PaxVax receives US marketing approval from FDA for cholera vaccine

13 June 2016 (Last Updated June 13th, 2016 18:30)

US-based biotechnology company PaxVax has received marketing approval from the US Food and Drug Administration (FDA) for cholera vaccine, Vaxchora.

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US-based biotechnology company PaxVax has received marketing approval from the US Food and Drug Administration (FDA) for cholera vaccine, Vaxchora.

The single-dose oral, live attenuated cholera vaccine has been developed for use in adults between 18 and 64 years of age.

Vaxchora is currently the only vaccine for cholera available in the US, as well as the only single-dose cholera vaccine licensed anywhere in the world.

PaxVax CEO and president Nima Farzan said: "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.

"We worked closely with the FDA on the development of Vaxchora and credit the agency's priority review programme for accelerating the availability of this novel vaccine."

The vaccine has been co-invented by University of Maryland School of Medicine (UM SOM) the Simon and Bessie Grollman Distinguished Professor Dr Myron M. Levine and UM SOM department of microbiology and immunology chairman James B. Kaper.

Additionally, the Vaxchora vaccine has been developed by PaxVax in close collaboration with the Centre for Vaccine Development at UM SOM.

Dr Levine said: "For travellers to the many parts of the world where cholera transmission is occurring and poses a potential risk, this vaccine helps protect them from this disease.

"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."

"It is a wonderful example of how public-private partnerships can develop medicines from bench to bedside."

Cholera is an acute intestinal diarrheal infection that is caused by bacterium Vibrio cholerae, which comes from ingesting contaminated water and food.

More than 80% of the reported cholera cases in the US are associated with travel to one of the 69 cholera-endemic countries in Asia, Africa and the Caribbean.

Vaxchora will be distributed through PaxVax's US marketing and sales organisation and is expected to be available in the market from the third quarter of this year.


Image: Scanning electron microscope image of Vibrio cholera. Photo: courtesy of Dartmouth College.