FDA Approves Cholera Vaccine

Cholera is rare in the United States, but travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. Travelers to such areas have relied on preventive strategies recommended by CDC to protect themselves against cholera, including safe food and water practices and frequent hand washing.

The U.S. Food and Drug Administration approved on June 10 a vaccine named Vaxchora for the prevention of cholera caused by serogroup O1 in adults 18 to 64 who are traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera, according to the agency.

Cholera is caused by Vibrio cholerae bacteria and is acquired by ingesting contaminated water or food. "Often the infection is mild; however, severe cholera is characterized by profuse diarrhea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. According to the World Health Organization, serogroup O1 is the predominant cause of cholera globally," according to FDA's announcement of the approval.

"The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions," said Dr. Peter Marks, MD, Ph.D., director of FDA's Center for Biologics Evaluation and Research.

Cholera is rare in the United States, but travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. Travelers to such areas have relied on preventive strategies recommended by CDC to protect themselves against cholera, including safe food and water practices and frequent hand washing.

Vaxchora is a live, weakened vaccine that is taken as a single oral liquid dose of approximately 3 fluid ounces at least 10 days before the individual travels to a cholera-affected area. FDA reported the vaccine's efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 U.S. volunteers ages18 to 45. Vaxchora efficacy was 90 percent among those challenged 10 days after vaccination and 80 percent among those challenged three months after vaccination. In addition, two placebo-controlled studies to assess the immune system's response to the vaccine were also conducted in the United States and Australia.

FDA granted the Vaxchora application fast track designation and priority review status. Vaxchora is manufactured by PaxVax Bermuda Ltd., which is located in Hamilton, Bermuda.

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