Vaxchora Now Available for Protection Against Cholera
PaxVax announced the availability of Vaxchora (oral cholera vaccine, live), the first vaccine for protection against cholera.
Vaxchora, a live, oral vaccine, was initially approved by the Food and Drug Administration (FDA) in June 2016 for use in the United States for adults aged 18-64 years traveling to cholera-affected areas as an active immunization against disease caused by Vibrio cholerae serogroup O1.
Also in June 2016, Vaxchora was unanimously recommended by the Centers for Disease Control and Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) for travelers to areas of active cholera transmission.
Vaxchora contains live attenuated cholera bacteria that replicate in the gastrointestinal (GI) tract of the recipient. Rises in serum vibriocidal antibody 10 days after vaccination with Vaxchora were associated with protection in a human challenge study.
The approval of Vaxchora vaccine was based on data from a 10- and 90-day cholera challenge trial in addition to two safety and immunogenicity trials in healthy adults that showed efficacy of >90% at 10 days and 79% at 3 months post-vaccination. Over 3,000 participants were enrolled in the Phase 3 clinical trial program that evaluated Vaxchora at study centers in Australia and the United States.
Vaxchora is available as single-dose carton containing two packets (buffer component + active component). Contents of both packets are reconstituted with purified bottled water to form one oral suspension dose of the vaccine.
For more information call (800) 535-5899 or visit PaxVaxConnect.com.