FDA: 2011-2012 vaccine approved for upcoming flu season Health Consultant

FDA: 2011-2012 vaccine approved for upcoming flu season

The U.S. Food and Drug Administration has announced the approval of the 2011-2012 influenza vaccine formulation. The approved vaccine formula will be used by the six manufacturers licensed and approved to produce and distribute the vaccine for the United States.

Five to 20 percent of the U.S. population contracts the flu each year. More than 200,000 people are hospitalized, and deaths range from 3,000 to 49,000, depending on the specific flu season, indicates the U.S. Centers for Disease Control and Prevention.

“Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States,” said Karen Midthun, M.D., director of the FDAs Center for Biologics Evaluation and Research. “It is important to get vaccinated every year, even if the strains in the vaccine do not change, because the protection received the previous year will diminish over time and may be too low to provide protection into the next year.”

Vaccination protects against the three virus strains deemed to be most common for an upcoming flu season. Each year, experts from the FDA, World Health Organization, CDC, and others in the public health community study virus samples and patterns collected worldwide to identify virus strains likely to cause the most illness during the upcoming influenza season. Based on that information and the recommendations of the FDAs Vaccines and Related Biological Products Advisory Committee, the strains selected for the upcoming season are:

A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
A/Perth /16/2009 (H3N2)-like virus
B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

The brand names and manufacturers of the vaccines for the upcoming season are:

Afluria, CSL Limited
Fluarix, GlaxoSmithKline Biologicals
FluLaval, ID Biomedical Corporation
FluMist, MedImmune Vaccines Inc.
Fluvirin, Novartis Vaccines and Diagnostics Limited
Fluzone, Fluzone High-Dose and Fluzone Intradermal, Sanofi Pasteur Inc.

Fluzone Intradermal, approved on May 9, 2011, will be available for those ages 18 years through 64 years. This vaccine is delivered into the skin, rather than the muscle, using a very small needle.

The CDCs Advisory Committee on Immunization Practices (ACIP) recommends that everyone 6 months of age and older receive an annual influenza vaccination. Additional information on the ACIP recommendations can be found at: .

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