Pfizer-BioNTech Comirnaty COVID-19 vaccine

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

On this page

• Who the vaccine is approved for
• Effectiveness
• Dosage
• Vaccine ingredients
• Possible side effects
• Vaccine review, approval and monitoring
• Get vaccinated

Who the vaccine is approved for

Pfizer-BioNTech Comirnaty^® COVID-19 vaccine

The vaccine is approved for people who are 6 months of age and older. Its safety and effectiveness in people younger than 6 months of age have not yet been established. This vaccine is also approved as a booster for people age 5 to 11 years as well as 16 years and older.

Pfizer-BioNTech Comirnaty^® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine

The Pfizer-BioNTech Comirnaty^® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine is approved as a primary series for people who are 6 months of age and older and as a booster for people who are 5 years of age and older. Its safety and effectiveness in younger people has not yet been established.

Pfizer-BioNTech Comirnaty^® Original and Omicron BA.1, bivalent COVID-19 vaccine

The Pfizer-BioNTech Comirnaty^® Original and Omicron BA.1, bivalent COVID-19 vaccine is approved as a booster for people who are 12 years of age and older. Its safety and effectiveness in younger people has not yet been established.

Pfizer-BioNTech Comirnaty^® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine

The Pfizer-BioNTech Comirnaty^® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine is approved for people who are 6 months of age and older. Its safety and effectiveness in people younger than 6 months has not yet been established.

Effectiveness

Clinical trials showed that beginning 1 week after the second dose, the Pfizer-BioNTech Comirnaty^® COVID vaccine was about:

• 95% effective in protecting trial participants from COVID-19 for those 16 years and older
• 100% effective for those 12 to 15 years old
• 90.7% effective for those 5 to 11 years old

Effectiveness data supporting the authorization in children ages 6 months to under 5 years are based on a comparison of immune responses in this age group to individuals ages 16 to 25 years. The data determined that the immune response to the vaccine for both age groups was comparable to the immune response of the older participants.

The Pfizer-BioNTech Comirnaty^® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine was shown to increase the immune response against the Omicron BA.4/BA.5 variants.

The Pfizer-BioNTech Comirnaty^® Original and Omicron BA.1, bivalent COVID-19 vaccine was shown to increase the immune response against the Omicron BA.1 variant.

The safety and effectiveness of the Pfizer-BioNTech Comirnaty^® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine is based on studies of Comirnaty^® (Original, Original/Omicron BA.4/BA.5).

Dosage

Primary series

• 12 years and older (2 doses of 30 micrograms, 21 days apart)
• 5 to 11 years (2 doses of 10 micrograms, 21 days apart)
• 6 months to 4 years (3 doses of 3 micrograms, the initial 2 doses are administered 21 days apart with the third dose at least 8 weeks after)

The dose for individuals 12 years of age and older (30 micrograms) is:

• 3 times the dose used for children 5 to 11 years of age (10 micrograms)
• 10 times the dose used for children 6 months to less than 5 years of age (3 micrograms).

Children aged 4 who will turn 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination. The interval between doses is determined by the child's age at the start of the vaccination series.

Booster doses (at least 6 months after previous dose)

• 12 years of age and older (30 micrograms)
• 5 to 11 years of age (10 micrograms)

Omicron XBB.1.5 subvariant vaccine doses (at least 6 months after previous dose)

• 12 years and older (30 micrograms)
• 5 to 11 years (10 micrograms)
• 6 months to 4 years (3 micrograms)

If the child of less than 5 years of age has not been previously vaccinated, Comirnaty^® XBB.1.5 should be administered as a 3-dose regimen.

Additional information

The currently available vaccine products with purple caps and a purple label border or gray caps with a gray label border are used to prepare the dose for individuals 12 years of age and older.

• The gray caps and a gray label border and blue caps and blue label border have improved stability with a change in buffer and are the only vials that do not require dilution to make handling and administration easier.

The vaccine vials with orange caps and an orange border on the label are used to prepare the dose for individuals 5 to less than 12 years of age.

The vaccine vials with maroon caps and maroon border on the label are used to prepare the dose for individuals 6 months to less than 5 years of age. This helps to distinguish these vials from those with the higher dose. This also makes it easier to administer smaller doses to younger children.

Learn more about:

• COVID-19 vaccine for children

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:

• COVID-19: 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, if appropriate. 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

Purple cap vials and label

Size:

• 6 doses of 0.3 mL (each 0.3 mL dose contains 30 micrograms)

Gray cap vials and label, and blue cap vials and label

Sizes for each type:

• 6 doses of 0.3 mL (each dose (0.3 mL) contains 30 micrograms)
• 1 dose of 0.3 ml (each dose (0.3ml) contains 30 micrograms)

Orange cap vials and label

Sizes for each type:

• 10 doses of 0.2 mL (each dose (0.2 ml) contains 10 micrograms)

Maroon cap vials and label

Sizes for each type:

• 10 doses of 0.2 mL (each dose (0.2 ml) contains 3 micrograms)

Medicinal ingredient

• mRNA

The mRNA sequence from the Pfizer-BioNTech Comirnaty^® COVID-19 vaccine is also included in the Pfizer-BioNTech Comirnaty^® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine. The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.4/BA.5 variants.

The mRNA sequence from the Pfizer-BioNTech Comirnaty^® COVID-19 vaccine is also included in the Pfizer-BioNTech Comirnaty^® Original and Omicron BA.1, bivalent COVID-19 vaccine. The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.1 variant.

The mRNA sequence included in the Pfizer-BioNTech Comirnaty^® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine targets the Omicron XBB.1.5 subvariant.

Other ingredients (ages 12 and older) (vials with purple cap and purple label border)

• ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
• ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
• 1,2-distearoyl-sn-glycero-3-phosphocholine
• cholesterol
• dibasic sodium phosphate dihydrate
• monobasic potassium phosphate
• potassium chloride
• sodium chloride
• sucrose
• water for injection

Other ingredients (vials with gray cap and gray label border, orange cap and orange label border, blue cap and blue label border, or maroon caps and maroon label border)

• ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
• ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
• 1,2-distearoyl-sn-glycero-3-phosphocholine
• cholesterol
• sodium chloride
• sucrose
• tromethamine
• tromethamine hydrochloride
• water for injection

This vaccine does not contain common food allergens, such as eggs, shellfish, gluten or nuts.

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 immune 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 diarrhea nausea vomiting swelling of the lymph nodes Most commonly reported symptoms specific to 6 months to less than 24 months: irritability/crying rash loss of appetite fever swelling of the lymph nodes

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 following vaccination 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 Pfizer-BioNTech 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, Pfizer-BioNTech Comirnaty^®transitioned to an authorization under the Food and Drug Regulations.

Find detailed technical information such as the product monograph and the regulatory decision summary:

• Pfizer-BioNTech Comirnaty^® vaccine regulatory information
• Pfizer-BioNTech Comirnaty^® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine regulatory information
• Pfizer-BioNTech Comirnaty^® Omicron XBB.1.5, monovalent COVID-19 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

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
• 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