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The 2025-26 COVID-19 vaccine contains the Omicron LP.8.1 variant. The Canadian Immunization Guide (CIG) recommends the 2025-26 COVID-19 vaccine for the following populations: Individuals ≥ 65 years of age Individuals ≥ 6 months of age who are/have: residents of long-term care (LTC) homes or other congregate living settings underlying medical conditions that increase their risk of severe COVID-19, including children with complex health needs (see → Underlying Medical Conditions Associated with More Severe COVID-19 Disease) pregnant Indigenous members of racialized and other equity-denied communities health care workers and other care providers in facilities and community settings The CIG suggests any individual 6 months and older may receive the 2025-26 COVID-19 vaccine. In Saskatchewan, COVID-19 vaccines are available to all individuals 6 months and older. Moderna Spikevax® will be the COVID-19 vaccine available in Saskatchewan pharmacies. This is an mRNA vaccine formulated with the Omicron LP.8.1 variant. Available formats are the multidose vial and single-dose prefilled syringe (PFS for 12 years and older only, coming later in the season). 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 are not immunocompromised and have not been previously vaccinated should receive two doses. If the child turns 5 before the second dose is given, the second dose should still be administered, at least 8 weeks after the first. 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 a valid Saskatchewan health services card to Public Health. Moderna Spikevax® DetailsClinical InformationIndicationHealth 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. AdministrationGive doses IM (deltoid) Dose≥ 12 Years 0.5 mL (50 mcg mRNA) multidose vial or single-dose prefilled syringe (PFS available later in season) ≥ 5 Years to <12 Years 0.25 mL (25 mcg mRNA) multidose vial ≥ 6 Months to < 5 Years 0.25 mL (25 mcg mRNA) multidose vial Pharmacy professionals are not permitted to immunize those under 5 years of age. Number of Doses and IntervalNon-Immunocompromised5 Years of Age and Older1 dose (regardless of number and type of previous COVID-19 vaccine received¥) ¥Children under the age of 5 years who are not immunocompromised and have not been previously vaccinated should receive two doses. If the child turns 5 before the second dose is given, the second dose should still be administered, at least 8 weeks after the first. Recommended interval from last COVID-19 vaccine dose: ≥ 8 weeks Recommended interval following SARS-CoV-2 Infection: Unimmunized individuals: Delay immunization by ≥8 weeks following SARS-CoV-2 infection. Previously immunized individuals: Consider delaying dose by 3 months following SARS-CoV-2 infection, but may be immunized sooner (i.e., when feeling better) if chosen. 6 Months to < 5 Years of AgeModerately to Severely Immunocompromised 5 Years of Age and OlderTable 1: Number of Doses and Interval of 2025-26 Moderna Spikevax® for Moderately to Severely Immunocompromised Individuals 5 Years and Older†COVID-19 Vaccine History (non-2025-26) Number of Doses of 2025-26 Formulation Required Interval Between Last Non-2025-26 Dose and 2025-26 Dose Interval Between 2025-26 Doses Recommended Interval Following SARS-CoV-2 Infection 0 doses 3 Not applicable ≥ 4-8 weeks ≥ 4-8 weeks 1 dose 2 ≥ 8 weeks ≥ 4-8 weeks ≥ 4-8 weeks 2 doses 1 ≥ 8 weeks Not applicable ≥ 4-8 weeks 3 or more doses 1 ≥ 8 weeks Not applicable Consider delaying 3 months but may be immunized sooner (i.e., when feeling better) if chosen. † Additional considerations apply to candidates and recipients of solid organ transplants and hematopoietic stem cell transplants. Refer to or → HSCT/SOT. 6 Months to < 5 Years of AgeAdverse Events Clinical information is inferred from several studies of previous formulations 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. 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. Technical InformationTable 2: Moderna Spikevax® (Omicron LP.8.1 Formulation, 2025-26) Product OverviewMultidose Vial Single-Dose, Prefilled Syringe DIN 02541270 Age ≥ 6 months ≥ 12 years Dilution DO NOT DILUTE DO NOT DILUTE Concentration 50 mcg / 0.5 mL 50 mcg / 0.5 mL Packaging Multidose preservative-free vials, 2.5 mL Royal blue cap; coral blue label Cartons of 10 vials Single-dose prefilled syringes, 0.5 mL Needles are not supplied. Cartons of 10 syringes Handling Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not shake. Appearance White to off-white dispersion—may contain white or translucent product-related particles; ensure no foreign particulate matter or discolouration. 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. Table 3: Storage and Stability of Moderna Spikevax® (Omicron LP.8.1 Formulation, 2025-26) Multidose Vials and Prefilled Syringes Multidose Vial Single-Dose, Prefilled Syringe Stability in Freezer Store at -50°C to -15°C (freezer) until the expiry date printed on the label. Thawing Thaw vials individually. Thaw in fridge 2°C to 8°C (takes 2 hours) Do not refreeze thawed vials. Thaw syringes individually or in carton of 10. Individual syringe: Carton of 10: Do not refreeze thawed syringes. When thawed at room temperature, do not return to fridge. Stability in Refrigerator (2°C to 8°C) Up to 50 days prior to first use within expiry date on label Stability at Room Temperature (up to 25°C) No more than 12 cumulative hours at 8°C to 25°C. Vials can be returned to fridge Time spent at room temperature must be tracked includes before and after puncture No more than 12 hours at 8°C to 25°C. Do not return to fridge. Stability after 1st Puncture Up to 24 hours at 2°C to 8°C. Vials must be discarded 24 hours after first puncture If the total time at room temperature exceeds 12 hours, the vials must be discarded includes before and after puncture Not ApplicableProtect from Light Store in original carton. Thawed vials and filled syringes can be handled in room light conditions. Store in original carton. Thawed prefilled syringes can be handled in room light conditions. Vulnerable PopulationsDefinition of Moderately to Severely Immunocompromised As per the , moderately to severely immunocompromised individuals include those with the following conditions: 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: Chronic kidney disease on dialysis Hematopoietic Stem Cell Transplant and Solid Organ TransplantHematopoietic 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. Underlying Medical Conditions Associated with More Severe COVID-19 DiseaseAs 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. ReferencesGeneral References Saskatchewan Immunization Manual eHealth COVID-19 Immunization Manual Canadian Immunization Guide Public Health Agency of Canada Last updated: 08 Oct 2025 (责任编辑：) |