Vaxchora
Product Vaxchora

Help protect patients where
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VAXCHORA

CDC RECOMMENDATION

What is 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.

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.

Demonstrated Efficacy Profile1

In a randomized, double-blind, placebo-controlled V. cholerae challenge study, VAXCHORA demonstrated vaccine efficacy in the prevention of moderate to severe diarrhea following challenge of V. cholerae O1 El Tor Inaba at 10 days and 3 months postvaccination.

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

Efficacy 10 days after vaccination1

Vaxchora

Thirty-three volunteers receiving placebo were challenged with Vibrio cholerae in an isolated clinical setting. The majority of placebo recipients (39/66, 59.1%) developed moderate or severe diarrhea after challenge. In the 10-day challenge group, 2 volunteers taking VAXCHORA (5.7%) developed moderate or severe diarrhea after challenge1.

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

Efficacy 3 months after vaccination1

Vaxchora

In the group challenge 3 months after vaccination, 4 volunteers taking VAXCHORA (12.1%) developed moderate or severe diarrhea after challenge1.

10-day and 30-day volunteers are different groups.

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.a,b,c,d

Duration of VAXCHORA is unknown.

a p<0.0001 vs placebo2.

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.

d Vaccine Efficacy = [(Attack Rate in Placebo Group – Attack Rate in Vaccine Group)/Attack Rate in Placebo Group] x 100.

VAXCHORA stimulated an immune response in more than 90% of recipients3,a

In a phase 3, randomized, double-blind, placebo-controlled trial of 3,146 volunteers, 94% of volunteers receiving VAXCHORA demonstrated seroconversion at Day 11 vs 4% receiving placebo (p<0.0001).

a Seroconversion defined as a ≥4-fold rise in vibriocidal antibody against homologous classical Inaba.

Safety Profile1

The safety of VAXCHORA was evaluated in more than 3,000 volunteers ages 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 postvaccinationa
Adverse
Reaction
VAXCHORA
(N=2789)
Placebob
(N=350)
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

MINUTES

Reconstitution should be completed within 15 minutes of removing the carton from the refrigerator, and travelers should consume the vaccine in the pharmacy or a Healthcare Professional's office within 15 minutes of reconstitution.

60

MINUTES

Travelers 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.

Vaxchora reconstitution

For medical inquiries about reconstitution of VAXCHORA, please contact Medical Information at (888) 483-9053.

How Supplied/Storage and Handling1

Vaxchora single dose

VAXCHORA is supplied as shown below.1 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 70460-004-001

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).

For medical inquiries about storage of VAXCHORA, please contact Medical Information at (888) 483-9053.

Indication and Important Safety Information for VAXCHORA® (Cholera Vaccine, Live, Oral)

Indication and Usage

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.

Important Safety Information

Contraindications

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.

Warnings and Precautions

  • 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.

Adverse Reactions

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%).

Drug Interactions

  • 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:

  • VAXCHORA [package insert]. Redwood City, CA: PaxVax, Inc.; 2019.

  • 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;62:1329-3135.

  • McCarty JM, et al. 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.

Indication and Important Safety Information for VAXCHORA® (Cholera Vaccine, Live, Oral)

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Indication and Usage

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

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