Vaxchora® Cholera Vaccine (CVD 103-HgR) Clinical Trials, Dosage, Indication, News, Side Effects
Vaxchora® (CVD 103-HgR) 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. The vaccine contains a weakened form of the cholera bacterium serogroup O1. The V. cholerae vaccine strain produces an incomplete, nontoxic version of the cholera toxin, replicating in the gastrointestinal tract.
Vaxchora is made in water and taken by mouth as a single dose at least ten days before the person is likely to contract cholera bacteria. Vaxchora is approved for use in adults 18 through 64 traveling to cholera-affected areas. Vaxchora is the only U.S. FDA-approved vaccine (2016) to prevent cholera: STN: 125597, and Dec. 23, 2020: BL 125597/123. The European Medicines Agency (EMA) noted that evidence from Vaxchora studies is relevant only for travelers visiting areas where cholera is present. It is not known how long the protection lasts. The EMA authorized Emergent Netherlands B.V. for Vaxchora in Jan. 2020: EMEA/H/C/003876.
The U.S. CDC Advisory Committee on Immunization Practices (ACIP) committee published its recommendations for using lyophilized CVD 103-HgR vaccine (CVD 103-HgR) Vaxchora on September 30, 2022. On Jan. 12, 2022, the U.S. CDC's vaccine committee reviewed the following presentations: Introduction to the Cholera Vaccine Session Pablo Sanchez, MD; Vaxchora Vaccine - Pediatric Dose Development James McCarty, MD; Evidence to Recommendations: CVD 103-HgR among children and adolescents aged 2–17 years Jennifer P. Collins, MD, MSc. Then, on Feb. 23, 2022, Jennifer P. Collins, MD, MSc, CDC Lead, Cholera Vaccine Work Group, presented 'Evidence to recommendations summary, considerations for use, and proposed policy option: CVD 103-HgR among children and adolescents aged 2–17 years.' The CDC confirmed eight cholera cases in the U.S. related to travelers on Dec. 5, 2022.
Gaithersburg, Maryland-based Emergent BioSolutions sold the vaccine to Bavarian Nordic (BVNRY) on May 15, 2023.
Vaxchora 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 CDC Advisory Committee on Immunization Practices recommends Vaxchora for adult travelers aged 18 to 64 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 yearly, causing nearly 100,000 fatalities worldwide. However, most people infected with V. cholerae do not experience symptoms.
Vaxchora Dosage
Vaxchora (CVD 103-HgR) is a live, weakened vaccine taken as a single, oral liquid dose of approximately three fluid ounces at least ten days before travel to a cholera-affected area.
Vaxchora Limitations of Use
The effectiveness of Vaxchora (CVD 103-HgR) has not been established in persons with pre-existing immunity due to previous exposure to V. cholerae or the receipt of a cholera vaccine. The safety and effectiveness of Vaxchora in pregnant or breastfeeding women are not yet known, and it is unknown 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 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 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 aims to prospectively collect data on the safety of VAXCHORA exposure on pregnant women and their offspring. The registry is strictly observational.
Cholera Outbreaks
As of 2024, various cholera outbreaks have been reported.
Vaxchora News
May 15, 2023 - Emergent BioSolutions announced it had completed the sale of its travel health business to Bavarian Nordic.
October 19, 2022 - A strained global supply of cholera vaccines has obliged the International Coordinating Group to temporarily suspend the standard two-dose vaccination regimen in cholera outbreak response campaigns, using a single-dose appearance.
July 5, 2022 - A study published in Nature Communications shows how O139 V. cholerae disappeared. But it caused several outbreaks in India and Bangladesh in the early 1990s and temporarily displaced O1 V. cholerae as the dominant, disease-causing variant.
June 13, 2022 - The Under-Secretary-General and Emergency Relief Coordinator Martin Griffiths approved the allocation of US$ 1.7 million from the Central Emergency Response Fund to support the urgent response to the cholera outbreak in Cameroon.
May 23, 2022 - Malawi Ministry of Health launched a national Oral Cholera Vaccination campaign targeting over 1.9 million people (over one year of age) living in cholera hot-spot districts in the southern region.
April 29, 2022 - Vaccination contributed to the fight against the cholera epidemic that affected seven regions of Niger, causing 5591 infections and 166 deaths, with a case-fatality rate of 3%. Vaccination coverage of 95%, combined with good patient management and hygiene and sanitation awareness, led to a significant decrease in the number of new cases until the epidemic was declared over in the following weeks.
February 23, 2022 - Pablo Sanchez, MD Chair, CDC Cholera Vaccine Work Group, presented: Introduction to the Cholera Vaccine Session.
January 12, 2022 - The U.S. CDC's ACIP meeting Cholera Presentation Slides were posted online.
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.
June 10, 2016 - The U.S. Food and Drug Administration approved Vaxchora, a vaccine for preventing cholera caused by serogroup O1 in adults 18 through 64 traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.
Vaxchora (CVD 103-HgR) Vaccine Cholera Clinical Trials
The Vaxchora vaccine continues to be studied in various clinical trials.
