Characteristics of COVID-19 Vaccines Available in Canada
SHA has a Vaccine Comparison table available in General Vaccine Information.
Pfizer-BioNTech |
Pfizer-BioNTech |
Moderna Spikevax™ |
AstraZeneca Vaxzevria™ |
Janssen |
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Vaccine Technology | mRNA | mRNA | mRNA | Viral vector ChAdOx1-S (recombinant) |
Viral vector Ad26.COV2.S (recombinant) |
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Packaging |
Multi-dose preservative-free vials containing 10 doses Cartons of 10 or 195 vials Orange cap; orange border on vial |
Multi-dose preservative-free vials containing 6a doses Cartons of 25 and 195 vials Purple cap; purple border on vial |
Multi-dose preservative-free available in 5 mL and 8 mL vials 8 mL vials are US-labelledb Regardless of vial size, maximum of 20 punctures per vial Cartons of 10 vials |
Multi-dose preservative-free vials containing 10 doses |
Multi-dose preservative-free vial containing 5 doses Cartons of 10 vials |
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Storage/Stability | |||||||||||||||||||||||||||||||||
Stability in Freezer |
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°Cc (ultrafreezer) until the expiry date printed on the label. These dates have been extended for some product.d Store and/or transport at -25°C to -15°C for up to 2 weeks.e |
Store at -25°C to -15°C (freezer) until the expiry date printed on the label. These dates have been extended for some product.f | Do not freeze. | May be stored and/or transported at -25°C to -15°C (freezer) until expiry date printed on vial and carton after “EXP”. | ||||||||||||||||||||||||||||
Thawing |
Thaw undiluted product in fridge (takes up to 4 hours). Do not refreeze thawed vials. |
Thaw undiluted product in fridge (takes up to 3 hours). Do not refreeze thawed vials. |
Thaw in fridge (takes 2.5 hours), let stand at room temperature for 15 minutes before administration. or Thaw at room temperature (takes 1 hour). Do not refreeze thawed vials. |
Not required Do not freeze. |
Thaw over night in fridge Do not refreeze thawed vials. |
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Stability in Refrigerator (2°C to 8°C) |
Undiluted product: up to 10 weeks |
Undiluted product: up to 31 days Thawed, undiluted product can be transported at 2°C to 8°C for up to 12 hours but this counts against the 31-day limit. |
Up to 30 days |
Store at 2° to 8°C until expiry date. Expiry date is found on vial label and refers to last day of that month. |
Up to 6 months, not exceeding original expiry date (EXP) See here for EU English-only labelled product. |
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Dilution |
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 |
Do not dilute | Do not dilute | ||||||||||||||||||||||||||||
Stability at Room Temperature (up to 25°C) |
Prior to dilution, no more than 12 hours (Time is additive: up to 24 hours at room temperature) |
Prior to dilution, no more than 2 hours (including any thaw time) (Time is additive: up to 8 hours at room temperature) |
Up to 24 hours Vials can be returned to fridge but time at room temperature must be tracked and not exceed 24 hours total. |
Store in a refrigerator (2°C to 8°C). No stability data of unopened vial at room temperature. See stability after 1st puncture. |
Stable for a total of 12 hours at 9°C to 25°C | ||||||||||||||||||||||||||||
Stability after 1st Puncture |
Up to 12 hours at 2°C to 25°C | Up to 6 hours at 2°C to 25°C |
Up to 24 hours at 2°C to 25°C Vials can be returned to fridge but time at room temperature must be tracked and not exceed 24 hours total. Time at room temperature includes any time at room temperature prior to puncture. Do not puncture and withdraw doses more than 20 times.h |
Up to 6 hours at room temperature (up to 25°C) Product can be returned to the fridge but the cumulative time at room temperature must not exceed 6 hours and cumulative storage once punctured must not exceed 48 hours. |
Up to 3 hours at room temperature (up to 25°C) Up to 6 hours at 2°C to 8°C |
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Protect from Light? | Yes. Store in original carton. |
Yes. Store in original carton. |
Yes. |
Yes. |
Yes. |
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Handling |
Invert gently 10 times during reconstitution. |
Invert gently 10 times during reconstitution. |
Swirl vial gently after thawing and between each withdrawal. |
None specified. Product is a solution. |
Swirl gently upright for 10 seconds. |
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Appearance |
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. |
White to off-white dispersion—may contain white or translucent product-related particles; ensure no foreign particulate matter or discolouration. |
Colourless to slightly brown, clear to slightly opaque solution; ensure no foreign particulate matter or discolouration. |
Colourless to slightly yellow, clear to very opalescent suspension; ensure no foreign particulate matter or discolouration. |
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Clinical Information | |||||||||||||||||||||||||||||||||
Age | Approved for individuals 5 to 11 years | Approved for individuals 12 years and older | Approved for individuals 6 years and older | Approved for individuals 18 years of age and older | Approved for individuals 18 years of age and older | ||||||||||||||||||||||||||||
Dosage for Primary Series | 0.2 mL (10 mcg mRNA) |
0.3 mL (30 mcg mRNA) |
≥ 12 years: 0.5 mL 6 to 11 years: 0.25 mL |
0.5 mL |
0.5 mL (5x1010 viral particles) |
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Schedule | # Doses to Complete Primary Series | 2 (3 if immunocompromised) |
2 |
2 (3 if immunocompromised) |
2i |
1j | |||||||||||||||||||||||||||
Minimum Interval Between 1st and 2nd Doses | 19 days per NACI | 19 days per NACI based on per-protocol design of the trial | 21 days per NACI based on the majority of participants in the trial received the 2nd dose 21 to 42 days after the 1st, as per the pre-defined window. |
28 days |
N/A | ||||||||||||||||||||||||||||
Authorized Interval Between 1st and 2nd Doses |
21 days | 21 days | 28 days |
4 to 12 weeks |
N/A | ||||||||||||||||||||||||||||
Ministry of Health Interval Between 1st and 2nd Doses |
21 days | 28 days (21 days is acceptable) |
28 days | 28 days | N/A | ||||||||||||||||||||||||||||
Optimal Interval Between 1st and 2nd Doses per NACIk | 8 weeks | 8 weeks | 8 weeks | At least 8 weeks | N/A | ||||||||||||||||||||||||||||
Booster Doses | Find information about doses, eligibility and intervals here. | ||||||||||||||||||||||||||||||||
Route of Administration | Intramuscular (deltoid preferred) | Intramuscular (deltoid preferred) | Intramuscular (deltoid preferred) | Intramuscular (deltoid preferred) | Intramuscular (deltoid preferred) | ||||||||||||||||||||||||||||
a. Packaging originally indicated 5 doses per vial though this has been updated to 6 doses per vial to minimize waste and increase access. 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. Moderna Tx, Inc. is providing US-labelled vaccine supplies in order to expedite the distribution of the vaccine in Canada. The contents are identical to the Canadian-labelled product. However, important differences in packaging and labelling include:
Continue to use the Canadian product monograph. For access to expiration dates, Canadian-specific labelling information and further details, see the Health Canada MedEffect notice. c. 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. d. Extensions to expiry dates for Pfizer-BioNTech Comirnaty™ ≥12 years product only (not pediatric product), as long as all approved storage conditions have been maintained, include:
e. 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. f. Health Canada has authorized a 2-month shelf life extension (from 7 months to 9 months) for certain product as long as approved storage requirements have been maintained:
g. 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. h. As per Health Canada Distribution of SPIKEVAX (elasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels, Nov 10, 2021 i. Individuals who received two doses of AstraZeneca Vaxzevria™ as a primary series are eligible to receive an mRNA vaccine (Pfizer-BioNTech Comirnaty™ or Moderna Spikevax™) booster dose 4 months or later after completion of their primary series. Novavax Nuvaxovid™ (only available through Public Health) may be given to those for whom mRNA vaccine is contraindicated, inaccessible, or refused. j. Janssen (Johnson & Johnson) single dose vaccine recipients are eligible for a booster dose with an mRNA vaccine 2 months or later following their vaccination. Novavax Nuvaxovid™ (only available through Public Health) may be given to those for whom mRNA vaccine is contraindicated, inaccessible, or refused. k. There is emerging evidence that longer intervals between the first and second doses of COVID-19 vaccines result in 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
Last updated13 May 2022 |
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