeze thawed vaccine
Record the date and time of discard on the vial label
Pre-filled Syringe
For illustrative purposes only
Thawing instructions
- Pre-filled syringes can be thawed in the refrigerator or at room temperature
Thaw in the refrigerator
Thaw between 2°C to 8°C (36°F to 46°F)
for 100 minutes for an individual syringe
or 160 minutes for a carton of 10 syringes.
Thaw at room temperature
Thaw between 15ºC and 25ºC
for 40 minutes for an individual syringe
or 80 minutes for a carton of 10 syringes.
Thawed storage
- Thawed pre-filled syringes can be handled in room light conditions
Storage Condition | Duration |
|---|---|
Refrigerator (2C ̊ to 8 ̊C) | 50 days |
Cool storage up to room temperature (8 ̊C to 25 ̊C) | 12 hours |
NEVER refreeze thawed vaccine
Syringes should not be returned to the refrigerator after being thawed at room temperature
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
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Please contact us if you have any questions about ordering and product availability or to arrange an appointment with our field staff.
Prescribing Information
Indication and clinical use:
Spikevax® (COVID-19 mRNA vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 6 months of age and older.
Pediatrics: Safety and efficacy in individuals <6 months of age has not yet been.
Contraindication:
- Hypersensitivity to the active ingredient or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.
Relevant warnings and precautions:
- Hypersensitivity and anaphylaxis
- Myocarditis and pericarditis
- Patients with acute infection
- Patients with hematologic disorders or on anticoagulant therapy
- Patients who are immunocompromised
- Syncope
- Vaccination with Spikevax may not protect all recipients
For more information:
Consult the Product Monograph at spikevaxpro.com/pm for important information regarding adverse reactions, drug interactions, and dosing, which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-866-MODERNA (1-866-663-3762).
References
- Spikevax Product Monograph. Moderna Biopharma Canada Corp.
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