Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States

These clinical considerations provide information to healthcare professionals and public health officials on use of COVID-19 vaccines. They are informed by:

• Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC)
• COVID-19 vaccine approval (licensure) under a Biologics License Application (BLA) or authorization under an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
• CDC’s Emergency Use Instructions (EUI) for FDA-approved vaccines
• The World Health Organization’s (WHO) Emergency Use Listing (EUL) or Prequalification of COVID-19 vaccines
• ACIP’s General Best Practice Guidelines for Immunization

COVID-19 vaccines

Two types of COVID-19 vaccines are recommended for use in the United States:

• mRNA vaccines
  • Moderna COVID-19 Vaccine (2024–2025 Formula) is authorized for children ages 6 months–11 years; SPIKEVAX is the licensed Moderna product for people ages 12 years and older. These vaccines are hereafter referred to as 2024–2025 Moderna COVID-19 Vaccine.
  • Pfizer-BioNTech COVID-19 Vaccine (2024–2025 Formula) is authorized for children ages 6 months–11 years; COMIRNATY is the licensed Pfizer-BioNTech product for people ages 12 years and older. These vaccines are hereafter referred to as 2024–2025 Pfizer-BioNTech COVID-19 Vaccine.
  • Protein subunit vaccine
    • Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula) is authorized for people ages 12 years and older. It is hereafter referred to as 2024–2025 Novavax COVID-19 Vaccine.

    The 2023–2024 Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines are no longer recommended and should not be used.

    There is no preferential recommendation for the use of any one COVID-19 vaccine over another when more than one recommended and age-appropriate vaccine is available.

    COVID-19 vaccine composition

    The 2024–2025 formulations for COVID-19 vaccines approved or authorized in the United States have been updated to a monovalent vaccine based on the Omicron JN.1-lineage of SARS-CoV-2, as follows:

    • Moderna and Pfizer-BioNTech: KP.2 strain
    • Novavax: JN.1 strain

    COVID-19 vaccine-specific package inserts and EUA fact sheets for healthcare providers (fact sheets) and U.S. COVID-19 Vaccine Product Information can be consulted for a full list of ingredients and information on the conditions of use, storage and handling, preparation, and administration procedures.

    Recommendations for the use of COVID-19 vaccines

    Groups recommended for vaccination

    COVID-19 vaccination is recommended for everyone ages 6 months and older in the United States for the prevention of COVID-19. There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children younger than age 6 months.

    CDC recommends that people receive all recommended COVID-19 vaccine doses. Vaccination is especially important for people at highest risk of severe COVID-19, including people ages 65 years and older; people with underlying medical conditions, including immune compromise; people living in long-term care facilities; and pregnant people to protect themselves and their infants.

    Vaccine dosage and administration

    General Best Practice Guidelines for Immunization apply to COVID-19 vaccination unless otherwise noted. People should receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination and follow the recommended dosing intervals (Table 1 and Table 2).

    COVID-19 vaccine doses should be administered by the intramuscular route.

    Overview of the COVID-19 vaccination schedule

    An overview of the 2024–2025 COVID-19 vaccination schedule is summarized below.

    For most people the minimum interval between their last 2023–2024 COVID-19 vaccine dose and their 2024–2025 COVID-19 vaccine dose is 8 weeks. However, there are exceptions for people who are completing a multidose initial vaccination series (i.e., children ages 6 months–4 years; people ages 6 months and older who are moderately or severely immunocompromised; and people ages 12 years and older who receive Novavax).

    Detailed vaccination schedules can be found in Table 1 for people who are not moderately or severely immunocompromised and in Table 2 for people who are moderately or severely immunocompromised. See Appendix A for recommendations for people who received COVID-19 vaccine outside the United States.

    Recommendations for people who are not moderately or severely immunocompromised

    Initial vaccination

    • Ages 6 months–4 years
      • 2 doses of 2024–­2025 Moderna OR
      • 3 doses of 2024–­2025 Pfizer-BioNTech
      • Ages 5–11 years
        • 1 dose of 2024–2025 Moderna OR
        • 1 dose of 2024–2025 Pfizer-BioNTech
        • Ages 12 years and older
          • 1 dose of 2024–2025 Moderna OR
          • 1 dose of 2024–2025 Pfizer-BioNTech OR
          • 2 doses of 2024–­2025 Novavax

          Received previous doses of a COVID-19 vaccine

          • Ages 6 months–4 years
            • 1 or 2 doses of 2024–­2025 mRNA vaccine from the same manufacturer as administered for initial vaccination, depending on the vaccine and the number of prior doses
            • Ages 5–11 years
              • 1 dose of 2024–­2025 Moderna OR
              • 1 dose of 2024–­2025 Pfizer-BioNTech
              • Ages 12 years and older
                • 1 dose of 2024–2025 Moderna OR
                • 1 dose of 2024–2025 Pfizer-BioNTech OR
                • 1 dose of 2024–2025 Novavax

                Recommendations for people who are moderately or severely immunocompromised

                Initial vaccination

                • Ages 6 months–4 years
                  • 3 doses of 2024–­2025 Moderna OR
                  • 3 doses of 2024–­2025 Pfizer-BioNTech
                  • Ages 5–11 years
                    • 3 doses of 2024–­2025 Moderna OR
                    • 3 doses of 2024–­2025 Pfizer-BioNTech
                    • Ages 12 years and older
                      • 3 doses of 2024–­2025 Moderna OR
                      • 3 doses of 2024–­2025 Pfizer-BioNTech OR
                      • 2 doses of 2024–­2025 Novavax

                      Received previous doses of a COVID-19 vaccine

                      • Recommended COVID-19 vaccine and number of 2024–­2025 doses are based on age and vaccination history

                      Additional doses: People who are moderately or severely immunocompromised ages 6 months and older may receive 1 or more age-appropriate additional doses of a 2024–2025 COVID-19 vaccine.

                      COVID-19 vaccination guidance for people who are not moderately or severely immunocompromised

                      The COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised is detailed in Table 1. The recommended vaccine and number of 2024–2025 COVID-19 vaccine doses are based on age and vaccination history.

                      Table 1. People who are not moderately or severely immunocompromised: Recommended COVID-19 vaccination schedule by COVID-19 vaccination history, September 6, 2024

                      Ages 6 months–4 years

                      • All COVID-19 vaccine doses in this age group should be from the same manufacturer; see Interchangeability of COVID-19 vaccines for information on circumstances in which vaccine from a different manufacturer may be considered.
                      Ages 6 months–4 years

                      COVID-19 vaccination history	2024–2025 vaccine	Number of 2024–2025 vaccine doses indicated	Dosage (mL/ug)	Interval between doses
                      Unvaccinated	Moderna	2	0.25 mL/25 ug	Dose 1: Day 0 Dose 2: 4–8 weeks after Dose 1*
                      	OR
                      	Pfizer-BioNTech	3	0.3 mL/3 ug	Dose 1: Day 0 Dose 2: 3–8 weeks after Dose 1* Dose 3: At least 8 weeks after Dose 2
                      1 dose any Moderna	Moderna	1	0.25 mL/25 ug	Dose 2: 4–8 weeks after Dose 1*
                      2 or more doses any Moderna, NOT including at least 1 dose 2024–2025 Moderna	Moderna	1	0.25 mL/25 ug	At least 8 weeks after last dose
                      2 or more doses any Moderna, INCLUDING at least 1 dose 2024–2025 Moderna	No further doses indicated
                      1 dose any Pfizer-BioNTech	Pfizer-BioNTech	2	0.3 mL/3 ug	Dose 2: 3–8 weeks after Dose 1* Dose 3: At least 8 weeks after Dose 2
                      2 doses any Pfizer-BioNTech	Pfizer-BioNTech	1	0.3 mL/3 ug	Dose 3: At least 8 weeks after Dose 2
                      3 or more doses any Pfizer-BioNTech, NOT including at least 1 dose 2024–2025 Pfizer-BioNTech	Pfizer-BioNTech	1	0.3 mL/3 ug	At least 8 weeks after last dose
                      3 or more doses any Pfizer-BioNTech, INCLUDING at least 1 dose 2024–2025 Pfizer-BioNTech	No further doses indicated

                      • See footnote † for guidance on children who transition from age 4 years to age 5 years during the initial vaccination series.
                      Ages 5–11 years

                      COVID-19 vaccination history	2024–2025 vaccine	Number of 2024–2025 doses indicated	Dosage (mL/ug)	Interval between doses
                      Unvaccinated	Moderna	1	0.25 mL/25 ug	—
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/10 ug	—
                      1 or more doses any mRNA, NOT including 1 dose any 2024–2025 mRNA vaccine	Moderna	1	0.25 mL/25 ug	At least 8 weeks after last dose
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/10 ug	At least 8 weeks after last dose
                      1 or more doses any mRNA, INCLUDING 1 dose any 2024–2025 mRNA vaccine	No further doses indicated

                      Ages 12 years and older

                      Ages 12 years and older

                      COVID-19 vaccination history §	2024–2025 vaccine	Number of 2024–2025 doses indicated	Dosage (mL/ug)	Interval between doses
                      Unvaccinated	Moderna	1	0.5 mL/50 ug	—
                      	OR
                      	Novavax	2	0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant	Dose 1: Day 0 Dose 2: 3–8 weeks after Dose 1 *
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/30 ug	—
                      1 or more doses any mRNA, NOT including 1 dose any 2024–2025 COVID-19 vaccine	Moderna	1	0.5 mL/50 ug	At least 8 weeks after last dose
                      	OR
                      	Novavax	1	0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant	At least 8 weeks after last dose
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/30 ug	At least 8 weeks after last dose
                      1 or more doses any mRNA, INCLUDING 1 dose any 2024–2025 COVID-19 vaccine	No further doses indicated
                      1 dose any Novavax	Novavax	1	0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant	Dose 2: 3–8 weeks after Dose 1* ‡
                      2 or more doses any Novavax, NOT including 1 dose any 2024–2025 COVID-19 vaccine	Moderna	1	0.5 mL/50 ug	At least 8 weeks after last dose
                      	OR
                      	Novavax	1	0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant	At least 8 weeks after last dose
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/30 ug	At least 8 weeks after last dose
                      2 or more doses any Novavax, INCLUDING 1 dose any 2024–2025 COVID-19 vaccine	No further doses indicated

                      * An 8-week interval between the first and second COVID-19 vaccine (Moderna, Novavax, and Pfizer-BioNTech) doses might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with these vaccines.

                      † Children who transition from age 4 years to age 5 years during the initial vaccination series should receive 1 dose of vaccine from the same manufacturer at the dosage for children ages 5–11 years on or after turning age 5 years:

                      • Moderna: 1 dose of 2024–2025 Moderna (0.25 mL/25 ug) 4–8 weeks after the first dose; there is no dosage change.
                      • Pfizer-BioNTech: 1 dose of 2024–2025 Pfizer-BioNTech (0.3 mL/10 ug). If the 10 ug dose is the second dose, administer 3–8 weeks after the first dose; if it is the third dose, administer at least 8 weeks after the second dose.
                      • Note: If more than 8 weeks have elapsed since receipt of the last dose of mRNA COVID-19 vaccine at the dosage for children ages 6 months–4 years, either 2024–2025 mRNA COVID-19 vaccine (Moderna, Pfizer-BioNTech) may be administered at the dosage for children ages 5–11 years.

                      ‡ If more than 8 weeks have elapsed since receipt of the first dose of Novavax, any 2024–2025 COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer-BioNTech) may be administered.

                      § People ages 18 years and older who received 1 or more doses of Janssen COVID-19 Vaccine, NOT including 1 dose of any 2024–2025 COVID-19 vaccine, should receive 1 dose of any 2024–2025 COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer-BioNTech) at least 8 weeks after the last dose.

                      Considerations for extended intervals for COVID-19 vaccine doses

                      An 8-week interval between the first and second mRNA COVID-19 vaccine (Moderna, Pfizer-BioNTech) doses and between the first and second doses of Novavax COVID-19 Vaccine might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with these COVID-19 vaccines.

                      While absolute risk remains small, an elevated risk for myocarditis and pericarditis has been observed among mRNA COVID-19 vaccine recipients, particularly in males ages 12–39 years (see COVID-19 vaccination and myocarditis and pericarditis for additional information). Cases of myocarditis and pericarditis were identified in clinical trials of Novavax COVID-19 Vaccine and through passive surveillance during post-authorization use outside the United States.

                      Under the current COVID-19 vaccination schedule (Table 1), the extended interval consideration applies only to the following people who are not moderately or severely immunocompromised:

                      • Ages 6 months–4 years, depending on their vaccination history
                      • Ages 12 years–64 years and receiving a 2-dose Novavax series

                      The minimum interval between the first and second doses continues to be recommended for:

                      • People who are moderately or severely immunocompromised
                      • People ages 65 years and older receiving Novavax vaccine
                      • Situations when the fullest possible protection needs to be achieved sooner (e.g., increased concern about an individual’s higher risk for severe disease)

                      COVID-19 vaccination guidance for people who are moderately or severely immunocompromised including additional doses

                      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. 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.

                      Additional doses: People who are moderately or severely immunocompromised may receive 1 or more age-appropriate additional dose(s) of 2024–2025 COVID-19 vaccine after the last 2024–2025 COVID-19 vaccine dose indicated in Table 2. For detailed guidance on administration of additional doses, consult Table 2.

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

                      Table 2. People who are moderately or severely immunocompromised: Recommended COVID-19 vaccination schedule by COVID-19 vaccination history, September 6, 2024

                      Ages 6 months–4 years

                      Ages 6 months–4 years

                      COVID-19 vaccination history	2024–2025 vaccine	Number of 2024–2025 doses indicated	Dosage (mL/ug)	Interval between doses
                      Unvaccinated	Moderna	3	0.25 mL/25 ug	Dose 1: Day 0 Dose 2: 4 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      	OR
                      	Pfizer-BioNTech	3	0.3 mL/3 ug	Dose 1: Day 0 Dose 2: 3 weeks after Dose 1 Dose 3: At least 8 weeks after Dose 2 See additional doses
                      1 dose any Moderna	Moderna	2	0.25 mL/25 ug	Dose 2: 4 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      2 doses any Moderna	Moderna	1	0.25 mL/25 ug	Dose 3: At least 4 weeks after Dose 2 See additional doses
                      3 or more doses any Moderna, NOT including at least 1 dose 2024–2025 Moderna	Moderna	1	0.25 mL/25 ug	At least 8 weeks after last dose See additional doses
                      3 or more doses any Moderna, INCLUDING at least 1 dose 2024–2025 Moderna	See additional doses
                      1 dose any Pfizer-BioNTech	Pfizer-BioNTech	2	0.3 mL/3 ug	Dose 2: 3 weeks after Dose 1 Dose 3: At least 8 weeks after Dose 2 See additional doses
                      2 doses any Pfizer-BioNTech	Pfizer-BioNTech	1	0.3 mL/3 ug	Dose 3: At least 8 weeks after Dose 2 See additional doses
                      3 or more doses any Pfizer-BioNTech, NOT including at least 1 dose 2024–2025 Pfizer-BioNTech	Pfizer-BioNTech	1	0.3 mL/3 ug	At least 8 weeks after last dose See additional doses
                      3 or more doses any Pfizer-BioNTech, INCLUDING at least 1 dose 2024–2025 Pfizer-BioNTech	See additional doses
                      ADDITIONAL DOSES: Children in this age group may receive 1 additional dose of 2024–2025 mRNA COVID-19 vaccine from the same manufacturer as the initial series at least 2 months after the last 2024–2025 mRNA vaccine dose indicated in the table. Further additional 2024–2025 mRNA dose(s) may be administered from the same manufacturer, informed by the clinical judgment of a healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last 2024–2025 mRNA vaccine dose.

                      • See footnote* for guidance on children who transition from age 4 years to age 5 years during the initial vaccination series.
                      Age 5-11 years

                      COVID-19 vaccination history	2024-2025 vaccine	Number of 2024-2025 doses indicated	Dosage (mL/ug)	Interval between doses
                      Unvaccinated	Moderna	3	0.25 mL/25 ug	Dose 1: Day 0 Dose 2: 4 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      	OR
                      	Pfizer-BioNTech	3	0.3 mL/10 ug	Dose 1: Day 0 Dose 2: 3 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      1 dose any Moderna	Moderna	2	0.25 mL/25 ug	Dose 2: 4 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      2 doses any Moderna	Moderna	1	0.25 mL/25 ug	Dose 3: At least 4 weeks after Dose 2 See additional doses
                      1 dose any Pfizer-BioNTech	Pfizer-BioNTech	2	0.3 mL/10 ug	Dose 2: 3 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      2 doses any Pfizer-BioNTech	Pfizer-BioNTech	1	0.3 mL/10 ug	Dose 3: At least 4 weeks after Dose 2 See additional doses
                      3 or more doses any Moderna or 3 or more doses any Pfizer-BioNTech, NOT including at least 1 dose any 2024–2025 mRNA vaccine†	Moderna	1	0.25 mL/25 ug	At least 8 weeks after last dose See additional doses
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/10 ug	At least 8 weeks after last dose See additional doses
                      3 or more doses any mRNA vaccine, INCLUDING at least 1 dose any 2024–2025 mRNA vaccine	See additional doses
                      ADDITIONAL DOSES: Children in this age group may receive 1 additional dose of 2024–2025 mRNA COVID-19 vaccine (either Moderna or Pfizer-BioNTech, regardless of the manufacturer for the initial series) at least 2 months after the last 2024–2025 mRNA vaccine dose indicated in the table. Further additional mRNA dose(s) may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last 2024–2025 mRNA vaccine dose.

                      *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

                      † 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 either Moderna or Pfizer-BioNTech, excluding receipt of 2024–2025 mRNA vaccine for any previous doses.

                      Ages 12 years and older

                      • See footnote* for guidance on children who transition from age 11 years to age 12 years during the initial vaccination series.
                      Ages 12 years and older

                      COVID-19 vaccination history †	Updated 2024-2025 vaccine	Number of 2024-2025 doses indicated	Dosage (mL/ug)	Interval between doses
                      Unvaccinated	Moderna	3	0.5 mL/50 ug	Dose 1: Day 0 Dose 2: 4 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      	OR
                      	Novavax	2	0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant	Dose 1: Day 0 Dose 2: 3 weeks after Dose 1 See additional doses
                      	OR
                      	Pfizer-BioNTech	3	0.3 mL/30 ug	Dose 1: Day 0 Dose 2: 3 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      1 dose any Moderna	Moderna	2	0.5 mL/50 ug	Dose 2: 4 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      2 doses any Moderna	Moderna	1	0.5 mL/50 ug	Dose 3: At least 4 weeks after Dose 2 See additional doses
                      1 dose any Pfizer-BioNTech	Pfizer-BioNTech	2	0.3 mL/30 ug	Dose 2: 3 weeks after Dose 1 Dose 3: At least 4 weeks after Dose 2 See additional doses
                      2 doses any Pfizer-BioNTech	Pfizer-BioNTech	1	0.3 mL/30 ug	Dose 3: At least 4 weeks after Dose 2 See additional doses
                      3 or more doses any Moderna or 3 or more doses any Pfizer-BioNTech, NOT including at least 1 dose any 2024–2025 COVID-19 vaccine‡	Moderna	1	0.5 mL/50 ug	At least 8 weeks after last dose See additional doses
                      	OR
                      	Novavax	1	0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant	At least 8 weeks after last dose See additional doses
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/30 ug	At least 8 weeks after last dose See additional doses
                      3 or more doses any mRNA vaccine, INCLUDING at least 1 dose any 2024–2025 COVID-19 vaccine	See additional doses
                      1 dose any Novavax	Novavax	1	0.5 mL/5 ug rS protein and 50 ug	Dose 2: 3 weeks after Dose 1 See additional doses
                      2 or more doses any Novavax, NOT including 1 dose any 2024–2025 COVID-19 vaccine	Moderna	1	0.5 mL/50 ug	At least 8 weeks after last dose See additional doses
                      	OR
                      	Novavax	1	0.5 mL/5 ug rS protein and 50 ug	At least 8 weeks after last dose See additional doses
                      	OR
                      	Pfizer-BioNTech	1	0.3 mL/30 ug	At least 8 weeks after last dose See additional doses
                      2 or more doses any Novavax, INCLUDING 1 dose any 2024–2025 COVID-19 vaccine	See additional doses
                      ADDITIONAL DOSES: People in this age group may receive 1 additional dose of any 2024–2025 COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer-BioNTech, regardless of the manufacturer for the initial series) at least 2 months following the last recommended 2024–2025 vaccine dose. Further additional doses may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last 2024–2025 COVID-19 vaccine dose.

                      *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

                      † People ages 18 years and older who received 1 or more doses of Janssen COVID-19 Vaccine, NOT including 1 dose of any 2024–2025 COVID-19 vaccine, should receive 1 dose of any 2024–2025 COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer-BioNTech) at least 8 weeks after the last dose. Additional doses may then be administered following the guidance in the table.

                      ‡ 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 Moderna, Novavax, or Pfizer-BioNTech, excluding receipt of 2024–2025 vaccine for any previous doses.

                      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 FDA-authorized conditions for use . Pemivibart is not authorized for treatment of COVID-19 or for post-exposure prophylaxis. Healthcare providers should consult the pemivibart authorized conditions for use and EUA frequently asked questions for the FDA-authorized conditions under which pemivibart may be used.

                      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 pemivibart 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 include 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/mm 3 , 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 ACIP’s General Best Practice Guidelines for Immunizations, the CDC Yellow Book, and the Infectious Diseases Society of America policy statement, 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host .

                      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 CDC 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.