Vaxchora Approved by FDA to Prevent Cholera Infection in Adults

Vaxchora Approved by FDA to Prevent Cholera Infection in Adults

According to the WHO, an estimated 3-5 million cases of cholera occur each year

June 15, 2016

The Food and Drug Administration (FDA) has announced its approval of Vaxchora, a vaccine for the prevention of cholera. The drug is approved to prevent the strain of the disease caused by serogroup O1 in adults 18 through 64 years of age.

While cholera is rare in the United States, travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. The disease is acquired by ingesting contaminated water or food and causes a watery diarrhea that can range from mild to extremely severe. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. According to the World Health Organization (WHO), serogroup O1 is the predominant cause of cholera globally.

Travelers to cholera-affected areas have relied on preventive strategies recommended by the Centers for Disease Control and Prevention (CDC) to protect themselves against cholera, including safe food and water practices and frequent hand washing. The approval of Vaxchora provides another line of defense against infection.

"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 Peter Marks in a written statement. Marks is the director of the FDA's Center for Biologics Evaluation and Research.

The FDA granted the Vaxchora application fast track designation and priority review status. These are distinct programs intended to facilitate and expedite the development and review of medical products that address a serious or life-threatening condition. In addition, the FDA awarded the manufacturer of Vaxchora a tropical disease priority review voucher. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of about three fluid ounces at least 10 days before travel to a cholera-affected area.

According to the CDC, an estimated 3-5 million worldwide cases of cholera infection occur each year, resulting in over 100,000 deaths.