SPIKEVAX Bivalent Original / Omicron BA.4/5 (elasomeran / davesomeran mRNA vaccine)
Resources for Canadian Healthcare Professionals and Patients
SPIKEVAX Bivalent (elasomeran / davesomeran) Original / Omicron BA.4/5 mRNA vaccine is indicated as a booster dose 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 safety and effectiveness of a booster dose of SPIKEVAX Bivalent (elasomeran / davesomeran) Original / Omicron BA.4/5 mRNA vaccine for individuals 6 years of age and older is inferred from studies of a booster dose of SPIKEVAX Bivalent (Original / Omicron BA.1).
The National Advisory Committee on Immunization (NACI) provides additional guidance on the use of the COVID-19 vaccines in Canada. Please refer to the COVID-19 vaccine: Canadian Immunization Guide and current vaccine statements.
The current SPIKEVAX Bivalent 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 Bivalent below. Check back as we update with additional educational content as it becomes available.
0.10 mg/mL Drug Identification Number (DIN): 02532352
The National Advisory Committee on Immunization (NACI)
The National Advisory Committee on Immunization (NACI) continues to recommend that bivalent Omicron-containing mRNA COVID-19 vaccines are the preferred booster products for the authorized age groups. There is currently no evidence to suggest any meaningful difference in protection between different bivalent booster vaccines targeting BA.1 versus BA.4/5.
Starting in the spring of 2023, NACI recommends an additional booster be offered to patients at increased risk of severe illness from COVID-19.
SPIKEVAX Bivalent Original / Omicron BA.4/5
SPIKEVAX Bivalent Original / Omicron (elasomeran / imelasomeran mRNA vaccine)
Resources for Canadian Healthcare Professionals and Patients
SPIKEVAX Bivalent (elasomeran / imelasomeran) Original / Omicron mRNA vaccine is indicated as a booster dose 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 National Advisory Committee on Immunization (NACI) provides additional guidance on the use of the COVID-19 vaccines in Canada. Please refer to the COVID-19 vaccine: Canadian Immunization Guide and current vaccine statements.
The current SPIKEVAX Bivalent 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 Bivalent below. Check back as we update with additional educational content as it becomes available.
0.10 mg/mL Drug Identification Number (DIN): 02530252
SPIKEVAX Bivalent Original / Omicron
Helpful Resources
- Addendum to the guidance on the use of COVID-19 vaccines in the fall of 2023
- National Advisory Committee on Immunization (NACI) Statement (as of July 11, 2023)
- Government of Canada Information on SPIKEVAX Bivalent (Original / Omicron)
- Government of Canada Information on SPIKEVAX Bivalent (Original / Omicron BA.4/5)
- Government of Canada COVID-19 Resources
Product Concerns
All designated vaccination sites need to maintain security around the storage of SPIKEVAX Bivalent within their facilities.
Make sure that vials of SPIKEVAX Bivalent arrive and are stored in their original packaging. If you suspect that the SPIKEVAX Bivalent 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.
Vial Expiration Checker
Find the expiration date here for any vial of Moderna COVID-19 Vaccine through the LOT number of the vial
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 Bivalent 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 Adverse Event Intake Portal or by calling 1-866-MODERNA (1-866-663-3762).