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First Single-Dose Cholera Vaccine Approved By FDA



The vaccine is designed to protect against cholera infection and is the world’s first single-dose preventative treatment.

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June 15, 2016 | by Sarah Massey, M.Sc.

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An oral cholera vaccine, PaxVax’s Vaxchora, has just been approved by the US Food and Drug Administration (FDA). The vaccine is designed to protect against cholera infection and is the world’s first single-dose preventative treatment.

“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. The vaccine is a live, attenuated bacteria which is administered via a single oral dose at least 10 days before an individual plans to travel to a cholera-endemic area.

Between 1.4 million and 4.3 million people worldwide become infected with cholera each year, according to statistics from the World Health Organization (WHO). The bacterial infection causes severe diarrhea which can be fatal just hours after the onset of symptoms.

While the Centers for Disease Control and Prevention (CDC) recommend that US travelers prevent infection with Vibrio cholera bacteria by avoiding suspicious food and water, most travelers fail to comply with these guidelines. It’s estimated that 98 percent of travelers to cholera-endemic regions – including those in the Caribbean, Asia and Africa – don’t heed the CDC’s warning.

Most travelers who develop cholera while visiting one of the 69 countries where the illness is common, do not die. They do, however, suffer from severely acute symptoms including dehydration and diarrhea. Without proper medical attention, a patient with cholera could die in less than 48 hours.

Interestingly, the CDC claims that the number of cholera cases in the US is severely underestimated. They believe that the actual number of patients who become ill as a result of the Vibrio cholera bacteria could be as much as 30 times higher than the estimate made using epidemiological methods.

Vaxchora was granted both fast track designation and priority review status by the FDA. PaxVax now hopes to make the vaccine available to those living in cholera-endemic countries.

Keywords: Cholera, Vaccine, FDA


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