Novavax’s updated protein-based COVID vaccine finally authorized by FDA

Enlarge / The Novavax Inc. Nuvaxovid COVID-19 vaccine. (credit: Getty | Bloomberg )

Novavax’s updated protein-based COVID-19 vaccine has finally won authorization from the Food and Drug Administration, a late-coming achievement that provides Americans with their only alternative to mRNA-based shots for the fall booster campaign now underway.

While the FDA’s authorization was announced Tuesday afternoon, the Centers for Disease Control and Prevention has already signed off on recommending the shot. Its September 12 recommendation that all Americans ages six months and up get an updated COVID-19 vaccine was a blanket recommendation for any updated shots authorized or approved by the FDA, which now includes Novavax. The vaccine will be available to everyone ages 12 and up.

The Novavax vaccine uses a traditional protein subunit-based design; it directly introduces the SARS-CoV-2 spike protein to our cells along with an established adjuvant that enhances immune responses. The spike protein is a key outer protein the virus uses to get into human cells. The mRNA vaccines, by contrast, are a newer design that introduces the genetic code for the spike protein, which the cells then translate into protein on their own. In either case, with a disembodied spike protein, the immune system gets a chance to identify and train defensive responses against the pandemic pathogen before a live SARS-CoV-2 virus comes knocking.