FDA approves Vaxchora for travelers to cholera-affected regions

The FDA today approved Vaxchora as a vaccine for preventing cholera for travelers, according to a press release from the agency.

Vaxchora (single-dose live cholera vaccine, PaxVax) is specifically formulated for cholera caused by serogroup O1, which is the predominant cause of the disease, the FDA stated.

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

The vaccine, which had been previously granted fast-track designation and priority review status, is the only vaccine that has been FDA approved for the prevention of cholera. Previously, travelers depended on prevention strategies such as frequent hand-washing and safe food and water practices recommended by the CDC.

As detailed by the FDA, the vaccine is "a live, weakened vaccine that is taken as a single, oral liquid dose of approximately 3 fluid oz at least 10 days before travel to a cholera-affected area." It was approved for adults aged 18 to 64 years.

Various studies assessed the vaccine's efficacy and safety, as well as the immune system response.

In a randomized, placebo-controlled human challenge study, the vaccine demonstrated an efficacy rate of 90% in recipients challenged 10 days after vaccination and 80% in recipients challenged 3 months after vaccination, according to the FDA release. In two placebo-controlled studies, 93% of adults aged 18 to 45 years and 90% of adults aged 46 to 64 years produced antibodies that indicated protection against cholera. In four randomized, placebo-controlled, multicenter trials involving 3,235 participants who received the vaccine, the most common adverse reactions reported were diarrhea, lack of appetite, nausea/vomiting, abdominal pain, headache and tiredness.