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FDA approves cholera vaccine for travelers
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The FDA recently announced that it has approved Vaxchora as a vaccine for preventing cholera in travelers.
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 in a press release.
“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 only FDA-approved cholera vaccine
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. 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.
ACIP recommends vaccine for travelers
On June 22, the CDC’s Advisory Committee on Immunization Practices voted unanimously to accept proposed recommendations for the oral cholera vaccine.
The vaccine was approved by the committee as a “category A” vaccination, defined as a vaccine for use on the basis of recommendations made for all patients in a specific age group or in a high-risk population.
Karen Wong, MD, MPH, medical epidemiologist at the CDC, presented the cholera vaccine group’s recommendation, which called for vaccination of patients aged 18 to 64 years traveling to areas with active cholera transmission. The attenuated cholera vaccine strain, CVD 103-HgR, is more specifically recommended for travelers who either have an increased risk for toxigenic Vibrio cholerae 01 exposure or those whose travel situations carry an increased risk for poor clinical outcomes due to the lack of available, adequate treatment facilities. The recommendation also defined high-risk travelers as those with blood type O or those on gastric acid-suppressing therapies.
The committee ultimately motioned to strike the “high-risk” qualifiers from the recommendation and voted to recommend the vaccine for all adult travelers to cholera-endemic areas.
Wong said currently there are extremely limited data on the use of CVD 103-HgR among pregnant patients and immunocompromised patients, such as those with HIV. The recommendation does not include any language for use among pregnant women, but does not explicitly recommend against vaccinating pregnant women. – by Chelsea Frajerman Pardes and David Costill
Disclosures: Marks and Wong report no relevant financial disclosures.