Novavax announced that they going to delay requesting Emergency Use Authorization, at least until June.
Their shares are down 31% over the last two days.
I haven’t been impressed by their published data, at least compared to the mRNA vaccines.
Unfortunate news. I’ve seen them expand their Phase 3 clinical trials multiple times and I’m not entirely certain as to why. They got hit with a manufacturing delay in October, multiple delays in their Phase 3 clinical trials, and now they’re hitting the problem of new cases bottoming out, which means not enough people in the trials are getting infected to successfully determine efficacy. So the results they expected at the beginning of April are now delayed until at least the end of May.
They have another unfortunate timing issue coming up as well: Pfizer and Moderna filing for full FDA approval. EUAs are typically contingent on there not being an approved alternative. Once Pfizer or Moderna gain full FDA approval, the EUA Novavax hasn’t even filed for yet may not be workable from a regulatory standpoint. They are really finding themselves in a very tight spot. At this point, they should be booking flights for their trial participants to go to COVID-19 hotspots. They need data and fast. (I’m joking, obviously)