Resources for healthcare professionals
Self-service tools and resources for your vaccination efforts
Spikevax Product Monograph
Spikevax Product Monograph
COVID-19 Patient Risk Assessment Tool
COVID-19 Patient Risk Assessment Tool
Use this to help identify patients at increased risk for severe disease and outcomes.
Spikevax DASH Guide
Spikevax DASH Guide
Stay up to date with the latest Spikevax information in our quick reference DASH (dosage, administration, storage, handling) Guide for healthcare professionals.
Temperature Excursion Tool
Temperature Excursion Tool
Assess Moderna COVID-19 vaccines that may have experienced temperature excursion prior to administration.
Patient Resources
Resources to help support your patients asking about COVID-19 vaccination
Spikevax Patient Medication Information
Spikevax Patient Medication Information
Vaccine finder
Vaccine finder
Find a COVID-19 vaccination provider near you.
FAQs
Have a question about Moderna vaccines? Browse the topics below to find the answers to some of the most frequently asked questions about placing, tracking, and receiving orders. If your question isn't addressed, our Customer Care Team is just a call away at 1-866-MODERNA (1-866-663-3762), or available by email at WeCare@modernatx.com.
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 all individuals at increased risk of SARS-CoV-2 exposure or severe COVID-19 disease.2
Eligibility for COVID-19 vaccination varies by province/territory. Please refer to your regional health authority for complete eligibility criteria.
SARS-CoV-2 Omicron XFG 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 mcg 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.
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 variant XFG.
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 recommendations2
NACI continues to strongly recommend COVID-19 immunization for individuals at increased risk of SARS-CoV-2 exposure or severe COVID-19 disease, including:
- 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 recommendations2
NACI recommends immunization for all 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).
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 the Public Health Agency of Canada (PHAC):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.
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 60 days prior to first use.1
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 have not yet been established.
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.
- National Advisory Committee on Immunization (NACI), An Advisory Committee Statement (ACS): Guidance on the Use of COVID-19 vaccines for 2025 to summer 2026. Published January 10, 2025.
- Public Health Agency of Canada (PHAC). COVID-19 signs, symptoms and severity of disease: A clinician guide. Available at: https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/signs-symptoms-severity.html#a3. Accessed July 14, 2026.
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