The FDA has approved the first flu shot injected with a tiny needle into skin cells rather than muscle.
Sanofi Pasteur said Tuesday that the Food and Drug Administration approved the company's Fluzone Intradermal vaccine for adults 18 through 64 years old. It will be available for the 2011-12 influenza season.
Flu shots generally are injected deep into muscle with a needle 1 inch to 1.5 inches long, a sight that distresses many patients.
Sanofi Pasteur's new product has a needle less than a tenth of an inch long, attached to a pre-filled syringe that holds a smaller amount of influenza vaccine than the company' standard flu shots. That's because the dermis, the skin layer just under the surface, has a high concentration of the dendritic cells that are key to generating an immune response.
The company, based in Swiftwater, Pa., said patients have said they prefer the shorter, slimmer needles of the Fluzone Intradermal vaccine, but there's no data yet on whether they are less painful than bigger needles. Reactions around the injection site, including redness, swelling and itching, were more common with the new vaccine than with an intramuscular vaccine, company research found.
The product is already marketed in Europe, Australia and Canada by Sanofi Pasteur, the vaccine division of French drug giant Sanofi, previously known as Sanofi-Aventis SA.
Olivier Charmeil, CEO of Sanofi Pasteur, said the product may help increase adult influenza immunization rates here.
Flu shots are now recommended for most Americans, but many adults don't get them. Complications from the flu kill tens of thousands of Americans in a typical year.