PaxVax announces progress on single-dose oral cholera vaccine
The application's clearance paves the way for PaxVax to begin clinical testing. The company said it has plans to initiate Phase III trials later this year.
The vaccine, currently known as PXVX-0200, is a single-dose, oral, live attenuated vaccine against cholera that has been previously approved and marketed in six other countries under the name Orochol.
Currently available cholera vaccines generally require two doses over the course of several weeks before becoming effective, but PXVX-0200 can protect against cholera in as little as seven days from the time of its administration. PaxVax said that the vaccine will be ideal for people traveling to areas where cholera is endemic.
"We expect our cholera vaccine will be the first vaccine for cholera available in the United States, and the only one-dose oral vaccine in the world," PaxVax Kenneth Kelley said. "Further, given that cholera is classified as a neglected tropical disease by the FDA, this product should qualify us for a priority review voucher."
PaxVax partnered with SynCo Bio Partners B.V., an Amsterdam-based biopharmaceutical manufacturing company with experience in live microbial biotherapeutics, to manufacture material for the clinical trials.