On August 22, 2024, the Food and Drug Administration amended the emergency use authorization (EUA) of Moderna COVID-19 Vaccine to include the 2024-2025 formula. The Moderna COVID-19 Vaccine (2024-2025 Formula) includes a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The Moderna COVID-19 Vaccine (2024-2025 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19.

Moderna COVID-19 Vaccine (2024-2025 Formula) is authorized for use as follows:

Individuals 6 months through 4 years of age:

• Unvaccinated individuals: Two doses of Moderna COVID-19 Vaccine (2024-2025 Formula) are administered. The second dose is administered 1 month after the first.
• Individuals who have received one previous dose of any Moderna COVID-19 Vaccine that is no longer authorized for use in the United States: A single dose of Moderna COVID-19 Vaccine (2024-2025 Formula) is administered 1 month after the previous dose.
• Individuals who have received two or more previous doses of any Moderna COVID-19 Vaccine that is no longer authorized for use in the United States: A single dose of Moderna COVID-19 Vaccine (2024-2025 Formula) is administered at least 2 months after the last previous dose.

Individuals 5 years through 11 years of age, regardless of vaccination status:

• A single dose of Moderna COVID-19 Vaccine (2024-2025 Formula). If previously vaccinated with any COVID-19 vaccine that is no longer authorized for use in the United States, administer at least 2 months after receipt of the last previous dose of any COVID-19 vaccine.

Immunocompromised individuals 6 months through 11 years of age:

• Complete at least a three-dose series with a COVID-19 vaccine, each dose one month apart. At least one dose should be with a COVID-19 vaccine (2024-2025 Formula).

Moderna COVID-19 Vaccine Fact Sheets and Materials

Moderna COVID-19 Vaccine Regulatory Information (Emergency Use Authorization)

Federal Register Notices