mRNA COVID-19 Vaccines Available in SK
As of July 24, 2023, the only mRNA COVID-19 vaccines available in Saskatchewan are bivalent, which are to be used for primary series and booster doses. Nuvaxovid™, a monovalent protein subunit vaccine, is available for those who cannot or choose not to receive mRNA vaccines (12 years and older).
- Overview of mRNA Vaccines Available in Saskatchewan
This is an overview of all mRNA COVID-19 vaccines available in Saskatchewan by age.
Age Vaccine Comments ≥ 6 Months to
<5 YearsModerna Spikevax™ Bivalent (Original/ Omicron BA.4/5)
50 mcg/0.5 mL
(royal blue cap/grey border)Use for primary series. This vaccine is not authorized by Health Canada to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of the vaccine for this purpose, with informed consent.
This age group is not eligible for booster doses.
Pharmacy professionals are not authorized to immunize children under 5 years of age.
5 Years Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5
10 mcg/0.2 mL
(orange cap/orange border)Use for primary series and booster doses. Moderna Spikevax™ Bivalent (Original/ Omicron BA.4/5)
50 mcg/0.5 mL
(royal blue cap/grey border)Use for primary series. This vaccine is not authorized to be used for booster doses in those < 6 years.
This vaccine is not authorized by Health Canada to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of the vaccine for this purpose, with informed consent.
≥ 6 Years to
<12 YearsPfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5
10 mcg /0.2 mL
(orange cap/orange border)Use for primary series and booster doses. Moderna Spikevax™ Bivalent (Original/ Omicron BA.4/5)
50 mcg/0.5 mL
(royal blue cap/grey border)Use for primary series and booster doses.
This vaccine is not not authorized by Health Canada to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of the vaccine for this purpose, with informed consent.
≥ 12 Years
Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5
30 mcg/0.3 mL
(grey cap/grey border)Use for primary series and booster doses. Moderna Spikevax™ Bivalent (Original /Omicron BA.4/5)
50 mcg/0.5 mL
(royal blue cap/grey border)Use for primary series and booster doses.
This vaccine is not authorized by Health Canada to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of the vaccine for this purpose, with informed consent.
Last updated: 10 Aug 2023
- Product Comparison Table of COVID-19 Vaccines Available in SK Pharmacies
The following table includes characteristics of the mRNA COVID-19 vaccines available in Saskatchewan pharmacies.
For more details about the included vaccines and/or information regarding COVID-19 vaccines only available through Public Health, see the Saskatchewan Immunization Manual and COVID-19 Vaccine Contraindications and Precautions document (available here).
Pfizer-BioNTech
Comirnaty®
Original & Omicron BA.4/BA.5
Orange Cap,
Orange Border
Pfizer-BioNTech Comirnaty® (Original/ Omicron BA.4/BA.5)
Grey Cap, Grey BorderModerna Spikevax™ Bivalent (Original/ Omicron BA.4/5)
Royal Blue Cap,
Grey BorderDILUTE BEFORE USE
DO NOT DILUTE
mRNA Vaccine Type Bivalent
Health Canada-Authorized Ages ≥ 5 Years to < 12 Years (primary series and booster)
≥ 12 Years (primary series and booster)
≥ 6 Years (booster)
SK-Authorized Ages ≥ 5 Years to < 12 Years (primary series and booster)
≥ 12 Years
(primary series and booster)≥ 6 Monthsa (primary series)
≥ 6 Years(booster)
Concentration 10 mcg/ 0.2 mL (5 mcg each Original and Omicron BA.4/BA.5)
30 mcg / 0.3 mL
(15 mcg each Original and Omicron BA.4/BA.5)50 mcg / 0.5 mL
(25 mcg each Original and Omicron BA.4/5)DIN 02533197
02531461
02532352
Packaging Multidose preservative-free vials containing 10 dosesb
Cartons of 10 vials
Orange cap; orange border on label
Multidose preservative-free vials containing 6 dosesb
Cartons of 10 vials
Grey cap; grey border on label
Multidose preservative-free 2.5mL vials
Cartons of 10 vials
Royal blue cap; grey border on label
Storage/Stability
Pfizer-BioNTech
Comirnaty®
Original & Omicron BA.4/BA.5
Orange Cap,
Orange BorderPfizer-BioNTech Comirnaty® (Original/Omicron BA.4/BA.5)
Grey Cap, Grey BorderModerna Spikevax™ Bivalent (Original/ Omicron BA.4/5) Royal Blue Cap, Grey Border
Stability in Freezer Store at -90°C to -60°C (ultrafreezer) for up to 18 months from date on label
Date on label is the date of manufacture.
Do not store at -25°C to -15°C.
Store at -90°C to -60°C (ultrafreezer) for up to 18 months from date on label (Formerly 12 months)
Date on label is the date of manufacture.
Do not store at -25°C to -15°C.
Store at -50°C to -15°C (freezer) until the expiry date printed on the label.c
Thawing Thaw in fridge (takes up to 4 hours)
or
Thaw 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 hours)
or
Thaw at room temperature (takes 45 minutes)After thawing, let stand at room temperature for 15 minutes before administering.
Do not refreeze thawed vials.
Stability in Fridge
(2°C to 8°C)Up to 10 weeks prior to dilution.
Up to 10 weeks prior to first use
Up to 30 days prior to first use
Dilution Dilute thawed vials once they have reached room temperature with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP
(diluent is single use, discard remaining diluent after withdrawing from vial).DO NOT DILUTE
Stability at Room Temperature (up to 25°C) Prior to dilution, no more than 12 cumulative hours at room temperature. Vials can be returned to fridge but time spent at room temperature must be tracked.
After dilution, use within 12 hours.
Prior to puncture, no more than 12 cumulative hours at room temperature. Vials can be returned to fridge (whether before or after puncture) but time spent at room temperature must be tracked.
After puncture, use within 12 hours of puncture.
No more than 24 cumulative hours at room temperature.
Vials can be returned to fridge (whether before or after puncture) but time spent at room temperature must be tracked.
Time at room temperature (punctured and unpunctured) must not exceed 24 hours total.
Stability after 1st Puncture Up to 12 hours at 2°C to 25°C
Up to 12 hours at 2°C to 25°C
Up to 24 hours at 2°C to 25°C. Discard after 24 hours.
The duration of time an unpunctured vial was stored at room temperature (if any) must be factored into time at room temperature after puncture.
Vials can be returned to fridge but the time at room temperature (punctured and unpunctured) is cumulative and must not exceed 24 hours total.
Do not puncture more than 10 times.Protect from Light Store in original carton.
Thawed vials and filled syringes can be handled in room light conditions.
Store in original carton.
Thawed vials and filled syringes can be handled in room light conditions.
Handling Invert gently 10 times after 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.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 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.
a. In Saskatchewan, this vaccine is used off-label for individuals 6 months and older for primary series, with informed consent. Pharmacy professionals can immunize individuals (5 years and older.
b. The stated number of 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 the stated number of doses from a single vial.
c. Expiry dates have been extended until October 30, 2023, for lots AT0709B and AT0710B. Use the Moderna Vial Expiration Checker to verify dates.Specific References
- Pfizer-BioNTech
- Product Monograph
- Comirnaty® Original & Omicron BA.4/BA.5
- Vaccination Storage & Dry Ice Safety Handling
- Dosage and Storage Guide
- Written communication, 17 Mar 2023
- Product Monograph
- Moderna
- Product Monograph
- SpikevaxTM Bivalent (Original/Omicron BA.4/5)
- Written communication: 12 Sep 2022; 26 Jan 2023
- Product Monograph
Last updated: 31 Jul 2023
- Pfizer-BioNTech
Details of COVID-19 Vaccines Available in SK
- Moderna Spikevax™ Bivalent (Original / Omicron BA.4/5) (Royal Blue Cap, Grey Border)
Indication
- Health Canada: booster dose following COVID-19 primary series vaccination (with any COVID-19 vaccine) for individuals 6 years and older.
- This vaccine is being used off-label, with informed consent, in Saskatchewan for primary series in individuals 6 months and older.
- Pharmacy professionals are not permitted to provide immunizations to children under 5 years of age.
Administration
- Give doses IM (deltoid)
Dose and Interval
Notes:
- If the interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.
Primary Series for Non-Immunocompromised Individuals (off-label)
- Dose
- ≥ 12 Years
- 2 doses of 0.5 mL (25 mcg Original / 25 mcg Omicron BA.4/5)
- ≥ 6 Months to < 12 Years (pharmacy professionals are not permitted to immunize children younger than 5 years)
- 2 doses of 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- 2 doses of 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- ≥ 12 Years
- Interval
- Dose 1: Day 0
- Dose 2: 8 weeks (optimal interval)
- An interval of 8 weeks is expected to provide a greater and more durable immune response.
- The dose can be provided earlier (minimum 4 weeks) if requested or operationally necessary for those 5 years and older.
Booster Doses for Non-Immunocompromised Individuals
- Dose
- ≥ 12 Years
- 0.5 mL (25 mcg Original / 25 mcg Omicron BA.4/5)
- ≥ 6 Years to < 12 Years
- 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- ≥ 12 Years
- Interval
- See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Primary Series for Moderately to Severely Immunocompromised Individuals (off-label)
- Dose
- ≥ 12 Years
- 3 doses of 0.5 mL (25 mcg Original / 25 mcg Omicron BA.4/5)
- ≥ 6 Months to < 12 Years (pharmacy professionals are not permitted to immunize children younger than 5 years)
- 3 doses of 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- 3 doses of 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- ≥ 12 Years
- Interval
- Dose 1: Day 0
- Dose 2: 4-8 weeks after Dose 1
- Dose 3: 4-8 weeks after Dose 2
- An interval of 8 weeks is expected to provide a greater and more durable immune response compared to shorter intervals; however, the benefits of this longer interval need to be weighed against the immunocompromised individual’s risks of exposure and severe outcomes between doses.
Booster Doses for Moderately to Severely Immunocompromised Individuals
- Dose
- ≥ 12 Years
- 0.5 mL (25 mcg Original / 25 mcg Omicron BA.4/5)
- ≥ 6 Years to < 12 Years
- 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5)
- ≥ 12 Years
- Interval
- See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Adverse Events
- Clinical information is based on Moderna Spikevax™ Bivalent BA.1 and have been extrapolated to Moderna Spikevax™ Bivalent (Original / Omicron BA.4/5).
- Frequency and severity of adverse events of Moderna Spikevax™ Bivalent BA.1 50 mcg were similar to Moderna Spikevax™ original (monovalent) 50 mcg.
- Common adverse events (≥ 10%)
- local reactions (pain, axillary swelling/tenderness)
- “COVID arm” is a local delayed (≥ 7 days) reaction with these symptoms; it is an expected reaction that resolves within 7 -10days. This does not need to be reported as an AEFI/AESI.
- fatigue
- headache
- myalgia
- arthralgia
- chills
- nausea/vomiting
- local reactions (pain, axillary swelling/tenderness)
- Rare adverse events
- Anyone experiencing symptoms associated with the conditions below should seek medical attention.
- Myocarditis and pericarditis have been reported in a small number of people receiving mRNA COVID-19 vaccines. Most cases followed vaccination with second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
- Symptoms may include chest pain, shortness of breath, irregular or fast/pounding heartbeat.
- Anaphylaxis is very rare but has been reported, in most cases, within 30 minutes of vaccination.
- Symptoms may include hives; swelling of face, tongue, or throat; difficulty breathing.
- Bell’s palsy has been reported in a small number of adults; symptoms typically resolve within a month.
- Symptoms may include weakness or paralysis on one side of the face.
- Myocarditis and pericarditis have been reported in a small number of people receiving mRNA COVID-19 vaccines. Most cases followed vaccination with second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
- Anyone experiencing symptoms associated with the conditions below should seek medical attention.
Drug Interactions
- Anti-SARS-CoV-2 Monoclonal Antibodies
- Evusheld™ (tixagevimab / cilgavimab)
- NACI recommends delaying administration of Evusheld™ for at least 14 days following COVID-19 vaccination.
- Information regarding effect of Evusheld™ on future COVID-19 vaccination is not available and NACI recommends timing be assessed on a case-by-case basis in consultation with clinical experts.
- Evusheld™ (tixagevimab / cilgavimab)
Product Information
- Product monograph: Spikevax™ Bivalent (Original / Omicron BA.4/5)
Non-Medicinal Ingredients
- acetic acid
- cholesterol
- DSPC (1,2-distearoyl-sn-glycero-3- phosphocholine)
- Lipid SM-102
- PEG2000-DMG (1,2-dimyristoyl-racglycerol,methoxy-polyethyleneglycol)
- sodium acetate trihydrate
- sucrose
- trometamol
- trometamol hydrochloride
- water for injection
Polyethylene glycol (PEG) and trometamol (tromethamine) are potentially allergenic ingredients.
Specific Reference
Last updated: 31 jul 2023
- Health Canada: booster dose following COVID-19 primary series vaccination (with any COVID-19 vaccine) for individuals 6 years and older.
- Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 (Orange Cap, Orange Border) ≥ 5 Years to < 12 Years
Indication
- Health Canada: immunization against COVID-19 (primary series and booster doses) for individuals ≥ 5 year to > 12 years of age.
Administration
- Give doses IM (deltoid)
Dose and Interval
Note: If the interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.
Primary Series for Non-Immunocompromised Individuals
- Dose
- 2 doses of 0.2 mL (5 mcg Original / 5 mcg Omicron BA.4/BA.5)
- Interval
- Dose 1: Day 0
- Dose 2: 8 weeks (optimal interval)
- An interval of 8 weeks is expected to provide a greater and more durable immune response; however the dose can be provided earlier (minimum 4 weeks) if requested or operationally necessary.
Booster Doses for Non-Immunocompromised Individuals
- Dose
- 0.2 mL (5 mcg Original / 5 mcg Omicron BA.4/BA.5)
- Interval
- See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Primary Series for Moderately to Severely Immunocompromised Individuals
- Dose
- 3 doses of 0.2 mL (5 mcg Original / 5 mcg Omicron BA.4/BA.5)
- Interval
- Dose 1: Day 0
- Dose 2: 4-8 weeks after Dose 1
- Dose 3: 4-8 weeks after Dose 2
- An interval of 8 weeks is expected to provide a greater and more durable immune response compared to shorter intervals; however, the benefits of this longer interval need to be weighed against the immunocompromised child’s risks of exposure and severe outcomes between doses.
Booster Doses for Moderately to Severely Immunocompromised Individuals
- Dose
- 0.2 mL (5 mcg Original / 5 mcg Omicron BA.4/BA.5)
- Interval
- See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Adverse Events
- Safety data for primary series and booster doses are based on clinical trial data and postmarketing surveillance of Pfizer-BioNTech Comirnaty® (monovalent) and clinical trial data of Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5.
- Common adverse events
- More common
- local reactions: pain at injection site, redness, and swelling
- “COVID arm” is a local delayed (≥ 7 days) reaction with these symptoms; it is an expected reaction that resolves within 7 days. This does not need to be reported as an AEFI/AESI.
- fatigue
- headache
- muscle pain
- local reactions: pain at injection site, redness, and swelling
- Less common (< 10%)
- chills
- joint pain
- fever
- vomiting
- diarrhea
- More common
- Rare adverse events
- Anyone experiencing symptoms associated with the conditions below should seek medical attention.
- Myocarditis and pericarditis are less frequent in children < 12 years old and were not reported in clinical trials.
- Symptoms may include chest pain, shortness of breath, irregular or fast/pounding heartbeat.
- Anaphylaxis is very rare but has been reported, in most cases, within 30 minutes of vaccination.
- Symptoms may include hives; swelling of face, tongue, or throat; difficulty breathing
- Bell’s palsy has been reported in a small number of adults; symptoms typically resolve within a month.
- Symptoms may include weakness or paralysis on one side of the face.
- Myocarditis and pericarditis are less frequent in children < 12 years old and were not reported in clinical trials.
- Anyone experiencing symptoms associated with the conditions below should seek medical attention.
Drug Interactions
- There are no known drug interactions with medications used in this age group.
Product Information
- Product monograph: Comirnaty® Original & Omicron BA.4/BA.5
Non-Medicinal Ingredients
- 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
Polyethylene glycol (PEG) and tromethamine are potentially allergenic ingredients.
Specific Reference
- Pfizer-BioNTech
Last updated: 31 Jul 2023
- Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 (Grey Cap, Grey Border) ≥ 12 Years
Indication
- Health Canada: immunization against COVID-19 (primary series and booster doses) for individuals 12 years and older.
Administration
- Give doses IM (deltoid)
Dose and Interval
Note: If the interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.
Primary Series for Non-Immunocompromised Individuals
- Dose
- 2 doses of 0.3 mL (15 mcg Original / 15 mcg Omicron BA.4/BA.5)
- Interval
- Dose 1: Day 0
- Dose 2: 8 weeks (optimal interval)
- An interval of 8 weeks is expected to provide a greater and more durable immune response; however the dose can be provided earlier (minimum 4 weeks) if requested or operationally necessary.
Booster Doses for Non-Immunocompromised Individuals
- Dose
- 0.3 mL (15 mcg Original / 15 mcg Omicron BA.4/BA.5)
- Interval
- See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Primary Series for Moderately to Severely Immunocompromised Individuals
- Dose
- 3 doses of 0.3 mL (15 mcg Original / 15 mcg Omicron BA.4/BA.5)
- Interval
- Dose 1: Day 0
- Dose 2: 4-8 weeks after Dose 1
- Dose 3: 4-8 weeks after Dose 2
- An interval of 8 weeks is expected to provide a greater and more durable immune response compared to shorter intervals; however, the benefits of this longer interval need to be weighed against the immunocompromised individual’s risks of exposure and severe outcomes between doses.
Booster Doses for Moderately to Severely Immunocompromised Individuals
- Dose
- 0.3 mL (15 mcg Original / 15 mcg Omicron BA.4/BA.5)
- Interval
- See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Adverse Events
- Safety data for primary series and booster doses are based on clinical trial data and postmarketing surveillance of Pfizer-BioNTech Comirnaty® (monovalent) and clinical trial data of Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5.
- Frequency and severity of adverse events of Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 are expected to be similar to those of Pfizer-BioNTech Comirnaty® original.
- Common adverse events (≥ 10%)
- local reactions (pain, redness, swelling)
- “COVID arm” is a local delayed (≥ 7 days) reaction with these symptoms; it is an expected reaction that resolves within 7-10 days. This does not need to be reported as an AEFI/AESI.
- fatigue
- headache
- myalgia
- chills
- arthralgia
- local reactions (pain, redness, swelling)
- Rare adverse events
- Anyone experiencing symptoms associated with the conditions below should seek medical attention.
- Myocarditis and pericarditis have been reported in a small number of people receiving mRNA COVID-19 vaccines. Most cases followed vaccination with second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
- Symptoms may include chest pain, shortness of breath, irregular or fast/pounding heartbeat.
- Anaphylaxis is very rare but has been reported, in most cases, within 30 minutes of vaccination.
- Symptoms may include hives; swelling of face, tongue, or throat; difficulty breathing.
- Bell’s palsy has been reported in a small number of adults; symptoms typically resolve within a month.
- Symptoms may include weakness or paralysis on one side of the face.
- Myocarditis and pericarditis have been reported in a small number of people receiving mRNA COVID-19 vaccines. Most cases followed vaccination with second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
- Anyone experiencing symptoms associated with the conditions below should seek medical attention.
Drug Interactions
- Anti-SARS-CoV-2 Monoclonal Antibodies
- Evusheld™ (tixagevimab / cilgavimab)
- NACI recommends delaying administration of Evusheld™ for at least 14 days following COVID-19 vaccination.
- Information regarding effect of Evusheld™ on future COVID-19 vaccination is not available and NACI recommends timing be assessed on a case-by-case basis in consultation with clinical experts.
- Evusheld™ (tixagevimab / cilgavimab)
Product Information
- Product monograph: Comirnaty® Original & Omicron BA.4/BA.5
Non-Medicinal Ingredients
- 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
- sucrose
- tromethamine
- tromethamine hydrochloride
- water for injection
Polyethylene glycol (PEG) and tromethamine are potentially allergenic ingredients.
Specific Reference
- Pfizer-BioNTech
Last updated: 31 jul 2023
- COVID-19 Vaccines Available in SK but Not in Community Pharmacies (Limited Information)
The vaccine below can be accessed by calling 1-833-SASK VAX (1-833-727-5829)
For further clinical information about this vaccine, see:
- Saskatchewan Immunization Manual
- Chapter 10: Biological Products
- Saskatchewan Ministry of Health
- COVID-19 Vaccine Contraindications & Precautions Background Document
- Available at: eHealth COVID-19 Immunization Manual
- Canadian Immunization Guide
Novavax NuvaxovidTM 5 mcg/0.5 mL
Indication
- Health Canada: Immunization against COVID-19 for individuals:
- 12 years and older (primary series)
- 18 years and older (booster - see notes)
Notes
- This is an adjuvanted recombinant protein subunit COVID-19 vaccine.
- mRNA COVID-19 vaccines are preferred, but this vaccine is an option for those who cannot take or choose not to take mRNA vaccines.
- NuvaxovidTM is permitted for off-label use as booster doses for those 12 years and older in SK.
Specific Reference
Last updated: 20 Mar 2022
- Saskatchewan Immunization Manual
COVID-19 Vaccine Eligibility and Recommendations
- General Eligibility
- Refer out-of-province individuals or those who do not have valid Saskatchewan health services card to Public Health.
- The eHR Viewer needs to be checked for all individuals to confirm vaccine eligibility and appropriate interval.
- The dose should be chosen according to vaccine recipient's age at presentation.
- Residents who received immunization in a different jurisdiction will be eligible to receive subsequent dose(s) in Saskatchewan. Individuals in this scenario will need to have documentation of their dose(s) from the jurisdiction in which they were received.
Specific References
- eHealth COVID-19 Immunization Manual
- Drug Plan & Extended Benefits
- COVID-19 Immunization Program: Policies and Procedures; 3 Jun 2021
Last updated: 23 Nov 2021
- Primary Series Eligibility
- All individuals 6 months and older who have not previously been immunized against COVID-19 are eligible for a COVID-19 vaccine primary series.
- Pharmacy professionals may administer vaccines to those 5 years and older.
- Omicron-containing bivalent vaccines are preferred; however, monovalent vaccine (Novavax Nuvaxovid™) may be provided with informed consent for those 12 years and older.
- Nuvaxovid™ is not available in pharmacies.
- If the same product that was used for the initial dose(s) is not available for subsequent dose(s), another mRNA bivalent COVID-19 vaccine can be used to complete the series.
- Incomplete primary series that were started with a monovalent (original) mRNA COVID-19 vaccine should be completed with an age-appropriate bivalent mRNA COVID-19 vaccine.
- Children who received Pfizer BioNTech Comirnaty® 3 mcg monovalent (original, maroon cap)
- This vaccine requires more doses to complete the primary series than other mRNA COVID-19 vaccines.
- non-immunocompromised children require three total doses to complete the primary series
- provide subsequent doses at intervals of 8 weeks (optimal); a minimum interval of 4 weeks is permitted
- moderately to severely immunocompromised children require four total doses to complete the primary series
- provide subsequent doses at intervals of 4 to 8 weeks
- non-immunocompromised children require three total doses to complete the primary series
- The primary series can be completed with subsequent doses of an age-appropriate bivalent mRNA COVID-19 vaccine. If a child requires four doses in their primary series, all four doses must be administered (may be a combination of monovalent or bivalent).
- See the Contraindications and Precautions Background Document available at the COVID-19 Immunization Manual for more information and example scenarios.
- This vaccine requires more doses to complete the primary series than other mRNA COVID-19 vaccines.
Specific Reference
- National Advisory Committee on Immunization
Last updated: 24 Jul 2023
- All individuals 6 months and older who have not previously been immunized against COVID-19 are eligible for a COVID-19 vaccine primary series.
- Booster Eligibility and Interval
Eligibility Quick Sheet
Bivalent Booster Eligibility- Omicron-containing bivalent vaccines are preferred; however, monovalent vaccine (Novavax Nuvaxovid™) may be provided with informed consent for those 12 years and older.
- Nuvaxovid™ is not available in pharmacies.
- All individuals 5 years and older are eligible for ONE age-appropriate bivalent booster dose (some individuals are eligible for a second bivalent dose, see below).
- Individuals who received a bivalent vaccine dose as part of a completed primary series are considered up to date and are not eligible for a booster dose.
- As of March 27, 2023, the following individuals are eligible for a 2nd age-appropriate bivalent booster dose (or a 1st bivalent booster if bivalent was received as part of the primary series):
- Adults 80 years of age and older
- Adult residents 18 years of age and older in long-term care facilities, personal care homes, and congregate living settings providing care for seniors (i.e. assisted living settings)
- Adults 18 years of age and older who are moderately to severely immunocompromised (See definition of moderately to severely immunocompromised.)
- All adults 65-79 years of age
- Those who have not had a COVID-19 infection are strongly encouraged to receive their second bivalent vaccine as they may be at higher risk of severe illness due to lack of hybrid immunity.
- Those who have a history of previous COVID-19 infection and request their second bivalent booster can receive it as long as 6 months (absolute minimum of 5 months) have passed since infection or last booster dose (whichever is longer).
- Eligible individuals should receive booster doses 6 months (absolute minimum interval of 5 months can be used if operationally required) or longer following their last COVID-19 vaccination or COVID-19 infection (whichever interval is longer as applicable):
- regardless of the number of COVID-19 doses previously received, as long as their primary series is complete, and
- regardless of the previous monovalent (original) or bivalent COVID-19 vaccine brand(s) received
- Individuals who received a monovalent (original) vaccine when informed consent was given for a bivalent, is considered a medication error. If this occurs, individuals can receive a bivalent dose after 6 months or should be directed to the Medical Health Officer (Public Health) if a shorter interval is requested.
- Pharmacists: if monovalent (original) vaccine is administered in error (bivalent intended), contact dpebimmunizations@health.gov.sk.ca who will coordinate with the appropriate agencies.
- New COVID-19 immunization programming and recommendations will be based on future epidemiology, data on waning immunity, new emerging variants, and new vaccines.
"Months" refer to calendar months. For example, if an individual received a dose Feb 5, 2023, using a 6-month interval, the next dose can be given Aug 5, 2023, or later.
Specific References
- Directives
- Spring 2023 Second COVID-19 Bivalent Booster Dose Eligibility and Interval Recommendations; Dr. Julie Kryzanowski, Deputy Medical Health Officer; March 23, 2023
- Clarification – Spring 2023 Second COVID-19 Bivalent Booster Dose Eligibility and Interval Recommendations; Dr. Saqib Shahab, Chief Medical Health Officer; April 18, 2023
Last updated: 24 Jul 2023
- Omicron-containing bivalent vaccines are preferred; however, monovalent vaccine (Novavax Nuvaxovid™) may be provided with informed consent for those 12 years and older.
- Recommended Interval Between Previous SARS-CoV-2 Infection and Subsequent COVID-19 Vaccine Doses
- Individuals infected with SARS-CoV-2 should receive COVID-19 vaccination as vaccination provides more reliable and stronger immune protection.
- See table below for recommended intervals for individuals 5 years and older.
- For children ≥ 6 months to < 5 years, the recommended interval is at least 8 weeks post-infection before receiving COVID-19 vaccination. Consider an interval of 4 to 8 weeks for moderately to severely immunocompromised children.
- A stronger immune response to vaccine is more likely with a longer interval between infection and vaccination.
Table: Recommended Intervals Between Previous SARS-CoV-2 Infection and COVID-19 Vaccination
SARS-CoV-2 Infection Timing Relative to COVID-19 Vaccination
Individuals 5 Years and Older
Suggested Interval between SARS-CoV-2 Infection and Vaccination
Infection prior to initiation or completion of primary vaccination series
(Primary series for individuals moderately to severely immunocompromised is 3 doses)
No previous history of MIS-C or MIS-A following vaccination
Not moderately to severely immunocompromised
Vaccine dose 3 months‡ after symptom onset or positive test (if asymptomatic)
No previous history of MIS-C or MIS-A following vaccination
Moderately to severely immunocompromisedVaccine dose 3 months^ after symptom onset or positive test (if asymptomatic) Previous history of MIS-C or MIS-A following vaccination
Regardless of immunocompromised status
Vaccine dose when recovered clinically or at least 90 days since onset of MIS-C or MIS-A, whichever is longer Infection prior to booster dose (either after primary series or previous booster dose) Individuals 5 years and older currently eligible for a booster dose
6 months* since previous infection
‡ NACI recommends 8 weeks
^ NACI recommends 4-8 weeks
* An absolute minimum interval of 5 months can be used on a case-by-case basis if operationally required.
MIS-A = multisystem inflammatory syndrome in adults; MIS-C = multisystem inflammatory syndrome in childrenLast updated: 27 Mar 2023
- Recipients of Non-Health Canada Authorized Vaccine
This information applies to non-immunocompromised individuals.
- Individuals who have received 1 dose of a non-Health Canada authorized vaccine should receive 1 bivalent mRNA dose at least 8 weeks after their dose to be considered up to date.
- Individuals who have received 2 doses of a non-Health Canada authorized vaccine should receive 1 bivalent mRNA dose at least 6 months after their 2nd dose to be considered up to date.
- Individuals who have received 3 doses of a non-Health Canada authorized vaccine should receive 1 bivalent mRNA dose at least 6 months after their third dose to be considered up to date.
For all individuals who have received a non-Health Canada authorized vaccine and are now considered up to date, see COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Last updated: 24 jul 2023
Moderately to Severely Immunocompromised
- Definition of Moderately to Severely Immunocompromised
Moderately to severely immunocompromised individuals include those with the following conditions:
- Recipients of active treatment for solid tumour or hematologic malignancies
- Recipients of solid-organ transplant and taking immunosuppressive therapy
- Recipients of hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)
- Recipients of chimeric antigen receptor (CAR)-T-cell therapy targeting lymphocytes
- Moderate to severe primary immunodeficiency with associated humoral and/or cell-mediated immunodeficiency or immune dysregulation
- HIV with prior AIDS defining illness or TB diagnosis in last 12 months before starting vaccine series, or severe immune compromised with CD4 count < 200/mm3 or prior CD4 fraction < 15% without HIV viral suppression
- Recipients of active treatment with the following categories of immunosuppressive therapies:
- anti-B cell therapies (monoclonal antibodies targeting CD19, CD20 and CD22)
- high-dose systemic corticosteroids (prednisone equivalent of ≥ 40 mg per day for more than 1 week)
- alkylating agents, antimetabolites, or tumor-necrosis factor (TNF) inhibitors and other biologic agents that are significantly immunosuppressive
- see list of immunosuppressive medications
- Chronic kidney disease on dialysis
Last updated: 27 Mar 2023
References
- General References
- Saskatchewan Immunization Guide
- Chapter 10: Biological Products
- COVID-19 Vaccine Contraindications and Precautions Background Document
- Available from the eHealth COVID-19 Immunization Manual
- Canadian Immunization Guide
- Saskatchewan Immunization Guide