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FDA Approves 2011-2012 Flu Vaccine


Yesterday, the U.S. Food and Drug Administration announced its approval of the 2011-2012 influenza (flu) vaccine formulation which will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

The 2011-2012 flu vaccine will protect against the three influenza viruses -- an influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus -- research indicates will be most common during the season.

The research is conducted each year by experts from the FDA, World Health Organization, CDC, and others in the public health community who study virus samples and patterns collected worldwide. Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for the 2011-2012 influenza 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.

In the United States, the winter months is the time for peak flu activity. Early flu outbreaks can happen as early as October, though most of the time influenza activity peaks in January or February.

Between 5% and 20% of the U.S. population develops influenza each year, leading to more than 200,000 hospitalizations from related complications, according to the U.S. Centers for Disease Control and Prevention (CDC). Influenza-related deaths vary yearly, ranging from a low of about 3,000 to a high of 49,000 people.

Vaccination remains the cornerstone of preventing influenza. CDC recommends that everyone 6 months and older get their yearly flu vaccine as soon as the 2011-2012 vaccines become available.

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“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 FDA’s 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.”

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; and 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.

In addition to vaccinations, it is important to follow these simple tips to help prevent the spread of the flu:

* Wash your hands often with soap and water.

* Use waterless alcohol-based hand gels (containing at least 60% alcohol) when soap is not available and hands are not visibly dirty.

* Cover your mouth and nose with a tissue when you cough or sneeze. Try to cough or sneeze into your elbow / upper sleeve rather than your hand. If you use a tissue, dispose of it in a wastebasket and then wash your hands.

* Do not go to work or school while ill with H1N1 flu.

Food and Drug Administration

Centers for Disease Control and Prevention