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  1. Coronavirus Disease 2019 (COVID-19)

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)

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
(August 19, 2022)
中文 (Chinese, Simplified)
환자와 의료진을 위한 정보지
(August 19, 2022)
한국어 (Korean)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO
(August 19, 2022)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA
(August 19, 2022)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(August 19, 2022)
Tiếng Việt (Vietnamese)

 

 

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