Valneva reports FDA Fast Track Designation for shigella vaccine candidate

Valneva SE and LimmaTech Biologics AG announced that the U.S. Food and Drug Administration has granted Fast Track designation to Shigella4V, or S4V, which the companies call “the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate,” for which Valneva obtained an exclusive worldwide license from LimmaTech. Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization. Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease.”