FDA grants EUA for Novavax COVID jab

July 14, 2022

The U.S. FDA has granted Novavax emergency use authorization for its COVID jab, Adjuvanted. 

The vaccine is a two-dose series administered three weeks apart, now authorized for the prevention of COVID-19 in individuals 18 and older. To make the determination, the FDA assessed data from an ongoing randomized, blinded, placebo-controlled study in which the shots proved to be 90.4% effective in preventing mild, moderate, or severe COVID-19. The trial included 26,000 participants who received the vaccine and 25,000 who received a placebo. 

Novavax’s Adjuvanted is different from other COVID jabs on the market in that it’s a protein vaccine. It contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. The spike protein is produced in insect cells and the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile. These adjuvants help enhance immune response through a number of mechanisms, including recruiting immune cells, enhancing antigen uptake and presentation as well as promoting antigen transport to lymph nodes. 

“Novavax COVID-19 vaccine, Adjuvanted, provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States,” said Peter Marks, director of the 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.”

The authorization comes as a small win for Novavax, as the journey brought many manufacturing and trial recruitment hurdles.