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.¹

The safety and effectiveness of SPIKEVAX for individuals 6 months of age and older is inferred from several studies of a primary series and booster dose of SPIKEVAX Bivalent (Original/Omicron BA.1) in individuals 6 months to 5 years of age, a booster dose study of SPIKEVAX Bivalent (Original/Omicron BA.1) in individuals >18 years of age, a booster dose study of SPIKEVAX XBB.1.5 in individuals > 18 years of age, as well as data from studies which evaluated the primary series and booster vaccination with SPIKEVAX (elasomeran).¹

According to NACI, COVID-19 vaccination is strongly recommended for previously vaccinated and unvaccinated individuals at increased risk of SARS-CoV-2 exposure or severe COVID-19 disease.²

Eligibility for 2025/26 COVID-19 vaccination varies by province/territory. Please refer to your regional health authority for complete eligibility criteria.

SARS-CoV-2 Omicron LP.8.1 variant

The most frequently reported adverse reactions after the Spikevax Bivalent 50 mcg booster dose were pain (77.3%), fatigue (54.9%), headache (43.9%), myalgia (39.6%), arthralgia (31.1%) and axillary swelling or tenderness (17.4%). The median duration of local and systemic adverse reactions was 2 days.¹

The most common adverse reactions after the SPIKEVAX original 50 µg booster dose (Dose in adults 18 years and older (n=377)) was fatigue (51.4%), headache (41.1%), myalgia (38.6%), and arthralgia (31.7%). The median duration of local and systemic adverse reactions was 2 days.¹

Please refer to the Product Monograph for additional safety information, as well as safety information for other cohorts.

Medicinal ingredients:¹

Each 0.5 mL dose of Spikevax contains 50 micrograms of mRNA encoding SARS-CoV-2 spike protein, 5'(m7G-5'-ppp- 5'-Gm) cap, 100-nucleotide 3' poly(A) tail. The mRNA encoding spike protein is derived from the Omicron LP.8.1 variant of Spikevax contains 50 micrograms [1] of SARS-CoV-2 LP.8.1 mRNA.

Non-medicinal ingredients:¹

• acetic acid
• cholesterol
• DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
• PEG2000-DMG (1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000)
• SM-102 (Heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate)
• sodium acetate trihydrate
• sucrose
• trometamol
• trometamol hydrochloride
• water for injection

Strong recommendation²
NACI recommends a COVID-19 vaccine for previously vaccinated and unvaccinated individuals at increased risk of SARS-CoV-2 exposure or severe COVID-19 disease, which includes the following individuals:

• all adults aged ≥65 years
• those aged ≥6 months who are:
  • residents of long-term care homes and other congregate living settings
  • with underlying medical conditions that place them at higher risk of severe COVID-19, including children with complex health needs
  • pregnant women and individuals who are pregnant
  • individuals in or from First Nations, Inuit and Métis communities
  • members of racialized and other equity-denied communities
  • healthcare workers and other care providers in facilities and community settings

Discretionary recommendation²

NACI recommends all other previously vaccinated and unvaccinated individuals (aged ≥6 months) who are not at increased risk for SARS-CoV-2 exposure or severe COVID-19 disease (i.e., not listed above) may receive a COVID-19 vaccine.

For individuals aged ≥6 months, COVID-19 vaccines may be given concurrently with (i.e., same day), or at any time before or after, non-COVID-19 vaccines (including live and non-live vaccines).¹

Underlying medical conditions associated with severe COVID-19 disease according to PHAC and NACI include:^2,3
Cancer
Chronic disease

• chronic kidney disease
• chronic liver diseases (cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis)
• chronic lung diseases (bronchiectasis, COPD, ILD, pulmonary hypertension, PE)
• cystic fibrosis
• diabetes mellitus (types 1 and 2)
• heart conditions (e.g., cardiomyopathies, HF)
• smoking (current or former)

Obesity (BMI ≥30 kg/m2)
Pregnancy and recent pregnancy

Vascular disease

• coronary artery disease
• cerebrovascular disease

Vulnerabilities, medical and/or social

• e.g., people who use substances regularly; persons experiencing homelessness or who are unhoused

Infection

• HIV
• tuberculosis

Immunocompromised

• primary immunodeficiency diseases
• solid organ or blood stem cell transplant
• immunosuppressed due to corticosteroids or other immunosuppressive medication

Disabilities

• e.g., Down syndrome; learning, intellectual, or developmental disabilities; ADHD; cerebral palsy; congenital disabilities; spinal cord injuries

Mental health disorders

• mood disorders, including MDD
• schizophrenia spectrum disorders

Your patient can use the Vaccine Finder.

Please follow the guidelines for the storage and handling of the vaccines to ensure their efficacy.

Spikevax DASH Guide

Spikevax Product Monograph

No, thawed vaccines cannot be refrozen. Once thawed, vials and pre-filled syringes can be stored refrigerated between 2° to 8°C for up to 50 days prior to first use.¹