Pfizer-BioNTech Comirnaty COVID-19 vaccine

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

Name: Pfizer-BioNTech Comirnaty®COVID-19 vaccine

Manufacturer: BioNTech Manufacturing GmbH

Type: mRNA

Status: Approved by Health Canada

Approved for: Age 5 and older

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

Number of doses: 2 doses

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Who the vaccine is approved for

The vaccine is approved for people who are 5 years of age and older. Its safety and effectiveness in people younger than 5 years of age have not yet been established.

Effectiveness

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

Dosage

This vaccine requires 2 doses (30 mcg each for ages 12 and older or 10 mcg each for ages 5 to 11) for maximum protection.

The dosing schedule approved by Health Canada is to give the 2 doses 21 days apart, based on evidence from clinical trials.

A booster dose of the Pfizer-BioNTech Comirnaty®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.

The currently available vaccine product with a purple cap is used to prepare the dose for individuals 12 years of age and older. This is three-times higher than the dose for children 5 to 11 years of age. The vaccine vials for dosing in ages 5 to 11 years have orange caps and an orange border on the label. This helps to distinguish these vials from those with the higher dose. This also helps to ensure the correct dose is administered to younger children.

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

Other ingredients (ages 12 and older)

Other Ingredients (5 to 11 years of age)Footnote *

Footnote *

Ages 5 to 11 Pfizer/BioNTech Comirnaty® modified formulation of BNT162b2 to accommodate the 10 mcg dose: This modified formulation offers an improved stability profile and is easier to use at administration sites. It uses a Tris-sucrose buffer instead of phosphate-buffered saline (PBS) and excludes sodium chloride and potassium chloride. The change in buffer is not considered clinically significant.

Return to footnote * referrer

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 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: Flu-like symptoms, such as:
  • redness
  • soreness
  • swelling
  • chills
  • fatigue
  • joint pain
  • headache
  • mild fever
  • muscle aches

Rare vaccine side effects

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

A severe allergic (anaphylaxis) reaction following vaccination 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 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:

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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