Novavax believes BLA ‘ready for approval,’ waiting on action from FDA

Novavax (NVAX) issued the following update on the FDA BLA for the company’s COVID-19 vaccine: “Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration’s Prescription Drug User Fee Act date for our Biologics License Application seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe 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 U.S. FDA. Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.”