NEW YORK — Sanofi Pasteur is set to roll out a minimally invasive flu shot in Canada and has filed an application for such a vaccination in the United States with the Food and Drug Administration.

The company, the vaccines division of sanofi-aventis Group, said Tuesday that it plans to ship the immunization, called Intanza, this fall in Canada, where it will be available through pharmacies.

Designed for patient comfort, Intanza has a tiny microneedle more than 10 times smaller than regular flu shot needles and pierces only the skin without penetrating the muscle, according to Sanofi Pasteur. The company added that Intanza also is proven to be as effective as the traditional intramuscular flu vaccine in provoking an immune response in the body.

In 2008, less than a third of Canadians age 12 years and older had a seasonal flu shot in the previous year, and according to a recent Canadian survey, up to one in four people experienced anxiety when they were shown the traditional 25mm needle used for intramuscular flu vaccination, Sanofi Pasteur reported. The company said that more than 80% of patients reported no pain or hardly any pain upon injection with Intanza, which has a 1.5mm microneedle. 

"Most Canadians recognize common flu symptoms such as fever, headache, fatigue and aches and pains, but they don’t realize how serious flu from influenza virus can really be," commented Dr. Jay Keystone, director of the Medisys Travel Health and Immunization Clinic in Toronto and professor of medicine at the University of Toronto. "Influenza can cause serious illness, absenteeism from work and, in the most severe cases, even hospitalization or death — that’s why immunization is so important, even for healthy adults. Despite all this, many Canadians are reluctant to get the flu shot because of the pain associated with having an injection in the muscle.

"Canadians need to be educated about the seriousness of influenza, the importance of immunization, and that they have choices beyond the traditional flu shot, such as Intanza," Keystone added. "I’m optimistic that this new option will encourage more Canadians to protect themselves."

On Monday, Sanofi Pasteur announced today that it has filed a Supplemental Biologics License Application (sBLA) with the FDA for a microneedle flu shot called Fluzone Intradermal. The company said that the file has been accepted by the FDA and an action date is expected in the first half of 2011.

"Upon FDA licensure, this new formulation of Sanofi Pasteur’s Fluzone vaccine will be the first vaccine available in the U.S. using a novel microinjection system for intradermal delivery of vaccine," stated Wayne Pisano, president and chief executive officer of Sanofi Pasteur. "We believe that Fluzone Intradermal Vaccine could be an important tool in increasing adult immunization rates due to its ease of use for health-care providers and the high-level of interest expressed by patients for this immunization option."

Sanofi Pasteur said it’s seeking licensure of Fluzone Intradermal in the U.S. for adults age 18 years to 64. The company added that besides in Canada, it already has licensed a microinjection system flu vaccine, marketed as Intanza/ IDflu, in Europe, Australia, New Zealand and other nations.