FDA on June 10 approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera. Often cholera is mild; however, severe cholera is characterized by profuse diarrhea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. "The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by CDC for travelers to cholera-affected regions," said Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research. Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area. Vaxchora’s efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 U.S. volunteers from 18 through 45 years of age. Of the 197 volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae, the bacterium that causes cholera. Vaxchora efficacy was 90% among those challenged 10 days after vaccination and 80% among those challenged 3 months after vaccination. Vaxchora is manufactured by PaxVax.