With VAXCHORA, help protect your clients where they may want to go

Why VAXCHORA?1

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.

Limitations of Use: The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

The Advisory Committee on Immunization Practices (ACIP) recommends VAXCHORA for children and adolescents
2 through 17 years of age and adults 18 through 64 years of age who are traveling to an area with active cholera transmission.2*

To read the full recommendation and see the most recent updates, visit the CDC website.

Read CDC Recommendation Here
  • *The CDC defines areas of active cholera transmission as administrative subdivisions where ≥100 cases have been reported within the past year.
  • CDC, Centers for Disease Control and Prevention.

Demonstrated Efficacy Profile1

Efficacy in adults

Study Design: VAXCHORA was studied in a randomized, double-blind, saline placebo–controlled V. cholerae challenge study conducted in US subjects 18 through 45 years of age with no prior history of cholera infection or travel to a cholera-endemic area in the previous 5 years. The primary endpoint was the prevention of moderate (≥3.0 L) to severe (≥5.0 L) diarrhea.3,a-d

VAXCHORA demonstrated vaccine efficacy in the prevention of moderate to severe diarrhea following challenge with V. cholerae O1 El Tor Inaba at 10 days and 3 months post-vaccination.

VAXCHORA recipients were divided into 2 cohorts, one challenged
at 10 days and the other at 3 months post-vaccination.

Cohort 1

68 healthy volunteers were randomized to receive VAXCHORA (n=35) or placebo (n=33) in the 10-day challenge1

Efficacy 10 days after vaccination1

cohort-1

In the 10-day challenge group, 2 volunteers receiving VAXCHORA (5.7%) developed moderate to severe diarrhea after challenge with V. cholerae.1

Cohort 2

66 healthy volunteers were randomized to receive VAXCHORA (n=33) or placebo (n=33) in the 3-month challenge1

Efficacy 3 months after vaccination1

cohort-2

In the 3-month challenge group, 4 volunteers taking VAXCHORA (12.1%) developed moderate to severe diarrhea after challenge withV. cholerae.1

Volunteers who received VAXCHORA were compared with a pooled group of volunteers who received placebo.

The majority of placebo recipients (39/66, 59.1%) developed moderate or severe diarrhea after being challenged with V. cholerae.

The duration of protection following vaccination with VAXCHORA is unknown

  • a P<0.0001 vs placebo.3
  • b The duration of shedding of the vaccine strain is unknown.
  • c Moderate or severe diarrhea defined as ≥3.0 L or ≥5.0 L, respectively, within 10 days after being challenged with V. cholerae 01 El Tor Inaba.3
  • d Vaccine efficacy=[(Attack Rate in Placebo Group – Attack Rate in Vaccine Group)/Attack Rate in Placebo Group] x 100.

Study 1

VAXCHORA stimulated an immune response in more than 90% of recipients4

Study Design: Study 1 was a randomized, double-blind, placebo-controlled trial of 3146 volunteers.

Seroconversiona occurred in 93.5% of vaccine recipients versus 4% in placebo recipients 10 days after vaccination4

Seroconversion after 10 days

cohort-3
  • a Seroconversion defined as a ≥4-fold rise in vibriocidal antibody against homologous classical Inaba.4
  • bP<0.0001.4

Substudy results4

VAXCHORA recipients demonstrated elevated antibody titers through 6 monthsa

  • In a substudy of 32 participants, cumulative seroconversion occurred in 96% of VAXCHORA recipients by 1 montha

  • Vibriocidal antibody geometric mean titers gradually declined over time but remained elevated through 6 months
  • a An immune substudy of 32 participants (26 VAXCHORA recipients and 6 placebo recipients) who were selected through a convenience sample and voluntarily enrolled.

Study 4

Study Design: VAXCHORA was studied in a randomized, double-blind, placebo-controlled safety and immunogenicity study conducted in US subjects 46 through 64 years of age with no prior history of cholera infection or travel to a cholera-endemic area in the previous 5 years.

Vibriocidal antibody seroconversion rates for the classical Inaba strain were compared at 10 days post-vaccination between subjects 46 through 64 years of age in Study 4 and subjects 18 through 45 years of age in Study 1.

VAXCHORA demonstrated a seroconversion ratea of 90.4% in adults 46 through
64 years of age1

Study 4b

Subjects 46 through 64 years of age
(VAXCHORA N=291c)

cohort-4

Seroconversion rates (95% confidence interval) were: Study 4, 90.4% (86.4%, 93.5%); Study 1 (subjects 18 through 45 years of age; VAXCHORA N=2687), 93.5% (92.5%, 94.5%); difference in seroconversion rates -3.1% (-6.7%, 0.4%).d

  • a Seroconversion rate is defined as the percentage of subjects who had at least a 4-fold increase in vibriocidal antibody titer at 10 days post-vaccination compared with baseline.
  • b Study compared data from Study 1 (NCT02094586) and Study 4 (NCT02100631).
  • c N represents number of subjects with analyzable samples at Day 1 and Day 11.
  • d Prespecified success criterion was that the lower bound of the two-sided 95% confidence interval on the difference in seroconversion rate (Study 4 minus Study 1) must be greater than -10 percentage points.

Efficacy in children and adolescents

Study 5

Study Design: VAXCHORA was studied in a randomized, double-blind, saline placebo-controlled safety and immunogenicity study conducted in US subjects 2 through 17 years of age not previously exposed to cholera. Randomization was stratified by age into
3 cohorts: Cohort 1: 12 to < 18 years of age; Cohort 2: 6 to < 12 years of age; Cohort 3: 2 to < 6 years of age.

Classical Inaba vibriocidal antibody seroconversion rates at 10 days post-vaccination were compared with seroconversion rates in adults 18 through 45 years of age.

VAXCHORA demonstrated a seroconversion ratea of 98.5% in subjects 2 through 17 years of age at 10 days post-vaccination1

Study 5b

Subjects 2 through 17 years of age
(VAXCHORA N=399c)

cohort-5

Co-primary criterion required the lower limit of the 98.3% confidence interval to be ≥ 70% for the VAXCHORA group. Seroconversion rates (98.3% confidence interval) were: Study 5, 98.5% (96.2%, 99.4%); Study 1 (subjects 18 through 45 years of age; VAXCHORA N=2687), 93.5% (92.3%, 94.6%); difference in seroconversion rates 5.0% (2.8%, 6.4%).d

  • a Seroconversion rate is defined as the percentage of subjects who had at least a 4-fold increase in vibriocidal antibody titer at 10 days post-vaccination compared with baseline
  • b Study compared data from Study 1 (NCT02094586) and Study 5 (NCT03220737).
  • c N represents number of subjects with analyzable samples at Day 1 and Day 11 in the immunogenicity evaluable population.
  • d Prespecified success criterion was that the lower bound of the two-sided 96.7% confidence interval on the difference in seroconversion rate (Study 5 minus Study 1) must be greater than -10 percentage points.

Demonstrated Safety Profile1

Safety in adults

The safety of VAXCHORA was evaluated in more than 3000 volunteers aged 18 to 64 years in 4 randomized, placebo-controlled, multicenter clinical trials

In a pooled analysis of adults aged 18 to 64 years, 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.

No serious adverse events were found to be related to vaccination

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%
Headache
28.9%
23.6%
Abdominal pain
18.7%
16.9%
Nausea/vomiting
18.3%
15.2%
Lack of appetite
16.5%
16.6%
Diarrhea
3.9%
1.2%
Fever
0.6%
1.2%
  • a Data are derived from Study 1 (NCT02094586).
  • c N represents number of subjects who completed a memory aid.

Safety in children and adolescents

The safety of VAXCHORA in children was evaluated in a randomized, placebo-controlled, multicenter clinical trial that included a total of 468 children 2 through 17 years of age

The safety analysis set included 468 VAXCHORA recipients and 75 placebo recipients.

In this trial, 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.

No serious adverse events were found to be related to vaccination

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 cohorta,b

Cohort 1
Ages 12 to < 18 years

Cohort 2
Ages 6 to < 12 years

Cohort 3
Ages 2 to < 6 years

Adverse reaction

VAXCHORA
(N=165)c

Placebo (saline)
(N=24)c

VAXCHORA
(N=157)c

Placebo (saline)
(N=25)c

VAXCHORA
(N=146)c

Placebo (saline)
(N=26)c

Tiredness
40.6%
37.5%
35.0%
32.0%
30.8%
23.1%
Headache
44.8%
45.8%
26.1%
24.0%
8.9%
7.7%
Abdominal pain
37.6%
16.7%
27.4%
24.0%
17.1%
15.4%
Lack of appetite
29.1%
12.5%
15.3%
20.0%
19.2%
11.5%
Nausea
22.4%
25.0%
14.0%
16.0%
6.8%
15.4%
Vomiting
5.5%
0.0
4.5%
0.0
1.4%
11.5%
Fever
1.2%
0.0
3.2%
4.0%
2.1%
3.8%
Diarrhea
3.6%
4.2%
0.0
0.0
0.7%
0.0

Cohort 1 Ages 12 to < 18 years

Adverse reaction

VAXCHORA
(N=165)b

Placebo (saline)
(N=24)b

Tiredness
40.6%
37.5%
Headache
44.8%
45.8%
Abdominal pain
37.6%
16.7%
Lack of appetite
29.1%
12.5%
Nausea
22.4%
25.0%
Vomiting
5.5%
0.0
Fever
1.2%
0.0
Diarrhea
3.6%
4.2%

Cohort 2 Ages 6 to < 12 years

Adverse reaction

VAXCHORA
(N=157)b

Placebo (saline)
(N=25)b

Tiredness
35.0%
32.0%
Headache
26.1%
24.0%
Abdominal pain
27.4%
24.0%
Lack of appetite
15.3%
20.0%
Nausea
14.0%
16.0%
Vomiting
4.5%
0.0
Fever
3.2%
4.0%
Diarrhea
0.0
0.0

Cohort 3 Ages 2 to < 6 years

Adverse reaction

VAXCHORA
(N=146)b

Placebo (saline)
(N=26)b

Tiredness
30.8%
23.1%
Headache
8.9%
7.7%
Abdominal pain
17.1%
15.4%
Lack of appetite
19.2%
11.5%
Nausea
6.8%
15.4%
Vomiting
1.4%
11.5%
Fever
2.1%
3.8%
Diarrhea
0.7
0.0
  • a Data are derived from Study 5 (NCT03220737).
  • b 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.
  • c N represents number of subjects who completed memory aid

Dosage and Administration1

VAXCHORA helps deliver cholera prevention in just 1 dose

1
DOSE

VAXCHORA is administered as a single oral dose.

10
DAYS

VAXCHORA should be administered at least 10 days before potential exposure to cholera.

15
MIN

Patients should consume the vaccine in a healthcare setting within 15 minutes of reconstitution.

60
MIN

Patients should not eat or drink for 60 minutes before and after ingestion of VAXCHORA.

How Supplied/Storage and Handling1

storage-img

How supplied1

VAXCHORA is supplied as shown below. The contents of both packets are reconstituted with purified bottled or spring bottled water, to form one oral dose of the vaccine.

Presentation
Carton NDC Number
Components

Single-dose carton
containing two packets

NDC 70460-004-01

Buffer Component Packet
NDC 70460-003-02

Active Component Packet
NDC 70460-002-02

Storage and handling1

  • Store VAXCHORA buffer component and active component packets refrigerated at 36°F to 46°F (2°C to 8°C)
  • Protect from light and moisture
  • Packets should not be out of refrigerated storage for more than 12 hours prior to reconstitution; when out of refrigerated storage, packets should not be exposed to temperatures above 80°F (27°C)
refernce-img

For medical inquiries about VAXCHORA, please contact Medical Information at (800) 533-5899 or medicalinformation@ebsi.com.
If you have additional questions, you can also make a Medical Information Request.

Visit the Resources page for more information about VAXCHORA.

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VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.

Limitations of Use: The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

VAXCHORA is contraindicated in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine.

Altered Immunocompetence: The safety and effectiveness of VAXCHORA have not been established in immunocompromised persons and the immunologic response to VAXCHORA may be diminished in immunocompromised individuals.

Shedding and Transmission: Because VAXCHORA may be shed in the stool of recipients for at least 7 days and the vaccine strain can potentially be transmitted to non-vaccinated close contacts (e.g., household contacts), use caution when considering whether to administer VAXCHORA to individuals with immunocompromised close contacts.

Adverse Reactions: In adults 18-45 years old, the most common adverse reactions (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-<18 years: headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%) and nausea (22%)
  • Cohort 2 – age 6-<12: tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%) and nausea (14%)
  • Cohort 3 – age 2-<6: tiredness (31%), lack of appetite (19%), and abdominal pain (17%)

Antibiotics: Avoid concomitant administration of VAXCHORA with oral systemic antibiotics since these agents may be active against the vaccine strain. Do not administer VAXCHORA to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

Antimalarial Prophylaxis: Immune responses to VAXCHORA may be diminished when administered concomitantly with chloroquine. Administer VAXCHORA at least 10 days before beginning chloroquine.

Immunosuppressive Treatments: Immunosuppressive therapies may reduce the immune response to VAXCHORA.

VAX FULL HCP ISI 01/2021

Please see full Prescribing Information.

References:

  1. Vaxchora [package insert], 12/2020; Emergent Travel Health Inc.
  2. Clinical update: cholera vaccine for travelers. Centers for Disease Control and Prevention. Updated June 8, 2022. Accessed June 13, 2022. https://wwwnc.cdc.gov/travel/
    news-announcements/cholera-vaccine-for-travelers
  3. Chen WH, Cohen MB, Kirkpatrick BD, et al. Single-dose live oral cholera vaccine CVD 103-HgR protects against human experimental infection with Vibrio cholerae 01 El Tor. Clin infect Dis. 2016;62(11):1329-1335.
  4. McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018;36(6):833-840.

Do not use in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine.

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