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FDA Approves Vaccines for 2008-09 Flu Season

Posted by Chrissie Cole
Thursday, August 07, 2008 6:43 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Flu Season, Influenza, Drug Products, CDC, Flu Drugs


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IMAGE SOURCE: © iStockPhoto/ flu vaccine given/Millanovic

U.S. Health officials have approved vaccines for the 2008-2009 flu season, which includes new strains that officials anticipate are most likely to circulate this season.

In what the U.S. Food and Drug Administration refers to as an “unusual occurrence” all three strains of the vaccine have been changed this year. Usually, only one or two strains are changed per year.

Producing new vaccines each year is a tough challenge in the fight against influenza, said Dr. Jesse Goodman, director of the FDA’s Center of Biologics Evaluation and Research. There is no other such instance that requires new vaccines to be made each year.

Officials modify vaccines each year according to strains they predict are most likely to circulate that season. Officials try to match the circulating strains and the strains contained in the vaccines as closely as possible for the best chance of protection from the virus.

To determine the best match, officials from the CDC, FDA and World Health Organization and other various organizations study virus samples and patterns collected worldwide throughout the year. Based on those findings the FDA decides which strains drug manufacturers should include in new vaccines for Americans.

The strains are selected in February of each year to allow drug manufacturers ample production time for the new vaccines.

While the preciseness of the match between the expected stains and those virus strains that actually cause the most sickness may not be precise, the vaccines may still help to provide some measure of protection. Having the vaccine may assist in reducing the severity of the virus and prevent flu-related health complications for thousands of Americans.

The six new vaccines and their manufacturers include: CSL Ltd’s Afluria; MedImmune Vaccines Inc. FluMist; Novartis Vaccines and Diagnostics Limited Fluvirin; Sanofi Pasteur Inc. Fluzone and GlaxoSmithKline Plc’s Fluarix and FluLaval, the FDA said on Tuesday.

Each vaccine includes the same three strains of the influenza virus. Experts included two strains from Type A, an H1N1 and an H3N2 version (the most common virus strain during the 2007-08 season), and one for Type B.

Influenza outbreaks can start as soon as October and last as long as May, according to the Centers for Disease Control and Prevention.

Each year anywhere from 5 to 20 percent of the U.S. population will contract the flu. About 200,000 people develop flu-related complications and are hospitalized every year and about 36,000 people die from the disease, according to the CDC.

For the great majority, the flu is not very serious, and the disease may last only a few days. But for certain immunocompromised populations, such as the elderly and the very young, complications from the flu may prove extremely severe or even deadly. For this reason getting a flu shot is all the more important.

This year’s flu vaccine was largely ineffective because new strains of the influenza virus were not predicted. Two of the three strains escaped the target of the flu shot making it about 44 percent effective and one of the worst years for flu cases and pneumonia among adults.


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