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Introduction

The COVID-19 vaccination schedule for people ages 6 months and older who are moderately or severely immunocompromised is detailed in Table 2. The recommended vaccine and number of 2024–2025 COVID-19 vaccine doses are based on age and vaccination history. People who are moderately or severely immunocompromised also have the option to receive additional doses of 2024–2025 COVID-19 vaccine under shared clinical decision-making after receiving all the recommended doses of 2024–2025 COVID-19 vaccine.

In all age groups, COVID-19 vaccine doses from the same manufacturer should be administered whenever recommended; see Interchangeability of COVID-19 vaccines for circumstances in which doses from different manufacturers may be considered.

For information on the use of pemivibart (Pemgarda™) for COVID-19 pre-exposure prophylaxis, see COVID-19 vaccination and pemivibart.

Table 2: COVID-19 vaccination schedule for people who are moderately or severely immunocompromised, October 31, 2024

2a: Ages 6 months–4 years

^{_{*COVID-19 vaccination history refers to all doses of COVID-19 vaccine from any manufacturer received before the availability of the 2024–2025 COVID-19 vaccines, and includes original, bivalent, and 2023–2024 COVID-19 vaccines.}}

^{†_{Dosage for Moderna: 0.25 mL/25 ug; dosage for Pfizer-BioNTech: 0.3 mL/3 ug.}}

^{‡_{Additional doses may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.}}

2b: Ages 5–11 years

<sup>*<sub>Children who transition from age 4 years to age 5 years during the initial vaccination series should complete the 3-dose series using the dosage for children ages 5–11 years for all doses received on or after turning age 5 years:
- Moderna series: 2024–2025 Moderna, 0.25 mL/25 ug; there is no dosage change
- Pfizer-BioNTech series: 2024–2025 Pfizer-BioNTech, 0.3 mL/10 ug</sub></sup>

^{†_{COVID-19 vaccination history refers to all doses of COVID-19 vaccine from any manufacturer received before the availability of the 2024–2025 COVID-19 vaccines and includes original, bivalent, and 2023–2024 COVID-19 vaccines.}}

^{‡_{Dosage for Moderna: 0.25 mL/25 ug; dosage for Pfizer-BioNTech: 0.3 mL/10 ug.}}

^{§_{Additional doses may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.}}

^{¶_{This COVID-19 vaccine history refers to previous receipt of 3 doses of mRNA vaccine from the same manufacturer (i.e., Moderna or Pfizer-BioNTech) for initial vaccination followed by 1 or more additional doses of any mRNA vaccine.}}

2c: Ages 12 years and older

<sup>*<sub>Children who transition from age 11 years to age 12 years during the initial vaccination series should complete the 3-dose series using the dosage for people ages 12 years and older for all doses received on or after turning age 12 years:
- Moderna series: 2024–2025 Moderna, 0.5 mL/50ug
- Pfizer-BioNTech series: 2024–2025 Pfizer-BioNTech, 0.3 mL/30 ug</sub></sup>

^{†_{COVID-19 vaccination history refers to all doses of COVID-19 vaccine from any manufacturer received before the availability of the 2024–2025 COVID-19 vaccines and includes original, bivalent, and 2023–2024 COVID-19 vaccines.}}

^{‡_{People ages 18 years and older who received 1 or more doses of Janssen COVID-19 Vaccine should receive 1 dose of any 2024–2025 COVID-19 followed by a second dose of any 2024–2025 COVID-19 vaccine 6 months (minimum interval 2 months) after the first dose. Additional doses of any 2024–2025 COVID-19 vaccine may be administered under shared clinical decision-making at least 2 months after last dose of any 2024–2025 vaccine.}}

^{§_{Dosage for Moderna: 0.5 mL/50 ug; dosage for Novavax: 0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant; dosage for Pfizer-BioNTech: 0.3 mL/30 ug.}}

^{¶_{Additional doses may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.}}

^{#_{This COVID-19 vaccine history refers to previous receipt of 3 doses of mRNA vaccine from the same manufacturer (i.e., Moderna or Pfizer-BioNTech) for initial vaccination or 2 doses of Novavax for initial vaccination followed by 1 or more additional doses of any COVID-19 vaccine.}}

Development of moderate or severe immunocompromise after vaccination: People who were vaccinated for COVID-19 and subsequently become moderately or severely immunocompromised should follow the COVID-19 vaccination schedule according to their age and prior COVID-19 vaccination history (Table 2); see Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies for vaccination of people who will shortly become moderately or severely immunocompromised (e.g., prior to organ transplant) and Considerations for COVID-19 revaccination.

COVID-19 vaccination and pemivibart

Pemivibart (Pemgarda™) is a monoclonal antibody for COVID-19 pre-exposure prophylaxis in people who are moderately or severely immunocompromised and unlikely to mount an adequate immune response to COVID-19 vaccination and who meet the . Pemivibart is not authorized for treatment of COVID-19 or for post-exposure prophylaxis. Healthcare providers should consult the pemivibart and for additional information.

Pemivibart is not a substitute for COVID-19 vaccination. People who are moderately or severely immunocompromised should receive COVID-19 vaccine according to the recommended schedule. Per the (EUA), administration of pemivibart should be deferred for at least 2 weeks after a dose of COVID-19 vaccine.

Description of moderate and severe immunocompromising conditions and treatment

Moderate and severe immunocompromising conditions and treatments but are not limited to:

• Active treatment for solid tumor and hematologic malignancies
• Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
• Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy
• Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy)
• Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
• Advanced HIV infection (people with HIV and CD4 cell counts less than 200/mm³, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) or untreated HIV infection
• Active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell-depleting agents)

Factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment.

For additional information about the degree of immune suppression associated with different medical conditions and treatments, providers can consult General Best Practices for Immunizations, the , and the Infectious Diseases Society of America policy statement, .

Self-attestation of immunocompromised status

People can self-attest to their moderately or severely immunocompromised status and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation.

Considerations for COVID-19 revaccination

Recipients of HCT or CAR-T-cell therapy who received 1 or more doses of COVID-19 vaccine prior to or during treatment should be revaccinated. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy and should follow the currently recommended schedule for people who are unvaccinated (Table 2).

Revaccination may also be considered for patients who received 1 or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab) that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies) according to the currently recommended schedule (Table 2). The suggested interval to start revaccination is about 6 months after completion of the B-cell-depleting therapy. Timing of vaccination for patients who receive B-cell-depleting therapies on a continuing basis (e.g., for treatment of certain autoimmune conditions such as rheumatoid arthritis or multiple sclerosis) is addressed in Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies.

A patient's clinical team is best positioned to determine the degree of immune compromise, need for revaccination, and appropriate timing of revaccination.

Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies

Administration of COVID-19 vaccines should not be delayed in patients taking immunosuppressive therapies. Whenever possible, COVID-19 vaccines should be administered at least 2 weeks before initiation or resumption of immunosuppressive therapies. For patients who receive B-cell-depleting therapies on a continuing basis, COVID-19 vaccines should be administered approximately 4 weeks before the next scheduled therapy.

Timing of COVID-19 vaccination should take into consideration:

• Current or planned immunosuppressive therapies
• Optimization of both the patient's medical condition and anticipated response to vaccination
• Individual benefits and risks

On a case-by-case basis, providers caring for these patients may administer Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines outside of the FDA and obÌåÓý dosing intervals when, based on their clinical judgment, the benefits of vaccination are deemed to outweigh the potential and unknown risks for the recipient who is immunocompromised.

The utility of serologic testing, cellular immune testing, or B-cell quantification to assess immune response to vaccination and guide clinical care has not been established. Such testing outside of the context of research studies is not recommended at this time.