The FDA approved PaxVax’s oral cholera vaccine on Friday, making it the first licensed cholera vaccine in the U.S. and the only single-dose cholera vaccine worldwide.
The Redwood City, CA-based biotech developed the vaccine, Vaxchora, for use by people traveling to areas where cholera is prevalent. The CDC currently recommends avoiding contaminated water or food to guard against cholera infection, but travelers tend not to comply with these precautions. A cholera vaccine would be an easy one-time alternative.
The FDA accepted PaxVax’s BLA for the vaccine in December, granting it priority review. While U.S. travelers were PaxVax’s initial target, CEO Nima Farzan previously told FierceVaccines that the company plans to eventually provide the vaccine to endemic countries.
“In line with our social mission, we have also begun development programs focused on bringing this vaccine to additional populations such as children and people living in countries affected by cholera,” Farzan said in a statement.
Vaxchora uses a weakened strain of the cholera virus in-licensed from the Center for Vaccine Development at the University of Maryland School of Medicine. The FDA approval is based on a 10-day and a 90-day cholera challenge trial, as well as two safety and immunogenicity trials in healthy adults. The vaccine demonstrated 90% efficacy at 10 days and 79% after three months. Its efficacy has not yet been demonstrated in people from areas where cholera is endemic.
The other cholera vaccines on the market are not FDA-approved. Valneva markets Dukoral, while Sanofi’s Shantha subsidiary sells the cheaper Shanchol. Both are two-dose vaccines. Vaxchora joins one other vaccine in PaxVax’s stable: Vivotif, the typhoid vaccine it picked up from Crucell in 2014. Since then, PaxVax has made moves to expand the commercial network it uses to distribute Vivotif. It will leverage this network to commercialize Vaxchora.
- here's the statement