CBS NEWS – Following a long-awaited submission of data to the Food and Drug Administration last month, Novavax announced Monday that it had formally filed a request for emergency use authorization of its protein-based COVID-19 vaccine in the United States.
If greenlighted by the FDA, Novavax’s shots could be the first COVID-19 doses available in the U.S. based on a kind of “protein subunit” technology that has been used for decades in other routine vaccinations.
Officials say having this option could help persuade some remaining vaccine holdouts to get the shots, as well as boost the Biden administration’s international vaccine donation goals.
Novavax’s president and CEO Stanley Erck said in a statement announcing the submission:
“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,”
Novavax’s vaccine would be for people aged 18 and over. But the share of American adults left to vaccinate is shrinking. Close to 90% of U.S. adults already have at least one dose of COVID-19 vaccine, according to the Centers for Disease Control and Prevention.
The vast majority were vaccinated with the mRNA-based vaccines developed by Moderna or Pfizer and BioNTech, which have proven safe and effective at curbing COVID-19 cases and deaths in millions of Americans.
However, federal health officials have long said that protein-based vaccines might still have a path to authorization, in the hopes of persuading holdouts unwilling or unable to receive the mRNA shots.
Dr. Peter Marks, the FDA’s top vaccines official, said at a conference last year:
“There are some people in the United States who still will not take our mRNA vaccines and they are waiting for a protein-based vaccine. And for us, anything we can do to help get a larger portion of our population vaccinated is something that we need to do” …