Recommendations of the Advisory Committee on Immunization Practices for Use of Cholera Vaccine

Cholera, caused by infection with toxigenic Vibrio cholerae bacteria of serogroup O1 (>99% of global cases) or O139, is characterized by watery diarrhea that can be severe and rapidly fatal without prompt rehydration. Cholera is endemic in approximately 60 countries and causes epidemics as well. Globally, cholera results in an estimated 2.9 million cases of disease and 95,000 deaths annually (1). Cholera is rare in the United States, and most U.S. cases occur among travelers to countries where cholera is endemic or epidemic. Forty-two U.S. cases were reported in 2011 after a cholera epidemic began in Haiti (2); however, <25 cases per year have been reported in the United States since 2012.

In 2016, lyophilized CVD 103-HgR (Vaxchora, PaxVax, Redwood City, California), a single-dose, live attenuated oral cholera vaccine, was approved by the Food and Drug Administration for the prevention of cholera caused by V. cholerae O1 in adults traveling to cholera-affected areas. Lyophilized CVD 103-HgR is the only cholera vaccine licensed for use in the United States. In June 2016, the Advisory Committee on Immunization Practices (ACIP) voted to recommend use of lyophilized CVD 103-HgR for prevention of cholera among adult travelers to areas with endemic or epidemic cholera caused by toxigenic V. cholerae O1, including areas with cholera activity during the last year that are prone to recurrence of cholera epidemics. ACIP considered evidence on safety and efficacy of the currently available formulation of CVD 103-HgR as well as that of a previously available formulation with identical phenotypic and genomic properties that was licensed and marketed in other industrialized countries before manufacture ceased in 2003 for business reasons (i.e., not because of safety or efficacy concerns) (3,4). This report provides new recommendations and guidance for vaccination providers and travelers about the use of lyophilized CVD 103-HgR. These recommendations apply to adults aged 18–64 years traveling to areas with endemic or epidemic cholera.