There are an estimated
3–5 million cholera cases every year, with up to 120,000 deaths globally.1
VAXCHORA® is not indicated to treat the symptoms or consequences of cholera, such as death.
Overview
Cholera is a diarrheal illness
caused by infection with V. cholerae (serogroup O1 and others) that often presents with mild to moderate symptoms.*,2
Severe cholera occurs in approximately 10% of cases.
It is characterized by profuse, watery diarrhea, nausea, and vomiting.2,3
Death can occur within hours.3
*Mild diarrhea may be defined as having a few loose, watery stools per day. Moderate diarrhea may be defined as having more than a few but not more than 10 loose, watery stools per day.
Risk factors
Where infection is
most likely to occur4
In 2025, the World Health Organization (WHO) identified
32 countries as areas of active cholera transmission4
-
Americas
Haiti
-
Middle East
Yemen
-
Asia
Afghanistan, Bangladesh, India, Myanmar, Nepal, Pakistan, Philippines, Thailand
-
Africa
Angola, Burundi, Chad, Congo, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Ghana, Kenya, Malawi, Mozambique, Namibia, Nigeria, Rwanda, Somalia, South Sudan, Sudan, Tanzania, Togo, Uganda, Zambia, Zimbabwe
Adapted from External Situation Report no. 32, WHO, November 2025. Reported cholera cases occurred between January and October 2025.4
The WHO considers the global risk of cholera to be “very high.”4
Recognizing who
may be at risk5
Patients travelling to areas
where there is…
- Overcrowding
- Poor sanitation
- Lower standards of cleanliness
- Limited access to safe drinking water
Those at higher risk of
dehydration, including…
-
Young children
-
Those with chronic health conditions, including
- - Diabetes
- - Heart failure
- - Kidney disease
VAXCHORA is not indicated:
- To prevent dehydration, hypovolemic shock, or death
- To prevent dehydration in individuals with chronic health conditions,
including diabetes, heart failure, and kidney disease
VAXCHORA—
the only one-dose cholera vaccine*,†,‡,6
VAXCHORA (Cholera Vaccine, Live Attenuated,
Oral) is indicated for the active immunization
against diarrheal disease caused by Vibrio cholerae
serogroup O1 in persons 2 to 64 years of age
travelling to cholera-affected countries.7
Administer a minimum
of 10 days before potential
cholera exposure.7
Onset of protection against
cholera diarrhea can be expected
1 week after administration.7
VAXCHORA’s
mechanism of action
VAXCHORA’s construction
- VAXCHORA contains live, attenuated cholera bacteria strain CVD 103-HgR.
- CVD 103-HgR is a modified strain of V. cholerae (serogroup O1 classical Inaba strain) that produces an immunogenic but inactive form of cholera toxin.
VAXCHORA in the body
*Comparative clinical significance unknown.
†The duration of protection is unknown.
‡The safety and effectiveness of revaccination with VAXCHORA vaccine have not been established.
The effectiveness of VAXCHORA vaccine has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of any prior cholera vaccine.
Efficacy and
safety profiles
VAXCHORA demonstrated efficacy in the prevention of moderate to severe diarrhea
upon challenge with V. cholerae O1 El Tor Inaba in healthy U.S. adults aged 18–45*,7
in 10-day challenge
(n=35; 95% CI [62.7%, 100%])†
in 3-month challenge
(n=33; 95% CI [49.9%, 100%])†
Diarrheal volume and vaccine efficacy in preventing moderate
to severe diarrhea following challenge with
V. cholerae O1 El Tor Inaba (intent-to-treat population)‡
VAXCHORA
demonstrated an excellent
safety profile in
evaluated populations3
VAXCHORA
demonstrated an
excellent safety
profile in evaluated populations3
ADULT PATIENTS
- 4 randomized, placebo-controlled, multicentre clinical trials
- 3,000+ participants
- Ages 18–64
PEDIATRIC PATIENTS
- 1 randomized, placebo-controlled, multicentre clinical trial
- 468 participants
- Ages 2–17
- The adverse reaction of diarrhea was significantly higher for the adult VAXCHORA subjects at 3.62% (115/3,177) compared with the placebo group at 1.63% (9/553) (p=0.0140). For the pediatric study, the incidence of diarrhea was 1.5% (7/468) in vaccine recipients compared to 1.3% (1/75) in placebo recipients. This vaccine-associated diarrhea was typically mild and resolved spontaneously within 2 days in the majority of cases.
-
Common adverse reactions observed more frequently in VAXCHORA recipients versus placebo recipients included headache (28.9% vs. 23.6%) in the adult trials, as well as tiredness (35.7% vs. 30.7%), abdominal pain (27.8% vs. 18.7%), and lack of appetite (21.4% vs. 14.7%) in the pediatric trials.
- -Overall, VAXCHORA was generally well tolerated in the pediatric population, with a solicited event profile very similar to adults.
- There were no serious adverse events judged to be related to the administration of vaccine.
*A randomized, double-blind, saline placebo-controlled V. cholerae challenge study conducted in 197 healthy adult
volunteers in the U.S. mean age of participants was 31 years. A subset of vaccine (dosage of 5 × 108 CFU) or placebo
recipients were randomized and challenged with live V. cholerae at either 10 days post-vaccination (n=68) or
3 months post-vaccination (n=66).
†Pre-specified criteria for success were that the lower bound of the two-sided 95% confidence interval for vaccine efficacy had to be ≥ 30% in both the 10-day and 3-month challenge groups.
‡Challenge strain was V. cholerae O1 El Tor Inaba N16961.
§Moderate or severe diarrhea (≥ 3 litres of diarrhea) within 10 days after challenge.
¶Combined placebo group comprised of all placebo recipients who were challenged at either 10 days (n=35) or
3 months (n=33) following vaccination.
VAXCHORA
dosing and administration7
Recommended dose
should take VAXCHORA.
Dosing considerations
VAXCHORA
- Is for oral use only.
- Must be reconstituted before using.
- Should not be taken 1 hour before or
1 hour after eating or drinking. -
Do not administer VAXCHORA in conjunction
with antibiotics, chloroquine, or within a
2-hour interval of typhoid vaccine Ty21a
(gastro-resistant capsules). See Product Monograph for details.
Important safety information7
Clinical use:
The safety and efficacy of VAXCHORA have not been established in children younger than 2 years of age. No data is available in individuals 65 years of age or older. However, those 65 years of age and older can be expected to be at risk of more severe complications of disease if infected by cholera.
The efficacy of VAXCHORA vaccine has not been evaluated in cholera-endemic areas. However, it provides protection to vaccine recipients from areas not endemic for cholera, such as Canada, travelling to areas posing a threat of diarrheal disease caused by cholera. Onset of protection against cholera diarrhea can be expected 1 week after administration.
VAXCHORA vaccine should be used in accordance with official recommendations, taking into account the epidemiological variability and the risk of contracting diarrheal illness in different geographical areas and in different conditions of travel. VAXCHORA vaccine has not been shown to protect against V. cholerae serogroup O139 or other non-O1 serogroups, which are uncommon causes of disease. The vaccine should not replace standard preventive hygiene measures. Travellers should take all necessary precautions to avoid contact with or ingestion of potentially contaminated food or water. Rehydration measures must be taken in the event of diarrhea.
Contraindications:
Do not use in persons who have a history of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA vaccine or to a previous dose of any cholera vaccine.
Relevant warnings and precautions:
VAXCHORA does not protect against V. cholerae O139 or other non-O1 serogroups of Vibrio cholerae.
Use caution when administering to individuals with immunocompromised close contacts due to theoretical risk of vaccine shedding in stool.
Postpone vaccination in individuals with acute gastroenteritis until after recovery.
Safety and effectiveness of VAXCHORA have not been established in immunocompromised persons.
There is very limited experience with using VAXCHORA during pregnancy. Use only if potential benefits to the mother outweigh any potential risks, including to the fetus.
Use caution when administering to people who are breastfeeding as a risk to the breastfed child cannot be excluded.
For more information:
Consult the VAXCHORA Product Monograph for important information relating to adverse events, drug interactions, and dosing that has not been discussed in this piece. The Product Monograph is also available by calling 1-833-203-7933.
Explore other vaccines offered by Bavarian Nordic.
References: 1. Cholera and enterotoxigenic Escherichia coli (ETEC) travellers’ diarrhea vaccine: Canadian Immunization Guide [Internet]; 2024 [cited 2025 Jan 8]. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-3-cholera-enterotoxigenic-escherichia-coli-travellers-diarrhea-vaccine.html. 2. Cholera [Internet]. World Health Organization; 2024 [cited 2025 Jan 9]. Available from: https://www.who.int/news-room/fact-sheets/detail/cholera. 3. Pindyck T, Gutelius B, Mintz E. Cholera [Internet]. Centers for Disease Control and Prevention; 2023 [cited 2025 Jan 9]. Available from: https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/cholera. 4. World Health Organization. Multi-country outbreak of cholera, external situation report #32 November 2025. World Health Organization; 2025 [cited 2026 Jan 9]. Available from: https://www.who.int/publications/m/item/multi-country-outbreak-of-cholera--external-situation-report--32--26-november-2025. 5. Public Health Agency of Canada. Risks of cholera [Internet]. Government of Canada; 2023 [cited 2025 Jan 9]. Available from: https://www.canada.ca/en/public-health/services/diseases/cholera/risks.html. 6. Data on file. Bavarian Nordic Canada Inc., December 4, 2024. 7. VAXCHORA Product Monograph. Bavarian Nordic Canada Inc., 2024.
