Vaxchora® Cholera Vaccine (CVD 103-HgR) Description 2022
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.
NOTE: In December 2020, the maker Vaxchora will temporarily stop making and selling it. This vaccine may be in limited supply or unavailable.
Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine (2016) to prevent cholera. STN: 125597. 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.
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.'
Gaithersburg, Maryland-based Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life.
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 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. However, most people infected with V. cholerae do not experience symptoms.
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 who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. 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 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's goal is to prospectively collect data on the safety of VAXCHORA exposure on pregnant women and their offspring. The registry is strictly observational.
Emergent BioSolutions Inc. (NYSE: EBS) Financial Reports
Feb. 24, 2022 - Emergent BioSolutions Inc. (NYSE: EBS) reported financial results. Q4 2021 total revenues of $723M and Adjusted EBITDA of $348M resulting in FY 2021 total revenues of $1,793M and Adjusted EBITDA of $518M, in line with prior guidance.
Vaxchora Cholera Vaccine News For 2016 - 2022
July 5, 2022 - A study published in Nature Communications shows how O139 V. cholerae disappeared. But it caused several outbreaks in India and Bangladesh in the early 1990s and temporarily displaced O1 V. cholerae as the dominant, disease-causing variant.
June 13, 2022 - The Under-Secretary-General and Emergency Relief Coordinator Martin Griffiths approved the allocation of US$ 1.7 million from the Central Emergency Response Fund to support the urgent response to the cholera outbreak in Cameroon.
June 2, 2022 - Laos has been subject to heavy flooding, especially in the Sanamxay district. As water levels rise, so do fears of cholera.
May 23, 2022 - Malawi Ministry of Health launched a national Oral Cholera Vaccination campaign targeting over 1.9 million people (over 1 year of age) living in cholera hot-spot districts in the southern region.
May 17, 2022 - Contaminated drinking water has been linked to a deadly cholera outbreak in central Pakistan, CNN reported.
May 7, 2022 - The Ministry of Health of South Sudan announced that a Cholera outbreak had been declared in Rubkona County, Unity State. To date, a total of 31 cases, including one death, have been reported.
May 3, 2022 - The U.S. CDC issued a Watch - Level 1, Practice Usual Precautions, for a cholera outbreak in Cameroons Centre, Littoral, South, Southwest, and North regions.
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.
April 17, 2022 - The WHO reported the cholera outbreak in Cameroon has escalated in recent weeks with a more than 3.5-fold increase as of March 27, 2022.
April 13, 2022 - GAVI reported Cameroon's cholera epidemic has killed at least 62 people and infected some 2,097 others since October 2021.
April 13, 2022 - A cholera outbreak was reported by Ahmedabad Municipal Corporation, with 54 cases confirmed in the first nine days of April 2022.
February 23, 2022 - Pablo Sanchez, MD Chair, CDC Cholera Vaccine Work Group, presented: Introduction to the Cholera Vaccine Session.
January 13, 2022 - Emergent BioSolutions presented an update at the 40th Annual J.P. Morgan Virtual Healthcare Conference.
January 12, 2022 - The U.S. CDC's ACIP meeting Presentation Slides were posted online.
December 27, 2021 - The Democratic Republic of the Congo launched a cholera vaccination campaign targeting 2 million people. The campaign is being carried out in Haut-Lomami, South Kivu, and Tanganyika provinces, with about 4 million doses delivered by the Global Task Force on Cholera Control. A two-round dose of oral cholera vaccine provides up to five-year protection.
November 2, 2021 - The WHO Africa reported 67 suspected cases, including three confirmed and five deaths (case fatality ratio (CFR 7.4%) had been reported in Cameroon.
June 18, 2021 - The ECDC reported several countries in Africa and Asia had reported cholera outbreaks. Major ongoing outbreaks are being reported from Bangladesh and Yemen. In addition, Haiti reported its last laboratory-confirmed case in February 2019.
June 16, 2021 - The Lancet published a study: Effectiveness of a killed whole-cell oral cholera vaccine in Bangladesh: further follow-up of a cluster-randomized trial. Interpretation: These findings provide further evidence of long-term effectiveness of killed whole-cell OCV, and therefore further support for the use of killed whole-cell OCVs to control endemic cholera, but indicate that protection is shorter-lived in children vaccinated before the age of 5 years than in people immunized at the age of 5 years or older.
June 12, 2021 - Ethiopia officially launched a preventive oral cholera vaccination campaign targeting 2 million people aged one year and above in the Tigray region to avert a potential outbreak in the north. The vaccination drive, which began on 10 June, will cover 13 priority districts in Tigray and is being carried out alongside measures such as water purification tablets and handwashing soaps to improve water, sanitation, and hygiene.
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.
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 years of age 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
Vaxchora vaccine continues to be studied in various clinical trials.