General Information

COVID-19 vaccines now contain one strain, XBB.1.5.

General Eligibility
  • COVID-19 XBB.1.5 vaccines are available to all individuals 6 months and older.
    • ≥ 6 months to < 12 years: mRNA is available
    • ≥ 12 years: mRNA or protein subunit are available (no preference)
  • It is highly recommended that the following populations receive this vaccine: 
    • individuals 50 years and older
    • residents of long-term care and other congregate living settings, including personal care homes and shelters
    • individuals 6 months and older with underlying medical conditions, including moderate to severe immunosuppression, that place them at higher risk of severe COVID-19 (see Vulnerable Populations below)
    • pregnant individuals
    • Indigenous peoples and those living in northern and remote communities
    • health care workers, first responders, caregivers, and other essential service workers
  • Individuals 5 years and older who are not immunocompromised may receive one dose of XBB.1.5 vaccine, regardless of number and type of previous COVID-19 vaccines (see exceptions below who may receive more doses). The dose may be administered at least 6 months (minimum 3 months) following the last COVID-19 vaccine dose or SARS-CoV-2 infection, whichever is later.
    • 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 less than 3 months (no minimum interval) after the last dose or infection.
  • Between April 8, 2024, and June 30, 2024, an additional XBB.1.5 dose is available for: 
    • Adults 65 years and older
    • Adults ≥18 years to <65 years residing in long-term care facilities, personal care homes, and congregate living setting (i.e. assisted living setting) that have residents 65 years and older.
      • Note, this does not apply to congregate living settings such as group homes, dorms, correctional institutions.
    • Individuals 6 months and older who are moderately to severely immunocompromised (see Vulnerable Populations)
    • The dose is to be given at least 6 months (minimum 3 months) following the last COVID-19 vaccine dose or SARS-CoV-2 infection, whichever is later. 
  • As of July 1, 2024, COVID-19 XBB.1.5 doses will only be available for the following, until further notice:
    • Unvaccinated children 6 months to < 5 years of age who are moderately to severely immunocompromised.
    • Children who started a vaccine series prior to the age of 5 years but did not complete before July 1, 2024 (regardless of immune status).
    • Moderately to severely immunocompromised individuals of any age who started a vaccine series but did not complete before July 1, 2024.
    • All other individuals will not be eligible for COVID-19 vaccine doses as of July 1, 2024, until further notice.
  • The number of doses varies based on number of previous doses received for those: 
  • The dose should be chosen according to vaccine recipient's age at presentation.
  • Pharmacy professionals are permitted to immunize those 5 years and older.
  • The following vaccines are only available through Public Health:
    • Novavax Nuvaxovid™ XBB.1.5 ≥12 years 
    • Pfizer-BioNTech Comirnaty® Omicron XBB.1.5 ≥ 5 years to < 12 years
  • 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.
Last updated: 17 Apr 2024

Details of COVID-19 Vaccines Available in SK

Moderna Spikevax® XBB.1.5 ≥ 6 Months (Royal Blue Cap, Coral Blue Font) 

Indication

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

Administration

  • Give doses IM (deltoid)

Dose and Interval

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

Table 1: Number of Doses and Interval of Moderna Spikevax® XBB.1.5 for Non-Immunocompromised Individuals 5 Years and Older (Regardless of Number and Type of Previous COVID-19 Vaccine Received)
*See General Eligibility for those eligible to receive an additional XBB.1.5 dose
AgeNumber of XBB.1.5   
Doses 		Interval
≥ 12 Years1≥ 6 months (minimum 3 months)    
from last COVID-19 vaccine dose or    
SARS-CoV-2 infection, whichever is later.†
≥  5 Years¥ to < 12 Years

¥ Non-immunocompromised children who started, but not completed, a primary series with a non-XBB.1.5 or XBB.1.5 vaccine when they were less than 5 years of age are recommended to receive 1 more dose of an XBB vaccine given 4 to 8 weeks after their last dose.  
† 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 less than 3 months (no minimum interval) after the last dose or infection.

Table 2: Number of Doses and Interval of Moderna Spikevax® XBB.1.5 for Moderately to Severely Immunocompromised Individuals 5 Years and Older¥,†

**Note: These individuals are eligible to receive an additional XBB.1.5 dose, which is not accounted for in this table, at least 6 months (minimum 3 months) following their last XBB.1.5 dose or SARS-CoV-2 infection, whichever is later.

COVID-19 Vaccine History  
(non-XBB.1.5) 		Number of XBB.1.5 Doses Interval Between Last Dose and First XBB.1.5 Dose*Interval Between XBB.1.5 Doses*
0 doses3Not applicable4-8 weeks
1 dose24-8 weeks4-8 weeks
2 doses14-8 weeksNot applicable
3 or more doses16 months (min 3 months)Not applicable

¥ Moderately to severely immunocompromised children who transition from 4 to 5 years old and have received at least one dose of Pfizer-BioNTech Comirnaty® (any formulation) before the age of 5 may require more doses and should follow the number of doses set in the ≥ 6 month to < 5 years schedule. Age-appropriate Spikevax® XBB.1.5 or Comirnaty® Omicron XBB.1.5 can be used to complete the series. See the Saskatchewan Immunization Manual - Chapter 10 → XBB.1.5 COVID-19 Vaccine Schedules, for details.

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

*An interval of 6 months (minimum 3 months) is recommended from previous SARS-CoV-2 infection.  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 less than 3 months (no minimum interval) after the last dose or infection.

Adverse Events

  • Clinical information is from a booster dose study of Spikevax® XBB.1.5 in individuals 18 years 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 are less frequent in children < 12 years old and were not reported in clinical trials.
        • Symptoms may include chest pain, shortness of breath, irregular or fast/pounding heartbeat.
      • Anaphylaxis is very rare but has been reported, in most cases, within 30 minutes of vaccination. 
        • Symptoms may include hives; swelling of face, tongue, or throat; difficulty breathing.
      • Bell's palsy has been reported in a small number of adults; symptoms typically resolve within a month.
        • Symptoms may include weakness or paralysis on one side of the face.

Product Information 

Non-medicinal Ingredients
  • acetic acid
  • cholesterol
  • DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
  • Lipid SM-102
  • PEG2000-DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
  • sodium acetate trihydrate 
  • sucrose
  • trometamol 
  • trometamol hydrochloride 
  • water for injection

Polyethylene glycol (PEG) and trometamol (tromethamine) are potentially allergenic ingredients.

Specific Reference
Last Updated: 08 Apr 2024
Pfizer-BioNTech Comirnaty® Omicron XBB.1.5 ≥ 12 Years (Grey Cap, Grey Label) 

Indication

  • Health Canada: immunization against COVID-19 in those ≥ 12 years

Administration

  • Give doses IM (deltoid)

Dose

  • 0.3 mL (30 mcg mRNA)

Interval

Non-Immunocompromised Individuals

  • 1 dose ≥ 6 months (minimum 3 months) from last COVID-19 vaccine dose or SARS-CoV-2 infection, whichever is later.
    • 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 less than 3 months (no minimum interval) after the last dose or infection.
  • See General Eligibility for those eligible to receive an additional XBB.1.5 dose.

Moderately to Severely Immunocompromised Individuals

Table 1: Number of Doses and Interval of Pfizer-BioNTech Comirnaty® Omicron XBB.1.5 for Moderately to Severely Immunocompromised Individuals 12 Years and Older†

**Note: These individuals are eligible to receive an additional XBB.1.5 dose, which is not accounted for in this table, at least 6 months (minimum 3 months) following their last XBB.1.5 dose or SARS-CoV-2 infection, whichever is later.

COVID-19 Vaccine History 
(non-XBB.1.5) 		Number of XBB.1.5 Doses Interval Between Last Dose and First XBB.1.5 Dose*Interval Between XBB.1.5 Doses*
0 doses3Not applicable4-8 weeks
1 dose24-8 weeks4-8 weeks
2 doses14-8 weeksNot applicable
3 or more doses16 months (min 3 months)Not applicable

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

*An interval of 6 months (minimum 3 months) is recommended from previous SARS-CoV-2 infection.  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 less than 3 months (no minimum interval) after the last dose or infection. 

Adverse Events

  • Clinical data are based on 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(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.

Specific Reference
Last updated: 08 Apr 2023
Product Comparison Table of COVID-19 Vaccines Available in SK Pharmacies

The following table includes characteristics of the mRNA COVID-19 vaccines available in Saskatchewan pharmacies.

For more details about the included vaccines and/or information regarding COVID-19 vaccines only available through Public Health, see the Saskatchewan Immunization Manual and COVID-19 Vaccine Contraindications and Precautions Background Document. 

 Moderna Spikevax® XBB.1.5    
Royal Blue Cap, Coral Blue Font   
 		Pfizer-BioNTech Comirnaty® Omicron XBB.1.5
Grey Cap, Grey Border
 DO NOT DILUTEDO NOT DILUTE
Health Canada-   
Authorized Age		≥ 6 months≥ 12 years
Concentration50 mcg / 0.5 mL  30 mcg / 0.3 mL
DIN0254127002541823
PackagingMultidose preservative-free 2.5 mL vials   

Cartons of 10 vials   

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

Cartons of 10 vials

Grey cap; grey border
 

Storage/Stability

  
 Moderna Spikevax® XBB.1.5    
Royal Blue Cap, Coral Blue Font  		Pfizer-BioNTech Comirnaty® Omicron XBB.1.5
Grey Cap, Grey Border
 
Stability in FreezerStore at -50°C to -15°C (freezer) until the expiry date printed on the label.a  Store at -90°C to -60°C (ultrafreezer) until the expiry date printed on the label.
Thawing

Thaw in fridge (takes 2 hours)   
or   
Thaw at room temperature (takes 45 minutes)

After thawing, let stand at room temperature for 15 minutes before administering.

Do not refreeze thawed vials

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
DilutionDO 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 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.

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.		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.


a. Expiry dates have been extended for some lots. Use the Moderna Vial Expiration Checker or check the VDTS to verify dates.

Specific References
Last Updated: 01 apr 2024
Pfizer-BioNTech Comirnaty® Omicron XBB.1.5 ≥ 5 Years to < 12 Years - Limited information

Refer individuals seeking this vaccine to Public Health as it is no longer available at Saskatchewan pharmacies. 

Indication

  • Health Canada: immunization against COVID-19 for individuals ≥ 5 years to < 12 years.

Notes

Specific Reference
Last updated: 01 Apr 2024
Novavax Nuvaxovid™ XBB.1.5 -  Limited Information 

Refer individuals seeking this vaccine to Public Health as it is not available at Saskatchewan pharmacies.  

Indication

  • Health Canada: immunization against COVID-19 for individuals 12 years and older.

Notes

Specific Reference
Last updated: 01 Apr 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 count < 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 Potentially Immunosuppressive Medications
  • Chronic kidney disease on dialysis
Last updated: 27 Sep 2023
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, XBB.1.5 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, vaccination with XBB.1.5 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 COVID-19 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.
Last updated: 19 Oct 2023
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 

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.

Last updated: 27 Sep 2023

References

General References