FDA approves Vaxchora, PaxVax' single-dose oral cholera vaccine

The US Food and Drug Administration has granted approval for privately-held PaxVax’ Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. The approval makes Vaxchora the only vaccine available in the US for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world.

“FDA approval of a new vaccine for a disease for which there has been no vaccine available is an extremely rare event. The approval of Vaxchora is an important milestone for PaxVax and we are proud to provide the only vaccine against cholera available in the US,” said Nima Farzan, chief executive and president of PaxVax, adding: “We worked closely with the FDA on the development of Vaxchora and credit the agency’s priority review program for accelerating the availability of this novel vaccine. 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.”

Commercial availability expected in 3rd-quarter