Moderna Spikevax COVID-19 vaccine

All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.

Name: Moderna Spikevax^® COVID-19 vaccine

Manufacturer: ModernaTX, Inc.

Type: mRNA

Status: Approved by Health Canada

Approved for: Age 6 and older

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

Number of doses: 2 doses

Who the vaccine is approved for

The vaccine is approved for people who are 6 years of age and older. Its safety and effectiveness in people younger than 6 years of age have 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 young adults (18-25 years old)

Dosage

The dosing schedule approved by Health Canada is to give 2 doses (100 mcg each for ages 12 and older or 50 mcg each for ages 6 to 11) one month apart, based on evidence from clinical trials.

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

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:

how provinces and territories make decisions about how, who and when to vaccinate

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

mRNA

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:
redness soreness swelling	chills fatigue joint pain headache mild fever muscle aches nausea vomiting

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

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

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