Moderna Spikevax COVID-19 vaccines

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

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 B.1.1.529 (BA.1))

The Moderna Spikevax^® Bivalent COVID-19 vaccine (Original/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.

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 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:

• 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 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.

The safety and effectiveness of the Moderna Spikevax^® Bivalent COVID-19 vaccine (Original/Omicron BA. 4/5) is based on studies of a booster dose of SPIKEVAX Bivalent (Original/Omicron B.1.1.529 (BA.1)).

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 12 years of age and older at least 4 months after completing their primary vaccine series.

A booster dose (50 micrograms) of the Moderna Spikevax^® Bivalent COVID-19 vaccine (Original/Omicron B.1.1.529 (BA.1) 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.

A booster dose (50 micrograms) of the Moderna Spikevax^® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) 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.

• 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 B.1.1.529 (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 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:

• 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:

• mRNA vaccines
• Viral vector vaccines

Vaccine ingredients

• Vials with a red cap contain 10 doses of 0.5 mL. One dose (0.5 mL) contains 100 micrograms of COVID-19 mRNA vaccine.
• Vials with a red cap contain 20 doses of 0.25 mL. One dose (0.25 mL) contains 50 micrograms of COVID-19 mRNA vaccine.
• Vials with a royal blue cap contain 5 doses of 0.5 mL. One dose (0.5 mL) contains 50 micrograms of COVID-19 mRNA vaccine.
• Vials with royal blue cap contain 10 doses of 0.25 mL. One dose (0.25 ml) contains 25 micrograms of COVID-19 mRNA vaccine.
• Vials with a royal blue cap and green Omicron label contain 5 doses of 0.5 mL. One dose (0.5 mL) contains 50 micrograms of COVID-19 Bivalent (Original/Omicron B.1.1.529 (BA.1)) mRNA vaccine booster.
• Vials with a royal blue cap and grey Omicron label contain 5 doses of 0.5 mL. One dose (0.5 mL) contains 50 micrograms of the COVID-19 Bivalent (Original/Omicron BA.4/5) mRNA vaccine booster.

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 B.1.1.529 (BA.1)). The bivalent booster also has an additional mRNA sequence that targets the Omicron B.1.1.529 (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:
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:

• 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 B.1.1.529 (BA.1)) regulatory information
• Moderna Spikevax^® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) 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
• What to expect at your vaccination
• Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19