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FDA Approves New Fluarix Vaccine for Upcoming Flu
Season
HHS says it is big step toward providing adequate
supply
Aug. 31, 2005 - The Food and Drug Administration
(FDA) today approved Fluarix, an influenza vaccine for adults that
contains inactivated virus. Fluarix is approved to immunize adults 18
years of age and older against influenza virus types A and B contained
in the vaccine. Influenza is also commonly called the flu.
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"FDA"s approval of Fluarix is a big step toward
providing an adequate supply of flu vaccine for the American public,"
said Mike Leavitt, Secretary of Health and Human Services (HHS). "Having
more manufacturers of influenza vaccine licensed in the U.S., and having
more vaccine dosages, is critical to public health and I applaud FDA for
taking such quick action to obtain and evaluate the data needed to
license Fluarix in time for this year"s influenza season."
The approval of Fluarix breaks new ground in that
it is the first vaccine approved using FDA"s accelerated approval
process. Accelerated approval allows products that treat serious or
life-threatening illnesses to be approved based on successfully
achieving an endpoint that is reasonably likely to predict ultimate
clinical benefit, usually one that can be studied more rapidly than
showing protection against disease. In this case, the manufacturer
demonstrated that after vaccination with Fluarix adults made levels of
protective antibodies in the blood that FDA believes are likely to be
effective in preventing flu. GlaxoSmithKline, the manufacturer of
Fluarix, will do further clinical studies as part of the accelerated
approval process to verify the clinical benefit of the vaccine.
"Previous shortages highlighted the need for
additional influenza vaccine manufacturers for the U.S. market," said
FDA Commissioner Lester Crawford. "Accelerated approval has allowed us
to evaluate and approve Fluarix in record time so that we can make
available additional safe and effective flu vaccines. I commend our
Center for Biologics for taking extraordinary steps to help us be better
prepared for both the upcoming and future flu seasons."
This success required close cooperation among the
FDA, the National Institutes of Health, and the product manufacturer,"
said Dr. Jesse Goodman, Director of FDA"s Center for Biologics
Evaluation and Research. "The dedicated staff of this Center is doing
everything possible to prepare for the upcoming flu season."
FDA based the accelerated approval of Fluarix on
thorough evaluation of safety and effectiveness data from four clinical
studies involving approximately 1,200 adults. Other data from
post-marketing reports in other countries where Fluarix is already
approved were also reviewed as part of FDA"s safety assessment.
In the United States it is estimated that more than
200,000 people are hospitalized from flu complications, and about 36,000
people die from flu each year. Although no vaccine is 100% effective
against preventing disease, vaccination is the best protection against
influenza and can prevent many illnesses and deaths.
Fluarix is manufactured in Dresden, Germany by
Sδchsisches Serumwerk (SSW), a subsidiary of GlaxoSmithKline Biologicals,
of Rixensart, Belgium. It will be distributed by GSK in Research
Triangle Park, NC.
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