Pfizer-BioNTech 
Comirnaty®
Orange Cap, 
Orange Border

Pfizer-BioNTech 
Comirnaty®
Purple Cap,
Purple Border

Pfizer-BioNTech 
Comirnaty®
Grey Cap, 
Grey Border

Pfizer-BioNTech 
Comirnaty® Original & Omicron BA.4/BA.5
Grey Cap, Grey Border

Multidose preservative-free vials containing 10 doses

Cartons of 10 and 195 vials

Orange cap; orange border on label

Multidose preservative-free vials containing 6^a doses

Cartons of 25 and 195 vials

Purple cap; purple border on label

Multidose preservative-free vials containing 6^a doses

Cartons of 10 and 195 vials

Grey cap; grey border on label 

Multidose preservative-free vials containing 6^a doses

Cartons of 10 vials

Grey cap; grey border on label 

Pfizer-BioNTech 
Comirnaty®
Orange Cap, 
Orange Border

Pfizer-BioNTech 
Comirnaty®
Purple Cap,
Purple Border

Pfizer-BioNTech 
Comirnaty®
Grey Cap, 
Grey Border

Store at -90°C to -60°C (ultrafreezer) for up to 12 months from date on label. (Formerly 9 months)

Date on label is the date of manufacture.

Do not store at -25°C to -15°C.

Store at -90°C to -60°C^b (ultrafreezer) until the expiry date printed on the label. These dates have been extended for some product.^c

Store at -25°C to -15°C for up to 2 weeks.^d 

Store at -90°C to -60°C (ultrafreezer) for up to 12 months from date on label.

Date on label is the date of manufacture.

Thaw undiluted product in fridge (takes up to 4 hours)
or
Thaw undiluted product at room temperature (takes ~30 minutes)

Do not refreeze thawed vials.

Thaw undiluted product in fridge (takes up to 3 hours)
or
Thaw undiluted product at room temperature (takes ~30 minutes)

Do not refreeze thawed vials.

Thaw in fridge (takes up to 6 hours)
or
Thaw at room temperature (takes ~30 minutes)

Do not refreeze thawed vials.

Undiluted product: up to 10 weeks

Undiluted product: up to 31 days

Dilute thawed vials once they have reached room temperature with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP.

Dilute thawed vials once they have reached room temperature with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP.

DO NOT DILUTE  

Prior to dilution, no more than 12 hours 

After dilution, use within 12 hours from time of dilution.^e  

(Time is additive: up to 24 hours at room temperature)

Prior to dilution, no more than 2 hours (including any thaw time)

After dilution, use within 6 hours from time of dilution.

(Time is additive: up to 8 hours at room temperature)

Prior to puncture, no more than 12 hours

After puncture, use within 12 hours of puncture.^f

 (Time is additive: up to 24 hours at room temperature) 

Prior to puncture, no more than 12 hours

After puncture, use within 12 hours of puncture.

 (Time is additive: up to 24 hours at room temperature)

Up to 12 hours at 2°C to 25°C ^f 

Up to 12 hours at 2°C to 25°C

Store in original carton.

Vials can be handled in room light conditions after dilution.

Store in original carton.

Thawed vials can be handled in room light conditions.

Invert gently 10 times during reconstitution.
Do not shake.

Before use, mix by inverting vaccine vial gently 10 times.
Do not shake.

BEFORE dilution: thawed suspension may contain white to off-white opaque amorphous particles.

AFTER dilution: white to off-white suspension; ensure no particulate matter/discolouration.

BEFORE dilution: thawed suspension may contain white to off-white opaque amorphous particles.

AFTER dilution: off-white suspension; ensure no particulate matter/ discolouration.

BEFORE inverting: may contain white to off-white opaque amorphous particles.

AFTER inverting: white to off-white suspension; ensure no visible particles/ discolouration.

Pfizer-BioNTech 
Comirnaty™ Original & Omicron BA.4/BA.5
Grey Cap, Grey Border 

This vaccine is not authorized to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of bivalent vaccines for this purpose, with informed consent, if an individual requests to start or complete their COVID-19 primary series with bivalent vaccine.

See information for original vaccines in the Saskatchewan Immunization Manual for details of intervals.

Number of doses to complete the primary series:
2 for non-immunocompromised; 3 for immunocompromised

The optimal interval between 1st and 2nd doses per NACI and MoH is 8 weeks^g 

a. Six doses can be achieved by using low dead-volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract 6 full doses from a single vial. 

b. On August 27, 2021, Health Canada expanded the Ultra Low Temperature storage conditions to now allow storage at -90°C to -60°C (-130°F to -76°F) versus the previously approved -80°C to -60°C (-112°F to -76°F). All references to storage conditions of -80°C to -60°C (-112°F to -76°F) on cartons and supporting printed material currently in Canada should now be considered between -90°C to -60°C (-130°F to -76°F.

c. Extensions to expiry dates for Pfizer-BioNTech Comirnaty® Purple Cap only (not Orange Cap or Grey Cap), as long as all approved storage conditions have been maintained, include:

• Products with labelled expiry date of Jun 2022 through August 2022 may remain in use for 3 months beyond printed date.

d. Vials stored/transported at -25°C to -15°C for up to 2 weeks may be returned (once) to the recommended storage condition of -90°C to -60°C. Total time the vials are stored and /or transported at -25°C to -15°C must be tracked and not exceed 2 weeks.

e. Vial labels and cartons may state that a vial should be discarded 6 hours after dilution; however, additional testing has been completed to support 12 hours of stability after dilution.

f. Vial labels and cartons may state that a vial should be discarded 6 hours after puncture; however, additional testing has been completed to support 12 hours of stability after puncture.

g. There is evidence that longer intervals between the first and second doses of COVID-19 vaccines result in a more robust and durable immune response and higher vaccine effectiveness. Local transmission of the SARS-CoV-2 virus, the degree of individual risk of exposure to the virus, and the need of a second dose for earlier protection should be considered when deciding the interval. People who completed their primary vaccine series using manufacturer-authorized intervals also have very good protection against severe COVID-19 disease and do not need to restart their vaccine series.

References

• Product Monographs
  • Comirnaty®
  • Comirnaty® Original & Omicron BA.4/BA.5
• Canadian Immunization Guide
  • COVID-19 Vaccine
• COVID-19 Vaccine Contraindications and Precautions Background Document
  • Available from eHealth COVID-19 Immunization Manual 
• Saskatchewan Immunization Manual
  • Chapter 10: Biological Products
• Pfizer-BioNTech
  • Pfizer-BioNTech COVID-19 Vaccine: Vaccination Storage & Dry Ice Safety Handling
  • The Pfizer-BioNTech COVID-19 Vaccine Dosage and Storage Guide
  • Written communication, 16 Feb 2022

Last updated

01 Nov 2022

Pfizer-BioNTech 
Comirnaty®
Orange Cap, 
Orange Border

Pfizer-BioNTech 
Comirnaty®
Purple Cap,
Purple Border

Pfizer-BioNTech 
Comirnaty®
Grey Cap, 
Grey Border

Moderna Spikevax™
Red Cap,
Blue Border

Multidose preservative-free vials containing 10 doses

Cartons of 10 and 195 vials

Orange cap; orange border on label

Multidose preservative-free vials containing 6^a doses

Cartons of 25 and 195 vials

Purple cap; purple border on label

Multidose preservative-free vials containing 6^a doses

Cartons of 10 and 195 vials

Grey cap; grey border on label 

Multidose preservative-free 5 mL vials

Cartons of 10 vials

Red cap; blue border on label

Store at -90°C to -60°C (ultrafreezer) for up to 12 months from date on label. (Formerly 9 months)

Date on label is the date of manufacture.

Do not store at -25°C to -15°C.

Store at -90°C to -60°C^b (ultrafreezer) until the expiry date printed on the label. These dates have been extended for some product.^c

Store at -25°C to -15°C for up to 2 weeks.^d 

Store at -90°C to -60°C (ultrafreezer) for up to 12 months from date on label.

Date on label is the date of manufacture.

Thaw undiluted product in fridge (takes up to 4 hours)
or
Thaw undiluted product at room temperature (takes ~30 minutes)

Do not refreeze thawed vials.

Thaw undiluted product in fridge (takes up to 3 hours)
or
Thaw undiluted product at room temperature (takes ~30 minutes)

Do not refreeze thawed vials.

Thaw in fridge (takes up to 6 hours)
or
Thaw at room temperature (takes ~30 minutes)

Do not refreeze thawed vials.

Thaw in fridge (takes 2.5 hours)
or
Thaw at room temperature (takes 1 hour)

After thawing, let stand at room temperature for 15 minutes before administering.

Do not refreeze thawed vials.

Undiluted product: up to 10 weeks

Undiluted product: up to 31 days

Up to 30 days prior to first use 

Dilute thawed vials once they have reached room temperature with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP.

Dilute thawed vials once they have reached room temperature with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP.

DO NOT DILUTE  

Prior to dilution, no more than 12 hours 

After dilution, use within 12 hours from time of dilution.^e  

(Time is additive: up to 24 hours at room temperature)

Prior to dilution, no more than 2 hours (including any thaw time)

After dilution, use within 6 hours from time of dilution.

(Time is additive: up to 8 hours at room temperature)

Prior to puncture, no more than 12 hours

After puncture, use within 12 hours of puncture.^f

 (Time is additive: up to 24 hours at room temperature) 

No more than 24 hours 

Vials can be returned to fridge but time at room temperature must be tracked and not exceed 24 hours total.

Up to 12 hours at 2°C to 25°C ^f 

Up to 24 hours at 2°C to 25°C

Vials can be returned to fridge but must track time at room temperature and not exceed 24 hours total. 

Time at room temperature includes any time at room temperature prior to puncture.

Do not puncture more than 20 times.

Store in original carton.

Vials can be handled in room light conditions after dilution.

Store in original carton.

Thawed vials can be handled in room light conditions.

Store in original carton.

Thawed vials and filled syringes can be handled in room light conditions. 

Invert gently 10 times during reconstitution.
Do not shake.

Before use, mix by inverting vaccine vial gently 10 times.
Do not shake.

Swirl vial gently after thawing
and between each withdrawal.
Do not shake.

BEFORE dilution: thawed suspension may contain white to off-white opaque amorphous particles.

AFTER dilution: white to off-white suspension; ensure no particulate matter/discolouration.

BEFORE dilution: thawed suspension may contain white to off-white opaque amorphous particles.

AFTER dilution: off-white suspension; ensure no particulate matter/ discolouration.

BEFORE inverting: may contain white to off-white opaque amorphous particles.

AFTER inverting: white to off-white suspension; ensure no visible particles/ discolouration.

White to off-white dispersion—may contain white or translucent product-related particles; ensure no foreign particulate matter or discolouration.

Moderna Spikevax™
Red Cap,
Blue Border

≥ 6 years to <12 years:
0.25 mL (50 mcg mRNA)

≥ 12 years:
0.5 mL (100 mcg mRNA)

Number of doses to complete the primary series:
2 for non-immunocompromised; 3 for immunocompromised

21 days per NACI 

28 days 

28 days

The optimal interval between 1st and 2nd doses per NACI and MoH is 8 weeks^g 

a. Six doses can be achieved by using low dead-volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract 6 full doses from a single vial. 

b. On August 27, 2021, Health Canada expanded the Ultra Low Temperature storage conditions to now allow storage at -90°C to -60°C (-130°F to -76°F) versus the previously approved -80°C to -60°C (-112°F to -76°F). All references to storage conditions of -80°C to -60°C (-112°F to -76°F) on cartons and supporting printed material currently in Canada should now be considered between -90°C to -60°C (-130°F to -76°F.

c. Extensions to expiry dates for Pfizer-BioNTech Comirnaty® Purple Cap only (not Orange Cap or Grey Cap), as long as all approved storage conditions have been maintained, include:

• Products with labelled expiry date of Jun 2022 through August 2022 may remain in use for 3 months beyond printed date.

d. Vials stored/transported at -25°C to -15°C for up to 2 weeks may be returned (once) to the recommended storage condition of -90°C to -60°C. Total time the vials are stored and /or transported at -25°C to -15°C must be tracked and not exceed 2 weeks.

e. Vial labels and cartons may state that a vial should be discarded 6 hours after dilution; however, additional testing has been completed to support 12 hours of stability after dilution.

f. Vial labels and cartons may state that a vial should be discarded 6 hours after puncture; however, additional testing has been completed to support 12 hours of stability after puncture.

g. There is evidence that longer intervals between the first and second doses of COVID-19 vaccines result in a more robust and durable immune response and higher vaccine effectiveness. Local transmission of the SARS-CoV-2 virus, the degree of individual risk of exposure to the virus, and the need of a second dose for earlier protection should be considered when deciding the interval. People who completed their primary vaccine series using manufacturer-authorized intervals also have very good protection against severe COVID-19 disease and do not need to restart their vaccine series.

References

• Product Monographs
  • Comirnaty®
  • Spikevax™
• Canadian Immunization Guide
  • COVID-19 Vaccine
• COVID-19 Vaccine Contraindications and Precautions Background Document
  • Available from eHealth COVID-19 Immunization Manual 
• Saskatchewan Health Authority
  • COVID-19 Vaccine Comparison Tables available in General Vaccine Information
• Saskatchewan Immunization Manual
  • Chapter 10: Biological Products
• Moderna
  • Written communication, 16 Feb 2022 and 12 Sep 2022
• Pfizer-BioNTech
  • Pfizer-BioNTech COVID-19 Vaccine: Vaccination Storage & Dry Ice Safety Handling
  • The Pfizer-BioNTech COVID-19 Vaccine Dosage and Storage Guide
  • Written communication, 16 Feb 2022

Last updated

01 Nov 2022