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FDA Approves Oral Cholera Vaccine Vaxchora
The FDA has granted marketing approval for Vaxchora (PaxVax Corporation), a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. It is the only vaccine available in the United States for cholera and is the only single-dose vaccine for cholera licensed anywhere in the world.
Vaxchora is expected to be commercially available in the U.S. in the third quarter of 2016.
The attenuated cholera strain used in the vaccine is CVD 103-HgR, which was licensed from the Center for Vaccine Development at the University of Maryland School of Medicine in 2010. Vaxchora is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas. The efficacy of Vaxchora has not been established in persons living in cholera-affected areas or in persons who have pre-existing immunity resulting from previous exposure to V. cholerae or from 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 FDA approval of Vaxchora was based on positive results from a 90-day cholera challenge trial as well as from two safety and immunogenicity trials in healthy adults, which demonstrated efficacy of more than 90% at 10 days and 79% at three months after vaccination. The most common adverse events included tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea.
More than 3,000 participants were enrolled in the phase 3 clinical trial program that evaluated Vaxchora at sites in the U.S. and Australia.
Source: PaxVax; June 10, 2016.