Sanofi Pasteur files for European approval of the flu vaccine

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, has filed a centralised marketing authorisation application in Europe for the first influenza vaccine delivered by an innovative intradermal (ID) microinjection system.

This file has been accepted for review by the European Medicines Agency (EMEA). In clinical trials involving more than 7,000 adult or elderly participants, the ID vaccine generated a superior level of seroprotective immune response against all tested influenza strains, compared with standard intramuscular (IM) influenza vaccination.

Vaccination via the ID route involves the introduction of the vaccine into the dermal layer of the skin. Due to the high concentration of specialised immune cells in this skin layer, and their ability to effectively stimulate an immune response, ID vaccination provides direct and efficient access to the immune system.

Sanofi Pasteur's novel ID influenza vaccine overcomes the technical difficulties that have historically limited the use of this route of administration3 and provides reliable, intradermal influenza immunisation. This has been made possible with the development of a new, easy-to-use, pre-filled microinjection system, developed in collaboration with sanofi pasteur's commercial partner, Becton, Dickinson. The thin needle of the micro-injection system has a length of only 1.5mm, which provides for minimally invasive vaccination and ensures that the antigen is consistently deposited in the dermal layer of the skin.