FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, adjuvanted, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The FDA states that the new vaccine has met the statutory criteria for issuance of an EUA in that the data support that the known and potential health benefits of the vaccine outweigh its known and potential risks in people 18 years of age and older, and that the vaccine may be effective in preventing COVID-19. “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 Novavax COVID-19 Vaccine, adjuvanted, is administered as a two-dose primary series, 3 weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. 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.

In a clinical trial, Novavax was 90.4% effective in preventing mild, moderate, or severe COVID-19. In the subset of participants 65 years of age and older, the vaccine was 78.6% effective. The clinical trial was conducted prior to the emergence of delta and omicron variants.

The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning that clinical trial data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted. The Fact Sheet for Recipients and Caregivers informs that in most people who have had myocarditis or pericarditis after receiving the vaccine, symptoms began within 10 days following vaccination and that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after vaccination: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart.