Posted by Michael Wonder on 03 Feb 2020
Emergent BioSolutions receives positive CHMP opinion for Vaxchora; anticipates near-term approval by European Medicines Agency
31 January 2020 - Emergent BioSolutions today announced that the CHMP of the EMA adopted a positive opinion for the approval of the company’s single-dose oral cholera vaccine, Vaxchora (Cholera vaccine, live, oral).
A marketing authorisation 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 immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 6 years of age.
The marketing authorisation will be valid in all 28 member states of the European Union.
