In a unanimous vote, the CDC’s Advisory Committee on Immunization Practices recommended PaxVax’s oral cholera vaccine for adults traveling to areas where cholera is prevalent. The vaccine, dubbed Vaxchora, is the only licensed cholera vaccine in the U.S. and the only single-dose cholera vaccine in the world.
The ACIP nod comes two weeks after the FDA approved the vaccine. It recommends the live attenuated vaccine for adults aged 18 to 64. Previously, the CDC recommended the avoidance of contaminated food and water to fend off cholera infection, but studies show that as many as 98% of travelers tend not to follow this advice.
While PaxVax lined up American travelers as its initial target, CEO Nima Farzan has previously told FierceVaccines that he plans to bring the vaccine to endemic countries as well.
The FDA approval was based on a 10-day and 90-day challenge study in addition to safety and immunogenicity trials in healthy adults. The vaccine posted 90% efficacy at the 10-day mark and 79% efficacy at the three-month mark. Its efficacy has not yet been proven in people from regions where cholera is endemic.
PaxVax expects Vaxchora to hit the market in September. PaxVax will use its existing sales structure to commercialize the vaccine. The Redwood City, CA-based company currently markets one vaccine, the typhoid jab Vivotif, that it picked up from Crucell two years ago.
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