Shares of Novavax (NVAX 6.60%) were rising 2.8% as of 11:30 a.m. EDT on Tuesday after moving as much as 5% higher earlier in the day. The gains came after the U.S. Centers for Disease Control and Prevention (CDC) provided updated guidance that participants in Novavax's phase 3 clinical trial of its COVID-19 vaccine candidate who received two doses meet the criteria for being considered fully vaccinated.
The CDC was clear that its updated guidance doesn't imply in any way that Novavax's vaccine, NVX-CoV2373, has been authorized by the Food and Drug Administration or has been recommended by the CDC or its Advisory Committee on Immunization Practices. With this in mind, nothing has materially changed for Novavax.
However, the CDC's update is certainly helpful for anyone who participated in Novavax's late-stage U.S. study. It's also arguably a feather in Novavax's cap that the company was the only vaccine maker singled out in the CDC's guidance revision.
Novavax still expects to file for Emergency Use Authorization (EUA) in the U.K. in the third quarter of this year, with submissions in Europe, Canada, Australia, and New Zealand soon thereafter. Another big potential catalyst for the vaccine stock will come in the fourth quarter with Novavax's anticipated EUA filing in the U.S.