Pharmaprojects R&D Pipeline News Feed
Intradermal 'flu vaccine receives first approval
09 Mar 2009
Sanofi Pasteur has received European approval for its intradermal influenza vaccine, Intanza, for the prevention of 'flu in adults and elderly patients. The trivalent seasonal vaccine is administered via microinjection into the dermal layer, where it stimulates immune responses against both types A and B influenza.
In a trial in 738 patients, Intanza produced higher seroprotective immune responses compared to the usual intramuscular vaccination. In another Phase II trial in 1000 patients, a 9 µg dose of the vaccine produced comparable efficacy to a 15 µg dose of a standard im vaccine.
The injection system, known as BD Soluvia, consists of a very fine needle, the width of a human hair and only 1.5mm long. This system is particularly advantageous because of the high concentration of immune cells within the dermal layer, which leads to an effective immune response. Studies have also shown the microneedle to be almost imperceptible as it penetrates the skin.
Chief executive of Sanofi Pasteur, Wayne Pisano, commented that the EU approval of Intanza marked "a key step towards recognition of the intradermal route as a promising alternative for influenza vaccine administration". With Intanza set to be available for the 2009-10 'flu season, Sanofi Pasteur now hopes that the ease and convenience of intradermal administration will lead to increased European coverage rate. A US filing is planned for the coming year.
