24 hour post-puncture stability
SPIKEVAX is preservative free. Once the vial has been entered (punctured), it should be discarded after 24 hours if refrigerated post-puncture or after 12 hours if stored at room temperature post-puncture.
Storage after thawing
Unpunctured Vial (Prior to first use) | Punctured Vial (After first dose has been withdrawn) |
|---|---|
Refrigerate at 2° to 8°C for up to 50 days. Cool storage up to room temperature 8° to 25°C for 12 hours | Refrigerate at 2° to 8°C for up to 24 hours. Cool storage up to room temperature 8° to 25°C for 12 hours |
Administration for multi-dose vial
Prior to injection, inspect each dose to:
Confirm liquid is white to off-white
Confirm liquid is white to off-white in colour in both vial and syringe.
- SPIKEVAX may contain white or translucent product-related particulates.
- Do not administer the vaccine if it is discoloured or contains other particulate matter.
- For detailed information regarding storage and handling, see the Product Monograph.
Verify syringe volume
Verify syringe volume based on recommended dose and dose volume (refer to the dosing information above).
- 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.
- Pierce the stopper preferably at a different site each time.
- Discard vial 24 hours after first puncture, even if vaccine remains in the vial.
Administer SPIKEVAX
Administer SPIKEVAX by intramuscular (IM) injection only
- The preferred site is the deltoid muscle of the upper arm or, in infants and young children, the anterolateral aspect of the thigh.
- A needle length of ≥1 inch should be used as needles <1 inch may be of insufficient length to penetrate muscle tissue in some adults. text
Blue cap SPIKEVAX 0.1 mg/mL Multidose vial 2.5 mL
For illustrative purpose only.
Storage after first dose has been withdrawn
Thawed vials can be handled in room light conditions.
- Once the vial has been entered, discard vial after 24 hours if refrigerated between 2° to 8°C (36° to 46°F) and discard vial after 12 hours if stored at room temperature.
- Record the date and time of first use on the vial label.
- Once the vial has been punctured to withdraw the initial dose, the vaccine should be used immediately.
- Any unused vaccine or waste material should be disposed of in accordance with local requirements.
- NEVER refreeze thawed vaccine
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 not established.
Contraindications:
- 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:
Please consult the Product Monograph at spikevaxpro.com/pm for important information relating to adverse reactions, drug interactions, and dosing information which has not been discussed in this piece. The Product Monograph is also available by calling us at 1-866-MODERNA (1-866-663-3762).
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