Novavax COVID-19 Vaccine, Adjuvanted
Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older.
The vaccine is authorized for emergency use to provide:
- A two-dose primary series to individuals 12 years of age and older.
- A first booster dose to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:
- Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate.
- Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.
Fact Sheets (English)
Information | Last Updated |
---|---|
Fact Sheet for Healthcare Providers Administering Vaccine | October 19, 2022 |
Fact Sheet for Recipients and Caregivers | October 19, 2022 |
Regulatory Information
Information | Date |
---|---|
Decision Memorandum | October 19, 2022 |
Letter of Authorization (reissued) | October 19, 2022 |
Decision Memorandum | August 19, 2022 |
Decision Memorandum | July 13, 2022 |
Advisory Committee Meeting Information | June 7, 2022 |
Media Materials
Information | Date |
---|---|
FDA Roundup | August 19, 2022 |
Press Release | July 13, 2022 |
Advisory Committee Meeting Webcast | June 7, 2022 |
Translations of the Fact Sheet for Recipients and Caregivers
接受者和护理者须知 (October 19, 2022) |
中文 (Chinese, Simplified) |
환자와 의료진을 위한 정보지 (October 19, 2022) |
한국어 (Korean) |
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO (October 19, 2022) |
Español (Spanish) |
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA (October 19, 2022) |
Tagalog (Tagalog) |
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC (October 19, 2022) |
Tiếng Việt (Vietnamese) |