Moderna Spikevax COVID-19 vaccines
All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.
Product names: Moderna Spikevax® COVID-19 vaccine; Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1); Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5); Moderna Spikevax® COVID-19 vaccine (Omicron XBB.1.5 subvariant)
Manufacturer: Moderna Biopharma Canada Corporation
Type: mRNA
Status: Approved by Health Canada
How it's given: Injection in muscle (usually the upper arm)
Number of doses:
2 doses for a primary series and 1 dose as a booster, except the Omicron XBB.1.5 subvariant vaccine.
Omicron XBB.1.5 subvariant vaccine doses:
- Age 5 years and older:
- 1 dose
- Individuals 6 Months to 4 Years of Age:
- 2 doses (not previously vaccinated)
- 1 dose (previously vaccinated)
Approved for:
As a booster dose in individuals age 6 years and older:
- Bivalent Original/Omicron BA.1 vaccine
- Bivalent Original/Omicron BA.4/5 vaccine
Primary series in individuals age 6 months and older, or as a booster dose in individuals age 12 years and older:
- Original COVID-19 vaccine
Individuals age 6 months and older:
- Omicron XBB.1.5 subvariant vaccine
On this page
- Who the vaccines are approved for
- Effectiveness
- Dosage
- Vaccine ingredients
- Possible side effects
- Vaccine review, approval and monitoring
- Get vaccinated
Who the vaccines are approved for
Moderna Spikevax® COVID-19 vaccine
The Moderna Spikevax® COVID-19 vaccine is approved for primary vaccination in people who are 6 months of age and older. Its safety and effectiveness in people younger than 6 months have not yet been established. This vaccine is also approved as a booster for people 12 years of age and older.
Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1)
The Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1) is approved as a booster for people who are 6 years of age and older. Its safety and effectiveness in younger people has not yet been established.
Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5)
The Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) is approved as a booster for people who are 6 years of age and older. Its safety and effectiveness in younger people has not yet been established.
Moderna Spikevax® Monovalent COVID-19 vaccine (Omicron XBB.1.5 subvariant)
The Moderna Spikevax® Monovalent COVID-19 vaccine (Omicron XBB.1.5 subvariant) is approved for people who are 6 months of age and older. It may be given to people who have been previously vaccinated or who have not been previously vaccinated.
Its safety and effectiveness in people younger than 6 months has not yet been established.
Effectiveness
Clinical trials showed that beginning 2 weeks after the second dose, the Moderna Spikevax® COVID vaccine was:
- 94.1% effective in protecting trial participants aged 18 and above against COVID-19
- 100% effective in trial participants 12 to 17 years old
- as effective in trial participants 6 to 11 years old as in young adults (18 to 25 years old)
- 37% effective in trial participants 2 to 5 years old
- 51% effective in trial participants 6 to 23 months old
The Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1) was shown to increase the immune response against the Omicron BA.1 variant. This means that the booster is expected to offer protection against this variant.
The safety and effectiveness of the Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA. 4/5) is based on studies of Spikevax® Bivalent (Original/Omicron BA.1).
The safety and effectiveness of the Moderna Spikevax® Monovalent COVID-19 vaccine (Omicron XBB 1.5) is based on studies of Spikevax® (Original, Original/Omicron BA.1 & XBB.1.5).
Dosage
Primary series
12 years and older (2 doses of 100 micrograms, 1 month apart)
6 to 11 years (2 doses of 50 micrograms, 1 month apart)
6 months to 5 years (2 doses of 25 micrograms, 1 month apart)
Dose volume depends on which series of the vaccine is being administered. The dose for people 12 years of age and older (100 micrograms) is:
- 2 times the dose used for children 6 to 11 years of age (50 micrograms)
- 4 times the dose used for children 6 months to 5 years of age (25 micrograms)
Booster doses
12 years and older (50 micrograms at least 4 months after their previous dose) Moderna Spikevax® COVID-19 vaccine, Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1), Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5)
6 to 11 years (25 micrograms at least 6 months after their previous dose) Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1), Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5)
Omicron XBB.1.5 subvariant vaccine doses
- 12 years and older (50 micrograms at least 6 months after their previous dose)
- 5 to 11 years (25 micrograms at least 6 months after their previous dose)
- 6 months to 4 years (25 micrograms at least 6 months after their previous dose). If the child has not been previously vaccinated, Spikevax XBB.1.5 should be administered a 2-dose regimen.
Dose labelling
Check the colour of the vial cap and the corresponding dose volumes to select the appropriate dose volume for the vaccine series being administered.
- The 0.2 mg/mL original strain multi-dose vial has a red plastic cap.
- The 0.1 mg/mL original strain multi-dose vial has a royal blue plastic cap.
- The bivalent Original/Omicron BA.1 0.1 mg/mL multi-dose vial has a royal blue plastic cap and green label.
- The bivalent Original/Omicron BA.4/5 0.1 mg/mL multi-dose vial has a royal blue plastic cap and grey label.
- The monovalent Omicron XBB 1.5 subvariant multi-dose vial has a royal blue plastic cap and coral blue label.
- The vials with royal blue caps make it easier to administer smaller doses.
Your province or territory decides when people receive their doses of the vaccine. These decisions are based on public health recommendations and the latest evidence.
Learn more about:
Mixed-dose schedules
A different vaccine may be offered for your second dose. For example, you may have received Pfizer-BioNTech Comirnaty® as your first dose and be offered Moderna Spikevax® as your second. This is known as a mixed vaccine series.
The National Advisory Committee on Immunization (NACI) recommends an mRNA vaccine (Pfizer-BioNTech Comirnaty® or Moderna Spikevax®) should be offered for your second dose.
Learn more about:
Vaccine ingredients
Red cap vials (COVID-19 mRNA vaccine)
Sizes:
- 10 doses of 0.5 mL (each 0.5 mL dose contains 100 micrograms) or;
- 20 doses of 0.25 mL (each 0.25 mL dose contains 50 micrograms)
Royal blue cap vials
Types:
- no label (COVID-19 mRNA vaccine)
- green label (COVID-19 Bivalent (Original/Omicron (BA.1)
- grey label (COVID-19 Bivalent (Original/Omicron BA.4/5)
- coral blue label COVID-19 Monovalent (Omicron XBB.1.5 subvariant)
Sizes for each type:
- 5 doses of 0.5 mL (each dose (0.5 mL) contains 50 micrograms) or;
- 10 doses of 0.25 mL (each dose (0.25 ml) contains 25 micrograms)
Medicinal ingredient
- mRNA
The mRNA sequence from Moderna Spikevax® COVID-19 vaccine is also included in the Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1). The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.1 variant.
The mRNA sequence from Moderna Spikevax® COVID-19 vaccine is also included in the Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5). The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.4/5 variants.
Other ingredients
- Acetic acid
- Cholesterol
- DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
- Lipid SM-102
- PEG2000-DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
- Sodium acetate trihydrate
- Sucrose
- Trometamol
- Trometamol hydrochloride
- Water for injection
This vaccine does not contain any:
- preservatives
- antibiotics
- adjuvants
- human materials
- animal-derived materials
- common food allergens
Possible side effects
After getting vaccinated, it's common to have temporary side effects. These can last a few hours to a few days after vaccination.
This is the body's natural response, as it's working hard to build protection against the disease.
Common vaccine side effects may include:
Symptoms at the injection site, such as: | More general symptoms, such as: |
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Most commonly reported symptoms specific to 6 months to 36 months:
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Rare vaccine side effects
Rare reactions that have been reported and confirmed after taking an mRNA vaccine are:
- Myocarditis and pericarditis
- Bell's palsy (facial paralysis)
A severe allergic (anaphylaxis) reaction is also rare. Signs and symptoms of anaphylaxis may include:
- hives (bumps on the skin that are often very itchy)
- swelling of the lips, face, tongue or airway
- difficulty breathing
- increased heart rate
- loss of consciousness
- sudden low blood pressure
- abdominal pain, vomiting and diarrhea
Call emergency services if you develop or witness any serious symptoms that could be an allergic reaction after vaccination.
Reporting a possible serious reaction
Contact your health care provider if you experience:
- a side effect following vaccination with a COVID-19 vaccine
- any persistent, new or worsening symptoms
Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.
Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report.
Vaccine review, approval and monitoring
Health Canada's independent drug review process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective. The benefits must also outweigh any risks.
The Moderna COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. The interim order expired on September 16, 2021. On this date, Moderna Spikevax® transitioned to an authorization under the Food and Drug Regulations.
Find detailed technical information such as the product monograph and the regulatory decision summary:
- Moderna Spikevax® vaccine regulatory information
- Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.1) regulatory information
- Moderna Spikevax® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) regulatory information
- Moderna Spikevax® Monovalent Omicron COVID-19 vaccine (Omicron XBB.1.5 subvariant) regulatory information
As COVID-19 vaccines are administered across Canada, our safety monitoring is ongoing. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to:
- monitor the use of all COVID-19 vaccines closely
- examine and assess any new safety concerns
Learn about the side effects we're currently monitoring.
Get vaccinated
How to get vaccinated near you
Related links
- COVID-19: Proof of vaccination
- Number of doses given in Canada
- Canada's vaccine supply and donation strategy
- All drugs and vaccines approved for COVID-19
- COVID-19 vaccines for children and youth
- National Vaccine Catalogue
- What to expect at your vaccination
- Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19
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