1. Basic Information
Disease Overview
- Cholera: Acute diarrheal illness caused by toxin-producing Vibrio cholerae, transmitted via contaminated food and water. Causes profuse watery diarrhea that can lead to fatal dehydration within hours if untreated. Case-fatality is <1% with prompt oral/IV rehydration, but up to 50% untreated. WHO estimates 1.3–4 million cases and 21,000–143,000 deaths annually worldwide, with major recent epidemics in Yemen, Haiti (historically), and parts of sub-Saharan Africa.
Vaccine Options
| Vaccine | Type | Schedule | Where Used |
|---|---|---|---|
| Vaxchora | Live attenuated (CVD 103-HgR), single oral dose | 1 dose, ≥10 days before travel; ages 2–64 | U.S. traveler use |
| Dukoral | Killed whole-cell + recombinant B subunit, oral | 2-dose series, 1–6 weeks apart | Canada, EU, other countries (not U.S.) |
| Shanchol / Euvichol | Killed bivalent whole-cell, oral | 2-dose series, 2 weeks apart | WHO-prequalified; used in mass campaigns/outbreak response via the global OCV stockpile in low- and middle-income countries |
Source: CDC Yellow Book; WHO Cholera vaccine position paper (2017).
Recommended For
- Adult travelers to areas with active cholera transmission, particularly those with limited access to safe food/water or working in humanitarian/healthcare settings.
- Populations in outbreak-affected or high-risk endemic areas, reached through WHO/UNICEF-coordinated mass vaccination campaigns using the global OCV stockpile (e.g., Yemen, Haiti, Mozambique, Democratic Republic of Congo).
Ingredients (Package Insert)
Structured composition for 1 branded product covered on this page, taken from FDA-approved package inserts (DailyMed / manufacturer prescribing information). Lists are per product — formulations differ by manufacturer and presentation. Click an ingredient name to open its safety-context page when available.
Vaxchora Emergent Travel Health / Bavarian Nordic · Live attenuated
Delivery
Route: Oral
Form: Oral solution
Dose volume: 100 mL after reconstitution
Presentation: buffer + active component sachets for reconstitution
Encapsulation / delivery vehicle
None (no nanoparticle/VLP encapsulation system)
Antigens
| Antigen | Type | Amount / dose |
|---|---|---|
| Vibrio cholerae CVD 103-HgR (live attenuated) | Live attenuated bacteria | 4 × 10^8 to 2 × 10^9 CFU |
Adjuvants
None listed on the package insert for this product (common for live attenuated and some inactivated whole-virus vaccines).
Preservatives
- None — Single-dose presentation; label states no preservative.
Excipients & residuals
| Ingredient | Category | Amount | Role |
|---|---|---|---|
| Sucrose | Stabilizer | label quantity | stabilizer |
| Ascorbic acid | Stabilizer | label quantity | antioxidant |
| Hydrolyzed casein | Stabilizer | label quantity | stabilizer |
| Buffer components (sodium bicarbonate, sodium carbonate, ascorbic acid, lactose) | Buffer | buffer sachet | gastric buffer |
Source: FDA package insert · Verified 2026-07-09
ⓘ How to read this section
Ingredient lists are sourced from official package inserts for the specific brands named above. Formulations can change between lots and over time — verify against the current label before any clinical decision. Presence of a substance does not by itself indicate harm; toxicology is dose-, route-, and context-dependent. Browse the full ingredient database: Vaccine Ingredients index.
Causality assessment & potential mechanisms
Conditions below combine WHO-style causality levels with potential biological mechanisms from the site mechanism catalog (ae_mechanisms_catalog.json). HRSA VICP table listing (where shown) indicates a compensable temporal association under U.S. program rules — not automatic proof of causation for every case. Mechanisms are hypothesis-level pathways with graded evidence.
| Condition | Time window | Causality | Potential mechanism(s) |
|---|---|---|---|
| GI reactogenicity (oral) | 0–3 days |
Very likely / Probable
Evidence: High |
Uncontrolled live attenuated vaccine replication (contributing · live_replication) In immunocompromised or otherwise susceptible hosts, live attenuated vaccine strains can replicate beyond the intended limited infection, causing disseminated disease or organ-specific infection. Adjuvant-driven local and systemic reactogenicity (primary · innate_inflammation) Aluminum or other adjuvants (e.g., AS01B) amplify innate immune signaling, producing injection-site inflammation and transient systemic symptoms (fever, myalgia, fatigue). |
| Anaphylaxis | 0–1 days |
Unclassifiable
Evidence: Very Low |
IgE-mediated hypersensitivity (anaphylaxis) (hypothetical · hypersensitivity) Pre-existing or newly formed IgE against vaccine antigens or excipients (e.g., gelatin, egg proteins, PEG, polysorbate) triggers mast-cell and basophil degranulation with systemic mediator release. Temporal association — mechanism unknown (alternative · unknown) Reports show temporal clustering after vaccination but a specific pathogenic pathway is not established; alternative (coincidental) explanations remain plausible. |
Framework: WHO causality + HRSA VICP (where applicable) + AE mechanism catalog.
Last updated: 2026-07-18.
Schema: schemas/vaccine_injury_table.schema.json
· Mechanisms: schemas/ae_mechanism.schema.json.
Not medical or legal advice.
2. Pre-Licensure Clinical Trial Data
Licensure trial design (ICAN / OpenVAERS)
This vaccine is not listed in ICAN’s childhood-schedule No Placebo Table (which covers CDC routine pediatric injectable products). Pre-licensure trial comparators for travel, adult, or specialty vaccines should be taken from FDA review documents and product labels in the sections below.
Source: OpenVAERS — No Placebo Table · ICAN original PDF · Attribution: Informed Consent Action Network (ICAN) via OpenVAERS · Last fetched: 2026-07-16. For many trials listing '6 months' safety review, ICAN notes review was typically ~30 days post-injection with a phone call at 6 months.
Efficacy evidence differs by vaccine class: Vaxchora's licensure relied on a human challenge model, while Shanchol/Dukoral efficacy comes from large field trials in endemic settings.
| Vaccine | Efficacy Data | Evidence Strength |
|---|---|---|
| Vaxchora | ~90% efficacy against moderate-to-severe diarrhea in a controlled human challenge study at 10 days post-vaccination; ~80% at 3 months. No large real-world field effectiveness trial exists, given the rarity of cholera exposure in short-term U.S. travelers | Moderate |
| Shanchol / Dukoral (killed whole-cell) | ~65–76% efficacy over ~2 years in large field trials (India, Bangladesh); lower and shorter-lived protection in children under 5 | Strong |
Key Limitations
- Vaxchora's licensure is challenge-study-based, not a field efficacy trial: Real-world effectiveness data in actual travelers remain limited.
- Reduced protection in young children: Killed whole-cell vaccines (Shanchol/Dukoral) are notably less effective and shorter-acting in children under 5, the group at highest risk of severe cholera in endemic settings.
- Vaxchora is a live vaccine: Vaccine organism shedding in stool is possible for up to 7 days; direct contact with immunocompromised individuals should be avoided during this window.
3. Post-Licensure Safety Data
Post-Licensure Safety Monitoring
| Vaccine | Key Post-Licensure Finding |
|---|---|
| Vaxchora | Post-marketing surveillance since 2016 U.S. licensure has not identified an unusual safety signal; most reports are mild GI symptoms |
| Shanchol/Euvichol | Deployed in tens of millions of doses via WHO/Gavi-supported mass campaigns; pharmacovigilance in these campaigns has not identified serious safety concerns |
| Dukoral | Long track record in Canada/EU travel medicine; well tolerated, mild GI symptoms most common |
⚠ Critical Caveat
No cholera vaccine is 100% effective, and none is a substitute for safe food, water, and sanitation practices while traveling in or living in affected areas.
Passive Surveillance: AE Type Breakdown (Multi-System)
Side-by-side view of U.S. VAERS, Health Canada Canada Vigilance, Japan JADER (PMDA), EU EudraVigilance, and live-scraped international systems via SurVigilance (VigiAccess, Lareb, DAEN, DMA, Medsafe). SurVigilance panels show MedDRA PT mention totals (not individual-case counts). Category assignment uses keyword matching — approximate, not official SOC coding. VAERS ZIP CAPTCHA downloads use this site’s vaers_pipeline.py; FAERS is bulk quarterly ZIP via SurVigilance (not product search).
VAERS (United States)
Canada Vigilance (Canada)
JADER (PMDA, Japan)
No matching vaccine reports in the current JADER public extract.
EudraVigilance (EU)
858
individual cases · adrreports.eu DAP export (up to 28/06/2026)
Reaction SOC breakdown not included in this workbook export.
SurVigilance: VigiAccess · Lareb · DAEN · DMA · Medsafe
VigiAccess (WHO)
Lareb (Netherlands)
DAEN (Australia)
DMA (Denmark)
Denmark DMA interactive ADR search is currently offline (Danish Medicines Agency IT transition; public overviews frozen at 12 Mar 2024). Live product PT tables cannot be retrieved until DKMA restores the search. See DKMA notice. Denmark continues to report into EU EudraVigilance (panel above).
Medsafe (New Zealand)
4. Documented Adverse Events — Evidence of Association
Rank-aggregated VAERS signal detection (rankv)
No pairs mapping to this product family appear in the rank-aggregated common-signal set from rankv (intersection of GPS, PRR, ROR, and BCPNN signals). That does not mean absence of all VAERS reports — only that no pair met the four-method consensus filter in the published pipeline.
- Methods combined: BCPNN (IC), GPS/EBGM, PRR, ROR — then rank aggregation.
- Data: ~30 years of public VAERS (rankv processed tables).
- Origin: precisionFDA “Gaining New Insights by Detecting Adverse Event Anomalies” challenge solution.
- Caveat: Disproportionality signals are statistical associations in spontaneous reports. They do not establish causality, incidence, or product defect. Many top pairs reflect administration/product-use coding rather than clinical injury.
Source: nanx.me/rankv · Code: github.com/nanxstats/rankv (MIT) · Built: 2026-07-30.
▶ Strong Evidence of Causal Association
- Mild GI symptoms (abdominal pain, nausea, diarrhea, vomiting): Most common reaction across all oral cholera vaccines, ~2–10%. Self-limited. Strong
- Fatigue/tiredness (Vaxchora): ~10–20% in trials. Self-limited. Strong
▶ Moderate or Preliminary Evidence
- Reduced efficacy/duration in children under 5 (killed whole-cell vaccines): Consistently observed across field trials, though the underlying immunologic reasons are not fully characterized. Limited mechanistic understanding
5. Disease Prevention Benefits
Outbreak Response Impact
| Setting | Outcome |
|---|---|
| Global OCV stockpile (established 2013) | Over 100 million doses of Shanchol/Euvichol deployed across dozens of outbreak-response and preventive campaigns worldwide through the WHO/UNICEF/IFRC/MSF-coordinated mechanism |
| Haiti post-earthquake outbreak response | OCV campaigns contributed to outbreak control alongside water/sanitation interventions |
| Yemen (ongoing epidemic, one of the largest in modern history) | Repeated OCV campaigns have been used to blunt transmission amid a humanitarian crisis with severely degraded water/sanitation infrastructure |
Source: WHO Global Task Force on Cholera Control; Gavi OCV stockpile reports.
6. Evidence Summary
Oral cholera vaccines provide moderate, time-limited protection and have become an important outbreak-response and traveler-protection tool alongside water, sanitation, and hygiene interventions. Efficacy is lower and shorter-lived in young children, the group most vulnerable to severe cholera, which remains an active area of vaccine development. All currently available vaccines are well tolerated, with mild self-limited GI symptoms being the dominant reported reaction.
| Domain | Evidence Grade | Key Finding |
|---|---|---|
| Vaxchora efficacy (challenge study) | Moderate | ~90% at 10 days, ~80% at 3 months |
| Shanchol/Dukoral field efficacy | Strong | ~65–76% over ~2 years, lower in children <5 |
| Reactogenicity | Strong | Mild, self-limited GI symptoms predominate |
| Outbreak-response impact | Strong | 100M+ doses deployed via global OCV stockpile |
7. International Surveillance & Global Data
Quick links to public pharmacovigilance databases and trial registries relevant to Cholera Vaccine. Reporting counts do not establish causality.
8. Curated Adverse Event Literature
Curated peer-reviewed literature linking specific adverse events to Cholera Vaccine. Each entry is a case report, case series, or related safety publication identified via PubMed. Expand Search PubMed for additional literature below to run custom queries.
9. Key References
- WHO. Cholera vaccines: WHO position paper. Wkly Epidemiol Rec. 2017;92(34):477–498.
- CDC. Cholera. CDC Yellow Book, Travelers’ Health. cdc.gov/yellowbook
- Chen WH, et al. Single-dose live oral cholera vaccine CVD 103-HgR protects against human challenge with Vibrio cholerae O1. Clin Infect Dis. 2016;62(11):1329–1335.
- Bi Q, et al. Protection against cholera from killed whole-cell oral cholera vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2017;17(10):1080–1088.
- WHO. Global Task Force on Cholera Control — OCV Stockpile. who.int