US labeling:
COVID-19 prevention: Active immunization to prevent COVID-19.
Note: Pfizer-BioNTech COVID-19 Vaccine, 2024-2025 Formula and Moderna COVID-19 Vaccine, 2024-2025 Formula are FDA approved for persons ≥12 years of age and available under emergency use authorization (EUA) for persons 6 months to <12 years of age. Approved/authorized ages vary by product; see EUA or product labeling for details (FDA 2024a, FDA 2024b, manufacturer’s labeling).
CDC recommendations:
The CDC recommends that all persons ≥6 months of age receive at least one age-appropriate 2024-2025 COVID-19 vaccine. The CDC does not have a preferential recommendation as to which vaccine is used. The specific number of doses depends on the person's age, COVID-19 vaccination history, immune status, and vaccine product (CDC 2024).
Moderate and severe immunocompromising conditions and treatments include but are not limited to (CDC 2024):
• Active treatment for solid tumor and hematologic malignancies
• Hematologic malignancies associated with poor responses to COVID-19 vaccines (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) regardless of current treatment status
• Receipt of solid-organ or islet transplant and taking immunosuppressive therapy
• Receipt of CAR-T-cell or hematopoietic cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)
• Moderate or severe primary immunodeficiency (eg, common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
• HIV infection (advanced or untreated)
• Active treatment with any of the following: High-dose corticosteroids (ie, prednisone ≥20 mg/day or equivalent for ≥2 weeks); alkylating agents; antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
Canadian and international labeling:
COVID-19 prevention (Comirnaty [Pfizer-BioNTech vaccine] and Spikevax [Moderna vaccine]): Active immunization to prevent COVID-19. Approved ages vary by product; see product labeling for details.
Note: Preparations of COVID-19 vaccines in Canada and internationally containing different components (eg, SARS-CoV-2 Original strain, Omicron BA.1, BA.4/BA.5, and XBB.1.5 variants) may be available; use caution.
Canadian guidance: The National Advisory Committee on Immunization has made recommendations on the use of COVID-19 vaccines; see recommendations for details (NACI 2023a, NACI 2023b).