Moderna COVID-19 Vaccine
Moderna COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age
On September 11, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Moderna COVID-19 Vaccine to include the 2023-2024 formula. The Moderna COVID-19 Vaccine (2023-2024 Formula) includes a monovalent (single) component that corresponds to the Omicron variant XBB.1.5 of SARS-CoV-2. The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19. The Moderna COVID-19 Vaccine, Bivalent is no longer authorized for use in the United States.
Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for use as follows:
Individuals 6 months through 4 years of age:
- Unvaccinated individuals: Two doses of Moderna COVID-19 Vaccine (2023-2024 Formula) are administered. The second dose is administered 1 month after the first.
- Individuals who have received one dose of any Moderna COVID-19 Vaccine, including Moderna COVID-19 Vaccine, Bivalent: A single dose of Moderna COVID-19 Vaccine (2023-2024 Formula) is administered 1 month after the previous dose.
- Individuals who have received two or more doses of any Moderna COVID-19 Vaccine, including Moderna COVID-19 Vaccine, Bivalent: A single dose of Moderna COVID-19 Vaccine (2023-2024 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 (2023-2024 Formula). If previously vaccinated with any COVID-19 vaccine, 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 (2023-2024 Formula).
Moderna COVID-19 Vaccine Fact Sheets and Materials
| Material | Audience | Last Updated |
|---|---|---|
| Fact Sheet | Recipient and Caregiver | September 11, 2023 |
| Fact Sheet | Healthcare Providers | November 1, 2023 |
| Dear Healthcare Provider Letter | Healthcare Professionals | November 1, 2023 |
| Dear Healthcare Provider Letter | Healthcare Professionals | September 11, 2023 |
Moderna COVID-19 Vaccine Regulatory Information (Emergency Use Authorization)
| Information | Date |
|---|---|
| Granting Letter | November 1, 2023 |
| Granting Letter | October 13, 2023 |
| Decision Memorandum | September 11, 2023 |
| Letter of Authorization (Reissued) | September 11, 2023 |
Federal Register Notices
| Title | Date |
|---|---|
| Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability | January 19, 2021 |
Translations of the Fact Sheet for Recipients and Caregivers
| 关于具有紧急使用授权（EUA）的预防2019年冠状病毒疾病(Covid-19)的 莫德纳二价疫苗的受种者和照顾者情况说明书 (September 11, 2023) |
中文 (Chinese, Simplified) |
| 코로나바이러스 감염증 2019(코로나19) 예방을 위한 긴급사용승인(EUA)을 받은 모더나 코로나19 2가 백신 접종자 및 보호자를 위한 사실 보고서 (September 11, 2023) |
한국어 (Korean) |
| HOJA DE INFORMACIÓN PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA BIVALENTE CONTRA EL COVID-19 DE MODERNA QUE CUENTA CON AUTORIZACIÓN DE USO DE EMERGENCIA (EUA) PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) (September 11, 2023) |
Español (Spanish) |
| FACT SHEET PARA SA MGA TUMATANGGAP AT TAGAPAG-ALAGA TUNGKOL SA BAKUNANG MODERNA PARA SA COVID-19 NA BIVALENT ALIN ANG MAY AWTORISASYON PARA SA PANG-EMERHENSYANG PAGGAMIT (EUA) PARA MAIWASAN ANG SAKIT NA CORONAVIRUS 2019 (COVID-19) (September 11, 2023) |
Tagalog (Tagalog) |
| TỜ THÔNG TIN DÀNH CHO NGƯỜI NHẬN VẮC-XIN VÀ NGƯỜI CHĂM SÓC VỀ VẮC-XIN NGỪA COVID-19 MODERNA, LƯỠNG TRỊ GIẤY PHÉP SỬ DỤNG KHẨN CẤP (EUA) ĐỂ PHÒNG CHỐNG BỆNH VI-RÚT CORONA 2019 (COVID-19) (September 11, 2023) |
Tiếng Việt (Vietnamese) |