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Resources for Canadian Healthcare Professionals and Patients

SPIKEVAX™ (elasomeran 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 years of age and older.

The current SPIKEVAX vial and carton labels are not Canadian-specific, as global, English-only labels are being used for the Canadian market.

For more information, please see the Health Product Risk Communications below.

Please find helpful resources for SPIKEVAX below. Check back as we update with additional educational content as it becomes available.

Drug Identification Number (DIN): 02510014

Storage, Handling, Dosage
and Administration

SPIKEVAX Product
Monograph

June 1, 2022

Videos

Withdrawing a SPIKEVAX 0.5mL (100 mcg mRNA) Primary Series Dose Video

Withdrawing a 0.5mL (100 mcg mRNA) Primary Series Dose

This video is intended to be used to show proper dosing of a 0.5mL (100 mcg mRNA) primary series dose for SPIKEVAX™ (elasomeran mRNA vaccine).

This video is intended to be used to show proper dosing and administration techniques for SPIKEVAX and is intended for healthcare professionals only.

Content portrayed in this video is only for instructional purposes. Actual handling and product manipulation should be performed in accordance with the Product Monograph and Health Canada-approved label, local regulations, and standard operating procedures.

Please contact 1-866-MODERNA (1-866-663-3762) with any inquiries pertaining to the content of this video.

For illustrative purposes only. Actual SPIKEVAX not shown. Please see full Product Monograph for more details.

0.5 mL (100 mcg mRNA) primary series dose

Moderna

Withdrawing a SPIKEVAX 0.25mL (50 mcg mRNA) Booster Dose or Pediatric (6 to 11 years) Dose Video

Withdrawing a 0.25mL (50 mcg mRNA) Booster Dose or Pediatric (6 to 11 years) Dose Video

This video is intended to be used to show proper dosing of a 0.25mL (50 mcg mRNA) booster dose or pediatric dose (6 to 11 years) for SPIKEVAX™ (elasomeran mRNA vaccine).

This video is intended to be used to show proper dosing and administration techniques for SPIKEVAX and is intended for healthcare professionals only.

Content portrayed in this video is only for instructional purposes. Actual handling and product manipulation should be performed in accordance with the Product Monograph and Health Canada-approved label, local regulations, and standard operating procedures.

Please contact 1-866-MODERNA (1-866-663-3762) with any inquiries pertaining to the content of this video.

For illustrative purposes only. Actual SPIKEVAX not shown. Please see full Product Monograph for more details.

0.25 mL (50 mcg mRNA) booster dose or pediatric dose (6 to 11 years)

Moderna

SPIKEVAX Primary Series vs Booster Dose or Pediatric Dose Video

SPIKEVAX™ (elasomeran mRNA vaccine) Primary Series vs Booster Dose or Pediatric Dose

This video is intended to be used to show proper dosing of a 0.5mL (100 mcg mRNA) primary series dose compared to a 0.25mL (50 mcg mRNA) booster dose or pediatric dose (6 to 11 years) of SPIKEVAX™ (elasomeran mRNA vaccine).

This video is intended to be used to show proper dosing and administration techniques for SPIKEVAX and is intended for healthcare professionals only.

Content portrayed in this video is only for instructional purposes. Actual handling and product manipulation should be performed in accordance with the Product Monograph and Health Canada-approved label, local regulations, and standard operating procedures.

Please contact 1-866-MODERNA (1-866-663-3762) with any inquiries pertaining to the content of this video.

For illustrative purposes only. Actual SPIKEVAX not shown. Please see full Product Monograph for more details.

Primary Series dose - 0.5 mL (100 mcg mRNA)

Booster dose – 0.25 mL (50 mcg mRNA)

Moderna

Proper Vial Swirl Technique for SPIKEVAX Video

Proper Vial Swirl Technique for SPIKEVAX™ (elasomeran mRNA vaccine)

This video is intended to be used to show a proper vial swirl technique for SPIKEVAX™ (elasomeran mRNA vaccine).

This video is intended to be used to show proper dosing and administration techniques for SPIKEVAX and is intended for healthcare professionals only.

Content portrayed in this video is only for instructional purposes. Actual handling and product manipulation should be performed in accordance with the Product Monograph and Health Canada-approved label, local regulations, and standard operating procedures.

Please contact 1-866-MODERNA (1-866-663-3762) with any inquiries pertaining to the content of this video.

For illustrative purposes only. Actual SPIKEVAX not shown. Please see full Product Monograph for more details.

Swirl vial gently after thawing and between each withdrawal.

Do not shake. Do not dilute the vaccine.

Please see full Product Monograph for more details.

Moderna

How to Puncture the SPIKEVAX Multidose Vial up to 20 Times Video

How to puncture the SPIKEVAX™ multidose vial up to 20 times

This video is intended to be used to show a proper way to puncture the SPIKEVAX™ multidose vial multiple times.

This video is intended to be used to show proper dosing and administration techniques for SPIKEVAX and is intended for healthcare professionals only.

Content portrayed in this video is only for instructional purposes. Actual handling and product manipulation should be performed in accordance with the Product Monograph and Health Canada-approved label, local regulations, and standard operating procedures.

Please contact 1-866-MODERNA (1-866-663-3762) with any inquiries pertaining to the content of this video.

For illustrative purposes only. Actual SPIKEVAX not shown. Please see full Product Monograph for more details.

Use a different insertion point at various locations of the vial septum for each withdrawal to reduce potential leakage of vaccine.

Do not puncture the vial more than 20 times.

Moderna

Reporting Adverse Events

Managing marketed health product-related side effects depends on healthcare professionals and patients reporting them. Any serious or unexpected side effects in patients receiving SPIKEVAX should be reported to your local Health Unit.

If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory and send it to your local Health Unit.

In addition, you can report side effects to Moderna at 1-866-MODERNA (1-866-663-3762).

Product Concerns

All designated vaccination sites need to maintain security around the storage of SPIKEVAX within their facilities.

Make sure that vials of SPIKEVAX arrive and are stored in their original packaging. If you suspect that the SPIKEVAX you have purchased may be counterfeit, if there are any irregularities with packaging, and/or with the arrival of the shipments, please contact us at 1‑866‑663‑3762 or visit www.modernatx.com, or report a complaint to Health Canada.