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
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:
- 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
Dosage
The dosing schedule approved by Health Canada is to give 2 doses (30 mcg each for ages 12 and older or 10 mcg each for ages 5 to 11) 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 6 months after completing their primary vaccine series.
The currently available vaccine products with purple caps and grey caps are used to prepare the dose for individuals 12 years of age and older. The grey caps have improved stability with a change in buffer and no longer require dilution to make handling and administration easier. The dose for individuals 12 years of age and older 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.
Dosing interval
Vaccination schedules are generally determined by clinical trials, usually before a vaccine is authorized. The spacing of doses in the clinical trial usually becomes the recommended schedule unless other evidence is available.
The recommended spacing between doses is included in the recommendations from the National Advisory Committee on Immunization (NACI) following its review of available data and based on their expert advice. For example, NACI recommends that the doses for children ages 5 to 11 be given 8 weeks apart.
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. 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
- Vials with a purple cap and purple label border contain 6 doses of 0.3 mL after dilution. One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine
- Vials with a grey cap and grey label border contain 6 doses of 0.3 mL (does not require dilution). One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine
- Vials with an orange cap and orange label border contain 10 doses of 0.2 mL after dilution. One dose (0.2 mL) contains 10 micrograms of COVID-19 mRNA vaccine
Medicinal ingredient
- mRNA
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 (ages 12 and older) (vials with grey cap and grey 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
Other ingredients (5 to 11 years of age) (vials with orange cap and orange label border)Footnote *
- 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
- Footnote *
-
Ages 5 and older Pfizer/BioNTech Comirnaty® modified formulation of BNT162b2: 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.
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.
Rare vaccine side effects
Rare reactions that have been reported and confirmed after taking an mRNA vaccine are:
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:
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.
Entire content available on: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html
