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Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) Authorized For Individuals 12 Years of Age and Older

Fact Sheets Novavax Fact Sheet Translations Vacunas contra el COVID-19

On August 30, 2024, the Food and Drug Administration amended the emergency use authorization (EUA) of Novavax COVID-19 Vaccine, Adjuvanted to include the 2024-2025 formula. The Novavax COVID-19 Vaccine, Adjuvanted, (2024-2025 Formula) includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2. The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use in the United States.

Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is authorized for use in individuals 12 years of age and older as follows:

  • Individuals who have never been vaccinated with any COVID-19 vaccine: two doses of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) are administered three weeks apart.
  • Individuals who have been vaccinated only with one dose of any Novavax COVID-19 Vaccine, Adjuvanted: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is administered at least 3 weeks after receipt of the previous dose.
  • Individuals who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of Novavax COVID-19 Vaccine, Adjuvanted: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) at least 2 months after the last dose of the COVID-19 vaccine.
  • Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 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 Updated
Fact Sheet for Healthcare Providers Administering Vaccine August 30, 2024
Fact Sheet for Recipients and Caregivers August 30, 2024

Regulatory Information (Emergency Use Authorization)

Information Date
Letter of Authorization (Reissued) August 30, 2024
Decision Memo - Novavax COVID-19 Vaccine, Adjuvanted August 30, 2024
Advisory Committee Meeting Information June 7, 2022

Federal Register Notices

Title Date
Authorization 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
 

受种人和照护者情况说明书
(August, 2024)		 中文 (Chinese, Simplified)
접종자와 보호자를 위한 팩트 시트
(August, 2024)		 한국어 (Korean)
FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA
(August, 2024)		 Tagalog (Tagalog)
TỜ THÔNG TIN DÀNH CHO NGƯỜI NHẬN VÀ NGƯỜI CHĂM SÓC
(August, 2024)		 Tiếng Việt (Vietnamese)

 

 

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