General Information 

  • For 2024-2025, the available COVID-19 vaccines include Pfizer Comirnaty® and Moderna Spikevax®, which are mRNA vaccines formulated with the Omicron KP.2 variant. These vaccines are referred to as 2024-2025 COVID-19 vaccines.
    • The recombinant protein subunit vaccine, Novavax Nuvaxovid®, will NOT be available.
  • The Canadian Immunization Guide (CIG) suggests anyone can receive a 2024-2025 COVID-19 vaccine, but the vaccine is recommended in the following populations:
    • Individuals ≥ 65 years of age
    • Individuals ≥ 6 months of age who: 
      • are residents of long-term care (LTC) homes or other congregate living settings
      • have underlying medical conditions that increase their risk of severe COVID-19, including children with complex health needs (see Vulnerable Populations → Underlying Medical Conditions Associated with More Severe COVID-19 Disease)
  • In Saskatchewan, COVID-19 vaccines are available to all individuals 6 months and older.
    • In Saskatchewan pharmacies:
      • Pfizer Comirnaty® will be used for individuals 12 years of age and older.
      • Moderna Spikevax® will be used for children ≥ 5 years to < 12 years of age. 
        • Moderna Spikevax® can also be used in individuals ≥ 12 years if Pfizer Comirnaty® is not available, if requested by the individual, and/or to reduce wastage of punctured Spikevax® vials at the end of each day.        
           
  • Pharmacy professionals are not permitted to immunize those under 5 years old; refer to public health.
  • Check vaccination history of 5-year-old children. Those who have received previous doses of COVID-19 vaccine before the age of 5 years may require more than one dose and/or different intervals. See Saskatchewan Immunization Manual: Chapter 10 →2024-25 COVID-19 Immunization Schedules for details.         
     
  • Individuals 5 years and older who are NOT moderately to severely immunocompromised may receive one dose of vaccine, regardless of number of previous COVID-19 vaccines. 
    • Interval following last COVID-19 vaccine dose: ≥ 8 weeks 
      • For residents of LTC, personal care homes (PCH), and other senior congregate living facilities (i.e., assisted living facilities), the vaccine can be administered less than 8 weeks after the last dose. 
    • Interval following SARS-CoV-2 infection: consider delaying dose for 3 months from recent symptom onset or positive test in previously immunized individuals.
      • The dose can be provided earlier if the individual chooses and is feeling better. 
      • For residents of LTC, PCH, and other senior congregate living facilities (i.e., assisted living facilities), the vaccine can be provided earlier.        
         
  • Individuals 5 years of age and older who ARE moderately to severely immunocompromised may require more than one COVID-19 vaccine dose, depending on vaccination history. 
    • See Vulnerable Populations → Definition of Moderately to Severely Immunocompromised
    • Number of doses: 
      • Individuals who have received at least 2 previous COVID-19 vaccine doses (regardless of when and which formulation), may receive 1 dose of 2024-2025 COVID-19 vaccine.
      • Individuals who have received 1 or no previous COVID-19 vaccine doses may receive 2 or 3 doses of 2024-2025 COVID-19 vaccine, respectively. 
    • Intervals for those receiving only 1 dose of 2024-2025 COVID-19 vaccine:
      • ≥ 8 weeks following last dose of non-2024-2025 COVID-19 vaccine (includes the Omicron.XBB.1.5 formulation)
      • Consider delaying dose for 3 months from recent symptom onset or positive test for SARS-CoV-2 infection.
        • The dose can be provided earlier if the individual chooses and is feeling better.
    • Intervals for those receiving 2 or 3 doses of 2024-2025 COVID-19 vaccine:
      • ≥ 8 weeks following last dose of non-2024-2025 COVID-19 vaccine (includes the Omicron.XBB.1.5 formulation) 
      • ≥ 4 to 8 weeks following last dose of 2024-2025 COVID-19 vaccine
      • ≥ 4 to 8 weeks following symptom onset or positive test for SARS-CoV-2 infection.        
         
  • The dose should be chosen according to vaccine recipient's age at presentation.
  • The eHR Viewer needs to be checked for all individuals to confirm vaccine status.
  • Refer out-of-province individuals or those who do not have valid Saskatchewan health services card to public health.

Vaccine-Specific Information 

2024-25 Moderna Spikevax® ≥ 6 Months (Royal Blue Cap, Coral Blue Label) 

Indication

  • Health Canada: immunization against COVID-19 in those 6 months of age and older.
    • Pharmacy professionals are not permitted to administer immunizations to children under 5 years of age. 

Administration

  • Give doses IM (deltoid)

Dose

  • ≥ 12 Years
    • 0.5 mL (50 mcg mRNA)
  • ≥ 5 Years to <12 Years
    • 0.25 mL (25 mcg mRNA)
  • ≥ 6 Months to < 5 Years  
    • 0.25 mL (25 mcg mRNA)
    • Pharmacy professionals are not permitted to immunize those under 5 years of age.

Number of Doses and Interval

Non-Immunocompromised 

Children 6 Months to < 5 Years of Age
Individuals 5 Years of Age and Older

Table 1:  Number of Doses and Interval of 2024-25 Moderna Spikevax® for Non-Immunocompromised Individuals 5 Years of Age and Older (regardless of number and type of previous COVID-19 vaccine received)

AgeNumber of Doses of 2024-25 FormulationInterval†
From Last COVID-19 Vaccine DoseFollowing SARS-CoV-2 Infection
≥ 12 Years1≥ 8 weeksPreviously immunized individuals may consider delaying dose by 3 months, but may be immunized sooner (i.e., feeling better) if chosen.
≥ 5 Years¥ to <12 Years

† For the purposes of vaccinating those living in personal care homes, long term care and other senior congregate living facilities (i.e. assisted living facilities), the vaccine can be administered earlier than these intervals.  
¥ Non-immunocompromised children who have received previous doses of COVID-19 vaccine before the age of 5 years may require more than one dose and/or different intervals. See Saskatchewan Immunization Manual: Chapter 10 → 2024-25 COVID-19 Immunization Schedules for details.  

Moderately to Severely Immunocompromised

Children 6 Months to < 5 Years of Age
Individuals 5 Years and Older

Table 2: Number of Doses and Interval of 2024-25 Moderna Spikevax® for Moderately to Severely Immunocompromised Individuals 5 Years of Age and Older†  

COVID-19 Vaccine History  (non-2024-25)# of 2024-25 DosesInterval
Between Last Non-2024-25 Dose and 2024-25 DoseBetween 2024-25 DosesFollowing SARS-CoV-2 Infection (recommended)
0 doses3Not applicable≥ 4-8 weeks≥ 4-8 weeks
1 dose2≥ 8 weeks≥ 4-8 weeks≥ 4-8 weeks
2 doses1≥ 8 weeksNot applicable≥ 4-8 weeks
3 or more doses1≥ 8 weeks*Not applicableMay consider delaying 3 months but may be immunized sooner (i.e., feeling better) if chosen.*

† Additional considerations apply to candidates and recipients of solid organ transplants and hematopoietic stem cell transplants. Refer to the 2024-25 COVID-19 Vaccine Contraindications and Precautions document or Vulnerable Populations → HSCT/SOT.

* For the purposes of vaccinating those living in personal care homes, long term care and other senior congregate living facilities (i.e. assisted living facilities), the vaccine can be   
administered earlier than these intervals. 

Adverse Events

  • Clinical information is from a booster dose study of Spikevax® XBB.1.5 in individuals 18 years of age and older as well as earlier formulations as primary series and booster doses in individuals 6 months and older. 
  • Common adverse events (≥ 10%) 
    • local reactions (pain, axillary swelling/tenderness, redness)
      • “COVID arm” is a local delayed (≥ 7 days) reaction with these symptoms; it is an expected reaction that resolves within 7 -10 days. This does not need to be reported as an AEFI/AESI.
    • fatigue
    • headache
    • myalgia
    • arthralgia
    • chills
    • fever
    • nausea/vomiting
    • decreased appetite
    • enlarged lymph nodes
    • hypoaesthesia (decreased sense of touch or sensation, numbness) or paraesthesia (tingling, itching or pricking sensation)
    • dizziness
  • Rare Adverse Events
    • Anyone experiencing symptoms associated with the conditions below should seek medical attention.
      • Myocarditis and pericarditis have been reported in a small number of people. Most cases followed vaccination with second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
        • Symptoms may include chest pain, shortness of breath, irregular or fast/pounding heartbeat.
      • Anaphylaxis is very rare but has been reported, in most cases, within 30 minutes of vaccination.
        • Symptoms may include hives; swelling of face, tongue, or throat; difficulty breathing.
      • Bell’s palsy has been reported in a small number of adults; symptoms typically resolve within a month.
        • Symptoms may include weakness or paralysis on one side of the face.

Product Information 

Non-medicinal Ingredients
  • acetic acid
  • cholesterol
  • DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
  • SM-102 ((Heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate)
  • PEG2000-DMG (1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol 2000)
  • sodium acetate trihydrate
  • sucrose
  • trometamol
  • trometamol hydrochloride
  • water for injection

Polyethylene glycol (PEG) and trometamol (tromethamine) are potentially allergenic ingredients, though any vaccine ingredient may be a potential allergen.

There is a potential cross-reactivity between PEG and polysorbates. 

Specific Reference
Last updated: 17 Oct 2024
2024-25 Pfizer-BioNTech Comirnaty® ≥ 12 Years (Dark Grey Cap, Light Grey Label) 

Indication

  • Health Canada: immunization against COVID-19 in those 12 years of age and older  

Administration

  • Give doses IM (deltoid)

Dose

  • ≥ 12 Years
    • 0.3 mL (30 mcg mRNA)

Number of Doses and Interval

Non-Immunocompromised 

Table 3:  Number of Doses and Interval of 2024-25 Pfizer-BioNTech Comirnaty® for Non-Immunocompromised Individuals 12 Years of Age and Older (regardless of number and type of previous COVID-19 vaccine received)

Number of Doses of 2024-25 FormulationInterval†
From Last COVID-19 Vaccine DoseFollowing SARS-CoV-2 Infection
1≥ 8 weeksPreviously immunized individuals may consider delaying dose by 3 months, but may be immunized sooner (i.e., feeling better) if chosen.

† For the purposes of vaccinating those living in personal care homes, long term care and other senior congregate living facilities (i.e. assisted living facilities), the vaccine can be administered earlier than these intervals.  

Moderately to Severely Immunocompromised

12 Years of Age and Older

Table 4: Number of Doses and Interval of 2024-25 Pfizer-BioNTech Comirnaty® for Moderately to Severely Immunocompromised Individuals 12 Years of Age and Older†  

COVID-19 Vaccine History
(non-2024-25)		# of 2024-25 DosesInterval
Between Last Non-2024-25 Dose and 2024-25 DoseBetween 2024-25 DosesFollowing SARS-CoV-2 Infection (recommended)
0 doses3Not applicable≥ 4-8 weeks≥ 4-8 weeks
1 dose2≥ 8 weeks≥ 4-8 weeks≥ 4-8 weeks
2 doses1≥ 8 weeksNot applicable≥ 4-8 weeks
3 or more doses1≥ 8 weeks*Not applicableMay consider delaying 3 months but may be immunized sooner (i.e., feeling better) if chosen.*

† Additional considerations apply to candidates and recipients of solid organ transplants and hematopoietic stem cell transplants. Refer to the 2024-25 COVID-19 Vaccine Contraindications and Precautions document or Vulnerable Populations → HSCT/SOT.

* For the purposes of vaccinating those living in personal care homes, long term care and other senior congregate living facilities (i.e. assisted living facilities), the vaccine can be   
administered earlier than these intervals.

Adverse Events

  • Clinical data are based on previous monovalent and bivalent Pfizer-BioNTech Comirnaty® formulations.
    • Common (≥ 10%) adverse events
      • local reactions: pain at injection site, redness, and swelling
        • “COVID arm” is a local delayed (≥ 7 days) reaction with these symptoms; it is an expected reaction that resolves within 7-10 days. This does not need to be reported as an AEFI/AESI.
      • fatigue
      • headache
      • myalgia
      • chills
      • arthralgia
      • chills
      • fever
      • joint pain
      • diarrhea
      • nausea
      • vomiting
      • enlarged lymph nodes
    • Less common (<10%) adverse events
      • excessive sweating
      • night sweats
      • malaise
    • Rare adverse events
      • Anyone experiencing symptoms associated with the conditions below should seek medical attention.
        • Myocarditis and pericarditis have been reported in a small number of people. Most cases followed vaccination with second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
          • Symptoms may include chest pain, shortness of breath, irregular or fast/pounding heartbeat.
        • Anaphylaxis is very rare but has been reported, in most cases, within 30 minutes of vaccination.
          • Symptoms may include hives; swelling of face, tongue, or throat; difficulty breathing.
        • Bell’s palsy has been reported in a small number of adults; symptoms typically resolve within a month.
          • Symptoms may include weakness or paralysis on one side of the face. 

Product Information

Non-Medicinal Ingredients
  • ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis (hexane-6,1-diyl)bis (2-hexyldecanoate)
  • ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
  • cholesterol
  • DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine
  • sucrose
  • tromethamine
  • tromethamine hydrochloride  
  • water for injection

Polyethylene glycol (PEG) and tromethamine are potentially allergenic ingredients though any vaccine ingredient may be a potential allergen.

There is a potential cross-reactivity between PEG and polysorbates. 

Specific Reference 
Last updated: 17 Oct 2024
Product Comparison Table of COVID-19 Vaccines Available in Saskatchewan
 Moderna Spikevax® 
(Omicron KP.2 2024-25 Formulation) 
Royal Blue Cap, Coral Blue Label 
 		Pfizer-BioNTech Comirnaty® 
(Omicron KP.2 2024-25 Formulation) 
Dark Grey Cap, Light Grey Label
 DO NOT DILUTEDO NOT DILUTE
Health Canada- 
Authorized Age		≥ 6 months≥ 12 years
Concentration50 mcg / 0.5 mL30 mcg / 0.3 mL
DIN0254127002541823
PackagingMultidose preservative-free 2.5 mL vials 

Cartons of 10 vials 

Royal blue cap; coral blue label 
 		Multidose preservative-free 2.25 mL vials 

Cartons of 10 vials 

Dark grey cap; light grey label 
 

Storage/Stability

 Moderna Spikevax® 
(Omicron KP.2 2024-25 Formulation) 
Royal Blue Cap, Coral Blue Label		Pfizer-BioNTech Comirnaty® 
(Omicron KP.2 2024-25 Formulation) 
Dark Grey Cap, Light Grey Label 
 
Stability in FreezerStore at -50°C to -15°C (freezer) until the expiry date printed on the label.aStore at -90°C to -60°C (ultra-low temperature freezer) until the expiry date printed on the carton.
Thawing

Thaw in fridge (2°C to 8°C) (takes 2 hours) 
After thawing, let stand at room temperature for 15 minutes before administering. 

or 

Thaw at 15°C to 25°C (takes 45 minutes)

Do not refreeze thawed vials

Thaw in fridge (2°C to 8°C) (takes up to 6 hours) 

or

Thaw at room temperature up to 25°C (takes ~30 minutes) 

Do not refreeze thawed vials

Stability in Refrigerator 
(2°C to 8°C)		*UPDATED* 
Up to 50 days prior to first use within expiry date on label		Up to 10 weeks prior to first use within expiry date on carton
DilutionDO NOT DILUTE
Stability at Room Temperature 
(up to 25°C)

*UPDATED* 

No more than 12 cumulative hours at room temperature. 

Vials can be returned to fridge but time spent at room temperature must be tracked and total time cannot exceed 12 hours (includes before and after puncture).

Prior to puncture, no more than 12 cumulative hours at room temperature.

Vials can be returned to fridge but time spent at room temperature must be tracked and total time cannot exceed 12 hours (includes prior to puncture only).

Stability after 
1st Puncture

*UPDATED*

Up to 24 hours at 2°C to 8°C. 

Up to 12 hours at > 8°C to 25°C

Vials must be discarded 24 hours after first puncture when stored in the fridge. If the total time at room temperature (includes before and after puncture) exceeds 12 hours, the vials must be discarded. 

Up to 12 hours at 2°C to 25°C (does not include time at room temperature prior to 1st puncture)
Stability SummaryPfizer-BioNTech Comirnaty® can be stored at room temperature 12 hours before puncture and then again 12 hours after puncture whereas Moderna Spikevax® can be stored at room temperature for only 12 hours total (before and after puncture). 
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.

a. Expiry dates may be extended for some lots. Use the Moderna Vial Expiration Checker or check the VDTS, Panorama, or CQE to verify dates.

Specific References
Last Updated: 28 oct 2024

Vulnerable Populations

Definition of Moderately to Severely Immunocompromised

As per the Canadian Immunization Guide, moderately to severely immunocompromised individuals include those with the following conditions:

  • Immunocompromised due to solid tumour or hematologic malignancies or treatments of these conditions
  • 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 AIDS-defining illness or TB diagnosis in last 12 months before starting vaccine series, or severe immune compromise with CD4 < 200 cells/µl or CD4% < 15%, or without HIV viral suppression 
  • Recipients of recent 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 ≥ 2 mg/kg/day or 20 mg/day if weight > 10 kg, for ≥ 14 days)
    • alkylating agents, antimetabolites, or tumor-necrosis factor (TNF) inhibitors and other biologic agents that are significantly immunosuppressive
    • see list of immunosuppressive medications
  • Chronic kidney disease on dialysis
Hematopoietic Stem Cell Transplant and Solid Organ Transplant
  • Hematopoietic stem cell transplant and solid organ transplant recipients are considered moderately to severely immunocompromised and there are specific recommendations for COVID-19 vaccine schedules and timing. 
    • There are also some recommendations for transplant candidates.
Hematopoietic Stem Cell Transplant (HSCT)
  • HSCT recipients MUST speak to their cancer care team / specialist.
    • Pre-transplant
      • If feasible, a COVID-19 vaccine series should be administered at least 4 weeks prior to starting conditioning regimen.
    • Post-transplant
      • Postpone vaccination in severe, uncontrolled acute graft versus host disease (GVHD), grade 3-4. 
      • For previously immunized or unimmunized HSCT recipients, immunization with COVID-19 vaccine can be initiated 4 months after HSCT (3 months post-autologous transplant for patients who will be started on maintenance therapy post-transplant).
      • Vaccinated HSCT recipients should receive a booster dose 3 months after their previous vaccine dose.
      • HSCT recipients with previous COVID-19 infection should defer vaccination for 3 months post-infection.
    • The HSCT Program will provide a letter to recipients to take into their immunizer when they are eligible to start their COVID-19 vaccination series with schedule to return in 4 weeks, 8 weeks, then 3 months for booster.
Solid Organ Transplant (SOT)
  • Medically stable SOT recipients followed up by the Saskatchewan Transplant Program DO NOT NEED to consult their specialist prior to immunization with COVID-19 vaccines.
  • Pre-transplant
    • Unvaccinated SOT candidates should receive 3 doses (using min. 4-week intervals)) of mRNA vaccine as a primary series, with the final dose given 1-2 weeks prior to transplantation whenever possible. If indicated, an additional dose given 3 months after the last vaccine dose may be recommended by the Transplant Program.
    • Post-transplant
      • Unvaccinated SOT recipients should receive 3 doses (using min. 4-week intervals) of mRNA vaccine as a primary series. If indicated, an additional dose given 3 months after the last vaccine dose may be recommended by the Transplant Program.
      • Vaccinated SOT recipients should receive an additional dose given 3 months after their previous vaccine dose as recommended by the Transplant Program.
      • All SOT recipients should wait at least 1 month post-transplant to continue vaccine series, regardless of induction therapy.
      • SOT recipients undergoing active treatment for acute rejection should defer vaccination for 1 month.
      • SOT recipients who have received rituximab should defer vaccination for at least 3 months.
      • SOT recipients with previous COVID-19 infection should defer vaccination for 3 months post-infection.
    • The Saskatchewan Transplant Program will provide a letter for recipients to take into their immunizer when they are eligible for their first dose and it will specify that the recipient return for a second dose 3 months later.
Underlying Medical Conditions Associated with More Severe COVID-19 Disease

As per the Public Health Agency of Canada, individuals with the following medical conditions are at greater risk of more severe COVID-19 disease:

  • Cancer
  • Cerebrovascular disease
  • Chronic kidney disease
  • Chronic liver disease (limited to: cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis)
  • Chronic lung disease (limited to: bronchiectasis, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, pulmonary embolism)
  • Cystic fibrosis
  • Diabetes mellitus, type 1 and type 2
  • Disabilities (e.g., Down syndrome, learning, intellectual, or developmental disabilities; ADHD; cerebral palsy; congenital disabilities; spinal cord injuries)
  • Heart conditions (e.g., cardiomyopathies, coronary artery disease, heart failure, etc.)
  • HIV infection
  • Mental health disorders (limited to: mood disorders, including depression; schizophrenia spectrum disorders)
  • Obesity
  • Pregnancy and recent pregnancy
  • Primary immunodeficiency disease
  • Smoking, current or former
  • Solid organ or blood stem cell transplant
  • Tuberculosis
  • Use of corticosteroids or other immunosuppressive medication (see list of immunosuppressive medications)

Certain medical and/or social vulnerabilities, may make it more difficult for patients to recognize, clearly communicate, or act on symptoms' progression. Affected individuals may include: people experiencing intellectual, developmental, or cognitive disabilities; people who use substances regularly; people who live with mental health conditions; and persons experiencing homelessness or who are unhoused. These patients need closer attention and monitoring. 
 

References

General References

Last updated: 16 Oct 2024