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

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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:

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:

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

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.

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:

Royal blue cap vials

Types:

Sizes for each type:

Medicinal ingredient

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

This vaccine does not contain any:

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:
  • redness
  • soreness
  • swelling
  • chills
  • fatigue
  • joint pain
  • headache
  • mild fever
  • muscle aches
  • nausea
  • vomiting
  • enlarged lymph nodes
  • decreased sense of touch or sensation, numbness or tingling, itching or pricking sensation
  • dizziness

Most commonly reported symptoms specific to 6 months to 36 months:

  • irritability/crying
  • sleepiness
  • loss of appetite

Rare vaccine side effects

Rare reactions that have been reported and confirmed after taking an mRNA vaccine are:

A severe allergic (anaphylaxis) reaction is also rare. Signs and symptoms of anaphylaxis may include:

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:

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:

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:

Learn about the side effects we're currently monitoring.

Get vaccinated

How to get vaccinated near you

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