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.
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
|Vaccine efficacy % g,h
[95% CI i]
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.
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:
Step 1: Locate the 2 packets:
the buffer component (Packet 1)
and the active component
Step 2: Pour 100 mL of cold or room temperature (41°F-72°F; 5°C-22°C) purified bottled or spring bottled water into a clean, disposable cup. Do not use tap water, sparkling (carbonated) water, non-purified or non-spring bottled water, other beverages, or other liquids.
Step 3: Use scissors to cut the top off the buffer component packet.
Step 4: Empty buffer component packet contents into cup. Effervescence will occur.
Step 5: Using a disposable stirrer, stir until the buffer component completely dissolves.
Step 6: Use scissors to cut the top off the active component packet.
Step 7: Empty the active component packet contents (lyophilized V. cholerae CVD 103-HgR) into the cup containing the buffer solution.
Step 8: Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates. The active component may not dissolve completely.
Step 9: Vaxchora must be consumed within 15 minutes of reconstitution. The recipient should drink the full contents of the cup at once. Some residue may remain in the cup and should be discarded with the cup.
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
- 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
||Carton NDC Number
Single dose carton
containing two packets
Buffer Component Packet
Active Component Packet
- 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.
Please see full Prescribing Information.
- Typhoid fever: general information. Centers for Disease Control and Prevention website. http://www.cdc.gov/nczved/divisions/dfbmd/diseases/typhoid_fever/. Updated 2013. Accessed November 24, 2015.
- VIVOTIF (Typhoid Vaccine Live Oral Ty21a) [package insert]. Redwood City, California: PaxVax, Inc; 2015.
- Jackson BR, Iqbal S, Mahon B. Updated Recommendations for the Use of Typhoid Vaccine-Advisory Committee on Immunization Practices, United States, 2015. CDC Morbidity and Mortality Weekly Report. 2015;64(11):305-308.
- Centers for Disease Control and Prevention. Typhoid & paratyphoid fever. CDC Health Information for International Travel 2016. New York, NY: Oxford University Press; 2015 http://www.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/typhoid-paratyphoid-fever. Accessed December 3, 2015.
- Pasetti MF, Simon JK, Sztein MB, Levine MM. Immunology of gut mucosal vaccines. Immunol Rev. 2011;239(1):125-148.
- Siegrist CA 2 - Vaccine immunology. In: Offit SAP, ed. Vaccines (Sixth Edition). London: W.B. Saunders; 2013. http://www.who.int/immunization/documents/Elsevier_Vaccine_immunology.pdf. Accessed December 3, 2015.
- Guzman CA, Borsutzky S, Griot-Wenk M, et al. Vaccines against typhoid fever. Vaccine. 2006;24(18):3804-3811. http://www.sciencedirect.com/science/article/pii/S0264410X05006766.
- Typhoid vaccine monograph for professionals. Drugs.com. http://www.drugs.com/monograph/typhoid-vaccine.html. Updated 2015. Accessed January 6, 2015.