FDA Grants EUA for Novavax COVID-19 Vaccine

Authorization is for adults 18 and older

FDA has issued an emergency use authorization (EUA) for the Novavax COVID-19 vaccine, adjuvanted for the prevention of COVID caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

The shot—the fourth in the US to receive such designation behind Pfizer-BioNTech, Moderna, and Johnson & Johnson—is to be administered as two separate doses, three weeks apart. The vaccine 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.

The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study conducted in the US and Mexico. The effectiveness of the vaccine was assessed in clinical trial participants 18 years of age and older who did not have evidence of SARS-CoV-2 infection through six days after receiving the second vaccine dose. Among these participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo.

Overall, the vaccine was 90.4% effective in preventing mild, moderate, or severe COVID, with 17 cases of COVID occurring in the vaccine group and 79 cases in the placebo group. No cases of moderate or severe COVID were reported in participants who received the vaccine, compared with nine cases of moderate COVID and four cases of severe COVID reported in placebo recipients.

In the subset of participants 65 years of age and older, the vaccine was 78.6% effective. It's important to note that the clinical trial was conducted before the emergence of the delta and omicron variants.

“ .. Novavax COVID-19 vaccine, adjuvanted provides another alternative for adults, and adds another vaccine to the COVID-19 vaccine supply for the United States,” says Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. “The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”