Vaxchora Vaccine Description
Vaxchora is a live attenuated recombinant V. cholerae O1 Inaba Vaccine Strain CVD 103-HgR, which can synthesize the immunogenic nontoxic B subunit of CT (encoded by the ctxB gene). Vaxchora is an oral vaccine 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 V. cholerae vaccine strain produces an incomplete, nontoxic version of the cholera toxin; it then replicates in the gastrointestinal tract.
Vaxchora is the only FDA-approved vaccine for the prevention of cholera. STN: 125597.
Gaithersburg, Maryland-based Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life.
Vaxchora Vaccine Indication
Vaxchora is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to an active cholera-affected area. Active transmission is defined as having cases reported within the past year.
The vaccine's benefits include preventing moderate to severe diarrhea caused by cholera bacteria in immunologically naive individuals. Cholera is a life-threatening illness that causes diarrhea. Cholera is caused by eating or drinking the Vibrio cholera bacteria.
The US CDC Advisory Committee on Immunization Practices recommends Vaxchora for adult travelers aged 18 to 64 years who visit an area of active cholera transmission. Active transmission is defined as having cases reported within the past year.
Cholera, an acute bacterial disease of the small intestine, causes severe vomiting, diarrhea, and dehydration that can become life-threatening. It is estimated that three million to five million cholera cases occur each year, causing nearly 100,000 fatalities worldwide. Most people infected with V. cholerae do not experience symptoms. However, the bacterium remains for up to 10 days in the feces, which is shed into the environment, potentially infecting other people. In people who experience symptoms, the infection can lead to death within hours if not treated, says the U.S. CDC.
The bacteria is spread through water or food that has stood in it. Up to 50 countries with limited access to clean water are more likely to have outbreaks.
Vaxchora Vaccine Dosage
Vaxchora is a live, weakened vaccine taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area.
Vaxchora has been reported to reduce the chance of severe diarrhea in people by 90% at 10 days after vaccination and by 80% at 3 months after vaccination.
The safety and effectiveness of Vaxchora in pregnant or breastfeeding women are not yet known, and it is also not known how long protection lasts beyond 3 – 6 months after getting the vaccine.
Side effects from Vaxchora are uncommon and may include tiredness, headache, abdominal pain, nausea and vomiting, lack of appetite, and diarrhea.
Vaxchora Vaccine Limitations of Use
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.
Store Vaxchora buffer component and active component packets refrigerated at 36°F to 46°F (2°C to 8°C). Packets should not be out of refrigerated storage for more than 15 minutes before reconstitution; when out of refrigerated storage, packets should not be exposed to temperatures above 80°F (27°C)
Vaxchora Vaccine Pregnancy Registry
Vaxchora (Cholera Vaccine, Live, Oral) Pregnancy Registry has been established to monitor the safety of Vaxchora use during pregnancy.
Vaxchora is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Studies have not been performed among pregnant women who have taken Vaxchora. The pregnancy registry's goal is to prospectively collect data on the safety of VAXCHORA exposure on pregnant women and their offspring. The registry is strictly observational.
To Enroll In the Vaxchora Pregnancy Registry Or To Find Out More Information, Please Call The Registry Telephone Number Directly (1-800-533-5899).
Vaxchora Vaccine News
February 18, 2021 - Emergent BioSolutions Inc. reported financial results for the quarter and year ended December 31, 2020. The Company also reaffirmed its full-year 2021 forecast.
December 23, 2020 - The U.S. FDA approved the draft package insert labeling submitted under amendment #19, dated December 7, 2020, and the draft carton and container labeling submitted under amendment #6, dated August 28, 2020.
February 13, 2020 - U.S. FDA approved the draft package insert labeling submitted in the original supplement on October 18, 2019.
January 31, 2020 - EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children. The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended marketing authorization for cholera vaccine (recombinant, live, oral) (Vaxchora, Emergent Netherlands BV) for protection against cholera in adults and children, according to an EMA summary of the opinion.
October 2017 - Vaxchora: The First FDA-Approved Cholera Vaccination in the United States.
Vaxchora Vaccine Clinical Trials
Clinical Trial NCT03220737: A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age Last update posted on December 24, 2020. This Phase 4 study's primary goal is to evaluate the safety and immunogenicity of VAXCHORA in 550 children ages 2 years to <18 years of age in developed countries.
Clinical Trial NCT03251495: Immunologic Responses to a Live Attenuated Oral Cholera Vaccine - Last update posted on August 19, 2020. This Phase 2 study's primary objective is to evaluate the cholera vaccine's antibody response, Vaxchora®, in healthy subjects.