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  1. Coronavirus Disease 2019 (COVID-19)

Novavax COVID-19 Vaccine, Adjuvanted

July 13, 2022: FDA authorizes emergency use of Novavax COVID-19 Vaccine, Adjuvanted. Read the press release.

Novavax COVID-19 Vaccine, Adjuvanted is available under EUA to prevent COVID-19 in individuals 12 years of age and older.

The vaccine is authorized for emergency use as a two-dose primary series. The two doses are given three weeks apart.

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.

Common Side Effects

The most commonly reported side effects by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever. Read more about side effects on the Fact Sheet for Recipients and Caregivers.

Fact Sheets (English)

Regulatory Information

Information Date
Letter of Authorization (reissued) 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
(July 13, 2022)
中文 (Chinese, Simplified)
환자와 의료진을 위한 정보지
(July 13, 2022)
한국어 (Korean)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO
(July 13, 2022)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA
(July 13, 2022)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(July 13, 2022)
Tiếng Việt (Vietnamese)

 

 

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