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Table.  

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.

Table.  

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.

CME / ABIM MOC / CE

Cholera Vaccine: Recommendations of the Advisory Committee on Immunization Practices, 2022

  • Authors: Jennifer P. Collins, MD; Edward T. Ryan, MD; Karen K. Wong, MD; Matthew F. Daley, MD; Adam J. Ratner, MD; Grace D. Appiah, MD; Pablo J. Sanchez, MD; Bruce J. Gutelius, MD
  • CME / ABIM MOC / CE Released: 4/3/2023
  • Valid for credit through: 4/3/2024, 11:59 PM EST
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  • Credits Available

    Physicians - maximum of 0.75 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.75 ABIM MOC points

    Nurses - 0.75 ANCC Contact Hour(s) (0.5 contact hours are in the area of pharmacology)

    Pharmacists - 0.75 Knowledge-based ACPE (0.075 CEUs)

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

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.

The goal of this activity is for learners to be better able to describe recommendations for the use of lyophilized CVD 103-HgR cholera vaccine in the United States, based on a report from the CDC’s Advisory Committee on Immunization Practices.

Upon completion of this activity, participants will:

  • Assess background and rationale for cholera vaccine recommendations using CVD 103-HgR, based on an Advisory Committee on Immunization Practices report
  • Evaluate recommendations for prevention of severe cholera among travelers, based on an Advisory Committee on Immunization Practices report
  • Examine the contraindications, precautions, and other considerations for use of CVD 103-HgR, based on an Advisory Committee on Immunization Practices report


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Faculty

  • Jennifer P. Collins, MD

    Division of Foodborne, Waterborne, and Environmental Diseases
    National Center for Emerging and Zoonotic Infectious Diseases
    Centers for Disease Control and Prevention
    Atlanta, Georgia

    Disclosures

    Jennifer P. Collins, MD, has no relevant financial relationships.

  • Edward T. Ryan, MD

    Harvard Medical School
    Massachusetts General Hospital
    Boston, Massachusetts

    Disclosures

    Edward T. Ryan, MD, has no relevant financial relationships.

  • Karen K. Wong, MD

    Division of Foodborne, Waterborne, and Environmental Diseases
    National Center for Emerging and Zoonotic Infectious Diseases
    Centers for Disease Control and Prevention
    Atlanta, Georgia

    Disclosures

    Karen K. Wong, MD, has no relevant financial relationships.

  • Matthew F. Daley, MD

    Institute for Health Research
    Kaiser Permanente Colorado
    Denver, Colorado

    Disclosures

    Matthew F. Daley, MD, has no relevant financial relationships.

  • Adam J. Ratner, MD

    New York University Grossman School of Medicine
    New York, New York

    Disclosures

    Adam J. Ratner, MD, has no relevant financial relationships.

  • Grace D. Appiah, MD

    Division of Global Migration and Quarantine
    National Center for Emerging and Zoonotic Infectious Diseases
    Centers for Disease Control and Prevention
    Atlanta, Georgia

    Disclosures

    Grace D. Appiah, MD, has no relevant financial relationships.

  • Pablo J. Sanchez, MD

    Nationwide Children’s Hospital
    The Ohio State University College of Medicine
    Columbus, Ohio

    Disclosures

    Pablo J. Sanchez, MD, has no relevant financial relationships.

  • Bruce J. Gutelius, MD

    Division of Foodborne, Waterborne, and Environmental Diseases
    National Center for Emerging and Zoonotic Infectious Diseases
    Centers for Disease Control and Prevention
    Atlanta, Georgia

    Disclosures

    Bruce J. Gutelius, MD, has no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer Medscape, LLC

    Disclosures

    Laurie Barclay, MD, has no relevant financial relationships.

Compliance Reviewer/Nurse Planner

  • Leigh Schmidt, MSN, RN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

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    Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.


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CME / ABIM MOC / CE

Cholera Vaccine: Recommendations of the Advisory Committee on Immunization Practices, 2022

Authors: Jennifer P. Collins, MD; Edward T. Ryan, MD; Karen K. Wong, MD; Matthew F. Daley, MD; Adam J. Ratner, MD; Grace D. Appiah, MD; Pablo J. Sanchez, MD; Bruce J. Gutelius, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 4/3/2023

Valid for credit through: 4/3/2024, 11:59 PM EST

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Abstract and Introduction

Abstract

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.

Introduction

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.