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Vaccine Pregnancy: §4.6: there are limited data from the use of Vaxchora in pregnant women and animal studies are insufficient with respect to reproductive toxicity — this vaccine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus. Breast-feeding: it is unknown whether Vaxchora is excreted in human milk and a risk to the breastfed child cannot be excluded; a decision must be made whether to discontinue breast-feeding or to abstain from the vaccine, taking into account the benefit of breast-feeding for the child and of the vaccine for the woman. Fertility: no human or animal data available.

Cholera vaccine (live attenuated, oral)

Brand names: Vaxchora

This is a single-dose oral live attenuated cholera vaccine derived from a genetically modified V. cholerae O1 strain, used for active immunisation of adult travellers against cholera caused by serogroup O1.

Adult dose

Dose: Active immunisation against disease caused by Vibrio cholerae serogroup O1 — VAXCHORA (cholera vaccine, recombinant, live, oral), adults and children aged 2 years and older. §4.2 verbatim: 'A single oral dose should be administered at least 10 days prior to potential exposure to Vibrio cholerae O1. Consumption of less than a half dose may result in decreased protection. If less than half the dose is consumed, consideration may be given to repeating a full dose of Vaxchora within 72 hours.' The dose is one reconstituted dose — the SPC states no milligram or unit figure.
Route: Oral. §4.2 verbatim: 'Oral use. For instructions on reconstitution of Vaxchora prior to administration, see section 6.6. Eating and drinking should be avoided 60 minutes before and after oral ingestion of this vaccine. The reconstituted vaccine forms a slightly cloudy suspension that may contain some white particulates. After reconstitution, the suspension should be drunk within 15 minutes. The recipient should drink the full contents of the cup at once.'
Frequency: A single dose, at least 10 days before potential exposure. §4.2 verbatim on revaccination: 'No data are available on revaccination interval.'
Source: UK SPC (eMC) for Vaxchora, cholera vaccine (recombinant, live, oral), §4.2 posology plus §4.3, §4.4/4.5, §4.6 and §4.8 (https://www.medicines.org.uk/emc/product/100640/smpc). TRUNCATION WARNING: §4.4/4.5 was cut at the source-fetch limit part-way through the interaction text, so the interaction list below is PARTIAL — in particular the full oral typhoid vaccine and antibacterial timing guidance was not retrieved. NO maxDose FIELD IS SET: the regimen is a single dose and the SPC states no ceiling. §4.4: 'Vaxchora confers protection specific to Vibrio cholerae serogroup O1. Immunisation does not protect against Vibrio cholerae O139 or other species of Vibrio. This vaccine does not provide 100% protection.' 'The protection afforded by this vaccine may be reduced in HIV-infected individuals.' 'Vaxchora shedding in the stools was studied for 7 days post-vaccination, and was observed in 11.3% of vaccine recipients. The duration of shedding of the vaccine strain is unknown. There is a potential for transmission of the vaccine strain to non-vaccinated close contacts.' 'In individuals with acute gastroenteritis, vaccination should be postponed until after recovery.' Clinical trials were conducted in individuals aged 2 to 64 years; there are no immunogenicity or efficacy data in individuals over 64 years of age. Contains lactose and sucrose, and 863 mg of sodium per dose (43% of the WHO recommended maximum daily intake of 2 g of sodium for a healthy adult). Record the name and batch number of the administered product. NOTE ON SOURCES: providers.openfda is null; providers.who is a reference link only (WHO eEML entry 435, https://list.essentialmeds.org/medicines/435) with no extracted dosing, so no WHO figure has been used.

Paediatric dose

Route: Oral — reconstituted suspension, drunk within 15 minutes, the full contents of the cup at once; avoid eating and drinking for 60 minutes before and after
Frequency: A single dose, at least 10 days prior to potential exposure — children aged 2 years and older receive the same single dose as adults
NOT WEIGHT-BASED, so dosePerKg is null and the weight calculator is deliberately left unset. This is the LABEL'S OWN paediatric statement, not an adult dose scaled. §4.2 verbatim: 'Adults and children aged 2 years and older: A single oral dose should be administered at least 10 days prior to potential exposure to Vibrio cholerae O1.' and 'Paediatric population: The safety and efficacy of Vaxchora in children less than 2 years has not been established. No data are available.' §4.8: a clinical trial was conducted in 550 children aged 2 to <18 years; the types of adverse reaction are expected to be similar to adults, with some more common in children — fatigue (35.7% vs 30.2%), abdominal pain (27.8% vs 18.4%), vomiting (3.8% vs 0.2%), decreased appetite (21.4% vs 15.7%) and pyrexia (2.4% vs 0.8%). Verify against a children's formulary and the national immunisation schedule before use.

Dose adjustments

Renal

Not stated in the product information we used — check the full SPC.

Hepatic

Not stated in the product information we used — check the full SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
  • Individuals with congenital immune deficiency or receiving immunosuppressive treatment
  • PRECAUTION (§4.4, not a §4.3 contraindication): in individuals with acute gastroenteritis, vaccination should be postponed until after recovery, because protection against cholera may be diminished
  • PRECAUTION (§4.4): contains lactose and sucrose — patients with rare hereditary problems of galactose intolerance, total lactase deficiency, glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine

Side effects

  • Very common: fatigue (30.2%), headache (28.3%), abdominal pain (18.4%), nausea/vomiting (17.9%), decreased appetite (15.7%)
  • Common: diarrhoea
  • Uncommon: dizziness; flatulence, constipation, abdominal distension, dyspepsia, abnormal faeces, dry mouth, eructation; rash; arthralgia; pyrexia
  • Rare: chills
  • Paediatric (2 to <18 years, 550 children): the same types of reaction as adults, with fatigue, abdominal pain, vomiting, decreased appetite and pyrexia reported more often than in adults

Interactions

  • Antibacterial agents and/or chloroquine — §4.4: 'Concomitant administration with antibacterial agents and/or chloroquine should be avoided because protection against cholera may be diminished.'
  • Oral typhoid vaccine — §4.5: 'There should be an interval of 2 hours between the administration of this vaccine and of typhoid vaccine' (the sentence was cut at the fetch limit; confirm against the full section)
  • §4.5: no interaction studies have been performed with Vaxchora; data and clinical experience from other vaccines may be applicable
  • This interaction list may be incomplete — check the full SPC.

Monitoring

  • Traceability — §4.4: record clearly the name and batch number of the administered product
  • Timing: give at least 10 days before potential exposure; if less than half a dose is consumed, consider repeating a full dose within 72 hours (§4.2)
  • Counsel on residual risk — §4.4: the vaccine does not provide 100% protection and protects only against V. cholerae serogroup O1 (not O139 or other Vibrio species); vaccinees should still follow hygiene advice and exercise caution over food and water in cholera-affected areas
  • Counsel on contacts — §4.4: vaccine strain shedding in stools was observed in 11.3% of recipients over the 7 days studied, and transmission to non-vaccinated close contacts is possible

Clinical monograph

How it works

The attenuated organism transiently colonises the gut and induces a mucosal and systemic antibody response against V. cholerae O1 without producing active cholera toxin.

Prescribing in practice

  • As a live vaccine it should generally be avoided in significantly immunocompromised patients and in pregnancy unless the benefit clearly outweighs the risk.
  • It is reconstituted with the supplied buffer and taken on an empty stomach, avoiding food and drink around the dose.
  • Vaccine organisms can be shed in the stool for a period, so attention to hand hygiene reduces any theoretical transmission to close contacts, and it does not protect against the O139 serogroup.

Monitoring

No routine laboratory monitoring is required; observe for immediate hypersensitivity after dosing.

Counselling the patient

  • Take the single dose on an empty stomach and avoid food and drink for the recommended period around it.
  • Wash hands carefully after using the toilet for several days, and continue normal food and water precautions abroad.

Evidence & guidelines

Single-dose live attenuated oral cholera vaccine is supported by controlled human challenge and immunogenicity data summarised in its SPC and travel-health guidance.

Reference: UK Green Book; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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