Spikevax® (COVID-19 Vaccine, mRNA)

SPIKEVAX is updated.

COVID-19 has evolved. Our updated KP.2 mRNA vaccine is available for Spring 2025.^1,2

One size fits all*

One simple vial presentation, for all individuals 6 months of age and older.

Still recommended for eligible patients. Still available.³

The SPIKEVAX (COVID-19 mRNA vaccine) formulation remains recommended for eligible patients and available for Spring 2025 vaccination.

Guidance on the use of COVID-19 vaccines for 2025 to summer 2026³

NACI

National Advisory Committee on Immunization Strong Recommendation

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):

All adults 65 years of age or older
•
Those 6 months of age and older who are:
- Residents of long-term care homes and other congregate living settings;
- Individuals with underlying medical conditions that place them at higher risk of severe COVID-19, including children with complex health needs:
- Pregnant women and individuals who are pregnant;
- Individuals in or from First Nations, Inuit and Métis communities;
- Members of racialized and other equity-denied communities; and
- Health care workers and other care providers in facilities and community settings

For Spring 2025 (April – June 2025)

For those previously vaccinated, most are recommended to receive only one dose per year. However, some populations are recommended to also receive a second annual dose to mitigate the waning protection from COVID-19 vaccines. The following individuals who were previously vaccinated and are at increased risk of severe COVID-19 disease should receive a second dose of COVID-19 vaccine per year:

Adults 80 years of age and older
Adult residents of long-term care homes and other congregate living settings for seniors
Individuals 6 months of age and older who are moderately to severely immunocompromised (due to an underlying condition or treatment)

NACI National Advisory Committee on Immunization Discretionary Recommendation

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 Spring 2025 (April – June 2025)

Previously vaccinated adults 65 to 79 years of age who are at increased risk of severe COVID-19 disease may receive a second dose of COVID-19 vaccine per year (discretionary recommendation).

Vaccination Timing & Considerations

Additionally, the minimum interval between COVID-19 doses is 3 months for previously vaccinated individuals. When deciding on the best time to get vaccinated, individuals can consider factors such as time since their last dose, test-confirmed SARS-CoV-2 infection, local virus circulation, and personal circumstances such as travel, major medical procedures, or large gatherings.

For the full statement please see: Guidance on the use of COVID-19 vaccines for 2025 to summer 2026.³

Underlying medical conditions associated with more severe COVID-19 disease

Cancer
Cerebrovascular disease
Chronic kidney disease
Chronic liver diseases (limited to: cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis)
Chronic lung diseases (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 diseases

Smoking, current or former
Solid organ or blood stem cell transplant
Tuberculosis
Use of corticosteroids or other immunosuppressive medication

One size fits all.

Download to view the full Dosing Administration Storage and Handling Document for healthcare providers.

SPIKEVAX DASH document

Indication and clinical use

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.

Pediatrics: Safety and efficacy in individuals <6 months of age not established.

Contraindications:

Hypersensitivity to the active ingredient or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.

Relevant warnings and precautions:

Hypersensitivity and anaphylaxis
Myocarditis and pericarditis
Patients with acute infection
Patients with hematologic disorders or on anticoagulant therapy
Patients who are immunocompromised
Syncope
Vaccination with SPIKEVAX may not protect all recipients

For more information:

Please consult the Product Monograph at spikevaxpro.com/pm for important information relating to adverse reactions, drug interactions, and dosing information which has not been discussed in this piece. The Product Monograph is also available by calling us at 1-866-MODERNA (1-866-663-3762).

Footnotes

* 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.

**There is limited evidence on clinical risk factors for severe COVID-19 disease in pediatric populations. Children at increased risk for severe outcomes may include children who are medically fragile/have medical complexities, children with more than one comorbidity, children with neurological disorders, children with chronic lung disease, and children with Down syndrome (Trisomy 21), and other immunocompromising conditions.

‡Autonomous decisions should be made by Indigenous Peoples with the support of healthcare and public health partners in accordance with the United Nations Declaration on the Rights of Indigenous Peoples Act.

References

SPIKEVAX Product Monograph, December 2024

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