Pharmaprojects R&D Pipeline News Feed
EU filing for Sanofi Pasteur's intradermal 'flu vaccine
22 Feb 2008
Sanofi Pasteur's intradermal seasonal influenza vaccine is now awaiting approval in the EU. The vaccine is delivered via microinjection into the dermal layer of the skin, where the high concentration of immune cells produces a rapid immune response. If approved, it will be the first marketed influenza vaccine to be delivered intradermally.
The filing was based on trials in over 7,000 subjects demonstrating the vaccine's efficacy and safety. Of particular note were results from a Phase II trial in subjects over 60 years old, in which the vaccine showed superior seroprotection rates against strains H1H1, H3N2 and influenza B, compared to intramuscular injection. It also showed comparable efficacy at a lower dose than a standard vaccine.
The primary benefit of the intradermal vaccine is therefore likely to be in enhancing immune responses in elderly patients, who have weaker immune systems and are less responsive to standard vaccination. Furthermore, the simpler and less painful intradermal injection may increase vaccination uptake. Following the acceptance of the EU MAA, Sanofi Pasteur plans to submit a US filing by year end. With the global influenza vaccine market estimated at US$3bn, this new vaccine holds a great deal of potential for Sanofi Pasteur.
