Summary by Futu AI
On November 11, 2024, Novavax, Inc., a biotechnology company specializing in the development of vaccines, announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination vaccine and its stand-alone influenza vaccine candidates. This clearance by the FDA allows Novavax to proceed with the planned Phase 3 clinical trial. The clinical hold, which was initially put in place on October 16, 2024, followed a report of a serious adverse event in a participant from a Phase 2 trial completed in 2023. Novavax provided additional information to the FDA, which led to the reclassification of the adverse event and the conclusion that it was not related to the vaccine. Novavax is now preparing to resume trial activities promptly. The company's Chief Medical Officer, Dr. Robert Walker, expressed gratitude towards the FDA for their cooperation and confirmed the company's intention to initiate the Phase 3 trial as soon as possible.
