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Introduction

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 obÌåÓý
• COVID-19 vaccine  (licensure) under a  (BLA) or authorization under an  (EUA) by the U.S. Food and Drug Administration (FDA)
• obÌåÓý's Emergency Use Instructions (EUI) for FDA-approved vaccines
• The World Health Organization's (WHO)  (EUL) or  of COVID-19 vaccines
• General Best Practices for Immunization

Types of COVID-19 vaccines

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

• mRNA vaccines
  • is authorized for children ages 6 months–11 years; 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.
  • is authorized for children ages 6 months–11 years; 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
  • 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 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. obÌåÓý recommends that people stay up to date with COVID-19 vaccination.

obÌåÓý 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 women to protect themselves and their infants.

Vaccine dosage and administration

General Best Practices 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 (Table 1 and Table 2).

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

Overview of the COVID-19 vaccination schedule

This section provides an overview of the recommendations for 2024–2025 COVID-19 vaccination. Detailed vaccination schedules, including age-appropriate vaccines, dosages, and intervals between doses, can be found in Table 1 for people vaccinated under the routine schedule (i.e., people who are not moderately or severely immunocompromised) and in Table 2 for people who are moderately or severely immunocompromised.

For recommendations for people who were vaccinated outside the United States, see page on Special Situations and Populations.

Routine COVID-19 vaccination

• Children ages 6 months–4 years:
  • Unvaccinated: Should receive a multidose initial series with a 2024–2025 mRNA vaccine.
  • Previously completed an initial series: Should receive 1 dose of a 2024–2025 mRNA vaccine from the same manufacturer as the initial series.
  • Initiated but did not complete an initial series: Consult Table 1.
• People ages 5–64 years:
  • Should receive 1 dose of an age-appropriate 2024–2025 COVID-19 vaccine.
  • People ages 12–64 years who are unvaccinated and receive the 2024–2025 Novavax COVID-19 Vaccine for initial vaccination should receive 2 doses of 2024–2025 Novavax COVID-19 Vaccine.
• People ages 65 years and older:
  • Should receive 2 doses of any 2024–2025 COVID-19 vaccine, spaced 6 months (minimum interval 2 months) apart.
  • People ages 65 years and older who are unvaccinated and receive Novavax COVID-19 Vaccine for initial vaccination should receive 2 doses of 2024–2025 Novavax COVID-19 Vaccine followed by a third dose of any 2024–2025 COVID-19 vaccine dose 6 months (minimum interval 2 months) after the second dose.

COVID-19 vaccination for people who are moderately or severely immunocompromised

• Unvaccinated: Should receive a multidose initial series with an age-appropriate 2024–2025 COVID-19 vaccine and 1 dose of a 2024–2025 COVID-19 vaccine 6 months (minimum interval 2 months) after completing the initial series.
• Previously completed an initial series: Should receive 2 doses of an age-appropriate 2024–2025 COVID-19 vaccine, spaced 6 months (minimum interval 2 months) apart.
• Initiated but did not complete an initial series: Consult Table 2.
• May receive additional age-appropriate 2024–2025 COVID-19 vaccine doses under shared clinical decision-making.