FDA accepts approval application for Fluzone Intradermal

SWIFTWATER, Pa. The Food and Drug Administration has accepted a regulatory approval application for a flu vaccine administered in the skin.

Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis, announced Monday that the FDA had accepted its application for Fluzone Intradermal (influenza virus vaccine). The company expects the FDA to take action on the vaccine in the first half of next year.

Adult vaccinations usually are injected into the muscle via a needle that is 1 in. to 1.5 in., but intradermal vaccinations allow the injection of the vaccine into the dermal layer of the skin with an extremely thin needle that’s 1.5 mm in length.

“Upon FDA licensure, this new formulation of Sanofi Pasteur’s Fluzone will be the first vaccine available in the U.S. using a novel micro-injection system for intradermal delivery of vaccine,” Sanofi Pasteur president and CEO Wayne Pisano said.