![]() 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. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. In making this determination, the FDA can assure the public and medical community that a thorough analysis and evaluation of the available safety and effectiveness data and manufacturing information have been conducted. The data support that the known and potential benefits of the vaccine outweigh its known and potential risks in people 18 years of age and older, and that this vaccine may be effective in preventing COVID-19. The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted has met the statutory criteria for issuance of an EUA. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.” ![]() “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. “Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
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