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                Coronavirus (COVID-19) | CBER-Regulated Biologics

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          Moderna COVID-19 VaccineCoronavirus (COVID-19) | CBER-Regulated Biologics Moderna COVID-19 Vaccine
  
  					Moderna COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age
	
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    PrintFact Sheets Fact Sheet Translations Vacunas contra el COVID-19

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 UpdatedFact Sheet
			Recipient and Caregiver
			September 11, 2023Fact Sheet
			Healthcare Providers
			November 1, 2023Dear Healthcare Provider Letter
			Healthcare Professionals
			November 1, 2023Dear Healthcare Provider Letter
			Healthcare Professionals
			September 11, 2023

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

Information
			DateGranting Letter
			November 1, 2023Granting Letter
			October 13, 2023Decision Memorandum
			September 11, 2023Letter of Authorization (Reissued)
			September 11, 2023

Federal Register Notices

Title
			DateAuthorizations 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)

                                                                                  Content current as of:
      11/01/2023
              
              
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			  Infectious Disease
			    			       			    			       CoronavirusCoronavirus (COVID-19) | CBER-Regulated Biologics
 
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