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 and Moderna Spikevax® Bivalent COVID-19 vaccine (Original and Omicron B.1.1.529 (BA.1))

Manufacturer: ModernaTX, Inc.

Type: mRNA

Status: Approved by Health Canada

Approved for: Primary series in individuals age 6 months and older, or as a booster dose in individuals age 18 years and older (Moderna Spikevax® COVID-19 vaccine)

As a booster dose in individuals age 18 years and older (Moderna Spikevax® Bivalent COVID-19 vaccine)

How it's given: Injection in muscle (usually the upper arm)

Number of doses: 2 doses for primary series and 1 dose as a booster

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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 18 years of age and older.

Moderna Spikevax® Bivalent COVID-19 vaccine (Original and Omicron B.1.1.529 (BA.1))

The Moderna Spikevax® Bivalent COVID-19 vaccine (Original and Omicron B.1.1.529 (BA.1)) is approved as a booster for people who are 18 years of age and older. Its safety and effectiveness in younger people 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 and Omicron B.1.1.529 (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.

Dosage

Primary series

The dosing schedule approved by Health Canada is to give 2 doses (100 micrograms each for ages 12 years and older, 50 micrograms each for ages 6 to 11 years, and 25 micrograms each for ages 6 months to 5 years) 1 month apart, based on evidence from clinical trials.

Dose volume depends on which series of the vaccine is being administered. The dose for individuals 12 years of age and older (100 micrograms) is twice the dose used for children 6 to 11 years of age (50 micrograms) and four times the dose used for children 6 months to 5 years of age (25 micrograms).

Booster doses

A booster dose (50 micrograms) of the Moderna Spikevax® COVID-19 vaccine may be administered in individuals 18 years of age and older at least 6 months after completing their primary vaccine series.

A booster dose (50 micrograms) of the Moderna Spikevax® Bivalent COVID-19 (original/omicron) vaccine may be administered in individuals 18 years of age and older at least 4 months after completing their primary vaccine series or a previous booster dose.

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

Medicinal ingredient

The mRNA sequence from Moderna Spikevax® COVID-19 vaccine is also included in the Moderna Spikevax® Bivalent COVID-19 vaccine. The bivalent booster also has an additional mRNA sequence that targets the Omicron B.1.1.529 (BA.1) variant.

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

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.

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