PaxVax's cholera vaccine wins FDA nod


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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

“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

Related Articles:
FDA accepts PaxVax's BLA for cholera vaccine, grants it priority review
Cerberus Capital management invests $105M in PaxVax


Suggested Articles

FDA officials say Novartis took too long to launch a formal probe into allegations of Zolgensma data manipulation.

Should Johnson & Johnson owe billions to fix Oklahoma's opioid crisis? After weeks of trial testimony, a judge will have his say Monday afternoon.

After Endo and Allergan agreed to settle with two Ohio counties on opioid charges this week, the state’s AG has a message: You’re not off the hook.