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: 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 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)
Regulatory Information (Emergency Use Authorization)
Federal Register Notices
Translations of the Fact Sheet for Recipients and Caregivers
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Content current as of:
08/30/2024
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