Novavax‘s (NASDAQ: NVAX) investigational coronavirus vaccine is on its way to the big finish line: regulatory authorization. The company recently reported positive phase 3 data. And now, regulatory agencies in the U.S., Europe, the U.K., and Canada are conducting rolling reviews. If Novavax follows in the footsteps of more advanced rivals Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA), we could imagine a vaccine on the market in a matter of weeks.
But one element may hold Novavax back in the U.S. While the U.S. Food and Drug Administration (FDA) may still grant the candidate emergency use authorization (EUA), the agency might wait a bit longer to make its decision. Let’s take a closer look at why the FDA might take its time on this one — and what it means for Novavax investors.