www.fdanews.com/articles/177108-fda-greenlights-paxvaxs-cholera-vaccine
FDA Greenlights PaxVax’s Cholera Vaccine
June 16, 2016
The FDA has approved PaxVax’s vaccine Vaxchora for preventing cholera in patients between the ages of 18 and 64 traveling to cholera-affected areas.
In a placebo-controlled study, Vaxchora produced antibodies indicative of cholera resistance in 93 percent of participants between the ages of 18 and 45. A second study among 46 to 64 year-olds found the vaccine produced those antibodies in 90 percent of participants.
Vaxchora’s most common adverse effects include tiredness, headache, abdominal pain, nausea, lack of appetite and diarrhea. The agency had granted Vaxchora fast track and priority review status.
PaxVax did not respond to a request for comment.