Help protect patients where they may want
to go with VAXCHORA

Why VAXCHORA1?

VAXCHORA for oral suspension is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas.

The Advisory Committee on Immunization Practices recommends VAXCHORA for adult travelers aged 18 to 64 years who are visiting an area of active cholera transmission. Active transmission is defined as having cases reported within the past year.2

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

CDC Recommendation

Demonstrated Efficacy Profile1

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,b,c,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.

The 10-day and 3-month cohorts consisted of different volunteers.

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 or severe diarrhea after challenge.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 or severe diarrhea after challenge.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 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,a

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

Seroconversion occurred in 94% 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.

Safety Profile1

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).
  • b N represents number of subjects who completed a memory aid.

Dosing and Administration1

VAXCHORA delivers 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

Reconstitution should be completed within 15 minutes of removing the carton from the refrigerator, and 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 60 minutes after ingestion of VAXCHORA.

Reconstitution and Disposal1

The procedures below are provided as general guidelines for the preparation and reconstitution of VAXCHORA, which must be performed in a health care setting equipped to dispose of medical waste. Please refer to Prescribing Information for complete reconstitution and disposal information.

Preparation, reconstitution, and administration

Prepare and administer VAXCHORA in a healthcare setting equipped to dispose of medical waste.

reconstitution reconst-mob1 reconst-mob2 reconst-mob3 reconst-mob4 reconst-mob5 reconst-mob6 reconst-mob7 reconst-mob8 reconst-mob9 reconst-mob10 reconst-mob11
refernce-img

For medical inquiries about reconstitution of VAXCHORA, please contact Medical Information at
(800) 533-5899.

How Supplied/Storage and Handling1

storage-img

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 15 minutes 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 storage of VAXCHORA, please contact Medical Information at
(800) 533-5899.

Visit the Videos & Resources page for more information about VAXCHORA.

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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.

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 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.

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

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.

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%).

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 11/2019

Please see full Prescribing Information.

References:

  1. VAXCHORA [package insert]. Redwood City, CA: PaxVax, Inc.; February 2020.
  2. Clinical update: cholera vaccine for travelers. Centers for Disease Control and Prevention. Updated March 10, 2020. Accessed March 20, 2020.
    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 O1 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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