Medical Editor: John P. Cunha, DO, FACOEP
What Is Vaxchora?
Vaxchora (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholera serogroup O1. Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas.
What Are Side Effects of Vaxchora?
Common side effects of Vaxchora include:
- tiredness
- headache
- abdominal pain
- nausea
- vomiting
- lack of appetite
- diarrhea, and
- fever
Dosage for Vaxchora
After preparation, a single dose of Vaxchora is 100 mL, which is administered a minimum of 10 days before potential exposure to cholera. Avoid food or drink for 60 minutes before and after Vaxchora vaccine administration.
What Drugs, Substances, or Supplements Interact with Vaxchora?
Vaxchora may interact with systemic antibiotics, and chloroquine. Tell your doctor all medications and supplements you use and other vaccines you recently received.
Vaxchora During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant before receiving Vaxchora. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vaxchora during pregnancy. Vaxchora is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Vaxchora. Consult your doctor before breastfeeding.
Additional Information
Our Vaxchora (Cholera Vaccine, Live, Oral) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
25 Ways to Stay Well Abroad in Pictures See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Common side effects may include:
- nausea, vomiting, diarrhea;
- stomach pain, loss of appetite;
- headache; or
- feeling tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
SIDE EFFECTS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
The most common adverse reactions for adults (incidence > 3%) were tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%).
The most common adverse reactions for children and adolescents (incidence ≥10%) were:
- Cohort 1 - age 12 to <18 years: headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%) and nausea (22%).
- Cohort 2 - age 6 to <12 years: tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%) and nausea (14%).
- Cohort 3 - age 2 to <6 years: tiredness (31%), lack of appetite (19%), and abdominal pain (17%).
Clinical Trials Experience
Trials In Adults
The safety of VAXCHORA was evaluated in four randomized, placebo-controlled, multicenter clinical trials. A total of 3235 adults 18 through 64 years of age received one dose of VAXCHORA and 562 received placebo [physiologic saline (N=551) or lactose (N=11)]. Overall, the mean age was 32.5 years; 53.8% of trial participants were female; 67.1% were White, 27.3% were Black or African American, 1.8% were Asian, 1.7% were multiracial, 1.3% were other, 0.6% were American Indian or Alaskan Native and 0.3% were Native Hawaiian or Pacific Islander. There were 9.3% Hispanic or Latino participants.
Solicited Adverse Reactions
Adults 18 through 45 years of age received VAXCHORA in a multi-center, double-blind, randomized (8:1), placebo-controlled trial conducted in the United States and Australia (Study 1). The safety analysis set included 2789 VAXCHORA recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 1 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of VAXCHORA or placebo in Study 1.
Table 1: Rates of Solicited Adverse Reactions Reported in VAXCHORA Trial Participants 18 to 45 Years of Age During 7 Days Post-Vaccination - Study 1a
| Adverse Reaction | VAXCHORA (N=2789)b % |
Placebo (Saline) (N=350)b % |
| Tiredness | 31.3 | 27.4 |
| Mild | 18.7 | 16.3 |
| Moderate | 12.0 | 9.9 |
| Severe | 0.7 | 1.2 |
| Potentially life-threatening | 0.0 | 0.0 |
| Headache | 28.9 | 23.6 |
| Mild | 18.9 | 14.6 |
| Moderate | 9.6 | 8.8 |
| Severe | 0.5 | 0.3 |
| Potentially life-threatening | 0.0 | 0.0 |
| Abdominal Pain | 18.7 | 16.9 |
| Mild | 12.1 | 12.0 |
| Moderate | 6.2 | 5.0 |
| Severe | 0.4 | 0.0 |
| Potentially life-threatening | 0.0 | 0.0 |
| Nausea/Vomiting | 18.3 | 15.2 |
| Mild | 13.3 | 11.4 |
| Moderate | 4.7 | 3.8 |
| Severe | 0.3 | 0.0 |
| Potentially life-threatening | 0.0 | 0.0 |
| Lack of Appetite | 16.5 | 16.6 |
| Mild | 11.7 | 12.2 |
| Moderate | 4.4 | 4.4 |
| Severe | 0.3 | 0.0 |
| Potentially life-threatening | 0.0 | 0.0 |
| Diarrhea | 3.9 | 1.2 |
| Mild | 2.4 | 0.9 |
| Moderate | 0.7 | 0.3 |
| Severe | 0.8 | 0.0 |
| Potentially life-threatening | 0.04 | 0.0 |
| Fever | 0.6 | 1.2 |
| Mild | 0.2 | 0.3 |
| Moderate | 0.3 | 0.9 |
| Severe | 0.07 | 0.0 |
| Potentially life-threatening | 0.04 | 0.0 |
| aData are derived from Study 1 (NCT02094586). bN represents number of subjects who completed a memory aid. Grading scales are defined as follows: Tiredness, Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization. Vomiting: Mild = 1-2 episodes/24 hours, Moderate = >2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock. Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization. Fever: Mild = 38.0-38.4°C/100.4-101.1°F, Moderate = 38.5-38.9°C/101.2- 102.0°F, Severe = 39.0-40.0°C/102.1-104.0°F, Potentially Life Threatening = >40.0 °C/104.0 °F. |
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Serious Adverse Events
In a pooled analysis of the four clinical studies, 0.6% (20/3235) of VAXCHORA recipients and 0.5% (3/562) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.
Pediatric Trial
The safety of VAXCHORA in children was evaluated in one randomized, placebo-controlled, multicenter clinical trial. A total of 468 children 2 through 17 years of age received one dose of VAXCHORA and 75 received placebo (physiologic saline). The mean age was 9.0 years; 51.6% were male; 59.5% were White, 31.3% were Black, 7.7% were multiracial, 0.9% were Asian, and 0.6% were American Indian/Alaskan Native. There were 8.7% Hispanic or Latino participants.
Solicited Adverse Reactions
Children 2 through 17 years of age received VAXCHORA in a multi-center, double-blind, randomized (6:1), placebo-controlled trial conducted in the United States (Study 5). Randomization was stratified by age, and children were enrolled in three separate age cohorts: 12 to < 18 years (Cohort 1), 6 to < 12 years (Cohort 2), and 2 to < 6 years (Cohort 3). The safety analysis set included 468 VAXCHORA recipients and 75 placebo recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 2 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of VAXCHORA or placebo in Study 5 for the 3 study cohorts.
Table 2: Rates of Solicited Adverse Reactions Reported in VAXCHORA Pediatric Trial (Study 5) Participants 2 to 17 Years of Age During 7 Days Post-Vaccination by Age cohort
| Adverse Reaction | Cohort 1 Ages 12 to <18 years VAXCHORA (N=165)b % |
Cohort 1 Ages 12 to <18 years Placebo (Saline) (N=24)b % |
Cohort 2 Ages 6 to <12 years VAXCHORA (N=157)b % |
Cohort 2 Ages 6 to <12 years Placebo (Saline) (N=25)b % |
Cohort 3 Ages 2 to <6 years VAXCHORA (N=146)b % |
Cohort 3 Ages 2 to <6 years Placebo (Saline) (N=26)b % |
| Tiredness | 40.6 | 37.5 | 35.0 | 32.0 | 30.8 | 23.1 |
| Mild | 31.5 | 33.3 | 22.3 | 20.0 | 19.2 | 15.4 |
| Moderate | 8.5 | 0.0 | 12.1 | 12.0 | 11.6 | 7.7 |
| Severe | 0.6 c | 4.2 | 0.6 | 0.0 | 0.0 | 0 |
| Headache | 44.8 | 45.8 | 26.1 | 24.0 | 8.9 | 7.7 |
| Mild | 34.5 | 45.8 | 19.1 | 20.0 | 6.8 | 3.8 |
| Moderate | 9.7 | 0.0 | 5.7 | 4.0 | 2.1 | 3.8 |
| Severe | 0.6 | 0.0 | 1.3 | 0.0 | 0.0 | 0.0 |
| Abdominal Pain | 37.6 | 16.7 | 27.4 | 24.0 | 17.1 | 15.4 |
| Mild | 28.5 | 12.5 | 23.6 | 16.0 | 14.4 | 15.4 |
| Moderate | 8.5 | 4.2 | 3.8 | 8.0 | 2.7 | 0.0 |
| Severe | 0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Lack of Appetite | 29.1 | 12.5 | 15.3 | 20.0 | 19.2 | 11.5 |
| Mild | 23.6 | 12.5 | 12.7 | 16.0 | 12.3 | 7.7 |
| Moderate | 5.5 | 0.0 | 1.9 | 4.0 | 6.8 | 3.8 |
| Severe | 0.0 | 0.0 | 0.6 | 0.0 | 0.0 | 0.0 |
| Nausea | 22.4 | 25.0 | 14.0 | 16.0 | 6.8 | 15.4 |
| Mild | 17.0 | 20.8 | 12.1 | 8.0 | 6.2 | 15.4 |
| Moderate | 4.8 | 4.2 | 1.9 | 8.0 | 0.7 | 0.0 |
| Severe | 0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Vomiting | 5.5 | 0.0 | 4.5 | 0.0 | 1.4 | 11.5 |
| Mild | 3.6 | 0.0 | 2.5 | 0.0 | 1.4 | 7.7 |
| Moderate | 1.2 | 0.0 | 1.9 | 0.0 | 0.0 | 3.8 |
| Severe | 0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Fever | 1.2 | 0.0 | 3.2 | 4.0 | 2.1 | 3.8 |
| Mild | 0.6 | 0.0 | 0.0 | 0.0 | 0.7 | 0.0 |
| Moderate | 0.0 | 0.0 | 0.6 | 4.0 | 0.7 | 0.0 |
| Severe | 0.6 | 0.0 | 2.5 | 0.0 | 0.7 d | 3.8 |
| Diarrhea | 3.6 | 4.2 | 0.0 | 0.0 | 0.7 | 0.0 |
| Mild | 1.8 | 0.0 | 0.0 | 0.0 | 0.7 | 0.0 |
| Moderate | 0.0 | 4.2 | 0.0 | 0.0 | 0.0 | 0.0 |
| Severe | 1.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| aData are derived from Study 5 (NCT03220737). bN represents number of subjects with a completed a memory aid. cIncludes 1 case evaluated in the emergency room for an associated viral pharyngitis considered not related to vaccination. dIncludes 1 case with temperature greater than 40°C considered not related to vaccination Pediatric Grading scales are defined as follows: Tiredness, Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization. Vomiting: Mild = 1-2 episodes/24 hours, Moderate = >2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock. Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization. Fever: Mild = 38.0-38.4°C/100.4-101.1°F, Moderate = 38.5-38.9°C/101.2-102.0°F, Severe = 39.0-40.0°C/102.1-104.0°F, Potentially Life Threatening = >40.0 °C/104.0 °F. |
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In total, 13.2% of VAXCHORA recipients reported an unsolicited adverse event that was considered related to study treatment, compared to 9.3% for placebo recipients.
The most frequent unsolicited adverse event for VAXCHORA was loose stool in Cohort 1 (13.9%), Cohort 2 (11.5%) and Cohort 3 (5.5%).
Serious Adverse Events
In Study 5, 0.2% (1/468) of VAXCHORA recipients and 1.3% (1/75) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.
DRUG INTERACTIONS
Food And Drink
Avoid food or drink for 60 minutes before and after vaccine administration [see Restrictions On Eating and Drinking].
Concomitant Vaccines Or Medications
Vaccines
No data are available on concomitant administration of VAXCHORA with other vaccines.
Antibiotics
Avoid concomitant administration of VAXCHORA with systemic antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response. Do not administer VAXCHORA to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
Antimalarial Prophylaxis
Data from a study with a similar product indicate that the immune responses to VAXCHORA may be diminished when VAXCHORA is administered concomitantly with chloroquine. Administer VAXCHORA at least 10 days before beginning antimalarial prophylaxis with chloroquine.
Immunosuppressive Treatments
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to VAXCHORA [see Use In Specific Populations].
Read the entire FDA prescribing information for Vaxchora (Cholera Vaccine, Live, for Oral Administration)
© Vaxchora Patient Information is supplied by Cerner Multum, Inc. and Vaxchora Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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