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