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SPIKEVAX (COVID-19 mRNA vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 6 months of age and older.

SPIKEVAX (COVID-19 mRNA vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 6 months of age and older.

The safety and effectiveness of SPIKEVAX for individuals 6 months of age and older is inferred from several studies of a primary series and booster dose of SPIKEVAX Bivalent (Original/Omicron BA.1) in individuals 6 months to 5 years of age, a booster dose study of SPIKEVAX Bivalent (Original/Omicron BA.1) in individuals >18 years of age, a booster dose study of SPIKEVAX XBB.1.5 in individuals > 18 years of age, as well as data from studies which evaluated the primary series and booster vaccination with SPIKEVAX (elasomeran).

According to NACI, COVID-19 vaccination is recommended for previously vaccinated and unvaccinated individuals at increased risk of SARS-CoV-2 infection or severe COVID-19 disease.

Omicron KP.2 variant

The most frequently reported adverse reactions after the SPIKEVAX Bivalent 50 mcg booster dose were pain (77.3%), fatigue (54.9%), headache (43.9%), myalgia (39.6%), arthralgia (31.1%) and axillary swelling or tenderness (17.4%). The median duration of local and systemic adverse reactions was 2 days.

The most common adverse reactions after the SPIKEVAX original 50 µg booster dose (Dose in adults 18 years and older (n=377)) was fatigue (51.4%), headache (41.1%), myalgia (38.6%), and arthralgia (31.7%). The median duration of local and systemic adverse reactions was 2 days.

Please refer to the product monograph for additional safety information, as well as safety information for other cohorts.

Medicinal ingredients:

Each 0.5 mL doseEach 0.5 mL dose of SPIKEVAX contains 50 micrograms of mRNA encoding SARS-CoV-2 spike protein, 5'(m7G-5'-ppp- 5'-Gm) cap, 100-nucleotide 3' poly(A) tail. The mRNA encoding spike protein is derived from the Omicron KP.2 variant. of SPIKEVAX contains 50 micrograms of SARS-CoV-2 KP.2 mRNA.

Non-medicinal ingredients:

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

NACI recommends a COVID-19 vaccine for previously vaccinated and unvaccinated individuals at increased risk of SARS-CoV-2 exposure or severe COVID-19 disease, which includes the following individuals (strong recommendation):

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  All adults 65 years of age or older
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  Those 6 months of age and older who are:

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    Residents of long-term care homes and other congregate living settings;
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    Individuals with underlying medical conditions that place them at higher risk of severe COVID-19, including children with complex health needs:
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    Pregnant women and individuals who are pregnant;
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    Individuals in or from First Nations, Inuit and Métis communities;
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    Members of racialized and other equity-denied communities; and
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    Health care workers and other care providers in facilities and community settings

NACI recommends that all other previously vaccinated and unvaccinated individuals (6 months of age and older) who are not at increased risk for SARS-CoV-2 exposure or severe COVID-19 disease (i.e., not listed above) may receive a COVID-19 vaccine (discretionary recommendation)

For individuals 6 months of age and older, COVID-19 vaccines may be given concurrently with (i.e., same day), or at any time before or after, non-COVID-19 vaccines (including live and non-live vaccines).

Underlying medical conditions associated with more severe COVID-19 disease:

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

Your patient can use the Book Now tool.

Please follow the guidelines for the storage and handling of the vaccines to ensure their efficacy.

SPIKEVAX (COVID-19 mRNA vaccine):

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  DASH document
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  Product monograph

No, thawed vaccines cannot be refrozen. Once thawed, vials can be stored refrigerated between 2° to 8°C for up to 50 days prior to first use.