|Cholera bacteria--Courtesy of CDC|
Right now, there is no FDA-approved cholera vaccine for U.S. travelers heading to high-risk countries. A California company hopes to change that soon: On Monday, PaxVax said it planned to submit a Biologics License Application (BLA) for its oral single-dose candidate in mid-2015.
The announcement accompanied Phase III trial results from a study designed to evaluate the safety and ability to induce an immune response of three consecutive lots of the vaccine candidate, to be submitted under the name Vaxchora. In 3,000 subjects in the Australia and the U.S., each of the three lots met a pre-set immunological endpoint for consistency of manufacture.
"U.S. travelers currently have limited options to protect themselves against cholera, and we are pleased with the progress we are making in bringing an effective single-dose cholera vaccine to travelers and potentially those suffering endemic disease in developing countries in the future," PaxVax CEO Kenneth Kelley said in a statement.
|PaxVax CEO Kenneth Kelley|
If approved, PXVX0200 will be the first single-dose cholera vaccine, which would reduce the number of hoops travelers have to jump through, especially for those who are traveling on short notice.
Already on the market in Europe are Dukoral, marketed by Johnson & Johnson's ($JNJ) Crucell, and Sanofi's ($SNY) Shanchol. Both are two-dose oral vaccines, but neither is FDA-approved. Merck's ($MRK) Indian JV, Hilleman Laboratories, teamed up in June with Sweden's Gotovax to develop and make available a low-cost, powdered cholera vaccine to developing countries.
Redwood City, CA-based PaxVax was founded in 2007 and includes a licensed vaccine for typhoid (Vivotif) in its portfolio, as well as vaccines that are in clinical development for anthrax, HIV and H5N1. Other vaccines in the works include those for malaria, dengue, rabies and herpes simplex virus.
- read the release