Age group | Outcome | Ranking |
---|---|---|
Adult (18–64 years) | Cholera death | Critical |
Cholera diarrhea, life threatening | Critical | |
Cholera diarrhea, severe | Critical | |
Cholera diarrhea, any severity | Important | |
Induction of vibriocidal antibody response | Important | |
Serious adverse events | Critical | |
Systemic adverse events | Critical | |
Impact on effectiveness of coadministered vaccines and medications | Critical | |
Pediatric (2–17 years) | Cholera diarrhea, moderate to severe | Critical |
Cholera diarrhea, any severity | Critical | |
Serious adverse events | Critical | |
Nonserious adverse events | Important |
TABLE 1. Outcomes and rankings used for GRADE assessments of lyophilized CVD 103-HgR vaccine, by age group — Advisory Committee on Immunization Practices Cholera Vaccine Work Groups, United States, 2015–2022
Abbreviations: GRADE = Grading of Recommendations, Assessment, Development, and Evaluation.
Work group | ACIP meeting topic | Date of presentation |
---|---|---|
Adult | Overview of cholera epidemiology and lyophilized CVD 103-HgR vaccine | October 2015 |
GRADE assessment | February 2016 | |
Proposed recommendations, public comment, and vote | June 2016 | |
Pediatric | Overview of cholera epidemiology and lyophilized CVD 103-HgR vaccine | February 2021 |
GRADE assessment and EtR framework | January 2022 | |
EtR summary, considerations for use, proposed policy option, public comment, and vote | February 2022 |
TABLE 2. Timeline of Cholera Vaccine Work Group presentations to the Advisory Committee on Immunization Practices — United States, 2015–2022
Abbreviations:ACIP = Advisory Committee on Immunization Practices; EtR = Evidence to Recommendations; GRADE = Grading of Recommendations, Assessment, Development, and Evaluation.
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This activity is intended for infectious disease clinicians, internists, pediatricians, public health officials, gastroenterologists, nurses, pharmacists, and other clinicians who treat and manage patients at risk for cholera, in whom vaccine may be indicated.
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This report summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for the use of lyophilized CVD 103-HgR vaccine (CVD 103-HgR) (Vaxchora, Emergent BioSolutions, Gaithersburg, MD) in the United States. The live attenuated oral cholera vaccine is derived from: Vibrio cholerae O1 and is administered in a single dose. Cholera is a toxin-mediated bacterial gastrointestinal illness caused by toxigenic V. cholerae serogroup O1 or, uncommonly, O139. Up to 10% of infections manifest as severe cholera (i.e., cholera gravis), profuse watery diarrhea that can cause severe dehydration and death within hours. Fluid replacement therapy can reduce the fatality rate to <1%. Risk factors for cholera gravis include high dose exposure, blood group O, increased gastric pH (e.g., from antacid therapy), and partial gastrectomy. Cholera is rare in the United States, but cases occur among travelers to countries where cholera is endemic or epidemic and associated with unsafe water and inadequate sanitation. Travelers might be at increased risk for poor outcomes from cholera if they cannot readily access medical services or if they have a medical condition that would be worsened by dehydration, such as cardiovascular or kidney disease. This report describes previously published ACIP recommendations about use of CVD 103-HgR for adults aged 18–64 years and introduces a new recommendation for use in children and adolescents aged 2–17 years. ACIP recommends CVD 103-HgR, the only cholera vaccine licensed for use in the United States, for prevention of cholera among travelers aged 2–64 years to an area with active cholera transmission. Health care providers can use these guidelines to develop the pretravel consultation for persons traveling to areas with active cholera transmission.
Cholera is an acute, watery diarrheal illness, primarily caused by toxigenic V. cholerae serogroup O1 that can be severe and rapidly fatal without proper treatment. CVD 103-HgR, a single-dose, live attenuated oral cholera vaccine derived from V. cholerae O1, is the only cholera vaccine licensed for use in the United States. In June 2016, the Food and Drug Administration (FDA) approved CVD 103-HgR for the prevention of cholera caused by V. cholerae O1 in adults aged 18–64 years traveling to cholera-affected areas.[1] In June 2016, ACIP voted to recommend use of CVD 103-HgR for prevention of cholera among adult travelers to areas with active cholera transmission.[2] In December 2020, FDA extended the approved usage to include children and adolescents aged 2–17 years.[3] In February 2022, ACIP voted to recommend the use of CVD 103-HgR for children and adolescents aged 2–17 years traveling to an area with active cholera transmission. ACIP recommends CVD 103-HgR for prevention of cholera among travelers aged 2–64 years to an area with active cholera transmission. Health care providers can use these guidelines to develop the pretravel consultation for persons traveling to areas with active cholera transmission.