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Live attenuated cholera vaccine: Drug information

Live attenuated cholera vaccine: Drug information
(For additional information see "Live attenuated cholera vaccine: Patient drug information" and see "Live attenuated cholera vaccine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Vaxchora
Pharmacologic Category
  • Vaccine;
  • Vaccine, Live (Bacterial)
Dosing: Adult
Cholera prevention

Cholera prevention: Oral: 100 mL (single dose) administered ≥10 days prior to potential cholera exposure.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Live attenuated cholera vaccine: Pediatric drug information")

Cholera prevention

Cholera prevention: Note: Dose should be administered ≥10 days prior to potential cholera exposure.

Refrigerated formulation:

Children 2 to <6 years: Oral: 1 packet in 50 mL of buffer solution as a single dose.

Children ≥6 years and Adolescents: Oral: 1 packet in 100 mL of buffer solution as a single dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Oral:

Vaxchora: (100 mL)

Generic Equivalent Available: US

No

Product Availability

As of December 2020, the manufacturer has temporarily stopped manufacturing and distributing Vaxchora. Supplies may be limited or unavailable.

Medication Guide and/or Vaccine Information Statement (VIS)

In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html.

Administration: Adult

Oral: Avoid eating or drinking for 60 minutes before and after oral ingestion. It is recommended to consume vaccine within 15 minutes of reconstitution; however, it may be consumed within 4 hours of reconstitution; consume within 30 minutes of reconstitution if table sugar or stevia have been added. Drink full contents of the cup at once; discard any residue that may remain in cup after consumption. If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Administration: Pediatric

Oral: Avoid eating or drinking for 60 minutes before and after oral ingestion. It is recommended to consume vaccine within 15 minutes of reconstitution; however, it may be consumed within 4 hours of reconstitution; consume within 30 minutes of reconstitution if table sugar or Stevia have been added. Drink full contents of the cup at once; discard as medical waste any residue that may remain in cup after consumption. If accessed under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Use: Labeled Indications

Cholera prevention: Active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following: Adult travelers (aged 18 to 64 years) from the US to an area of active cholera transmission (ACIP [Wong 2017]).

Limitations of use: Effectiveness has not been established in persons living in cholera-affected areas or in persons who have preexisting immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Abdominal pain (children, adolescents, and adults: 17% to 38%), anorexia (children and adolescents: 19% to 29%), nausea and vomiting (adults: 18%)

Nervous system: Fatigue (children, adolescents, and adults: 31% to 41%), headache (children and adults: 9% to 29%)

1% to 10%:

Gastrointestinal: Diarrhea (adults: 4%; children: <1%), vomiting (children and adolescents: 5%)

Miscellaneous: Fever (adolescents: 1%)

Contraindications

History of severe allergic reaction (eg, anaphylaxis) to any component of the formulation or to a previous dose of any cholera vaccine

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2021]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2021]).

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices (ACIP) recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Kroger 2021]).

Special populations:

• Altered immunocompetence: Severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) generally should not receive live vaccines; safety and effectiveness have not been established and immunocompromised patients may have a reduced response to vaccination or may have an adverse event secondary to replication (ACIP [Kroger 2021]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live, attenuated vaccines should not be administered for at least 3 months after immunosuppressive therapy (IDSA [Rubin 2014]).

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2021]).

• Transmission of virus: Bacteria may be shed in the stool of the recipient for at least a week. For ≥14 days following vaccination, recipient should wash their hands thoroughly after using the bathroom and before preparing or handling food. The manufacturer recommends caution when considering use in individuals with close contact to immunocompromised persons.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Antibiotics: May diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Chloroquine: May diminish the therapeutic effect of Cholera Vaccine. Management: Administer cholera vaccine at least 10 days prior to initiation of chloroquine. Risk D: Consider therapy modification

Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Risk D: Consider therapy modification

Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Immunosuppressants (Therapeutic Immunosuppressant Agents): Vaccines (Live) may enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

RiTUXimab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. RiTUXimab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification

Pregnancy Considerations

The cholera vaccine is not systemically absorbed following maternal oral administration and is not expected to result in fetal exposure. Following administration, the vaccine's bacteria may be shed in the maternal stool for ≥7 days, potentially exposing the newborn to the vaccine strain during vaginal delivery. Maternal cholera infection is associated with adverse pregnancy outcomes, including fetal death.

Breastfeeding Considerations

The cholera vaccine is not systemically absorbed following maternal oral administration and is not expected to result in exposure to the breast-feeding infant.

Mechanism of Action

Contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient. Immune mechanisms conferring protection against cholera following receipt of cholera vaccine have not been determined.

Efficacy: In a study of adults 18 to 45 years of age, the efficacy against the occurrence of moderate to severe diarrhea was 90.3% at 10 days post-vaccination and 79.5% at 3 months post-vaccination.

Pharmacokinetics

Absorption: Oral: No systemic absorption.

Excretion: Feces

Brand Names: International
  • Shanchol (MY, TH)


For country code abbreviations (show table)
  1. Collins JP, Ryan ET, Wong KK, et al. Cholera vaccine: recommendations of the Advisory Committee on Immunization Practices, 2022. MMWR Recomm Rep. 2022;71(2):1-8. doi:10.15585/mmwr.rr7102a1 [PubMed 36173766]
  2. Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed April 30, 2021.
  3. Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-e100. [PubMed 24311479]
  4. Vaxchora freezer formulation (cholera vaccine) [prescribing information]. Redwood City, CA: PaxVax Bermuda Ltd; October 2017.
  5. Vaxchora refrigerated formulation (cholera vaccine) [prescribing information]. Redwood City, CA: Emergent Travel Health Inc; April 2022.
  6. Wong KK, Burdette E, Mahon BE, et.al. Recommendations of the Advisory Committee on Immunization Practices for Use of Cholera Vaccine. MMWR Recomm Rep. 2017;66(18):482-485.
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