mRNA COVID-19 Vaccines Available in SK

Overview of mRNA COVID-19 Vaccines Available in SK

An overview of all mRNA COVID-19 vaccines available in Saskatchewan by age. Includes vaccines not available in Saskatchewan community pharmacies (i.e., only available through Public Health or physicians/nurse practitioners).

Table of all Monovalent (Original) mRNA Vaccines Available in Saskatchewan 
AgeVaccineComments
≥ 6 Months to < 5 Years

Pfizer-BioNTech Comirnaty®     
3 mcg/0.2 mL     
(maroon cap/maroon border)

Use for primary series.

No booster doses have been approved for this age group.

These vaccines are not available in SK pharmacies.

Moderna Spikevax™     
25 mcg/0.25 mL     
(royal blue cap/purple border)

5 Years

Pfizer-BioNTech Comirnaty®     
10 mcg/0.2 mL     
(orange cap/orange border)

Use for primary series.

For booster doses, bivalent is preferred. If monovalent is chosen, use this vaccine.

Moderna Spikevax™     
25 mcg/0.25 mL     
(royal blue cap/purple border)

Use for primary series.

For booster doses, use Comirnaty® (preferably bivalent).

This vaccine is not available in SK pharmacies.

≥ 6 Years to        
< 12 Years

Pfizer-BioNTech Comirnaty®     
10 mcg/0.2 mL      
(orange cap/orange border)

Use for primary series.

For booster doses, bivalent is preferred, but monovalent (original) may be used.

≥ 12 Years

Pfizer-BioNTech Comirnaty®     
30 mcg/0.3 mL     
(grey cap/grey border)

Use for primary series.

For booster doses, bivalent vaccines are preferred but monovalent (original) may be used.

Non-mRNA COVID-19 Vaccines available in Saskatchewan through Public Health and physicians/nurse practitioners:

  • Janssen Jcovden™ (viral vector, ≥ 18 years)
  • Novavax Nuvaxovid ™ (protein subunit, ≥ 12 years)
Last updated: 26 apr 2023
Table of all Bivalent mRNA Vaccines Available in Saskatchewan
AgeVaccineComments
5 Years

Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5     
10 mcg/0.2 mL     
(orange cap/orange border)

Use for booster doses.

Bivalent vaccines are not authorized for use as primary series in children < 12 years old.

This vaccine is not available in SK pharmacies.

≥ 6 Years to        
<12 Years		Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5     
10 mcg /0.2 mL     
(orange cap/orange border)

Use for booster doses.

Bivalent vaccines are not authorized for use as primary series in children < 12 years old.

This vaccine is not available in SK pharmacies.

Moderna Spikevax™ Bivalent  (Original /Omicron BA.4/5)     
50 mcg/0.5 mL     
(royal blue cap/grey border)

Use for booster doses.

Bivalent vaccines are not authorized for use as primary series in children < 12 years old.

≥ 12 Years

 

Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5      
30 mcg/0.3 mL     
(grey cap/grey border)

Use for booster doses.

This vaccine is not Health Canada authorized to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of the vaccines for this purpose, with informed consent, if an individual ≥ 12 years old requests to start or complete their COVID-19 primary series with bivalent vaccine. Those who have received one or more doses of bivalent vaccine as part of the primary series are not eligible for booster doses at this time.

Moderna Spikevax™ Bivalent  (Original /Omicron BA.4/5)     
50 mcg/0.5 mL     
(royal blue cap/grey border)

Use for booster doses.

This vaccine is not Health Canada authorized to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of the vaccines for this purpose, with informed consent, if an individual ≥ 12 years old requests to start or complete their COVID-19 primary series with bivalent vaccine. Those who have received one or more doses of bivalent vaccine as part of the primary series are not eligible for booster doses at this time.

Last updated: 29 may 2023

Details of mRNA COVID-19 Vaccines Available in SK 

Monovalent (Original)

Pfizer-BioNTech Comirnaty® ≥ 5 to < 12 Years (Orange Cap)

Indication

  • Health Canada: Immunization against COVID-19 (primary series and booster) for individuals ≥ 5 years to < 12 years of age
    • Monovalent vaccines are best reserved for primary series doses.
    • Age-appropriate Omicron-containing bivalent mRNA COVID-19 vaccines are recommended for booster doses; however Pfizer-BioNTech Comirnaty® monovalent may be used for booster doses if requested, with informed consent. 

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 (10 mcg mRNA)
      • *To complete a primary series started with Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap), non-immunocompromised children require 3 doses. If the child transitions from 4 years old to 5 years old during the vaccine series, they should still receive the number of doses recommended as part of their initial primary series.  This also applies to mixed vaccine series (i.e. if at least one Moderna Spikevax™ 25 mcg dose has been given as a dose in the primary series). 
        • E.g. Non-immunocompromised child received 2 doses of Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap) and turns 5 years old before the 3rd dose. Based on the initial schedule when they started the series, their primary series would consist of three doses. Therefore, one dose of Pfizer-BioNTech Comirnaty® 10 mcg (Orange cap) will be required to complete the primary series. The Contraindications and Precautions Background Document available at the COVID-19 Immunization Manual includes more examples.       
           
  • Interval
    • Dose 1: Day 0
    • Dose 2: 8 weeks (optimal interval)
      • 8 weeks is recommended, but dose can be provided at a shorter interval† if chosen.
        • † ≥ 21 days if first dose was Comirnaty®; ≥ 28 days if first dose was SpikevaxTM.
      • Based on NACI recommendation, the minimum interval is 19 days between doses (any doses provided at an earlier interval would be considered invalid and need to be repeated).
        • This interval is not a recommended interval and should only be used to determine dose validity.
    • Dose 3 (if primary series started with Pfizer-BioNTech Comirnaty® 3 mcg): 8 weeks after 2nd dose
    • An interval of 8 weeks is expected to provide a greater and more durable immune response as well as reduce the risk of myocarditis or pericarditis; severe outcomes from the Omicron variant are expected to remain low in these children during the time between doses.

Boosters for Non-Immunocompromised Individuals

(See Indication; bivalent preferred)

  • Dose
    • 0.2 mL (10 mcg mRNA)       
       
  • Interval
    • See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval

Primary Series for Moderately to Severely Immunocompromised Individuals

(See Definition of Moderately to Severely Immunocompromised)

  • Dose
    • 3* doses of 0.2 mL (10 mcg mRNA)
      • *To complete a primary series started with Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap), immunocompromised children require 4 doses. If the child transitions from 4 years old to 5 years old during the vaccine series, they should still receive the number of doses recommended as part of their initial primary series.  This also applies to mixed vaccine series (i.e. if at least one Moderna Spikevax™ 25 mcg dose has been given as a dose in the primary series). 
        • E.g. Immunocompromised child received 2 doses of Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap) and turns 5 years old before the 3rd dose. Based on the initial schedule when they started the series, and because they are immunocompromised, their primary series would consist of four doses. Therefore, TWO doses of Pfizer-BioNTech Comirnaty® 10 mcg (Orange cap) will be required to complete the primary series. The Contraindications and Precautions Background Document includes more examples.       
           
  • Interval
    • Dose 1: Day 0
    • Dose 2: 4 to 8 weeks after 1st dose
      • 4 to 8 weeks is recommended, but dose can be provided at a shorter interval† if chosen.
        • † ≥ 21 days if first dose was Comirnaty®; ≥ 28 days if first dose was SpikevaxTM.
      • Based on NACI recommendation, the minimum interval is 19 days between doses (any doses provided at an earlier interval would be considered invalid and need to be repeated).
        • This interval is not a recommended interval and should only be used to determine dose validity.
    • Dose 3: 4 to 8 weeks after 2nd dose
    • Dose 4 (if primary series started with Pfizer-BioNTech Comirnaty® 3 mcg): 4 to 8 weeks after 3rd dose
    • 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.

Boosters for Moderately to Severely Immunocompromised Individuals

(See Indication; bivalent preferred)

  • Dose
    • 0.2 mL (10 mcg mRNA)       
       
  • Interval
    • See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval

Adverse Events

  • Only short- to medium-term data are available at this time. Surveillance will continue for long-term adverse events.
  • Reported adverse events were mild or moderate, more common following the 2nd dose, and generally resolved within 1-2 days.
  • Common adverse events included:  
    • More common
      • local reactions: pain at injection site, redness, and swelling (up to 74%)
      • fatigue (39%)
      • headache (28%)
      • muscle pain (12%)
    • Less common (<10%)
      • fever
      • chills
      • vomiting/diarrhea
      • muscle/joint pain
  • Rare Adverse Events
    • No cases of myocarditis, pericarditis, anaphylaxis, Bell’s palsy, or appendicitis reported. However, these would not be expected given the size of the trial and will continue to be monitored.

Drug Interactions

  • There are no known drug interactions with medications used in this age group.

Product Information

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
Last updated: 21 Mar 2023
Pfizer-BioNTech Comirnaty® (Monovalent, Grey Cap) ≥ 12 Years

Indication

  • Health Canada: Immunization against COVID-19 for individuals:
    • 12 years and older (primary series)
    • 16 years and older (booster)
      • Monovalent vaccines are best reserved for primary series doses.
      • Age-appropriate Omicron-containing bivalent mRNA COVID-19 vaccines are recommended for booster doses; however, in Saskatchewan, Pfizer-BioNTech Comirnaty® monovalent may be used for booster doses (including for those ≥ 12 years to < 16 years) if requested, with informed consent. 

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 (30 mcg mRNA)          
       
  • Interval
    • Dose 1: Day 0
    • Dose 2: 8 weeks (optimal interval)
      • 8 weeks is recommended, but dose can be provided at a shorter interval† if chosen.
        • † ≥ 21 days if first dose was Comirnaty®; ≥ 28 days if first dose was a different COVID-19 vaccine
      • Based on NACI recommendation, the minimum interval is 19 days between doses (any doses provided at an earlier interval would be considered invalid and need to be repeated).
        • This interval is not a recommended interval and should only be used to determine dose validity. 

Boosters for Non-Immunocompromised Individuals

(See Indication; bivalent preferred)

  • Dose
    • 0.3 ml (30 mcg mRNA)        
       
  • Interval
    • See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval

Primary Series for Moderately to Severely Immunocompromised Individuals

(See Definition of Moderately to Severely Immunocompromised)

  • Dose
    • 3 doses of 0.3 ml (30 mcg mRNA)        
       
  • Interval
    • Dose 1: Day 0
    • Dose 2: 4 to 8 weeks after 1st dose
      • 4 to 8 weeks Is recommended, but dose can be provided ≥ 21 days after 1st dose if chosen.
      • Based on NACI recommendation, the minimum interval is 19 days between doses (any doses provided at an earlier interval would be considered invalid and need to be repeated).
        • This interval is not a recommended interval and should only be used to determine dose validity.
    • Dose 3: 4 to 8 weeks after 2nd dose
      • 4 to 8 weeks Is recommended, but dose can be provided ≥ 21 days after 2nd dose if chosen.
    • 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.

Boosters for Moderately to Severely Immunocompromised Individuals

(See Indication; bivalent preferred)

  • Dose
    • 0.2 mL (10 mcg mRNA)       
       
  • Interval
    • See COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval

Adverse Events 

  • Only short to medium term data are available at this time. Surveillance will continue for long-term adverse events. Reported adverse events were mild or moderate, more common following the 2nd dose, and generally resolved within a few days. Common adverse events included:  
    • pain at injection site
    • fatigue
    • headache
    • muscle pain
    • chills
    • joint pain
    • fever
  • Rare Adverse Events
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with COVID-19 vaccines have been reported in a small number of people. Most cases followed vaccination with mRNA COVID-19 vaccine.
      • Symptoms can include chest pain, shortness of breath, or palpitations (feelings of having a fast-beating, fluttering or pounding heart). In many cases, these conditions are mild and require little to no treatment. However, more severe cases can lead to heart muscle damage.
      • Health Canada has issued a statement regarding updates to Pfizer-BioNTech Comirnaty® and Moderna Spikevax™ labels.
    • Bell's palsy / facial paralysis was reported in four recipients in the vaccine group compared to none in the placebo group in the clinical trial. There have been rare cases reported postmarket in Canada and internationally. It typically presents as sudden weakness or paralysis on one side of the face and generally starts to improve within a few weeks. 

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.

Product Information

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
Last updated 28 Dec 2022
COVID-19 Vaccines Available in SK but Not in Community Pharmacies (Limited Information)
The vaccines below can be accessed by calling 1-833-SASK VAX (1-833-727-5829)

For further clinical information about these vaccines, see: 

Moderna Spikevax™ Monovalent 25 mcg/0.25 mL (Royal Blue Cap)  

Indication

  • Health Canada: immunization against COVID-19 for individuals (see notes):
    • 6 months and older (primary series)
    • 12 years and older (booster)

Notes

  • Moderna Spikevax™ 25 mcg/0.25 mL (monovalent, royal blue cap) has been approved for use in individuals 6 months of age and older for primary series (6 months and older) and booster doses (12 years and older)
    • this formulation is only being used in those ≥ 6 months to < 6 years of age for primary series doses in Saskatchewan and is not available in pharmacies. 
  • NACI and the Ministry of Health recommend Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap) in 5-year-old children (both products are approved for this age), for the primary series. Moderna Spikevax™ 25 mcg (monovalent, royal blue cap) may be offered to children in this age group if requested or if Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap) is not readily available.
Specific References
Last updated: 09 Mar 2023

Pfizer-BioNTech Comirnaty® Monovalent 3 mcg/0.2 mL (Maroon Cap) 

Indication

  • Health Canada: immunization against COVID-19 (primary series) for individuals ≥ 6 Months to < 5 Years

Notes

  • The primary series requires more doses than required for other mRNA COVID-19 vaccines:
    • 3 doses for non-immunocompromised individuals
    • 4 doses for moderately to severely immunocompromised individuals
Specific Reference
Last updated: 30 Mar 2023

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

Janssen JCovdenTM  0.5 mL

Indication

  • Health Canada: immunization against COVID-19 (primary series and booster) for individuals 18 years and older

Notes

  • This is a viral vector COVID-19 vaccine.
    • mRNA COVID-19 vaccines are preferred for primary series and booster doses, but this vaccine is an option for those who cannot take or choose not to take mRNA vaccines.
Specific Reference
Last updated: 20 Mar 2022

Bivalent 

Moderna Spikevax™ Bivalent (Original / Omicron BA.4/5) (Royal Blue Cap, Grey Border)  ≥ 6 years

Indication

  • Health Canada: booster dose following COVID-19 primary series vaccination (with any COVID-19 vaccine) for individuals 6 years and older
    • The Saskatchewan Ministry of Health supports permissive administration of this bivalent vaccine as a primary COVID-19 immunization series with informed consent if an individual 12 years and older requests to start or complete their COVID-19 primary series with this vaccine.
    • Bivalent vaccines are not permitted for use as the primary series in children < 12 years of age.    

Administration

  • Give doses IM (deltoid)

Dose

(Non-immunocompromised and moderately to severely immunocompromised)

  • ≥ 12 Years (off-label for those 12 years to < 18 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)  

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 days. This does not need to be reported as an AEFI/AESI.
    • fatigue
    • headache
    • myalgia
    • arthralgia 
    • chills
    • nausea/vomiting  
  • Rare Adverse Events 
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with COVID-19 vaccines have been reported in a small number of people. 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.
      • There were no cases of myocarditis or pericarditis reported in the studies. However, myocarditis and pericarditis are rare adverse events so would not be expected to be discovered in studies of < 1000 participants. Data suggests risk is lower following booster doses compared to the 2nd dose of a primary series. Monitoring real-world conditions will continue.

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.

Product Information

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: 29 may 2023
Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 (Grey Cap, Grey Border) ≥ 12 Years

Indication

  • Health Canada: booster dose following COVID-19 primary series vaccination for individuals 12 years and older.
    • The Saskatchewan Ministry of Health supports permissive administration of this bivalent vaccine as a primary COVID-19 immunization series with informed consent if an individual requests to start or complete their COVID-19 primary series with this vaccine. Those who have received one or more doses of bivalent vaccine as part of the primary series are not eligible for booster doses at this time.

Administration

  • Give doses IM (deltoid)

Dose

(Non-immunocompromised and moderately to severely immunocompromised )

  • 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

  • Clinical information is based on the Pfizer-BioNTech Comirnaty® BA.1 Bivalent (30 mcg) candidate (which was not marketed). These results have been extrapolated to 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 and Pfizer-BioNTech Comirnaty® BA.1 Bivalent when administered as a fourth dose.
  • 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 days. This does not need to be reported as an AEFI/AESI.
    • fatigue
    • headache
    • myalgia
    • chills
    • arthralgia
  • Rare adverse events
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with COVID-19 vaccines have been reported in a small number of people. 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.
      • There were no cases of myocarditis or pericarditis reported in the study. However, myocarditis and pericarditis are rare adverse events so would not be expected to be discovered in such a small study (n= 305). Data suggest risk is lower following booster doses compared to the 2nd dose of a primary series. Monitoring real-world conditions will continue.

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.

Product Information

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
Last updated: 28 Dec 2022
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: 

Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 10 mcg/0.2 mL (Orange Cap/Orange Border) 

Indication

  • Health Canada: booster dose following COVID-19 primary series vaccination for individuals ≥ 5 Years to < 12 Years

Notes

  • This is the only Omicron-containing bivalent COVID-19 vaccine authorized for this age group.
  • This vaccine is not permitted for use as part of a primary series.
Specific Reference
Last updated: 30 Mar 2023

Product Comparison Tables

The following tables include characteristics of mRNA COVID-19 vaccines available in Saskatchewan pharmacies (monovalent and bivalent).

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® Vaccines
 

Pfizer-BioNTech Comirnaty® Orange Cap, Orange Border

Pfizer-BioNTech Comirnaty®     
Grey Cap, Grey Border

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

 DILUTE BEFORE USEDO NOT DILUTE
mRNA Vaccine TypeMonovalent (Original)Bivalent
Authorized Ages  ≥ 5 Years to        
< 12 Years		≥ 12 Years
Concentration10 mcg / 0.2 mL30 mcg / 0.3 mL30 mcg / 0.3 mL            
(15 mcg each Original and Omicron BA.4/BA.5)
DIN  025224540252786302531461
Packaging

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 dosesa

Cartons of 10 and 195 vials

Grey cap; grey border on label

Multidose preservative-free vials containing 6 dosesa

Cartons of 10 vials

Grey cap; grey border on label

Storage/Stability

 

Pfizer-BioNTech Comirnaty®   
Orange Cap, Orange Border

Pfizer-BioNTech Comirnaty®   
Grey Cap, Grey Border

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

Stability in Freezer

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.

Thawing

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

Do not refreeze thawed vials.

Stability in Refrigerator            
(2°C to 8°C)

Undiluted product: up to 10 weeks

Up to 10 weeks prior to first use
DilutionDilute thawed vials once they have reached room temperature with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP.

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 (whether before or after puncture) but time spent at room temperature must be tracked.

After dilution, use within 12 hours from time of dilution.b 

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

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.c

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

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.

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

Stability after            
1st Puncture		Up to 12 hours at 2°C to 25°CcUp to 12 hours at 2°C to 25°C
Protect from Light

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.

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

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. 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.

c. 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.

Specific References
Last updated: 21 Mar 2023
Moderna Spikevax™ Vaccines
 

Moderna Spikevax™   
Bivalent (Original /Omicron BA.4/5)   
Royal Blue Cap,   
Grey Border

 

DO NOT DILUTE

mRNA Vaccine Type

Bivalent

Authorized Ages

       ≥ 6 Years

Concentration

50 mcg / 0.5 mL    
(25 mcg each Original and Omicron BA.4/5)

DIN

02532352

Packaging

Multidose preservative-free  2.5mL vials

Cartons of 10 vials

Royal blue cap; grey border on label

Storage and Stability 

 

Moderna Spikevax™ Bivalent  (Original/Omicron BA.4/5)    
 Royal Blue Cap, Grey Border

Stability in Freezer

Store at -50°C to -15°C (freezer) until the expiry date printed on the label.

Thawing

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 Refrigerator (2°C to 8°C)

Up to 30 days prior to first use

Dilution

DO NOT DILUTE

Stability at Room Temperature (up to 25°C)

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 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 10 times.

Protect from Light

Store in original carton.

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

Handling

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

Appearance

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

Specific References
Last updated: 29 may 2023

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
Last updated: 23 Nov 2021
Booster Eligibility and Interval

Eligibility Quick Sheet       
Bivalent Booster Eligibility 

  • For booster doses, Omicron-containing bivalent vaccines are preferred; however, monovalent vaccines may be provided with informed consent. 
  • 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:
    • 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 Sep 5, 2022, using a 6-month interval, the next dose can be given March 5, 2023, or later.

Specific References
Last updated: 26 apr 2023
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 immunocompromised		Vaccine 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 children
Specific Reference
Last 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 mRNA dose to complete the primary series.            
     
  • In Saskatchewan, individuals who have received 2 or more doses of a non-Health Canada authorized vaccine do not need further vaccines to complete the primary series.            
     
  • For booster dose eligibility following completion of the primary series, see COVID-19 Vaccine Eligibility and Recommendations → Booster Eligibility and Interval
Last updated: 31 Jan 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