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Content current as of October 12, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.
- The disease and why it matters
- Video and figures
- Get CE credit
- Products available
- Who should get it
- Dosing and schedule, including catch-up
- Administration
- Storage and handling
- Contraindications and precautions
- Safety and adverse events
- Special populations
- Counseling pearls for the pharmacy counter
- Common patient questions
- References
The disease and why it matters
Cholera is an acute bacterial intestinal infection caused by toxigenic Vibrio cholerae O1 or O139; it most commonly manifests as acute watery diarrhea in an afebrile person, is often mild or asymptomatic, and severe disease (cholera gravis) occurs in approximately 10% of episodes with profuse rice-water stools that can rapidly cause severe volume depletion. [1]
Untreated cholera can cause death within hours, with a case-fatality ratio that can reach 50% for untreated cholera and less than 1% with adequate and timely rehydration. [1]
Cholera is endemic to approximately 50 countries, primarily in South Asia, Southeast Asia and Africa; since 2022 there has been a surge of outbreaks worldwide, with over 29 countries reporting outbreaks or cases, and in 2023 WHO assessed the global cholera risk as very high and declared a grade 3 emergency. During 2017 to 2022 the United States had 39 confirmed cholera cases among people who traveled internationally in the week before illness. [1]
Travelers who consistently observe safe food, water, sanitation and hand hygiene precautions have virtually no risk of infection; risk is greater for people without access to safe water or food, and people with inadequate gastric acidity (for example from acid-blocking medication) have greater risk of infection, and along with those with blood type O are at greater risk of developing severe disease. [1]
Video and figures
Video
Get CE credit
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Products available
CVD 103-HgR, a live, attenuated, single-dose oral cholera vaccine (Vaxchora), is the cholera vaccine licensed in the United States; no country or territory requires vaccination against cholera as a condition for entry. [1]
| Item | Statement |
|---|---|
| Manufacturer (FDA page) | Bavarian Nordic A/S [2] |
| Indication | Active immunization against disease caused by Vibrio cholerae serogroup O1; approved for use in persons 2 through 64 years of age traveling to cholera-affected areas [3] |
| Limitations of use | Effectiveness not established in persons living in cholera-affected areas or with pre-existing immunity from previous exposure or cholera vaccine; not shown to protect against serogroup O139 or other non-O1 serogroups [3] |
| Presentation | Suspension for oral administration supplied as a packet of the buffer component and a packet of the active component (lyophilized V. cholerae CVD 103-HgR) [3] |
The FDA VAXCHORA page is marked content current as of 06/12/2024 and the label is revised 01/2024; the FDA page names Bavarian Nordic as the manufacturer while the Yellow Book names Emergent BioSolutions. [2] [3] [1]
Who should get it
CDC / ACIP (Yellow Book 2026, cholera chapter)
As of April 23, 2025
ACIP recommends CVD 103-HgR vaccine for pediatric and adult travelers (2 to 64 years old) visiting areas of active cholera transmission, defined as a province, state or other administrative subdivision within a country with endemic or epidemic cholera caused by toxigenic V. cholerae O1, including areas prone to recurrence of epidemics that have had cholera activity within the past year; locations with rare sporadic cases are not considered active areas, and the vaccine is not routinely recommended for most travelers from the United States. [1]
FDA label (VAXCHORA)
As of June 12, 2024
The label says Vaxchora is approved for persons 2 through 64 years of age traveling to cholera-affected areas. [3]
Healthcare and response workers in cholera-affected areas (for example during an outbreak or after a disaster) might also be at increased risk, as are people without access to safe water or food who do not follow handwashing recommendations or do not use latrines or other sanitation systems. [1]
Dosing and schedule, including catch-up
Administer Vaxchora as a single oral dose at least 10 days before potential cholera exposure. [1] [3]
After preparation a single dose is 100 mL for persons 6 through 64 years of age or 50 mL for children 2 through 5 years of age. [3]
The safety and efficacy of revaccination with CVD 103-HgR have not been established, and the duration of protection beyond that assessed at 90 days is uncertain. [1]
In clinical efficacy trials adults aged 18 to 45 years who received Vaxchora were protected against severe diarrhea after oral V. cholerae O1 challenge at 10 days (vaccine efficacy 90%) and at 3 months (vaccine efficacy 80%); in children aged 2 to 17 years serum vibriocidal antibody seroconversion occurred on day 11 in more than 97% of recipients, but protective efficacy was not assessed. [1]
Administration
- Prepare and administer Vaxchora in a healthcare setting equipped to dispose of medical waste; for oral administration only. [3]
- Pour 100 mL of cold or room temperature (5 to 22 °C) bottled water into a clean disposable cup, empty the buffer component packet into the cup (effervescence will occur) and stir until dissolved; for children 2 through 5 years discard half of the buffer solution after mixing; then empty the active component packet (lyophilized V. cholerae CVD 103-HgR) into the cup. Do not use tap water, non-purified bottled water, other beverages or liquids. [3]
- Instruct recipients to avoid eating or drinking for 60 minutes before and after oral ingestion. [3]
- Avoid tap water because in the United States it usually contains chlorine and can kill the active agent (Yellow Book). [1]
The Yellow Book specifies "purified, non-carbonated, non-flavored bottled or spring bottled water" for reconstituting the buffer, whereas the label lists purified, spring or sparkling (carbonated) bottled water; the two sources differ on carbonated water. [1] [3]
Storage and handling
- Store the buffer component and active component packets refrigerated at 36 to 46 °F (2 to 8 °C); protect from light and moisture; packages may be stored at 48 to 77 °F (9 to 25 °C) for no more than 24 hours prior to reconstitution. [3]
Contraindications and precautions
| Source | Statement |
|---|---|
| Vaxchora label | Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Vaxchora or to a previous dose of any cholera vaccine. [3] |
| Yellow Book | Contraindicated in people with a history of severe allergic reaction to the ingredients of this or any other cholera vaccine. [1] |
| Antibiotics | Avoid concomitant systemic antibiotics because they may be active against the vaccine strain; do not administer to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination. [3] |
| Chloroquine | Immune responses may be diminished with concomitant chloroquine; administer Vaxchora at least 10 days before beginning antimalarial prophylaxis with chloroquine. [3] |
| Atovaquone-proguanil | Two studies showed co-administration of atovaquone/proguanil with CVD 103-HgR failed to diminish the vaccine's immunogenicity. [1] |
Shedding: Vaxchora may be shed in the stool for at least 7 days and the vaccine strain could be transmitted to non-vaccinated close contacts, so caution should be used when considering vaccination of people with immunocompromised close contacts; the label advises vaccine recipients to wash their hands thoroughly after using the bathroom for at least 14 days after vaccination. [3] [1]
Safety and adverse events
Adverse reactions in adults (incidence above 3%): tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%). [3]
In children and adolescents (10% or more): ages 12 to under 18 years, headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%) and nausea (22%); ages 6 to under 12 years, tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%) and nausea (14%); ages 2 to under 6 years, tiredness (31%), loss of appetite (19%) and abdominal pain (17%). [3]
The Yellow Book reports no vaccine-related serious adverse events among participants aged 2 to 64 years in clinical trials, and that serious adverse events were rare among recipients of the previously marketed related formulations (Orochol and Mutacol). [1]
Special populations
Pregnancy and lactation: the Yellow Book says safety and effectiveness have not been established in women who are pregnant or lactating; the label says Vaxchora is not absorbed systemically after oral administration and maternal use is not expected to result in fetal exposure, that maternal cholera disease is associated with adverse pregnancy outcomes including fetal death, and that the vaccine strain may be shed in the stool of the vaccinated mother for at least 7 days with potential transmission to the infant during vaginal delivery. [1] [3]
Age and immune status: Vaxchora is not licensed for children younger than 2 years or adults 65 years and older; safety and effectiveness have not been established in immunocompromised individuals; immunosuppressive therapies may reduce the immune response; in people living with HIV no difference in adverse events was reported between recipients of an older formulation and placebo. [1] [3]
Other vaccines: the VIS asks recipients to tell the provider if they are taking oral typhoid vaccine, and the label says no data are available on concomitant administration of Vaxchora with other vaccines. [4] [3]
Counseling pearls for the pharmacy counter
- Besides being vaccinated, follow five basic steps in cholera areas: drink and use safe water, wash hands often with soap and safe water, use toilets when possible (otherwise bury feces at least 100 feet from any water body), peel raw fruits and vegetables and cook food thoroughly, and clean up safely. [4]
- Cholera vaccine is a live, attenuated vaccine that can be shed in stool for at least 7 days; always wash hands thoroughly after using the bathroom and before preparing or handling food. [4]
- Tell the provider about a previous allergic reaction to cholera vaccine, pregnancy, a weakened immune system or close contacts with one, recent antibiotics, oral typhoid vaccine, or anti-malaria drugs now or planned within 10 days. [4]
- Tiredness, headache, abdominal pain, nausea, vomiting, lack of appetite and diarrhea can happen after cholera vaccine, most commonly within 7 days. [4] [3]
Common patient questions
A traveler leaves for Haiti in 5 days. Is Vaxchora still useful?
Vaxchora should be administered at least 10 days before potential cholera exposure, so a departure in 5 days does not meet the labeled timing. [3]
The patient finished azithromycin 5 days ago. Can Vaxchora be given?
No. Do not administer Vaxchora to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination. [3]
Which malaria prophylaxis can be taken with Vaxchora?
Chloroquine may diminish the immune response, so begin chloroquine at least 10 days after Vaxchora; the Yellow Book says atovaquone/proguanil did not diminish immunogenicity in two studies. [3] [1]
A 70-year-old is traveling to an outbreak area. Is Vaxchora an option?
Vaxchora is approved for ages 2 through 64 years; safety and effectiveness have not been established in adults 65 years of age or older. [3]
References
- Centers for Disease Control and Prevention. Cholera. In: CDC Yellow Book: Health Information for International Travel, 2026 edition. Page dated April 23, 2025. Accessed October 12, 2026. https://www.cdc.gov/yellow-book/hcp/travel-associated-infections-diseases/cholera.html. Accessed October 12, 2026.
- U.S. Food and Drug Administration. VAXCHORA product page (content current as of 06/12/2024). Accessed October 12, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxchora. Accessed October 12, 2026.
- VAXCHORA (cholera vaccine, live, oral), suspension for oral administration: prescribing information, revised 01/2024. Bavarian Nordic A/S. U.S. Food and Drug Administration. Accessed October 12, 2026. https://www.fda.gov/media/179631/download?attachment. Accessed October 12, 2026.
- Centers for Disease Control and Prevention. Cholera vaccine: what you need to know. Vaccine Information Statement, January 31, 2025. Accessed October 12, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/cholera.html. Accessed October 12, 2026.
For professional education. Check current labeling and guidance before acting. Not medical advice.
