Flu Vaccine Microinjection Fluzone Approved By FDA

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Main Category: Flu / Cold / SARS
Also Included In: Immune System / Vaccines;  Regulatory Affairs / Drug Approvals
Article Date: 11 May 2011 - 10:00 PDT


A new intradermal microinjection delivery system - Fluzone Intradermal (Influenza Virus Vaccine) - has been approved by the Food and Drug Administration (FDA). The flu vaccine is to be used for patients aged 18 to 64 years of age to protect against influenza subtypes A and type B.

An intradermal injection is given into the skin.

The Fluzone Intradermal vaccine has an ultra-fine needle, only 10% of the length of most intramuscular vaccines for flu. It generates an immune response from the dendritic skin cells. Dendritic cells are special types of cells that are key regulators of the immune system.

Olivier Charmeil, President and CEO, Sanofi Pasteur, the makers of the vaccine, said:

"The microinjection delivery system utilized in Fluzone Intradermal vaccine provides reliable and easy delivery of the vaccine into the dermal layer of the skin, an attractive site for immunization. Sanofi Pasteur is proud to bring this innovation in influenza vaccine administration to the U.S., offering health-care providers a new tool that may help enhance adult influenza immunization rates."

According to Sanofi Pasteur, its microinjection intradermal influenza vaccines have been licensed in over 40 nations, including many in Europe, Canada and Australia, under the brand names Intanza® or IDflu® vaccines.

Fluzone Intradermal vaccine has a novel, user-friendly pre-filled microinjection system that consistently deposits vaccine antigens into adults' dermal layer of skin, where a high concentration of dendritic cells exist.

Clinical studies demonstrated that the Fluzone Intradermal vaccine triggered a similar immune response rate to that found intramuscularly-administered Fluzone.

Typical adult vaccines are injected into muscle using a 1 to 1.5 inch needle (25 to 38 mm). The Fluzone Intradermal vaccine needle is ultra fine and 0.06 inches (1.5 mm) long.

The Fluzone vaccine has 15 mcg of hemagglutinin per strain of influenza in a 0.5 mL dose. The Fluzone Intradermal vaccine, in a 0.1 mL dose, contains 9 mcg of hemagglutinin per strain of influenza.

US health care providers will be able to use the Fluzone Intradermal vaccine for the coming influenza season (2011-2012).

Sanofi-Pasteur developed the new vaccine with syringe maker Becton Dickinson.

Sanofi-Pasteur informs that between 5% to 20% of the US population gets flu every year, of which approximately 226,000 have to be admitted to hospital because of complications. It is not easy to predict how severe a looming flu season is going to be.

Between 3,000 to 49,000 thousand people can die in one flu season, depending on the virus' severity. Flu, along with pneumonia is the eighth leading cause of death in the USA.

Written by Christian Nordqvist


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