Cholera is an acute intestinal infection caused by the ingestion of food or water contaminated with the Vibrio cholerae (V. cholerae) bacterium. An infection with V. cholerae can cause profuse diarrhea, vomiting, circulatory collapse and shock. Cholera is an extremely virulent illness that affects both children and adults and can kill within hours if left untreated.
Cholera incidence has increased steadily since the beginning of the millennium and outbreaks continue to pose a significant public health risk to indigenous populations and travelers where access to adequate water and sanitation resources are constrained. According to the WHO, 3-5 million people suffer from this disease annually, with up to 200,000 deaths. Sub-Saharan Africa and Asia, as well as other developing regions in the Caribbean and South America, have been particularly vulnerable to outbreaks. These regions are also prone to outbreaks following disaster situations where there is disruption of water and sanitation systems or the displacement of populations into overcrowded camps.
About VaxchoraTM (Cholera Vaccine, Live, Oral)
Vaxchora is an oral vaccine indicated 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 effectiveness of Vaxchora has not been established in persons living in cholera-affected areas or 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.
The FDA approval of Vaxchora is based on positive results from a 10 and 90-day cholera challenge trial, as well as two safety and immunogenicity trials in healthy adults that demonstrated efficacy of more than 90 percent at 10 days and 79 percent at 3 months post vaccination1. The most common adverse reactions were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea. More than 3,000 participants were enrolled in the Phase 3 clinical trial program that evaluated Vaxchora at sites in Australia and the United States.
1. Chen WH, Cohen MB, Kirkpatrick BD. Single-Dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection with Vibrio cholerae O1 El Tor. Clinical Infectious Diseases 2016; doi: 10.1093/cid/ciw145