23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, as of our PDUFA date of April 1 2025 and through today.

We have recently received formal communication from the FDA in the form of an information request for a post-marketing commitment to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the post-marketing commitment request and move to approval as soon as possible.

Read Novavax press release