U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

Core Points - Novavax, Inc. has received clearance from the U.S. FDA to proceed with its Phase 3 trial for the COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates after addressing all clinical hold issues [1][2] - The clinical hold was initially imposed due to a serious adverse event reported during a Phase 2 trial, which was later determined to be unrelated to the vaccine [2] Company Overview - Novavax, Inc. is focused on developing innovative vaccines to combat serious infectious diseases, utilizing a recombinant protein approach and its patented Matrix-M adjuvant to enhance immune response [3] - The company's portfolio includes a COVID-19 vaccine and candidates for the CIC and stand-alone influenza vaccines, with its adjuvant also being used in other vaccine collaborations [3]