Cholera Vaccine for Travelers Approved

The FDA has approved Vaxchora, a vaccine that can prevent cholera caused by serogroup 01 in adults aged 18 to 64 years who are traveling to cholera-affected areas.

Vaxchora, the only FDA-approved vaccine for cholera prevention, comes in a single, oral liquid dose of around 3 fluid ounces. It should be taken at least 10 days before travel.

Its efficacy was shown in a placebo-controlled study of nearly 200 adults aged 18 to 45 years.

The volunteers orally ingested Vibrio cholera, and 68 received Vaxchora and 66 received placebo. The vaccine was 90% efficacious in those who took the bacterium 10 days after vaccination, and it was 80% efficacious in the study participants who received the vaccine 3 months before ingesting the bacterium.

For those who were symptomatic, antibiotics and fluid replacement were made available. In addition, the investigators provided antibiotics to those who did not develop symptoms in order to prevent transmission of cholera into the community.

There were also 2 placebo-controlled studies to examine patients’ immune system response to the vaccine in patients aged 18 to 64 years. In those aged 18 to 45 years, 93% of the Vaxchora recipients produced antibodies suggesting protection against cholera. Antibodies were produced in 90% of those aged 46 to 64 years.

The vaccine’s safety was studied in 4 trials. Around 3200 people received Vaxchora, and 562 received placebo. The most common adverse events associated with Vaxchora were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea.

“The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the CDC for travelers to cholera-affected regions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

Individuals may contract cholera by ingesting contaminated water or food. It results in watery diarrhea that may range from moderate to severe. Cholera can also lead to vomiting and dehydration. Without antibiotic treatment and fluid replacement, it can be life-threatening.