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Sanofi Pasteur MSD submits new vaccine delivery system to EMEA

A potentially more effective way of administering vaccines could be on the cards if Sanofi Pasteur MSD's first seasonal influenza vaccine delivered by intradermal microinjection is approved by the European Medicines Agency.

A potentially more effective way of administering vaccines could be on the cards if Sanofi Pasteur MSD's first seasonal influenza vaccine delivered by intradermal (ID) microinjection is approved by the European Medicines Agency (EMEA).

Sanofi Pasteur MSD's application for the vaccine is the first in Europe to deliver a vaccine using BD Soluvia, a microinjection system developed by Becton, Dickinson and Company (BD).
The vaccine will be targeted at the elderly.

The EMEA has accepted the filing and has begun its review.

Most vaccines are injected into the muscle, but the BD microneedle allows the vaccine to be delivered within the dermal layer of the skin. 

Clinical trials were carried out with more than 7,000 patients to evaluate the safety and its ability to generate an immune response.

In participants over 60 years the ID vaccine generated a superior level of seroprotective immune response against all tested influenza strains, compared with standard intramuscular (IM) influenza vaccination.

"As a natural consequence of ageing, the immune system of the elderly becomes less able to fight off influenza infection as well as the more serious influenza-related complications.  This underscores the strong rationale for a better-performing vaccine in the elderly," explains Dr Jean-Pierre Michel, professor and chair of rehabilitation and geriatrics at the University of Geneva Medical School in Switzerland.

The dermal layer contains a dense network of lymphatic vessels feeding local lymph nodes, resulting in rapid and efficient access of the vaccine into the immune system.  It also contains a high concentration of potent immune cells that play a key role to initiate the immune response following vaccination. 
If approved, Sanofi Pasteur MSD will market the vaccine within Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the UK. Outside this territory, the vaccine will be marketed by Sanofi Pasteur.

13th February 2008

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