Planning guidance for immunization clinics for COVID-19 vaccines: Vaccine product comparison and overview of key features

DIN/SNOMED

02552078/61431000087108

02541858/60841000087109

02541858/60841000087109

02541823/60681000087100 

02541823/60681000087100

02552035/60681000087100

Type of vaccine

mRNA

mRNA

mRNA

mRNA

mRNA

mRNA

Antigen component

One dose (0.3 ml) contains 3 mcg of mRNA encoding Omicron LP.8.1 spike protein (embedded in lipid nanoparticles).

One dose (0.3ml) contains 10 mcg of mRNA encoding Omicron LP.8.1 spike protein (embedded in lipid nanoparticles).

One dose (0.3ml) contains 10 mcg of mRNA encoding Omicron LP.8.1 spike protein (embedded in lipid nanoparticles).

One dose (0.3 mL) contains 30 mcg of mRNA encoding Omicron LP.8.1 spike protein (embedded in lipid nanoparticles).

One dose (0.3 mL) contains 30 mcg of mRNA encoding Omicron LP.8.1 spike protein (embedded in lipid nanoparticles).

One dose (0.3 mL) contains 30 mcg of mRNA encoding Omicron LP.8.1 spike protein (embedded in lipid nanoparticles).

Date of authorization in Canada

August 18, 2025

August 18, 2025

August 18, 2025

August 18, 2025

August 18, 2025

August 18, 2025

Authorized ages for use

6 months to 4 years of age.

5 to 11 years of age.

5 to 11 years of age.

12 years of age and older.

12 years of age and older.

12 years of age and older.

Authorized dose

0.3 mL

(3 mcg of mRNA encoding LP.8.1 spike protein) for ages 6 months to 4 years of age.

0.3 mL

(10 mcg of mRNA encoding LP.8.1 spike protein) for ages 5 to 11 years of age.

0.3 mL

(10 mcg of mRNA encoding LP.8.1 spike protein) for ages 5 to 11 years of age.

0.3 mL
(30 mcg of mRNA encoding LP.8.1 spike protein) for ages 12 years and older.

0.3 mL
(30 mcg of mRNA encoding LP.8.1 spike protein) for ages 12 years and older.

0.3 mL
(30 mcg of mRNA encoding LP.8.1 spike protein) for ages 12 years and older.

Authorized schedule^{Table 1 Footnote a}

For the authorized schedule according to the product monograph, refer to the:

• Product monograph for Pfizer-BioNTech Comirnaty COVID-19 vaccine (PDF)

For the NACI recommended schedule, refer to the:

• COVID-19 chapter of the Canadian Immunization Guide

For the authorized schedule according to the product monograph, refer to the:

• Product monograph for Pfizer-BioNTech Comirnaty COVID-19 vaccine (PDF)

For the NACI recommended schedule, refer to the:

• COVID-19 chapter of the Canadian Immunization Guide

For the authorized schedule according to the product monograph, refer to the:

• Product monograph for Pfizer-BioNTech Comirnaty COVID-19 vaccine (PDF)

For the NACI recommended schedule, refer to the:

• COVID-19 chapter of the Canadian Immunization Guide

For the authorized schedule according to the product monograph, refer to the:

• Product monograph for Pfizer-BioNTech Comirnaty COVID-19 vaccine (PDF)

For the NACI recommended schedule, refer to the:

• COVID-19 chapter of the Canadian Immunization Guide

For the authorized schedule according to the product monograph, refer to the:

• Product monograph for Pfizer-BioNTech Comirnaty COVID-19 vaccine (PDF)

For the NACI recommended schedule, refer to the:

• COVID-19 chapter of the Canadian Immunization Guide

For the authorized schedule according to the product monograph, refer to the:

• Product monograph for Pfizer-BioNTech Comirnaty COVID-19 vaccine (PDF)

For the NACI recommended schedule, refer to the:

• COVID-19 chapter of the Canadian Immunization Guide

Nature of the antigen

Spike protein of Omicron LP.8.1 subvariant

Spike protein of Omicron LP.8.1 subvariant

Spike protein of Omicron LP.8.1 subvariant

Spike protein of Omicron LP.8.1 subvariant

Spike protein of Omicron LP.8.1 subvariant

Spike protein of Omicron LP.8.1 subvariant

Potential allergens

• Polyethylene glycol (PEG)
• Tromethamine (trometamol or Tris)

• Polyethylene glycol (PEG)
• Tromethamine (trometamol or Tris)

• Polyethylene glycol (PEG)
• Tromethamine (trometamol or Tris)

• Polyethylene glycol (PEG)
• Tromethamine (trometamol or Tris)

• Polyethylene glycol (PEG)
• Tromethamine (trometamol or Tris)

• Polyethylene glycol (PEG)
• Tromethamine (trometamol or Tris)

Adjuvant (if present)

None

None

None

None

None

None

Storage^{Table 1 Footnote b}

• Ultra-frozen at -90°C to -60°C.
• Do not store vials at -25°C to -15°C.
• Refrigerator (2°C to 8°C) for 10 weeks. Mark the 10-week refrigerated expiry date on the carton when transferred to the refrigerator.
• Room temperature up to 25°C: no more than a total of 12 hours prior to dilution and no more than 12 hours after dilution^{Table 1 Footnote c}.
• Once punctured, can be stored at room temperature or refrigerated (2°C to 25°C). Discard 12 hours after first puncture.
• Do not refreeze once thawed.
• Do not use beyond expiry date.

• Ultra-frozen at -90°C to -60°C.
• Do not store vials at -25°C to -15°C.
• Refrigerator (2°C to 8°C) for 10 weeks. Mark the 10-week refrigerated expiry date on the carton when transferred to the refrigerator.
• Room temperature up to 25°C: no more than a total of 12 hours before first puncture^{Table 1 Footnote c}.
• Once punctured, can be stored at room temperature or refrigerated (2°C to 25°C). Discard 12 hours after first puncture.
• Do not refreeze once thawed.
• Do not use beyond expiry date.

• Ultra-frozen at -90°C to -60°C.
• Do not store vials at -25°C to -15°C.
• Refrigerator (2°C to 8°C) for 10 weeks. Mark the 10-week refrigerated expiry date on the carton when transferred to the refrigerator.
• Room temperature up to 25°C: no more than a total of 12 hours before first puncture^{Table 1 Footnote c}.
• Do not refreeze once thawed.
• Do not use beyond expiry date.

• Ultra-frozen at -90°C to -60°C.
• Do not store vials at -25°C to -15°C.
• Refrigerator (2°C to 8°C) for 10 weeks. Mark the 10-week refrigerated expiry date on the carton when transferred to the refrigerator.
• Room temperature up to 25°C: no more than a total of 12 hours before first puncture^{Table 1 Footnote c}.
• Once punctured, can be stored at room temperature or refrigerated (2°C to 25°C). Discard 12 hours after first puncture.
• Do not refreeze once thawed.
• Do not use beyond expiry date.

• Ultra-frozen at -90°C to -60°C.
• Do not store vials at -25°C to -15°C.
• Refrigerator (2°C to 8°C) for 10 weeks. Mark the 10-week refrigerated expiry date on the carton when transferred to the refrigerator.
• Room temperature up to 25°C: no more than a total of 12 hours before first puncture^{Table 1 Footnote c}.
• Do not refreeze once thawed.
• Do not use beyond expiry date.

• Refrigerator at 2°C to 8°C.
• Before use, can be stored for up to 12 hours at room temperature (between 8°C to 25°C).
• Do not freeze.
• Do not use beyond expiry date.

Transport

• If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C; full cartons or individual unpunctured vials may also be transported at 2°C to 8°C.

• If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C; full cartons or individual unpunctured vials may also be transported at 2°C to 8°C.

• If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C; full cartons or individual unpunctured vials may also be transported at 2°C to 8°C.

• If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C; full cartons or individual unpunctured vials may also be transported at 2°C to 8°C.

• If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C; full cartons or individual unpunctured vials may also be transported at 2°C to 8°C.

• Pre-filled syringes may be transported at 2°C to 8°C and should never be frozen.

Handling instructions^{Table 1 Footnote d}

• Multidose vials can be thawed in the refrigerator (2°C to 8°C) where it may take up to 2 hours or at room temperature (up to 25°C) for 30 minutes.
• Before dilution, allow the thawed vial to come to room temperature (up to 25°C), then mix by inverting the vaccine gently 10 times. Do not shake.
• The liquid will appear clear to slightly opalescent and may contain white to off-white opaque amorphous particles. Do not use if liquid is discoloured or if other particles are observed.
• For dilution instructions, see product monograph for Pfizer-BioNTech Comirnaty (PDF).
• Mark the date and time that the product should be discarded on the label (12 hours after first puncture for dilution).

• Multidose vials can be thawed in the refrigerator (2°C to 8°C) where it may take 6 hours or at room temperature (up to 25°C) for 30 minutes.
• Before use, invert the vaccine gently 10 times. Do not shake.
• The vaccine should appear as a clear to slightly opalescent suspension with no visible particles. Do not use if liquid is discoloured or if particles are observed after mixing.
• Mark the date and time that the product should be discarded on the label (12 hours after first puncture).
• Do not dilute.

• Single dose vials can be thawed in the refrigerator (2°C to 8°C) where it may take 2 hours or at room temperature (up to 25°C) for 30 minutes.
• Before use, invert the vaccine gently 10 times. Do not shake.
• The vaccine should appear as a clear to slightly opalescent suspension with no visible particles. Do not use if liquid is discoloured or if particles are observed after mixing.
• Do not dilute.

• Multidose vials can be thawed in the refrigerator (2°C to 8°C) where it may take 6 hours or at room temperature (up to 25°C) for 30 minutes.
• Before use, invert the vaccine gently 10 times. Do not shake.
• After inverting, the vaccine should appear as a white to off-white suspension with no visible particles. Do not use if liquid is discoloured or if particles are observed after inverting.
• Mark the date and time that the product should be discarded on the label (12 hours after first puncture).
• Do not dilute.

• Single dose vials can be thawed in the refrigerator (2°C to 8°C) where it may take 2 hours or at room temperature (up to 25°C) for 30 minutes.
• Before use, invert the vaccine gently 10 times. Do not shake.
• After inverting, the vaccine should appear as a white to off-white suspension with no visible particles. Do not use if liquid is discoloured or if particles are observed after inverting.
• Do not dilute.

• Prior to use, the pre-filled syringes can be stored for up to 12 hours at temperatures between 8°C to 25°C.
• Do not shake.
• The vaccine will be an off-white suspension. Do not use if the vaccine is discoloured or contains particulate matter.
• Remove tip cap by slowly turning the cap counterclockwise while holding the luer lock.
• After removing the tip cap and attaching an appropriate needle, the pre-filled syringes should be used immediately. If it cannot be used immediately, it must be used within 4 hours.

Reconstitution

• Yes – 0.9% sodium chloride diluent provided by the manufacturer^{Table 1 Footnote c}.
• 1.1 mL of diluent is added to the vial.
• Store diluent at room temperature.

No

No

No

No

No

Route of administration

Intramuscular

Intramuscular

Intramuscular

Intramuscular

Intramuscular

Intramuscular

Syringe and needle selection^{Table 1 Footnote e}

• 21-gauge or narrower needle for reconstitution.
• Standard syringes and needles can be used for administration as appropriate for intramuscular injection.

• Preferentially use a low dead-volume syringe and/or needle as appropriate for intramuscular injection.

• Standard syringes and needles can be used for administration as appropriate for intramuscular injection.

• Preferentially use a low dead-volume syringe and/or needle as appropriate for intramuscular injection.

• Standard syringes and needles can be used for administration as appropriate for intramuscular injection.

• Needle does not come with pre-filled syringe.
• Standard needles can be used for administration as appropriate for intramuscular injection.

Formats available

• Multidose vial.
• Contains 0.48 mL in a vial; 3 doses of 0.3 mL after dilution.
• Preservative-free.

• Multidose vial.
• Contains 2.25 mL in a vial; 6 doses of 0.3mL.
• Preservative-free.

• Single dose vial.
• Contains 1 dose of 0.3 mL.
• Preservative-free.

• Multidose vial.
• Contains 2.25 mL in a vial; 6 doses of 0.3 mL.
• Preservative-free.

• Single dose vial.
• Contains 1 dose of 0.3 mL.
• Preservative-free.

• Single dose pre-filled syringe.
• Contains 1 dose of 0.3 mL.
• Preservative-free.

Expiry date

The vaccine should not be used after the expiration date printed on the vials and cartons, or after the 10-week expiry date written on the carton when transferred to the refrigerator, whichever is soonest.

The vaccine should not be used after the expiration date printed on the vials and cartons, or after the 10-week expiry date written on the carton when transferred to the refrigerator, whichever is soonest.

The vaccine should not be used after the expiration date printed on the vials and cartons, or after the 10-week expiry date written on the carton when transferred to the refrigerator, whichever is soonest.

The vaccine should not be used after the expiration date printed on the vials and cartons, or after the 10-week expiry date written on the carton when transferred to the refrigerator, whichever is soonest.

The vaccine should not be used after the expiration date printed on the vials and cartons, or after the 10-week expiry date written on the carton when transferred to the refrigerator, whichever is soonest.

The vaccine should not be used after the expiration date printed on the carton and syringe label.