Sanofi Pasteur Files for EU Approval of Influenza Vaccine
February 13, 2008
Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has filed a centralized marketing authorization application, in Europe, for the first seasonal influenza vaccine delivered by an innovative intradermal microinjection system.
This file has been accepted for review by the European Medicines Agency (EMEA). Clinical trials, involving more than 7,000 adult or elderly participants, evaluated the safety and ability to generate an immune response of this novel intradermal (ID) seasonal influenza vaccine. The ID vaccine generated a superior level of seroprotective immune response against all tested influenza strains, compared with standard intramuscular influenza vaccination, in study participants.