FDA approves first cholera prevention vaccine

SILVER SPRING, Md. — The Food and Drug Administration has approved Vaxchora, a single-dose oral vaccine for the prevention of cholera in adults aged 18 to 64 years, the vaccine maker PaxVax announced Monday. Vaxchora is the only cholera prevention vaccine approved by the FDA. 

 

“The approval of Vaxchora is an important milestone for PaxVax and we are proud to provide the only vaccine against cholera available in the U.S.,” PaxVax president and CEO Nima Farzan said. “We worked closely with the FDA on the development of Vaxchora and credit the agency’s priority review program for accelerating the availability of this novel vaccine. In line with our social mission, we have also begun development programs focused on bringing this vaccine to additional populations such as children and people living in countries affected by cholera.”

 

Though cholera — which is acquired by ingesting contaminated water or food and can be life threatening in some cases — is uncommon in the United States, the FDA said that travelers to other parts of the world with inadequate water and sewage treatment and poor sanitation can be at risk. The liquid dose of about 3 fl. oz. is meant to be taken at least 10 days before travel to a cholera-infected area. 

 

“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, director of the FDA’s Center for Biologics Evaluation and Research.