Update on BLA seeking FDA approval for COVID 19 Vaccine- Novavax

Novavax can confirm that April 1, 2025, was the FDA’s Prescription Drug User Fee Act date for  Biologics License Application (BLA) seeking the approval of its COVID-19 Vaccine. As of Tuesday, April 1, the company had responded to all of the FDA’s information requests and  believes that our BLA is ready for approval. As of today, we continue to wait on action from the agency and have not yet received an official decision from the. FDA.. Our application included robust Phase III clinical trial data that showed the vaccine is safe and effective for the prevention of COVID-19. The company  is confident its well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.

Novavax believes that its r Biologics License Application (BLA) is approvable based on conversations with the FDA, as of the Prescription Drug User Fee Act (PDUFA) date of April 1  Novavax have recently received formal communication from the FDA in the form of an information request for a post-marketing commitment (PMC) to generate additional clinical data. The company looks forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.