Posted by Michael Wonder on 21 May 2019
Emergent BioSolutions announces granting of marketing authorisation in Five EU countries for its oral typhoid vaccine; expands availability across Europe
20 May 2019 - Emergent BioSolutions announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif (Typhoid Vaccine Live Oral Ty21a) in five additional European Union Member States, including France, Portugal, Poland, Czech Republic and Slovakia as well as approval of harmonised prescribing information in the EU also known as the Summary of Product Characteristics or SmPC.
In the U.S. and Europe, the vaccine is marketed under the name Vivotif® and in Germany under the name Typhoral® L. The vaccine is indicated for active oral immunization against typhoid fever, caused by Salmonella enterica serovar Typhi, (S. Typhi), in adults and children aged five years and older. The harmonized SmPC aligned the age indication and expanded the revaccination interval from one to three years following the most recent vaccination.
Typhoid fever is a potentially severe and life-threatening infection caused by the bacterium Salmonella enterica serovar Typhi (Salmonella Typhi). Typhoid Vaccine Live Oral Ty21a is an oral vaccine that stimulates an immune response against Salmonella Typhi. In the EU, it is taken as a three-capsule regimen with a single capsule being taken on days 1, 3, and 5.
