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                Coronavirus (COVID-19) | CBER-Regulated Biologics

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          Coronavirus (COVID-19) | CBER-Regulated Biologics
          Novavax COVID-19 Vaccine, AdjuvantedCoronavirus (COVID-19) | CBER-Regulated Biologics Novavax COVID-19 Vaccine, Adjuvanted
  
  					Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) Authorized For Individuals 12 Years of Age and Older
	
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    PrintFact Sheets Novavax Fact Sheet Translations Vacunas contra el COVID-19

On October 3, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Novavax COVID-19 Vaccine, Adjuvanted to include the 2023-2024 formula. The Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023-2024 formula). The Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.

Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is authorized for use in individuals 12 years of age and older as follows:

**Individuals previously vaccinated with any COVID-19 vaccine:** one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered at least 2 months after receipt of the last previous dose of an original monovalent (Original) or bivalent (Original and Omicron BA.4/BA.5) COVID-19 vaccine.
	**Individuals not previously vaccinated with any COVID-19 vaccine:**two doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) are administered three weeks apart.
	**Immunocompromised individuals**: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula).  Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.Fact Sheets (English)

Information
			Last UpdatedFact Sheet for Healthcare Providers Administering Vaccine
			October 3, 2023Fact Sheet for Recipients and Caregivers
			October 3, 2023

Regulatory Information (Emergency Use Authorization)

Information
			DateLetter of Authorization (Reissued)
			October 3, 2023Decision Memo - Novavax COVID-19 Vaccine, Adjuvanted
			October 3, 2023Advisory Committee Meeting Information
			June 7, 2022

Federal Register Notices

Title
			DateAuthorization of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability
			August 29, 2022

Translations of the Fact Sheet for Recipients and Caregivers

接受者和护理者须知
			(October 3, 2023)
			中文 (Chinese, Simplified)환자와 의료진을 위한 정보지
			(October 3, 2023)
			한국어 (Korean)HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO
			(October 3, 2023)
			Español (Spanish)FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA
			(October 3, 2023)
			Tagalog (Tagalog)TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
			(October 3, 2023)
			Tiếng Việt (Vietnamese)

                                                                                  Content current as of:
      10/17/2023
              
              
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			    			       			    			       CoronavirusCoronavirus (COVID-19) | CBER-Regulated Biologics
 
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