COVID-19 Vaccines Available

Vaccines Being Administered in SK Community Pharmacies

Pfizer-BioNTech Comirnaty® (Monovalent, Grey Cap) ≥ 12 Years

Product Information

Indication

  • Individuals 12 years of age and older.

Dose

Primary Series

2* x 0.3 ml (30 mcg mRNA) doses given IM (deltoid)

  • The recommended interval to the 2nd dose is at least 8 weeks after the 1st dose.
    • This longer interval is expected to result in a more robust and durable immune response.
    • 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.
  • The Health Canada-authorized interval is at least 3 weeks after the 1st dose.
  • 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.

*Moderately to severely immunocompromised individuals should receive 3 doses for the primary series with intervals of 4 to 8 weeks between all doses (though 21 days is acceptable between doses 1 and 2).   

For children who received Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap) for one or more doses and are 12 years old when they present for a subsequent dose, complete the series with Pfizer-BioNTech Comirnaty® 30 mcg (monovalent, grey cap).

NOTE: If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

Booster Doses

*Omicron-containing bivalent mRNA COVID-19 vaccines are preferred for booster doses but monovalent vaccine may be given with informed consent, if requested.*

  • 0.3 mL (30 mcg mRNA) for all booster doses  

See COVID-19 Vaccines Doses, Eligibility, and Intervals below for more details.

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.

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.

References
LAST UPDATED 28 Dec 2022
Pfizer-BioNTech Comirnaty® (Monovalent, Orange Cap)  ≥ 5 Years to < 12 Years

Product Information

Indication

  • Individuals ≥ 5 years to < 12 years of age

Dose

Primary Series

  • 2* x 0.2 ml (10 mcg mRNA) doses given IM (deltoid)
  • The recommended interval to the 2nd dose is at least 8 weeks after the 1st dose.
    • This interval is not a recommended interval and should only be used to determine dose validity.
    • This longer interval is expected to result in a more robust and durable immune response.
  • The Health Canada-authorized interval is at least 3 weeks after the 1st dose.
  • 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.

*Moderately to severely immunocompromised individuals should receive 3 doses for the primary series with intervals of 4 to 8 weeks between all doses (though 21 days is acceptable between doses 1 and 2).

  • For children who received one or more doses of Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap) as a first dose and are 12 years old when they present for their a subsequent dose, complete the series with Pfizer-BioNTech Comirnaty® 30 mcg (monovalent, grey cap).

NOTE: If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

Booster Doses

*Age-appropriate Omicron-containing bivalent mRNA COVID-19 vaccines are preferred for booster doses but Pfizer-BioNTech Comirnaty® monovalent (original) may be given with informed consent, if requested.*

  • 0.2 mL (10 mcg mRNA)
  • See COVID-19 Vaccines Doses, Eligibility, and Intervals below for more details.

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.

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.

References
LAST UPDATED: 09 Jan 2023
Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 (Grey Cap, Grey Border) ≥ 12 Years

Product Monograph   

Indication

  • Health Canada: Booster dose following COVID-19 primary series vaccination for individuals 12 years and older
    • The SK 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.

Dose

  • 0.3 mL (15 mcg Original / 15 mcg Omicron BA.4/Ba.5) given IM (deltoid)
  • See COVID-19 Vaccines Doses, Eligibility, and Intervals below for more details.
  • If using for primary series, see the monovalent Pfizer-BioNTech Comirnaty® vaccine information pages in the  Saskatchewan Immunization Manual for dose scheduling and intervals.

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.

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.

References
LAST UPDATED: 28 Dec 2022
Moderna Spikevax™ (Monovalent, Red Cap) ≥ 6 Years  

Product Monograph

Indication

  • Individuals 6 years of age and older

Dose

Primary Series

  • 12 years and older: 2* x 0.5 mL (100 mcg) doses given IM (deltoid)
  • ≥ 6 years to < 12 years: 2* x 0.25 mL (50 mcg) doses given IM (deltoid)  
    • The recommended interval to the 2nd dose is at least 8 weeks after the 1st dose.
      • This longer interval is expected to result in a more robust and durable immune response.
      • 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.
      • The Health Canada-authorized interval is at least 4 weeks after the 1st dose.
      • Based on NACI recommendation, the minimum interval is 21 days between doses 1 and 2 (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.

*Moderately to severely immunocompromised individuals should receive 3 doses for the primary series with an interval of 4 to 8 weeks between each dose.

NOTE: If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

Booster Doses

*Omicron-containing bivalent mRNA COVID-19 vaccines are preferred for booster doses but monovalent vaccine may be given with informed consent, if requested.*

Moderna Spikevax™ Booster Doses

  • 0.5 mL (100 mcg mRNA)
    • Residents of Long-Term Care (Special Care Homes), Personal Care Homes and Seniors’ Assisted Living, 12 years and older   
    • Individuals 70 years and older
    • Moderately to severely immunocompromised individuals 12 years and older (those who received a 3-dose primary series)
  • 0.25 mL (50 mcg mRNA)
    • All others 12 years and older eligible for booster dose

Children ≥ 5 years to < 12 years are eligible for a booster dose, preferably with an age-appropriate Omicron-containing bivalent mRNA vaccine. Moderna Spikevax™ monovalent is not to be used for booster doses in children < 12 years.

See COVID-19 Vaccines Doses, Eligibility, and Intervals below for more details.

Adverse Events

  • Only short-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 2-3 days.
  • Common adverse events included: 
    • pain, redness, swelling at the injection site
    • fatigue
    • headache
    • myalgia
    • chills
    • nausea or vomiting (children 6 to 11 years)
  • 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.
      • There were no cases of myocarditis or pericarditis reported in the study for children 6 to 11 years old.
        • Myocarditis and pericarditis are rare adverse events so would not be expected to be discovered in this study of ~4000 children. Monitoring real-world conditions will continue.
        • The risk of myocarditis and pericarditis has been higher among individuals 12 to 29 years who received Moderna Spikevax™ (100 mcg or 50 mcg booster) compared to those who received Pfizer-BioNTech Comirnaty® 30 mcg.
        • The risk of myocarditis and pericarditis seems to be much lower among male children 5 to 11 years who received Comirnaty® 10 mcg compared to male adolescents who received Comirnaty® 30 mcg.
        • Until more data are available, NACI preferentially recommends Pfizer-BioNTech Comirnaty® (Orange Cap) 10 mcg over Moderna Spikevax™ (Red Cap) 50 mcg for children ≥ 6 years to < 12 years. Moderna Spikevax™ 50 mcg should be given if Pfizer-BioNTech Comirnaty® (Orange Cap) 10 mcg is not available or is contraindicated (e.g. severe allergy to a component).
    • Bell’s palsy / facial paralysis was reported in three recipients in the vaccine group compared to one in the placebo group in the clinical trial. 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.

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 are potentially allergenic ingredients.

References
LAST UPDATED: 09 mar 2023
Moderna Spikevax™ Bivalent BA.1 (Royal Blue Cap, Green Border) ≥ 6 Years  

Product Monograph   

Indication

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

Dose

  • ≥ 12 Years
    • 0.5 mL (25 mcg Original / 25 mcg Omicron BA.1) given IM (deltoid)
    • If using for primary series, see the monovalent Moderna SpikevaxTM vaccine information pages in the Saskatchewan Immunization Manual for dose scheduling and intervals. 
       
  • ≥ 6 Years to < 12 Years
    • 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.1) given IM (deltoid)

See COVID-19 Vaccine Doses, Eligibility, and Intervals below for more details.

Adverse Events

  • Frequency and severity of adverse events of Moderna Spikevax™ Bivalent BA.1 given as a second booster dose were similar or lower compared to Moderna Spikevax™ monovalent 100 mcg (2nd primary doses) and Moderna Spikevax™ monovalent 50 mcg (1st booster doses). Safety of this vaccine in children ≥ 6 years to < 18 years has been inferred from data in those 18 years and older.

  • 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
  • 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 first doses of monovalent mRNA COVID-19 vaccine.
      • 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 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.

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.

References
LAST UPDATED:09 mar 2023
Moderna Spikevax™ Bivalent (Original / Omicron BA.4/5) (Royal Blue Cap, Grey Border)  ≥ 18 years ( ≥ 6 years SK)   

Product Monograph 

Indication

  • Booster dose following COVID-19 primary series vaccination (with any COVID-19 vaccine) for individuals 18 years and older
    • In SK, this vaccine can be used in individuals 6 years and older for booster doses (see dose).
    • The SK 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.    

Dose

  • ≥ 12 Years (off-label for those 12 years to < 18 years)
    • 0.5 mL (25 mcg Original / 25 mcg Omicron BA.4/5) given IM (deltoid)
    • If using for primary series, see the monovalent Moderna SpikevaxTM vaccine information pages in the Saskatchewan Immunization Manual for dose scheduling and intervals.
       
  • ≥ 6 Years to < 12 Years (off-label)
    • 0.25 mL (12.5 mcg Original / 12.5 mcg Omicron BA.4/5) given IM (deltoid)

See COVID-19 Vaccine Doses, Eligibility, and Intervals below for more details.

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.

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.

References                                        
Last updated: 21 Mar 2023 
 

Characteristics of mRNA COVID-19 Vaccines Available in Saskatchewan Pharmacies: By Vaccine Manufacturers 

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®
 

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.

Clinical Information

 

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

Dosage for Primary Series0.2 mL (10 mcg mRNA)0.3 mL (30 mcg mRNA)

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 in individuals 12 years and older, with informed consent, if an individual 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.

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

#Doses in Primary SeriesNumber of doses to complete the primary series:     
2 for non-immunocompromised;   
3 for immunocompromised
Minimum Interval Between 1st and 2nd Doses (used to determine validity)19 days per NACI
Authorized  Interval Between 1st and 2nd Doses21 days
MoH Minimum Interval Between 1st and 2nd Doses28 days (21 days is acceptable)
Optimal IntervalThe optimal interval between 1st and 2nd doses per NACI and MoH is 8 weeksd
Booster DosesFind information about doses, eligibility and intervals below.
Route of AdministrationIntramuscular (deltoid preferred)
MoH = Ministry of Health; NACI = National Advisory Committee on Immunization

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.

d. 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
LAST UPDATED: 21 mar 2023
Moderna Spikevax™
 

Moderna Spikevax™ 
Red Cap, 
Blue Border

Moderna Spikevax™ 
Bivalent BA.1   
Royal Blue Cap,
Green Border

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

 DO NOT DILUTE  
mRNA Vaccine TypeMonovalent (Original)Bivalent
Authorized Ages≥ 6 Years

≥ 18 Years (≥ 6 Years in SK)

Concentration100 mcg / 0.5 mL50 mcg / 0.5 mL     
(25 mcg each Original and Omicron BA.1)

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

DIN0251001402530252                 02532352
Packaging

Multidose preservative-free 5 mL vials

Cartons of 10 vials

Red cap; blue border on label

Multidose preservative-free 2.5 mL vials

Cartons of 10 vials

Royal blue cap; green border on label

Multidose preservative-free 2.5 mL vials

Cartons of 10 vials

Royal blue cap; grey border on label

Storage/Stability

 

Moderna Spikevax™     
Red Cap, Blue Border

Moderna Spikevax™ 
Bivalent BA.1     
Royal Blue Cap, Green Border

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

Stability in FreezerStore at -50°C to -15°C (freezer) until the expiry date printed on the label. The expiry date of some lots has been extended.aStore at -50°C to -15°C (freezer) until the expiry date printed on the label.
Thawing

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.

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 20 times.

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.

HandlingSwirl vial gently after thawing and between each withdrawal.     
Do not shake.
AppearanceWhite to off-white dispersion—may contain white or translucent product-related particles; ensure no foreign particulate matter or discolouration.

Clinical Information

 

Moderna Spikevax™   
Red Cap, Blue Border

Moderna Spikevax™ Bivalent  
Royal Blue Cap, 
Green Border

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

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

≥ 12 years:     
0.5 mL (100 mcg mRNA)

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 in individuals 12 years and older, with informed consent, if an individual 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.

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

#Doses in Primary SeriesNumber of doses to complete the primary series:     
2 for non-immunocompromised;   
3 for immunocompromised
Minimum Interval Between 1st and 2nd Doses (used to determine validity)

21 days per NACI

Authorized  Interval Between 1st and 2nd Doses

28 days

MoH Minimum Interval Between 1st and 2nd Doses28 days
Optimal IntervalThe optimal interval between 1st and 2nd doses per NACI and MoH is 8 weeksb
Booster DosesFind information about doses, eligibility, and intervals below.
Route of AdministrationIntramuscular (deltoid preferred) 

MoH = Ministry of Health; NACI = National Advisory Committee on Immunization

a.The expiry date of the following lots of Moderna Spikevax™ monovalent 0.2 mg/mL (red cap, blue border) have been extended as indicated: 

Expiry Date Extensions for Moderna Spikevax™ Monovalent 0.2 mg/mL 
LotExpiry Date Printed on LabelUpdated Expiry Date
010D22AJanuary 21, 2023April 21, 2023
011D22AJanuary 22, 2023April 22, 2023

b. 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
LAST UPDATED: 21 mar 2023

Characteristics of mRNA COVID-19 Vaccines Available in Saskatchewan Pharmacies: By Vaccine Type (Monovalent vs. 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).

Monovalent (Original) mRNA Vaccines
 

Pfizer-BioNTech      
Comirnaty®     
Orange Cap,      
Orange Border

Pfizer-BioNTech      
Comirnaty®     
Grey Cap,      
Grey Border

Moderna Spikevax™     
Red Cap,     
Blue Border

 DILUTE BEFORE USEDO NOT DILUTE
Authorized Ages≥ 5 Years to < 12 Years≥12 Years≥ 6 Years
Concentration10 mcg / 0.2 mL30 mcg / 0.3 mL100 mcg / 0.5 mL
DIN025224540252786302510014
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 5 mL vials

Cartons of 10 vials

Red cap; blue border on label

Storage/Stability

 

Pfizer-BioNTech      
Comirnaty®     
Orange Cap,      
Orange Border

Pfizer-BioNTech      
Comirnaty®     
Grey Cap,   
Grey Border

Moderna Spikevax™     
Red Cap, Blue 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.

Store at -50°C to -15°C (freezer) until the expiry date printed on the label. The expiry date of some lots has been extended.b
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.

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.

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

Undiluted product: up to 10 weeks

Up to 10 weeks prior to first use Up to 30 days 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 hours 

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

(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.d

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

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 d		Up to 12 hours at   
2°C to 25°C d 

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 20 times.

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.

Store in original carton.

Thawed vials and filled syringes 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.		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.

Clinical Information

 

Pfizer-BioNTech      
Comirnaty®     
Orange Cap,      
Orange Border

Pfizer-BioNTech      
Comirnaty®     
Grey Cap,      
Grey Border

Moderna Spikevax™     
Red Cap,     
Blue Border

Dosage for Primary Series0.2 mL (10 mcg mRNA)0.3 mL (30 mcg mRNA)

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

≥ 12 years:     
0.5 mL (100 mcg mRNA)

#Doses in Primary SeriesNumber of doses to complete the primary series:     
2 for non-immunocompromised; 3 for immunocompromised
Minimum Interval Between 1st and 2nd Doses (used to determine validity)19 days per NACI21 days per NACI
Authorized  Interval Between 1st and 2nd Doses21 days28 days
MoH Minimum Interval Between 1st and 2nd Doses28 days (21 days is acceptable)28 days
Optimal IntervalThe optimal interval between 1st and 2nd doses per NACI and MoH is 8 weekse 
Booster DosesFind information about doses, eligibility and intervals below.
Route of AdministrationIntramuscular (deltoid preferred) 
MoH = Ministry of Health; NACI = National Advisory Committee on Immunization

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. The expiry date of the following lots of Moderna Spikevax™ monovalent 0.2 mg/mL (red cap, blue border) has been extended as indicated: 

Expiry Date Extensions for Moderna Spikevax™ Monovalent 0.2 mg/mL 
LotExpiry Date Printed on LabelUpdated Expiry Date
010D22AJanuary 21, 2023April 21, 2023
011D22AJanuary 22, 2023April 22, 2023

c. 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.

d. 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.

e. 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
LAST UPDATED:08 feb 2023
Bivalent mRNA Vaccines
 

Moderna Spikevax™ Bivalent     
Royal Blue Cap,     
Green Border

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

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

 DO NOT DILUTE
Authorized Ages    ≥ 6 Years

≥ 18 Years 
(≥ 6 Years in SK)

≥12 Years 
Concentration50 mcg / 0.5 mL     
(25 mcg each Original and Omicron BA.1)

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

30 mcg / 0.3 mL     
(15 mcg each Original and Omicron BA.4/BA.5)
DIN02530252   0253235202531461
Packaging

Multidose preservative-free 2.5 mL vials

Cartons of 10 vials

Royal blue cap; green border on label

Multidose preservative-free 2.5 mL vials

Cartons of 10 vials

Royal blue cap; grey border on label

Multidose preservative-free vials containing 6 dosesa

Cartons of 10 vials

Grey cap; grey border on label 

Storage/Stability

 

Moderna Spikevax™ Bivalent     
Royal Blue Cap,     
Green Border

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

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

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

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 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.

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)		Up to 30 days prior to first useUp to 10 weeks 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. 

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) 

Stability after     
1st Puncture

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. 

Up to 12 hours at 2°C to 25°C

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 can be handled in room light conditions.

HandlingSwirl vial gently after thawing     
and between each withdrawal.     
Do not shake.		Before use, mix by inverting vaccine vial gently 10 times.     
Do not shake.
AppearanceWhite to off-white dispersion—may contain white or translucent product-related particles; ensure no foreign particulate matter or discolouration.

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

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

Clinical Information

 

Moderna Spikevax™ Bivalent     
Royal Blue Cap,     
Green Border

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

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

Dosage for Primary Series

These vaccines are not authorized to be used as a primary COVID-19 immunization series. However, the SK Ministry of Health supports permissive administration of either bivalent vaccine for this purpose in individuals 12 years and older, with informed consent, if an individual 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.

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

#Doses in Primary Series
Minimum Interval Between 1st and 2nd Doses (used to determine validity)
Authorized  Interval Between 1st and 2nd Doses
MoH Minimum Interval Between 1st and 2nd Doses
Optimal Interval
Booster DosesFind information about doses, eligibility and intervals below.
Route of AdministrationIntramuscular (deltoid preferred) 
MoH = Ministry of Health; NACI = National Advisory Committee on Immunization

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. 

References 
LAST UPDATED: 21 mar 2023

Other Vaccines (Limited Information)

Moderna Spikevax™ (Royal Blue Cap) ≥ 6 Months to < 6 Years
  • ≥ 6 Months to < 6 Years (25 mcg / 0.25 mL)
    • NOTE: Moderna Spikevax™ 25 mcg / 0.25 mL (monovalent, royal blue cap) has been approved for use in individuals 6 months of age and older; however, at this time, this formulation is only being used in those ≥ 6 months to < 6 years of age in Saskatchewan and is not available in pharmacies.  This information applies only to Spikevax™ (monovalent, royal blue cap) use in those ≥ 6 months to < 6 years of age.

Product Information

Indication

  • Individuals ≥ 6 months to < 6 years of age 

NOTE: 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), though 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.

Dose and Interval

Primary Series

Non-Immunocompromised Individuals

  • 2* x 0.25 ml (25 mcg mRNA) doses given IM (generally vastus lateralis if < 12 months of age; deltoid if ≥ 12 months of age)
    • Dose 1: Day 0
    • Dose 2: 8 weeks (optimal interval) after 1st dose
    • Dose 3 (if primary series started with Pfizer-BioNTech Comirnaty® 3 mcg): 8 weeks after 2nd dose

8 weeks is recommended, but dose can be provided at a shorter interval (≥ 28 days) if chosen. NACI recommends an interval of 8 weeks in non-immunocompromised individuals. This longer interval 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. If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

Moderately to Severely Immunocompromised Individuals

  • 3* x 0.25 ml (25 mcg mRNA) doses given IM (generally vastus lateralis if < 12 months of age; deltoid if ≥ 12 months of age) 
    • Dose 1: Day 0
    • Dose 2: 4 to 8 weeks after 1st dose
    • 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. If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

*NOTES:

  • Moderna Spikevax™ 100 mcg/0.5 mL (monovalent, red cap) is NOT to be used for this dose.
  • If a child presents who started the primary series with Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap) and Pfizer-BioNTech Comirnaty® is not available, the series may be completed with Moderna Spikevax™ 25 mcg/0.25 mL (monovalent, royal blue cap). However, children require 3 doses (if immune competent) or 4 doses (if immunocompromised) to complete the series. 
    • E.g. An immunocompromised child received 2 doses of Pfizer-BioNTech Comirnaty® 3 mcg (maroon cap) and turns 5 years old before the 3rd dose. Pfizer-BioNTech Comirnaty® monovalent 10 mcg (orange cap) is not available and the series is being completed with Moderna Spikevax™ 25 mcg/0.25 mL (monovalent, royal blue cap). Based on the initial schedule when the series was started, and because the child is immunocompromised, the primary series requires four doses. Therefore, TWO doses of Moderna Spikevax™ 25 mcg/0.25 mL (monovalent, blue cap) will be required to complete the primary series. The Contraindications and Precautions Background Document includes more examples.

It is recommended that children who received Moderna Spikevax™ 25 mcg (monovalent) as a 1st dose and are 6 years old when they present for their 2nd dose, preferably complete the series with Moderna Spikevax™ 50 mcg (monovalent, red cap). However, if Moderna Spikevax™ 25 mcg (monovalent, royal blue cap) or Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap) is given, the dose does not need to be repeated and the primary series is considered complete.

Booster Doses

  • Children under 5 years of age are not yet eligible for a booster dose.
  • Children ≥ 5 years to < 12 years are eligible for an age-appropriate booster dose, preferably with an Omicron-containing bivalent mRNA vaccine. No formulation of Moderna Spikevax™ monovalent is to be used as booster doses for children < 12 years.

Adverse Effects

  • Only short- to medium-term clinical trial 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 2-3 days.
  • Common adverse events included: 
    • Children ≥ 6 months to < 2 years of age
      • irritability/crying
      • local reactions: pain at injection site, redness, and swelling
      • loss of appetite
      • fever
    • Children ≥ 2 years to <6 years of age
      • irritability/crying
      • local reactions: pain at injection site, redness, and swelling
      • loss of appetite
      • fatigue
      • fever
      • headache
      • nausea/vomiting
      • chills
  • Rare Adverse Events
    • No cases of myocarditis, pericarditis, vaccine-related anaphylaxis, or multisystem inflammatory syndrome in children (MIS-C) were 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.

Non-Medicine 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 are potentially allergenic ingredients.

References
LAST UPDATED: 09 mar 2023
Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 (Orange Cap, Orange Border)   
≥ 5 Years to < 12 Years

Product Monograph

Indication

  • Health Canada: Booster dose following COVID-19 primary series vaccination (with any COVID-19 vaccine) for individuals ≥ 5 to < 12 years of age.

Dose

  • 0.2 mL (5 mcg Original / 5 mcg Omicron BA.4/BA.5) given IM (deltoid)

Adverse Events

  • Safety of this vaccine has primarily been inferred from the safety of booster doses of Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap) in this age group.
  • 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
  •  Rare adverse events
    • There were no reports of serious adverse events in the clinical data of booster doses of Pfizer-BioNTech Comirnaty® 10 mcg (monovalent, orange cap).

Drug Interactions

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

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.

References
LAST UPDATED: 09 Jan 2023
Novavax Nuvaxovid™ 

Nuvaxovid™ is an adjuvanted recombinant protein subunit COVID-19 vaccine. It can be accessed by calling 1-833-SASK VAX (1-833-727-5829).     

The product monograph is available  here.      

NACI's recommendations for use are available here.

Janssen Jcovden™

Product Information

Indication

  • Individuals 18 years of age and older 

Dose

Primary Series

  • 0.5 ml single* dose given IM (preferably deltoid)

*Immunocompromised individuals should preferably receive 3 doses of mRNA vaccine for the primary series. NACI recommends that immunocompromised individuals who have received a Janssen dose should receive 1 mRNA dose at least 28 days following the Janssen dose to complete the primary series.

Booster Doses

  • NACI recommends that individuals who received Janssen Jcovden™ as the primary series receive an mRNA vaccine booster dose 2 months or later after the Janssen dose.
  • Real-world evidence indicates that a booster dose of Janssen COVID-19 vaccine may not be as effective or immunogenic as a booster dose of an mRNA COVID-19 vaccine given as a homologous or heterologous booster.
  • Janssen Jcovden™ may be used for those in whom other COVID-19 vaccines are contraindicated or who state their preference to receive Janssen after receiving all the information.
  • See COVID-19 Vaccines Doses, Eligibility, and Intervals below for more details.

Adverse Events

Only short to medium term data are available at this time. Most adverse reactions occurred within 2 days following vaccination, were mild to moderate in severity, and of short duration (2 to 3 days). Surveillance will continue for long-term adverse events.

The most commonly reported adverse events included:

  • injection site pain
  • headache
  • fatigue
  • myalgia
  • nausea

Rare adverse events:

  • Thrombosis with Thrombocytopenia Syndrome (TTS)
    • The combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been reported post-market following vaccination with viral vector COVID-19 vaccines. The terminology of this syndrome has been evolving. In Canada, TTS following COVID-19 vaccination in combination with the presence of a specific biomarker is referred to as Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), and is considered a subset of TTS.
    • Individuals who have experienced TTS following vaccination with a viral vector COVID-19 vaccine should not receive a subsequent dose of a viral vector COVID-19 vaccine. They may receive further doses of mRNA COVID-19 vaccines following consultation with their clinical team, which may include a hematologist.
  • Capillary Leak Syndrome
    • Very rare cases of capillary leak syndrome (CLS) have been reported following immunization with viral vector COVID-19 vaccines. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition characterized by acute episodes of limb edema, hypotension, hemoconcentration and hypoalbuminemia. Individuals with a history of CLS should not receive Janssen.
  • Guillain-Barré Syndrome
    • Very rare events of demyelinating disorders, such as Guillain-Barré Syndrome (GBS), have been reported following vaccination with viral vector COVID-19 vaccines during post-authorization use.
  • Immune Thrombocytopenia (ITP)
    • Very rare cases of ITP have been reported following receipt of Janssen Jcovden™. This differs from VITT in that these cases were not associated with thrombosis.
  • Venous Thromboembolism (VTE)
    • Rare cases of VTE have been reported following receipt of Janssen Jcovden™. This differs from VITT in that these cases were not associated with thrombocytopenia.
    • The risk of VTE should be considered for individuals who are at increased risk for thromboembolism before receiving this vaccine.

Drug Interactions

  • Anti-SARS-CoV-2 monoclonal antibodies for treatment of COVID-19
    • 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.

Non-Medicinal Ingredients

  • 2-hydroxypropyl-β-cyclodextrin (HBCD)
  • Citric acid monohydrate
  • Ethanol
  • Hydrochloric acid
  • Polysorbate-80
  • Sodium chloride
  • Sodium hydroxide
  • Trisodium citrate dihydrate
  • Water for injection

Polysorbate 80 is a potentially allergenic ingredient.

References
LAST UPDATED: 28 Dec 2022
 
AstraZeneca Vaxzevria™ COVID-19 Vaccine

AstraZeneca Vaxzevria™ is no longer offered in Saskatchewan as existing supplies have expired and the Government of Canada is not securing additional doses. Information on this page is for general information only and will not be updated.

Product Information

Indication

Individuals 18 year and older

Dose

NOTE: If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

Primary Series

  • 2* x 0.5 ml doses given IM (preferably deltoid)
    • The 2nd dose should be given between 4 and 12 weeks after the 1st.
      • NACI advises an interval of at least 8 weeks between the 1st and 2nd doses is optimal.
      • Local transmission of the SARS-CoV-2 virus, the degree of individual risk of exposure to the virus, and the need of a 2nd dose for earlier protection should be considered when deciding the interval.
      • Individuals who completed their primary vaccine series using the manufacturer-authorized intervals also have very good protection against severe COVID-19 disease and do not need to restart their vaccine series.

*Immunocompromised individuals should preferably receive 3 doses of mRNA vaccine for the primary series. Those who have received 1 or 2 doses of Vaxzevria™ should receive 2 or 1 doses, respectively, of mRNA vaccine at least 28 days apart to complete the 3-dose series.

Booster Doses

  • It is recommended that individuals who received two doses of Vaxzevria™ as a primary series receive mRNA vaccines (Pfizer-BioNTech Comirnaty® or Moderna Spikevax™) for booster doses. Novavax Nuvaxovid™ (only available through Public Health) could be given to those for whom there is a contraindication to an mRNA vaccine. 
  • See COVID-19 Vaccines Doses, Eligibility, and Intervals below for more details.

Adverse Effects

  • Only short to medium term data are available at this time. Surveillance will continue for long-term adverse effects.
  • The most commonly reported adverse effects included:  
    • injection site tenderness
    • injection site pain
    • fatigue
    • headache
    • myalgia
    • malaise
    • pyrexia
    • chills
    • arthralgia
    • nausea
  • Rare adverse effects
    • VITT
      • The combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been reported post-market following vaccination with AstraZeneca Vaxzevria™. This adverse event is being referred to as Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT).
      • Health Canada has released a safety alert; the product monograph now includes this information in the Warnings and Precautions section.
      • Health Canada is  soliciting further data from AstraZeneca, will continue to monitor and will take further action if necessary. 
    • Capillary leak syndrome
      • Very rare cases of capillary leak syndrome (CLS) have been reported following immunization with AstraZeneca Vaxzevria™ COVID-19 vaccine. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition characterized by acute episodes of limb edema, hypotension, hemoconcentration and hypoalbuminemia. Individuals with a history of CLS should not receive AstraZeneca Vaxzevria™.
    • Guillain-Barré Syndrome
      • Very rare events of demyelinating disorders, such as Guillain-Barré Syndrome (GBS), have been reported following vaccination with AstraZeneca Vaxzevria™ during post-authorization use.
    • Thrombocytopenia
      • Cases of thrombocytopenia, including immune thrombocytopenia, have been reported following receipt of AstraZeneca Vaxzevria™. This differs from VITT in that these cases were not associated with thrombosis.

Drug Interactions

  • There are no known drug interactions. 
References
LAST UPDATED: 04 May 2022

COVID-19 Vaccine Doses, Eligibility, and Intervals 

General Information

mRNA COVID-19 Vaccines Available in Saskatchewan

The table below indicates which vaccines are available, according to age. See Choice of Vaccine below to help inform the decision of which vaccine(s) may be best or preferred for an individual.

Monovalent (Original)

AgeVaccineComments
≥ 6 Months to <5 YearsPfizer-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 YearsPfizer-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 YearsPfizer-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 Comirnaty®.

Moderna Spikevax™ 100 mcg/0.5 mL     
(red cap/blue border)
≥ 12 YearsPfizer-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.

Moderna Spikevax™ 100 mcg/0.5 mL     
(red cap/blue border)

Bivalent

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 YearsPfizer-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  BA.1 
50 mcg/0.5 mL 
(royal blue cap/green border)

Use for booster doses.

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

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

Use for booster doses.

This is HC authorized for 18 years and older for booster doses, but in SK it can be used for individuals 6 years and older.

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.

These vaccines are not 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 BA.1 
50 mcg/0.5 mL 
(royal blue cap/green border)

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

Use for booster doses.

This is HC authorized for 18 years and older for booster doses, but in SK it can be used for individuals 6 years and older.

These vaccines are not 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.

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

  • Janssen Jcovden™ (viral vector, ≥ 18 years)
  • Novavax Nuvaxovid ™ (protein subunit, ≥ 12 years)
References
LAST UPDATED: 21 mar 2023
Choice of Vaccine

mRNA vaccines (monovalent [original] or bivalent) are the recommended COVID-19 vaccine platform for everyone unless contraindicated.

Primary Series

  • Individuals ≥ 5 Years to < 12 Years
    • For the primary series, Pfizer-BioNTech Comirnaty® monovalent (original) is preferred to Moderna Spikevax™ monovalent (original) when both age-appropriate formulations of the vaccines are readily available.
      • It is unknown if a difference in risk of myocarditis and/or pericarditis exists in children < 12 years; however, Comirnaty® monovalent (original) is the preferred vaccine in this age group as a precaution.
    • For immunocompromised children this age who are receiving their primary COVID-19 vaccine series and both age-appropriate formulations of Spikevax™ monovalent (original) and Comirnaty® monovalent (original) are readily available, Spikevax™ monovalent (original) may be preferred due to potentially greater immune response (based on adult data).
    • Bivalent vaccines are not permitted for use as primary series in this age group.     
       
  • Individuals ≥ 12 Years to < 29 Years 
    • For the primary series, Pfizer-BioNTech Comirnaty® monovalent (original) is preferred to Moderna Spikevax™ monovalent (original) when both age-appropriate formulations of the vaccines are readily available because of risk of myocarditis/pericarditis.
      • There has been a lower reported rate of myocarditis/pericarditis following Comirnaty® monovalent (original) compared to Spikevax™ monovalent (original).  
      • Individuals in this age group opting to receive Spikevax™ monovalent should be informed of the increased risk of myocarditis/pericarditis compared to Comirnaty® monovalent (original).
    • For moderately to severely immunocompromised individuals who are receiving their primary COVID-19 vaccine series and both age-appropriate formulations of Spikevax™ monovalent (original) and Comirnaty® monovalent (original) are readily available, Spikevax™ monovalent (original) may provide a greater immune response.
    • For those 12 to 29 years who are moderately to severely immunocompromised and both Spikevax™ monovalent (original) and Comirnaty® monovalent (original) are available, consider:
      • patient values
      • factors that increase risk of myocarditis/pericarditis
        • males  
        • 2nd dose, especially at shorter intervals (at least 8 weeks preferred)
      • risks of acquiring COVID-19 infection
        • vaccination status and/or recent COVID-19 infection
        • degree of immune suppression
        • levels of SARS-CoV-2 circulating
        • characteristics of circulating variant(s)
        • level of exposure to SARS-CoV-2 (e.g. level of interaction with the public, personal protection measures taken)
    • Bivalent COVID-19 vaccines are not authorized to be used as a primary COVID-19 immunization series. However, the Ministry of Health supports permissive administration of this bivalent vaccine 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.     
       
  • Individuals ≥ 29 years 
    • Choose from either Pfizer-BioNTech Comirnaty® monovalent (original) or Moderna Spikevax™ monovalent (original).
    • For moderately to severely immunocompromised individuals who are receiving their primary COVID-19 vaccine series and both age-appropriate formulations of Spikevax™ monovalent (original) and Comirnaty® monovalent (original) are readily available, Spikevax™ monovalent (original) may provide a greater immune response.

Booster Doses

  • Individuals 5 Years
    • In Saskatchewan, all individuals 5 years of age are eligible for ONE Omicron-containing bivalent booster dose with Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 10 mcg 6 months* or longer following the last COVID-19 vaccine dose or COVID-19 infection (whichever interval is longer as applicable).
    • If an Omicron-containing bivalent mRNA COVID-19 vaccine is not readily available or desired, Pfizer-BioNTech Comirnaty®  monovalent (original)  10 mcg (orange cap) may be offered, with informed consent.  
       
  • Individuals ≥ 6 Years to < 12 Years
    • In Saskatchewan, all individuals ≥ 6 Years to < 12 Years are eligible for ONE age-appropriate Omicron-containing bivalent booster dose 6 months* or longer following the last COVID-19 vaccine dose or COVID-19 infection (whichever interval is longer as applicable).
    • Moderna Spikevax™ Bivalent (Original/Omicron BA.4/5) 25 mcg may be used off-label in SK for individuals ≥ 6 years to < 12 years for booster doses.
    • If an age-appropriate Omicron-containing bivalent mRNA COVID-19 vaccine is not readily available or desired, Pfizer-BioNTech Comirnaty® monovalent (original) 10 mcg (Orange Cap) may be offered, with informed consent.        
       
  • Individuals ≥ 12 Years 
    • In Saskatchewan, all individuals 12 years and older are eligible for an age-appropriate Omicron-containing bivalent booster dose 6 months* or longer following the last COVID-19 vaccine dose or COVID-19 infection (whichever interval is longer as applicable).
      • See Booster Doses → Eligibility and Interval below to review expanded eligibility criteria allowing for a second bivalent booster dose in select populations.
    • Moderna Spikevax™ Bivalent (Original/Omicron BA.4/5) 50 mcg is Health Canada-approved for booster doses for individuals 18 years and older. It may be used off-label in SK for individuals 12 years to < 18 years. 
    • If an Omicron-containing bivalent mRNA COVID-19 vaccine is not readily available or desired, a monovalent (original) mRNA COVID-19 vaccine may be offered, with informed consent.

* An absolute minimum interval of 5 months can be used on a case-by-case basis in exceptional circumstances such as individual risk, travel, vaccine availability, and administration efficiency.

"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.

References
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.     
     
  • See Booster Doses → Eligibility and Interval below for booster dose eligibility following completion of the primary series. 
References
LAST UPDATED: 31 jan 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.
  • If requested, vaccination can be provided before the recommended interval, as long as symptoms have resolved.

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 in exceptional circumstances such as individual risk, travel, vaccine availability, and administration efficiency. 
MIS-A = multisystem inflammatory syndrome in adults; MIS-C = multisystem inflammatory syndrome in children
References
  • Canadian Immunization Guide
  • COVID-19 Vaccine Contraindications and Precautions Background Document  
  • Directives
    • Spring 2023 Second COVID-19 Bivalent Booster Dose Eligibility and Interval Recommendations; Dr. Julie Kryzanowski, Deputy Medical Health Officer; March 23, 2023
LAST UPDATED: 27 mar 2023

Primary Series

Note: Moderna Spikevax™ Bivalent BA.1, Moderna Spikevax™ Bivalent (Original/Omicron BA.4/5) and Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 are not authorized to be used as a primary COVID-19 immunization series. 

However, the SK Ministry of Health supports permissive administration of either bivalent vaccine for this purpose in individuals 12 years and older (NOT < 12 years of age) with informed consent if an individual 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.

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

Dose

The dose should be chosen according to vaccine recipient’s age at presentation, which means some children may receive different doses to complete the series.

  • For example, a child who is 11 years old at the first dose and turns 12 years old before the next dose, would receive 10 mcg (Orange cap) and 30 mcg (Grey cap), respectively, of Pfizer-BioNTech Comirnaty®.   

Non-Immunocompromised Individuals

  • 2* doses of 0.2 mL (10 mcg mRNA)
    • See Interval below for information about timing of 2nd dose.

Moderately to Severely Immunocompromised Individuals

  • 3* doses of 0.2 mL (10 mcg mRNA)
    • See Eligibility below for included individuals.
    • See Interval below for information about timing of 2nd and 3rd doses.

*To complete a primary series started with Pfizer-BioNTech Comirnaty® 3 mcg (Maroon cap), children require 3 doses (if immune competent) or 4 doses (if immunocompromised). 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.
References
LAST UPDATED: 19 Dec 2022

Eligibility

General Eligibility

  • All Saskatchewan residents ages ≥ 5 to < 12 years without contraindications to the vaccine.
    • Individuals ≥12 years old on day of presentation are not eligible for Pfizer-BioNTech Comirnaty® 10 mcg (Orange Cap) and are to receive a vaccine authorized for their age.
  • Refer to General Information for more information on choosing a vaccine product. 
  • 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.
  • 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. 

Immunocompromised Individuals for 3rd Dose in Primary Series

Includes moderately to severely immunocompromised individuals 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
  • Individuals on dialysis or with chronic kidney disease (stage 5) 
References
  • Drug Plan & Extended Benefits
  • eHealth COVID-19 Immunization Manual
    • COVID-19 Vaccine Contraindications and Precautions Background Document
    • WS- COVID-19 Vaccine Eligibility and Procedure for Non-Residents and Residents Immunized Out of Province
LAST UPDATED: 21 mar 2023

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.

Non-Immunocompromised Individuals

  • 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 Spikevax™
    • 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.

Moderately to Severely Immunocompromised Individuals

See Eligibility above for included individuals.

  • 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
  • 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.
References
LAST UPDATED: 28 Oct 2022
Pfizer-BioNTech Comirnaty® ≥ 12 Years (Grey Cap)

Dose

The dose should be chosen according to vaccine recipient’s age at presentation.

  • For children who received Pfizer-BioNTech Comirnaty® 10 mcg (Orange Cap) for their first dose and who have turned 12 years old by the time the second dose is due, complete the series with Pfizer-BioNTech Comirnaty® 30 mcg (Grey Cap).

Non-Immunocompromised Individuals

  • 2 doses of 0.3 mL (30 mcg mRNA) 
    • See Interval below for information about timing of 2nd dose. 

Moderately to Severely Immunocompromised Individuals

  • 3 doses of 0.3 mL (30 mcg mRNA)
    • See Eligibility below for included individuals.
    • See Interval below for information about timing of 2nd and 3rd doses. 
References 
LAST UPDATED: 19 Dec 2022

Eligibility

General Eligibility

  • All Saskatchewan residents ≥ 12 years of age without contraindications to the vaccine.
  • Refer to General Information for more information on choosing a vaccine product.
  • 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.
  • 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. 

Immunocompromised Individuals for 3rd Dose in Primary Series

Includes moderately to severely immunocompromised individuals 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
  • Individuals on dialysis or with chronic kidney disease (stage 5)
References
LAST UPDATED: 21 mar 2023

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.

Non-Immunocompromised Individuals

  • 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.  

Moderately to Severely Immunocompromised Individuals

See Eligibility above for included individuals.

  • 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 ≥ 28 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.
References
LAST UPDATED: 23 Nov 2021
Moderna Spikevax™ ≥ 6 Years (Red Cap)

Dose

Non-Immunocompromised Individuals

  • ≥ 12 years
    • 2 doses of 0.5 mL (100 mcg mRNA)   
       
  • ≥ 6 years to < 12 years
    • 2 doses of 0.25 mL (50 mcg mRNA)

See Interval below for information about timing of 2nd dose

Moderately to Severely Immunocompromised Individuals

  • ≥ 12 years
    • 3 doses of 0.5 mL (100 mcg mRNA)   
       
  • ≥ 6 years to < 12 years
    • 3 doses of 0.25 mL (50 mcg mRNA)

See Eligibility below for included individuals.     
See Interval below for information about timing of 2nd and 3rd doses.

References
LAST UPDATED: 18 Mar 2022

Eligibility 

General Eligibility

  • All Saskatchewan residents ≥ 6 years of age without contraindications to the vaccine.
  • Refer to General Information for more information on choosing a vaccine product.
  • 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.
  • 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.

Immunocompromised Individuals for 3rd Dose of Primary Series

Includes moderately to severely immunocompromised individuals 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
  • Individuals on dialysis or with chronic kidney disease (stage 5) 
References
LAST UPDATED: 21 mar 2023

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.

Non-Immunocompromised Individuals

  • Dose 1: Day 0
  • Dose 2: 8 weeks (optimal interval)
    • 8 weeks is recommended, but dose can be provided at a shorter interval (≥ 28 days), if chosen.
    • Based on NACI recommendation, the minimum interval is 21 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.  

Moderately to Severely Immunocompromised Individuals

See Eligibility above for included individuals.

  • Dose 1: Day 0
  • Dose 2: ≥ 28 days* after 1st dose  
    • Based on NACI recommendation, the minimum interval is 21 days between doses 1 & 2 (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: ≥ 28 days* after 2nd dose  

*NACI recommends an optimal interval of 4 to 8 weeks: a longer interval 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

References
LAST UPDATED: 31 Jan 2023

Booster Doses 

Doses

Moderna SpikevaxTM Bivalent BA.1 ≥ 6 Years 
(Royal Blue Cap, Green Border)

  • Moderna Spikevax™ Bivalent BA.1 has been authorized by Health Canada for individuals ≥ 6 years as a booster dose for those previously immunized with a COVID-19 vaccine primary series.
  • This bivalent vaccine is not authorized to be used as a primary COVID-19 immunization series. However, the Ministry of Health supports permissive administration of this bivalent vaccine for this purpose in individuals 12 years and older with informed consent if an individual 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.
  • Use of bivalent vaccine for primary COVID-19 immunization series is not permitted for children < 12 years old. 

Booster Dose

  • ≥ 12 years
    • 0.5 mL (50 mcg mRNA) containing 25 mcg original and 25 mcg Omicron BA.1 variant  
       
  • ≥ 6 years to < 12 years
    • 0.25 mL (25 mcg mRNA) containing 12.5 mcg original and 12.5 mcg Omicron BA.1 variant
References
LAST UPDATED: 09 mar 2023

Moderna SpikevaxTM Bivalent (Original/Omicron BA.1) ≥ 18 Years (≥ 6 Years SK) 
(Royal Blue Cap, Green Border)

  • Moderna Spikevax™ Bivalent (Original/Omicron BA.4/5) has been authorized by Health Canada for individuals ≥ 18 years as a booster dose for those previously immunized with a COVID-19 vaccine primary series.
    • In Saskatchewan, this vaccine may be used off-label for booster doses in children ≥ 6 years to < 18 years.
  • This bivalent vaccine is not authorized to be used as a primary COVID-19 immunization series. However, the Ministry of Health supports permissive administration of this bivalent vaccine for this purpose in individuals 12 years and older with informed consent if an individual 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.
  • Use of bivalent vaccine for primary COVID-19 immunization series is not permitted for children < 12 years old.

Booster Dose

  • ≥ 12 years (off label in ≥ 12 years to < 18 years)
    • 0.5 mL (50 mcg mRNA) containing 25 mcg original and 25 mcg Omicron BA.4/5 variant
       
  • ≥ 6 years to < 12 years (off-label)
    • 0.25 mL (25 mcg mRNA) containing 12.5 mcg original and 12.5 mcg Omicron BA.4/5 variant
References
LAST UPDATED: 21 mar 2023

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

  • Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 has been authorized by Health Canada for individuals ≥ 12 years as a booster dose for those previously immunized with a COVID-19 vaccine primary series.
  • This bivalent vaccine is not authorized to be used as a primary COVID-19 immunization series. However, the Ministry of Health supports permissive administration of this bivalent vaccine for this purpose with informed consent if an individual 12 years and older 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.

Booster Dose

  • 0.3 mL (30 mcg mRNA) containing 15 mcg original and 15 mcg Omicron BA.4/BA.5 variant
References
LAST UPDATED: 18 Jan 2023

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

  • For individuals ≥ 5 to < 12 years, age-appropriate Omicron-containing bivalent COVID-19 vaccines are recommended for booster doses. 
    • Pfizer-BioNTech Comirnaty® 10 mcg monovalent (original) may be used if requested or if bivalent vaccine is not available. 

Booster Dose

  • 0.2 mL (10 mcg mRNA)
References
Last Updated:21 mar 2023

Pfizer-BioNTech Comirnaty® (Monovalent) ≥ 12 Years (Grey Cap)

  • For individuals 12 years and older, age-appropriate Omicron-containing bivalent COVID-19 vaccines are recommended for booster doses; however Pfizer-BioNTech Comirnaty® monovalent (original) may be used if requested or if bivalent vaccine is not available.

Booster Dose

  • 0.3 mL (30 mcg mRNA)
References
LAST UPDATED: 02 Nov 2022

Moderna SpikevaxTM (Monovalent) ≥ 12 Years 
(Red Cap)

  • For individuals 12 years and older, age-appropriate Omicron-containing bivalent COVID-19 vaccines are recommended for booster doses; however, Moderna Spikevax™ monovalent (original) may be used if requested or if bivalent vaccine is not available.
  • Moderna Spikevax™ (Red Cap) can be used for individuals ≥ 6 years for primary series doses and for individuals ≥ 12 years for booster doses.  

Booster Dose

  • The following individuals are to receive a dose of 0.5 mL (100 mcg mRNA):
    • Residents of Long-Term Care (Special Care Homes), Personal Care Homes and Seniors' Assisted Living residents, 12 years and older
    • Individuals 70 years and older
    • Moderately to severely immunocompromised individuals (those who received a 3-dose primary series), 12 years and older
  • All other individuals eligible for a booster are to receive a dose of 0.25 mL (50 mcg mRNA)^.

^Regardless of type of vaccine used for the primary series.

References
LAST UPDATED: 02 Nov 2022
Eligibility and Interval

Booster Dose Eligibility  

Eligibility Quick Sheet
Coming soon!

  • 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 below)
    • Adults 65-79 years of age, particularly if they do not have a known prior history of COVID-19 infection (verbal confirmation is acceptable from the client or their caregiver)
       
  • Eligible individuals should receive booster doses 6 months* 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.   
  • Refer to General Information above for more information on choosing a vaccine product.
  • New COVID-19 immunization programming and recommendations will be based on future epidemiology, data on waning immunity, new emerging variants, and new vaccines.

* An absolute minimum interval of 5 months can be used on a case-by-case basis in exceptional circumstances such as individual risk, travel, vaccine availability, and administration efficiency.

"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.

References
  • Canadian Immunization Guide
  • Saskatchewan Immunization Guide
  • COVID-19 Vaccine Contraindications and Precautions Background Document  
  • Directives
    • Spring 2023 Second COVID-19 Bivalent Booster Dose Eligibility and Interval Recommendations; Dr. Julie Kryzanowski, Deputy Medical Health Officer; March 23, 2023
LAST UPDATED: 27 mar 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
  • Individuals on dialysis or with chronic kidney disease (stage 5) 
Reference
LAST UPDATED: 27 mar 2023