Cholera is an acute enteric infection caused by the bacterium Vibrio cholerae O1 or O139. It is transmitted by the ingestion of water or food containing the organism. The illness principally occurs in countries with insufficient access to safe water and proper sanitation, with even more dramatic impact in areas where basic environmental infrastructures are disrupted or have been destroyed. Contaminated water supplies are the main source of cholera infection, although raw shellfish, uncooked fruits and vegetables and other foods also can harbor V. cholerae and therefore present a risk of infection.
The infectious dose of wild type cholera in humans is in the range of 102 - 106 bacteria. Cholera is characterized in its most severe form (cholera gravis) by a sudden onset of acute electrolyte-rich watery diarrhea that can lead to severe dehydration and death. The extremely short incubation period (approximately 12 hours to 5 days) contributes to the sometimes sudden onset of outbreaks and the quick rise in number of cases.
Cholera (primarily O1) remains an important public health concern primarily in developing countries. Until recently, there was no cholera vaccine available in the United States. PaxVax re-developed a live attenuated bacterial vaccine containing the CVD 103-HgR vaccine strain of Vibrio cholerae serogroup O1, biotype classical, serotype Inaba. Vaxchora is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. The effectiveness of Vaxchora has not been established in: persons living in cholera-affected areas; persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.The development of CVD 103HgR and subsequent US FDA licensure of Vaxchora will be discussed as well as an overview of typical development & regulatory pathways for prophylactic vaccines including possible opportunities for a Zika vaccine.
Mr. Farzan joined PaxVax in September of 2011 and is currently Chief Executive Officer and President. Nima joined PaxVax from Novartis AG where he spent over seven years in a number of positions of increasing responsibility including pharmaceutical marketing, sales and development in both global and US positions. Most recently, he had been the Vice President of Marketing for Novartis Vaccines USA where he was responsible for marketing, market access, pricing and key account sales and helped launch multiple new vaccines. Prior to Novartis, Nima worked at DoubleTwist, Inc. a genomics company and was a consultant at The Boston Consulting Group. He has his MBA from Harvard Business School and an undergraduate degree in Human Biology from Stanford University.