What is Vaxchora? 2

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.


Demonstrated Efficacy Profile 2

Vaxchora was evaluated in 3 randomized, double-blind, placebo-controlled studies.

  • Protective efficacy evaluated against a live cholera challenge.

  • Safety and immunogenicity evaluated in 2 additional clinical trials.

10-day and 3-month protective efficacy demonstrated against a live cholera challenge 2,a


a The efficacy of Vaxchora (i.e., preventing moderate or severe diarrhea [ ≥3.0 L cumulative purge within 10 days after challenge]) was evaluated in a phase 3 live cholera challenge study (Study 2 [NCT01895855]; N = 197). Subjects received one dose of Vaxchora or placebo. Vaccine efficacy was assessed at 2 different intervals by administering live cholera organisms to volunteers who had received Vaxchora or placebo. Two separate groups were challenged with an oral dose of V. cholerae El Tor Inaba at either 10 days (N = 35) or 3 months (N = 33) post vaccination. 2

Vaccine efficacy in the prevention of moderate to severe diarrhea following challenge with V. cholerae (intent-to-treat population) 2


10-day challenge b,d

N = 35 e

3-month challenge b,d

N = 33 e

Combined Placebo b,c
10-day or 3-month challenge d

N = 66 e

Number of subjects with moderate or severe diarrhea (attack rate) f 2
Vaccine efficacy % g,h
[95% CI i]
[62.7%, 100.0%]
[49.9%, 100.0%]

b Data are derived from Study 2 (NCT01895855). c Combined placebo group comprised of all placebo recipients who were challenged at either 10 days (N = 33) or 3 months (N = 33) following vaccination. d Challenge strain was V. cholerae O1 El Tor Inaba N16961. e N = number of subjects challenged in each group. f Moderate or severe diarrhea (≥3 liters of diarrhea) within 10 days after challenge. g Vaccine Efficacy = [(Attack Rate in Placebo Group – Attack Rate in Vaccine Group)/Attack Rate in Placebo Group] x 100. h Pre-specified criteria for success were that the lower bound of the two-sided 95% confidence interval for vaccine efficacy must be ≥30% in both the 10-day and 3-month challenge groups. i CI = confidence interval.


Demonstrated Safety Profile

Vaxchora has demonstrated safety profile with more than 3,000 subjects ages 18 to 64 years in clinical trials. 2

Rates of solicited adverse reactions reported in Vaxchora trial participants 18 to 45 years of age at 7 days post vaccination 2

Induces an Anticholera Immune Response

Vaxchora is a live, attenuated vaccine.

The V. cholerae vaccine strain in Vaxchora produces an incomplete, nontoxic version of the cholera toxin.

Vaxchora replicates in the gastrointestinal tract.


Dosing + Administration


Preparation, Reconstitution, and Administration

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. 2

Vaxchora should be reconstituted as follows 2:

Vaxchora does not require thawing prior to reconstitution. 2
Patients should not eat or drink for 60 minutes before and
60 minutes after administration of Vaxchora. 2

Disposal instructions

  • Dispose of the cup, packets, and stirrer according to standard procedures for medical waste. 2
  • Inactivate any spilled vaccine and clean any non-disposable equipment used in the preparation of Vaxchora with 70% isopropyl alcohol or 10% bleach solution. 2

How Supplied/Storage and Handling

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. 2


Vaxchora Product Presentation

Presentation Carton NDC Number Components

Single dose carton
containing two packets

NDC 70460-001-01

Buffer Component Packet
NDC 70460-003-02


Active Component Packet
NDC 70460-002-02

  • Protect from light and moisture. 2
  • Packets do not require thawing prior to preconstitution. 2
  • Packets should not be out of frozen storage for more than 15 minutes prior to reconstitution. 2
  • When out of frozen storage, packets should not be exposed to temperatures above 80°F (27°C). 2



See a collection of websites that provide useful information about health and safety while traveling.


Here you will find an assortment of helpful resources about Vaxchora.



  1. PaxVax, Inc. FDA approves Vaxchora, PaxVax's single-dose oral cholera vaccine.
    http://paxvax.com/about/news/fda-approves-vaxchora-paxvax%E2%80%99ssingle-dose-oral-cholera-vaccine. Accessed June 13, 2016.
  2. Vaxchora [package insert]. Hamilton, Bermuda: PaxVax Bermuda Ltd.; 2016.