Vaxchora Indication Expanded to Include Children

December 22, 2020 – The U.S. FDA has approved an expanded indication for Vaxchora® (cholera vaccine, live) oral suspension, manufactured by Emergent Travel Health. The vaccine, which was previously approved to immunize adults age 18-64, is now approved to immunize individuals 2-64 years of age. Vaxchora is indicated to provide active immunization against disease caused by Vibrio cholerae serogroup O1 in individuals traveling to cholera-affected areas.

An infectious species of bacteria, Vibrio cholerae can cause mild to severe illness in humans. However, it only causes cholera when a person is infected with one of two serogroups of the bacteria – serogroup O1 or serogroup O139. V. cholerae bacteria of these types produce cholera toxin, which can cause severe, life-threatening disease. In early stages of infection, patients may experience profuse, watery diarrhea as well as nausea, vomiting, thirst, cramps, restlessness, and irritability. Cholera can lead to significant dehydration, resulting in kidney failure, shock, coma, and death.

Vaxchora must be prepared and administered in a healthcare setting equipped to dispose of medical waste. Recommended dosing for patients 6-64 years of age is 100mL, administered as a single oral dose, at least 10 days before potential exposure. Patients under the age of six should receive a single 50mL oral dose at least 10 days before potential exposure. All patients should avoid eating or drinking for 60 minutes before and after administration of the vaccine.

According to the U.S. Centers for Disease Control and Prevention (CDC), Emergent Travel Health temporarily ceased production and sale of Vaxchora in December 2020. As a result, the product may be in limited supply or unavailable.