CHMP recommends approval of Vaxchora vaccine for cholera.- Emergent BioSolutions

Emergent BioSolutions announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the approval of the company’s single-dose oral cholera vaccine, Vaxchora (Cholera Vaccine, Live, Oral). A marketing authorization decision from the European Commission is anticipated within three months from positive opinion. If approved, Vaxchora will be the only single-dose oral vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults and children from 6 years of age. The marketing authorization will be valid in all 28 member states of the European Union (EU).The positive CHMP opinion is based on data from five randomized, double-blind, placebo-controlled clinical trials, including a Phase I safety and immunogenicity study, a Phase III challenge study, where Vaxchora demonstrated 90.3% efficacy at 10 days and 79.5% efficacy at 3 months, a Phase III safety and immunogenicity study that examined lot-to-lot consistency, a Phase III study that demonstrated a similar immune response in older adults compared with younger adults, and a Phase IV study in children that demonstrated a similar immune response in children compared to younger adults.Comment: Approved in the U.S. in June 2016, the vaccine is marketed as Vaxchora and is the only vaccine licensed by the U.S. Food and Drug Administration for active immunization against cholera caused by Vibrio cholerae serogroup O1. In May 2017, the Centers for Disease Control and Prevention published its recommendation for the use of Vaxchora in adults 18-64 years traveling from the U.S. to areas of active cholera transmission.